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  • Electronic Resource  (156)
  • 2000-2004  (156)
  • chemotherapy  (81)
  • Quality of life  (75)
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  • Electronic Resource  (156)
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  • 1
    ISSN: 1433-0385
    Keywords: Keywords: Inguinal hernia ; Plug-and-patch repair ; Results ; Quality of life ; Geriatric ; Elderly. ; Schlüsselwörter: Leistenhernie ; Plug-und-Patch-Reparation ; Ergebnisse ; Lebensqualität ; geriatrisch ; älter.
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Zusammenfassung. Im Rahmen einer prospektiven Beobachtungsstudie wurden die perioperativen Ergebnisse der Plug-und-Patch-Reparation bei Patienten ≥ 65 Jahre untersucht und zusätzlich bei 34 konsekutiven Patienten die Lebensqualität vor und 3 Monate postoperativ standardisisiert mit Hilfe der Short Form (SF) 36 – einem validierten Lebensqualitätsbogen – erhoben. Von August 1994 bis Februar 1999 wurden 147 Patienten mit einem Durchschnittsalter von 73 ± 5 Jahren (65–92 Jahre) in der Plug-und-Patch-Technik zumeist in Lokalanaesthesie (LA: n = 124; 84 %, ITN: n = 23; 16 %) operiert. Die präoperativen Risikofaktoren waren vor allem Alkoholkonsum, Hypertonus, Diabetes mellitus, coronare Herzerkrankung, Nikotinkonsum, cerebrale Erkrankungen, Hyperlipidämie und pulmonale Erkrankungen. Nach anaesthesiologischer Einschätzung bestand in der Mehrzahl ein Stadium ASA II (ASA I: n = 14; 9 %, ASA II: n = 82; 56 %, ASA III: n = 51; 35 %). Die durchschnittliche Operationszeit betrug 41 ± 17 Min. (26–73). Intraoperative Komplikationen traten nicht auf, postoperative Komplikationen bestanden vor allem in oberflächlichen Wundhämatomen (n = 6; 3,7 %), und -infektionen (n = 1; 0,6 %), Seromen (n = 7; 3,8 %), Harnverhalt (n = 3; 1,8 %) sowie ilioinguinalem Schmerzsyndrom (n = 3; 1,8 %). Der postoperative Schmerzmittelbedarf betrug 4,9 ± 1,8 g Novalgin®über durchschnittlich 4 ± 3 Tage. Die Dauer des postoperativen Klinikaufenthaltes lag bei 2 ± 1 Tagen, die Einschränkung alltäglicher Verrichtungen bei 6 ± 3 Tagen. Bei der klinischen Nachuntersuchung ergab sich in allen Fällen ein regelrechter Befund ohne Hinweis auf ein Rezidiv oder Spätkomplikationen. Bei der Lebensqualität zeigte sich 3 Monate postoperativ eine signifikante Verbesserung (p 〈 0,05) in den Dimensionen: physische Funktion, Schmerz, Vitalität und soziale Funktion im Vergleich zu den präoperativen Werten. Tendentiell günstiger aber nicht signifikant waren postoperativ die Dimensionen Rolleneinschränkung sowie psychische und globale Gesundheit.
    Notes: Abstract. In a prospective study the perioperative results of plug-and-patch repair were investigated in patients ≥ 65 years, and quality of life was assessed using the SF36 preoperatively and 3 months after the procedure in 34 consecutive patients. From August 1994 to February 1999 147 patients with a mean age of 73 ± 5 years (65–92 years) were operated on using the plug-and-patch technique, mostly under local anesthesia (LA: n = 124, 84 %, ITN: n = 23, 16 %). Preoperative risk factors were alcohol consumption, hypertonus, diabetes mellitus, ischemic heart disease, smoking, cerebrovascular disease, hyperlipidaemia and pulmonary disease. Most of the patients were ASA II (ASA I: n = 14, 9 %, ASA II: n = 82, 56 %, ASA III: n = 51, 35 %). No intraoperative complications occurred, postoperative complications consisted of superficial wound hematoma (n = 6, 3.7 %) and infection (n = 1, 0.6 %), seroma (n = 7, 3.8 %), urinary retention (n = 3, 1.8 %) and ilioguinal pain syndrome (n = 3, 3.8 %). The total amount of postoperative analgesic consumption was 4.9 ± 1.8 g Novalgin for about 4 ± 3 days. The duration of postoperative hospitalization was 2 ± 1 days and limitation of daily activities 6 ± 3 days. Clinical examinations after 3 months revealed no recurrence or late complications. Investigation of quality of life showed a significant improvement in the SF36 domains of physical activity, pain, vitality, and social functioning after the operation. No significant change was observed for physical, emotional, and global health.
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  • 2
    Electronic Resource
    Electronic Resource
    Springer
    Der Urologe 39 (2000), S. 527-529 
    ISSN: 1433-0563
    Keywords: Schlüsselwörter Interstitielle Zystitis ; Epidemiologie ; Inzidenz ; Prävalenz ; Lebensqualität ; Keywords Interstitial cystitis ; Epidemiology ; Incidence ; Prevalence ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Abstract Available data on the epidemiology of interstitial cystitis (IC) are heterogeneous. Its prevalence ranges between 16 and 510 females/100,000 inhabitants and the incidence at 1.2–2.6/100,000 females with a mean age of 42–52 years. The disease tends to affect women (female:male ratio 9–10:1) and Caucasians (〉90%). The quality of life of patients suffering from IC is reduced to a significant degree in almost every aspect (work, social events, leisure activities). Financial expenses (medical as well as economical) associated with the disease are considerable. There is an enormous need to promote IC education and research in order to support affected patients effectively in the future.
    Notes: Zusammenfassung Die vorliegenden Daten zur Epidemiologie der interstitiellen Zystitis sind sehr heterogen. Die Prävalenz beträgt 16–510 Frauen/100.000 Einwohner, die Inzidenz liegt zwischen 1,2–2,6 /100.000 Frauen mit einem mittleren Alter bei Diagnosestellung von 42–52 Jahren. Die Geschlechterverteilung bevorzugt das weibliche im Verhältnis zum männlichen Geschlecht (9–10 Frauen/1 Mann) mit einer ethnischen Bevorzugung der Kaukasier (〉90%). Die Lebensqualität der betroffenen Patienten ist in fast allen Lebensbereichen (Arbeit, Soziales, Freizeit) signifikant eingeschränkt. Die Kosten (sowohl medizinisch als auch volkswirtschaftlich) sind erheblich. Es besteht ein enormer Weiterbildungs- und Forschungsbedarf, um durch einen besseren Kenntnisstand den Patient(inn)en mit IC wirkungsvoll helfen zu können.
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  • 3
    ISSN: 1434-3932
    Keywords: Schlüsselwörter  Bauchaortenaneurysma ; Lebensqualität ; Endovaskuläre Therapie ; Keywords  Aortic aneurysm ; Quality of life ; Endovascular ; Conventional therapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Abstract   Patient satisfaction plays an increasing part in the analysis of the outcome of medical treatment. The aim of the study was to compare health-related quality of life in patients with abdominal aortic aneurysm after endovascular or conventional surgery. A total of 40 patients were included (20 treated by endovascular and 20 by conventional surgery). A questionnaire with 28 items similar to the SF-36 was answered during scheduled appointments. On the third postoperative day, the conventionally treated patients were more frequently confined to bed (80% vs. 32%) and complained of intervention-related pain (90% vs. 42%) and incisional pain (26% vs. 15%); 55% of the patients suffered from obstipation (vs. 5% of the endovascular group). Furthermore, the preoperative psychological stress seemed to be intensified. In comparable percentage, both the endovascular and conventionally treated patients were limited in social activities perioperatively. Sexual dysfunction was more frequent in the conventional group (33% vs. 13% three months postoperative). In addition, the conventionally treated patients were more limited in their physical activities (25% vs. 40%) and had more fear of ambulation (35% vs. 6%). The patients treated by an endovascular approach complained about frequent examinations (39% vs. 5%) that were often related to X-ray exposure (67% vs. 20%). All of the conventionally operated patients had a sense of improvement (vs. 89% of the endovascular group); nevertheless only 28% felt completely healthy, compared to 11% of the endovascular treated patients. Advantages of the endovascular treated patients were ”short hospital stay”, ”decreased pain”, ”smaller scars”, and a ”shorter confinement to bed”. After intervention the conventionally treated patients were more limited in almost all quality-of-life aspects. After 3 months, differences between the groups decreased except for sexual dysfunction and limited physical activities. The patients treated by endovascular surgery complained more about frequent X-ray examinations than the conventionally treated group.
    Notes: Zusammenfassung  Zur Bewertung eines Therapieerfolgs gewinnt der subjektive Aspekt der Patientenzufriedenheit zunehmend an Bedeutung. Ziel unserer Untersuchung war es, die medizinischen Aspekte der Lebensqualität vor, während und nach Behandlung eines infrarenalen Bauchaortenaneurysmas durch konventionelle oder endovaskuläre Operation zu vergleichen. Insgesamt 40 Patienten, 20 Patienten nach konventioneller und 20 Patienten nach endovaskulärer Bauchaortenaneurysmaausschaltung, die in unserer Klinik in dem Zeitraum 01.06.1997 bis 31.12.1998 operiert worden waren, erhielten einen in Anlehnung an den SF-36-Survey-Fragebogen entwickelten Fragenkatalog mit 28 Fragen über die perioperative Lebensqualität. Am 3. postoperativen Tag waren deutlich mehr konventionell operierte Patienten bettlägerig (80 vs. 32%), gaben stärkere Schmerzen (90 vs. 42%) sowie Narbenbeschwerden (26 vs. 15%) an und litten unter Verdauungsproblemen (55 vs. 5%). Sie waren außerdem vor der Operation durch den Eingriff psychisch belasteter als die Vergleichsgruppe. Die Patienten beider Gruppen fühlten sich perioperativ in einem vergleichbaren Prozentsatz in der Ausübung gesellschaftlicher Aktivitäten beeinträchtigt. In der konventionell operierten Patientengruppe waren postoperative Sexualfunktionsstörungen signifikant häufiger als bei den endovaskulären Patienten (33 vs. 13% 3 Monate postoperativ). Im postoperativen Intervall von 3 Monaten waren die konventionellen Patienten physisch weniger belastbar (25 vs. 40%) und hatten stärkere Angst, sich frei zu bewegen (35 vs. 6%); 39% der endovaskulären Patienten empfanden die postoperativen Kontrolluntersuchungen als belastend, 67% empfanden die Strahlenbelastung bei den Kontrollen als negativ (konventionell 5 bzw. 20%). Alle konventionell operierten Patienten hatten das Gefühl, dass das Bauchaortenaneurysma ausgeschaltet sei (endovaskulär 89%). Vollkommen gesund fühlten sich 3 Monate postoperativ lediglich 28% der konventionell operierten Patienten bzw. 11% der endovaskulären Patienten. Als größte Vorteile der endovaskulären Methode wurden ”kurzer Krankenhausaufenthalt”, ”wenig Schmerzen”, ”kleine Narbe” und ”kurze Bettlägerigkeit” genannt. Die konventionell therapierten Patienten sind in ihrer Lebensqualität perioperativ deutlich mehr beeinträchtigt als die endovaskulär behandelten. Nach 3 Monaten finden sich jedoch bis auf den Bereich der Sexualfunktionsstörungen, der physischen Belastbarkeit und der Bewegungsfreiheit keine signifikanten Unterschiede in beiden Kollektiven. Durch die regelmäßigen Nachuntersuchungen mit Strahlenexposition fühlen sich die endovaskulär behandelten Patienten stark belastet.
    Type of Medium: Electronic Resource
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  • 4
    Electronic Resource
    Electronic Resource
    Springer
    European journal of pediatrics 159 (2000), S. 268-272 
    ISSN: 1432-1076
    Keywords: Key words Glycogen storage disease type 1b ; Portacaval shunt ; Ferrit MRI of liver adenoma ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  In two girls with glycogen storage disease (GSD) type 1b, terminolateral portacaval shunt (PCS) with partial circular resection of the lobus quadratus of the liver was performed at the age of 12 and 10 years, respectively. At that time, the patients had a height of −3.1 and −1.7 SDS, respectively. PCS resulted in a spectacular growth spurt of 35 cm within the first 5 years after surgery in both of them. As first sign of puberty, breast enlargement started 2.5 years after PCS in both patients. Improved glucose tolerance was evidenced by increased levels of blood glucose and insulin after PCS. Diet with raw cornstarch (CS), 2g/kg body weight four times daily, was started 8 years after PCS in patient 1, but initiated with nightly gastric feeding at the age of 2 years in patient 2, 8 years before PCS. Treatment with recombinant granulocyte colony-stimulating factor (rhGCSF), 6 μg/kg body weight every 36–48 h, was started 20 years after PCS in patient 1, but only 1 month before PCS in patient 2. Progressive development of up to 7–8 liver adenomas was observed after PCS, but without conclusive signs of malignancy on Ferrit MRI. The PCS is still open 23 and 7 years after PCS, respectively. Terminolateral PCS with partial circular resection of the lobus quadratus of the liver associated with dietary control and rhGCSF might still have a place in the treatment of GSD type 1b because it improves the tolerance to fasting and the quality of life and moreover yields excellent metabolic control. Conclusion Treatment of glycogen storage disease type 1b by portacaval shunt might be considered in patients with height-for-age below the 3rd percentile occurring in spite of dietary control, or before considering liver transplantation which, if necessary, can still be performed after shunt surgery.
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  • 5
    Electronic Resource
    Electronic Resource
    Springer
    Archives of gynecology and obstetrics 264 (2000), S. 51-53 
    ISSN: 1432-0711
    Keywords: Key words Self-expanding metallic endovascular stents ; Endometrial cancer ; Iliac vein thrombosis ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  There are few cases, to our knowledge, that report the successful treatment of iliac venous stenosis due to gynecologic malignancies with the use of self- expanding metallic endovascular stents. Our patient, who had right lower limb edema, had iliac lymph node metastases which caused iliac vein stenosis by direct invasion from endometrial cancer. The patient was not considered to be a good surgical candidate. A 10-mm diameter self-expanding metallic endovascular stent was placed in the external iliac vein. The patient’s symptoms of right lower limb edema improved dramatically, and she was discharged at 3 weeks after stent placement. The patient had no further symptoms, with continued resolution of the right leg edema during the 10 months following stent placement, at which time she died from the primary disease. The treatment to this patient with a self-expanding metallic endovascular stent proved to be very efficacious and less stressful than direct venous reconstruction or femorofemoral venous bypass grafting. In addition, this procedure dramatically improved the patient’s quality of life.
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  • 6
    ISSN: 1569-8041
    Keywords: BEACOPP ; chemotherapy ; dose intensification ; hematotoxicity ; Hodgkin's disease ; practicability
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Evidence is recently accumulating that the novelBEACOPP (bleomycin (B), etoposide (E), adriamycin (A), cyclophosphamide (C),vincristine (O), procarbazine (P), prednisone (P)) chemotherapy is a highlyeffective treatment for advanced stage Hodgkin's disease. Two dose variantsof BEACOPP are currently tested in a phase III randomized multicenter trialof the GHSG. To enable more extensive testing of BEACOPP we characterized itspracticability regarding schedule adherence, acute hematotoxicity and need forsupportive treatment. Patients and methods:Data of 858 patients (6592 therapy cycles)from 184 participating institutions were evaluated. Planned total drug dosesof the baseline variant (arm 1) were 80, 2400, 200, 5200, 11.2, 5600 and 4480mg/m2 for B, E, A, C, O, P and P, respectively. Compared to arm 1,the doses of E, A and C in the dose-intensified variant (arm 2) were escalatedby factor 2.0, 1.4, 1.92, respectively, using G-CSF assistance. Stepwise dosereductions were specified in case of dose-limiting toxicities. Both variantsare given in eight three-weekly courses. Results:Median dose adherence (dose actually given relative toplanned arm 1 dose) in arm 1 was 1.0 for all drugs. Relative dose escalationof E, A, and C actually maintained in arm 2 was 1.83, 1.37 and 1.77 (medians),respectively, and 70% of patients maintained elevated dose levelsthroughout the entire treatment. Dose-limiting toxicities occurred in25% of cycles in arm 2, most frequently due to leukocytopenia andthrombocytopenia. Time courses of leukocytes in arm 2 showed more severe butnot more prolonged leukocytopenia compared with arm 1. WHO grades 3–4infections were documented in 2.1% (arm 1) and 3.1% (arm 2) ofall cycles. Erythrocytes were transfused in 6% (arm 1) and 28%(arm 2), platelets in 〈1% (arm 1) and 6% (arm 2) of allcycles. Conclusions:Both BEACOPP schemes are practicable in a largemulticenter setting. Despite increased hematotoxicity, moderate doseescalation is safe for the majority of the patients with G-CSF assistance andstandard supportive treatment.
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  • 7
    ISSN: 1569-8041
    Keywords: chemotherapy ; 5-FU ; folinic acid ; gemcitabine ; Gemzar® ; pancreas cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Gemcitabine (Gemzar®) and 5-fluorouracil (5-FU)plus folinic acid (FA) both have proven activity in the treatment of patientswith advanced pancreatic cancer. The present study was initiated toinvestigate the efficacy of gemcitabine in combination with 5-FU–FA. Patients and methods:Thirty-eight patients, median age 60 years(range 34–70) with inoperable, stage IV, pancreatic cancer were enrolledinto the study and treated on an outpatient basis. All except one patientreceived at least one cycle of treatment with gemcitabine (1000mg/m2), followed by FA (200 mg/m2) and 5-FU (750mg/m2) administered as a 24-hour continuous infusion on days 1, 8,15 and 22 of a 42-day schedule. No patient had received prior chemotherapy orradiotherapy. All 38 patients were assessed for efficacy, toxicity and timeto progressive disease. Results:Two patients (5%), achieved a partial response andthirty-four patients (89%) achieved stable disease. There were twoearly deaths (≤4 weeks). The median time to progression was 7.1 months(range 0.4–18.1+; 95% confidence interval (95% CI):5.3–7.9 months). Three patients had a progression-free interval ofgreater than 12 months and 12 of 38 patients (32%) survived longer than12 months. The median overall survival was 9.3 months (range 0.5–26.5;95% CI: 7.3–13.0 months). The incidence of grade 3 and 4toxicities was low. Conclusions:The combination of gemcitabine and 5-FU–FA isactive and well tolerated and seems to offer an improvement inprogression-free interval over both gemcitabine monotherapy and 5-FU–FAtherapy.
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  • 8
    Electronic Resource
    Electronic Resource
    Springer
    Annals of oncology 11 (2000), S. 217-220 
    ISSN: 1569-8041
    Keywords: chemotherapy ; Guillain–Barré syndrome ; lymphoma ; polyneuropathy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract We describe a case of Guillain–Barré syndrome (GBS) in apatient with non-Hodgkin's lymphoma (NHL). A 21-year-old woman with a newlydiagnosed stage IV high-grade lymphoma (precursor T-cell NHL according to theR.E.A.L. Classification) developed flaccid quadriparesis and bilateral facialdiplegia after three weeks of treatment with vincristine, daunorubicin,L-asparaginase and prednisolone. The clinical course and neurologicalexamination were consistent with GBS. Despite treatment with intravenousimmunoglobulins her neurological symptoms progressed. Plasmapheresis wastherefore initiated followed by intravenous immunoglobulins. After partialremission of neurologic symptoms, induction chemotherapy with cyclophosphamideand cytarabine was continued without any further complication. Three monthslater, the lymphoma was in complete remission. GBS has been described inHodgkin's disease and after bone marrow transplantation but is rare in NHL.In patients with NHL who develop neurological symptoms, drug toxicity andnervous system infiltration are the leading cause of neuropathology, but GBSshould be considered in the differential diagnosis.
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  • 9
    ISSN: 1569-8041
    Keywords: brain tumor ; chemotherapy ; encephalopathy ; late neurological toxicity ; leucoencephalopathy ; primary cerebral lymphoma ; radiochemotherapy ; systematic follow-up
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Primary cerebral non-Hodgkin's lymphomas (NHL) inimmunocompetent patients (PCL) are located exclusively in the central nervoussystem, the eye, or meninges. Clinical management of these patients remainscontroversial. Patients and methods:Clinical characteristics of the patients andparameters influencing their outcome as of December 1998 were investigated andregistered in a database of 226 patients treated in the French Federation ofCancer Centers between 1980 and 1995. Results:Most PCL are diffuse large-cell NHL with a B phenotype.The incidence of PCL has been steadily increasing over the past 20 years insome but not all countries. The overall survival of primary cerebral lymphoma(PCL) patients in the published series, a median of 12–16 months and afive-year survival of 5%–20%, is poor. Several series havenow reported long-term survivals of more than 10 years and PCL may thereforebe a curable tumor in some patients. The optimal treatment of PCL is notknown. Complete resection of the tumor does not improve outcome andmultidisciplinary approaches combining chemotherapy and radiotherapy are nowcommonly used, although the superiority of combination over radiotherapy- orchemotherapy-alone has never been demonstrated in a phase III trial. Theoptimal chemotherapy regimen, the dose and even the usefulness of brainradiotherapy after chemotherapy are therefore still matters of debate.Recently, several authors have reported a relatively high incidence of lateneurological sequelae after PCL treatment. Conclusions:The optimal treatment of PCL patients remains to bedefined. Large cooperative international phase III trials are now required todefine and improve the optimal treatment of PCL and reduce its sequelae.
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  • 10
    Electronic Resource
    Electronic Resource
    Springer
    Diseases of the colon & rectum 43 (2000), S. 1206-1212 
    ISSN: 1530-0358
    Keywords: Fistula-in-ano ; Recurrence ; Incontinence ; Quality of life ; Lifestyle ; Satisfaction
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract PURPOSE: The surgical treatment of fistula-in-ano frequently results in recurrence of the fistula or postoperative anal incontinence. Despite these problems, most patients are satisfied with the results of their surgery. To clarify this apparent discrepancy, we attempted to identify factors that affect patient's lifestyles and may contribute to their satisfaction. METHODS: A questionnaire was mailed to 624 patients surgically treated for cryptoglandular fistula-in-ano at the University of Minnesota during a five-year period. Three hundred seventy-five patients returned their questionnaires. Patients who were followed up for a minimum of one year were included in this retrospective study. Associations between postoperative complications and patient satisfaction were identified by chi-squared tests and multiple logistic regression. Attributable fractions for patient dissatisfaction were calculated using study population dissatisfaction rates. RESULTS: Patient satisfaction was strongly associated with fistula recurrence, difficulty holding gas, soiling of undergarment, and accidental bowel movements. Effects of incontinence on patient quality of life were also significantly associated with patient satisfaction as was the number of lifestyle activities affected by incontinence. Patients with fistula recurrence reported a higher dissatisfaction rate (61 percent) than did patients with anal incontinence (24 percent), but the attributable fraction of dissatisfaction for incontinence (84 percent) was greater than that for fistula recurrence (33 percent). Patient satisfaction was not significantly associated with age, gender, history of previous fistula surgery, type of fistula, surgical procedure, time since surgery, or operating surgeon. CONCLUSION: Patient satisfaction after surgical treatment for fistula-in-ano is associated with recurrence of the fistula, the development of anal incontinence, and with the effects of anal incontinence on patient lifestyle. In our series of patients treated mainly with laying open of the fistula tract, patients with fistula recurrence had a higher dissatisfaction rate than did patients with anal incontinence. However, because anal incontinence was more prevalent than fistula recurrence, a higher fraction of dissatisfaction was attributable to anal incontinence.
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  • 11
    ISSN: 1534-4681
    Keywords: Breast cancer ; Quality of life ; Mental health ; Surgery
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: The aim of the present study was to examine whether type of surgery, age, and time since surgery influenced psychological distress and quality of life (QOL) in women treated for breast cancer. Methods: We surveyed 183 women who had undergone surgery for breast cancer. Psychological distress was measured with the Mental Health Inventory and QOL was measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Results: After controlling for stage of disease, radiation treatment, and age, there was a statistically significant interaction between type of surgery and time since surgery for the Mental Health Inventory total score, and a marginal interaction between type of surgery and time since surgery for the Global health status/QOL score. Women who had breast conservation surgery experienced significantly greater levels of psychological distress and marginally worse QOL from 40 months after surgery onward than did women who received a mastectomy. Conclusions: The effects of different surgical treatments for breast cancer on psychological distress and QOL become apparent only after a period of several years. Women, therefore, need counseling on the potentially positive and negative psychological implications of different surgical treatments for breast cancer.
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  • 12
    ISSN: 1530-0358
    Keywords: Fecal incontinence ; Quality of life ; Health surveys ; Reproducibility of results ; Outcome assessment (health care)
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract PURPOSE: This goal of this research was to develop and evaluate the psychometrics of a health-related quality of life scale developed to address issues related specifically to fecal incontinence, the Fecal Incontinence Quality of Life Scale. METHODS: The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items). RESULTS: Psychometric evaluation of these scales demonstrates that they are both reliable and valid. Each of the scales demonstrate stability over time (test/retest reliability) and have acceptable internal reliability (Cronbach alpha 〉0.70). Validity was assessed using discriminate and convergent techniques. Each of the four scales of the Fecal Incontinence Quality of Life Scale was capable of discriminating between patients with fecal incontinence and patients with other gastrointestinal problems. To evaluate convergent validity, the correlation of the scales in the Fecal Incontinence Quality of Life Scale with selected subscales in the SF-36 was analyzed. The scales in the Fecal Incontinence Quality of Life Scale demonstrated significant correlations with the subscales in the SF-36. CONCLUSIONS: The psychometric evaluation of the Fecal Incontinence Quality of Life Scale showed that this fecal incontinence-specific quality of life measure produces both reliable and valid measurement.
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  • 13
    Electronic Resource
    Electronic Resource
    Springer
    Diseases of the colon & rectum 43 (2000), S. 1497-1502 
    ISSN: 1530-0358
    Keywords: Ulcerative colitis ; Quality of life ; Pelvic pouch ; Dysplasia ; Cancer ; Colitis-associated neoplasia
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract PURPOSE: Despite high patient satisfaction with a pelvic pouch, patients experience some bowel dysfunction. Patients whose indication for surgery is neoplasia may have near-normal preoperative bowel function. We hypothesized that these patients would be less accepting of a poorer functional status after surgery, reflected in a poorer measure of quality of life. METHOD: Sixteen patients who had dysplasia or cancer as the primary indication for surgery were compared with a matched control group whose indication for surgery was failed medical therapy. Quality of life was assessed using one disease-specific instrument, the Inflammatory Bowel Disease Questionnaire, two generic quality-of-life instruments, the Sickness Impact Profile and the Short Form 36, and two utility assessments. RESULTS: The groups were well matched with no significant differences in functional outcome. Quality-of-life scores were high in both groups and there were no significant differences in overall quality of life between the two groups using all five instruments. There was evidence of a response shift phenomenon in the failed medical therapy control group. CONCLUSION: Quality of life of patients who have a pelvic pouch for colitis-associated neoplasia is excellent and the same as that of patients who have a pouch for failure of medical therapy.
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  • 14
    Electronic Resource
    Electronic Resource
    Springer
    Diseases of the colon & rectum 43 (2000), S. 326-332 
    ISSN: 1530-0358
    Keywords: Laparoscopic surgery ; Aged ; Colorectal surgery ; Morbidity ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract PURPOSE: The aim of this study was to determine rates of complications and extent of benefits for laparoscopic-assisted colectomy compared with open colectomy in patients older than age 75. METHODS: Forty-two patients undergoing laparoscopic-assisted colectomy (1992–1998) were matched to 42 open colectomy patients for gender, age, year of surgery, operating surgeon, and procedure. Health status (American Society of Anesthesiology score), previous abdominal surgery, conversion rate, surgical outcome, and need for assistance at admission and dismissal (independencevs. home with assistancevs. nursing facilities) were reviewed. RESULTS: Mean ages were 81.2 and 80.5 years for laparoscopic-assisted colectomy and open colectomy, respectively (P=not significant). Twenty-one laparoscopic-assisted colectomy and 23 open colectomy patients were females. American Society of Anesthesiology scores were comparable, as were rates of previous abdominal surgery (57 percent for laparoscopic-assisted colectomyvs. 62 percent for open colectomy;P=not significant). Mean operative times were longer for laparoscopic-assisted colectomy (190 minutes for laparoscopic-assisted colectomyvs. 142 minutes for open colectomy;P〈0.001); operating room times progressively decreased from 221 minutes in 1992 to 1995 to 147 in 1998 for laparoscopic right hemicolectomy (P〈0.001). The conversion rate for laparoscopic-assisted colectomy was 14.3 percent. There were no deaths in either group, and laparoscopic-assisted colectomy was associated with fewer morbidities (14.3 percent for laparoscopic-assisted colectomyvs. 33.3 percent for open colectomy;P=0.04), narcotic usage (2.7vs. 4.8 days;P〈0.001), time to return to bowel movements (3.9vs. 5.9 days;P〈0.001), and length of hospital stay (6.5vs. 10.2 days;P〈0.001). Independent status at admission in 37 laparoscopic-assisted colectomy and 38 open colectomy patients was maintained at discharge by 35 laparoscopic-assisted colectomyvs. 29 open colectomy patients (P=0.025). CONCLUSIONS: Laparoscopic-assisted colectomy is safe and beneficial, including preservation of postoperative independence, to the elderly when compared with open colectomy.
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  • 15
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    Ethik in der Medizin 12 (2000), S. 139-153 
    ISSN: 1437-1618
    Keywords: Key words: Motion pictures ; Medical ethics ; Physician-patient relationship ; Truth disclosure ; Informed consent ; Third-party consent ; Quality of life ; Euthanasia ; Terminally ill ; Schlüsselwörter: Film ; Medizinethik ; Arzt-Patient Beziehung ; Aufklärung ; Wahrheit sagen ; informed consent ; Lebensqualität ; Sterbehilfe ; Heilversuche
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine , Philosophy
    Description / Table of Contents: Zusammenfassung. Filme erzählen Geschichten. Spannungsvoll sind dabei vor allem jene Szenen, in denen Menschen vor Entscheidungskonflikte gestellt werden. Medizinethische Konflikte tauchen dabei nicht nur in Arztserien oder Krankheitsdarstellungen auf, sondern häufig in Genres, in denen diese Thematik kaum vermutet wird: Komödien, Western, Liebesfilmen, Gangster- und Kriminalfilmen. Indem Filme derartige Konflikte inszenieren und Lösungen bieten, greifen sie auf moralische Werthaltungen zurück und sind zugleich Seismographen für die gesellschaftliche Relevanz medizinethischer Themenfelder. Allerdings können im Film ethische Prinzipien der Entscheidungsfindung der Dramaturgie der Handlung zum Opfer fallen. Eine Analyse der dargestellten Konfliktsituationen ähnelt einer medizinethischen Fallbesprechung und stellt eine hilfreiche Ergänzung für die Vermittlung analytischer und kommunikativer Kompetenzen dar.
    Notes: Abstract. Movies tell stories. Thrilling are especially those situations, when people have to make ethical decisions. Issues of medical ethics crop up not only in hospital series, but often in genres where this subject is hardly to be supposed: comedies, westerns, love stories and gangster movies. Enacting these conflicts means offering a solution, and in doing so films refer to moral values and – at the same time – function as seismographs for the social relevance of bioethical topics. But it is possible that ethical principles of good decision-making fall victims to the drama of the story. Analysis of the portrayed conflict is similar to a case discussion in bioethics and represents a helpful adjunct to the procurement of analytical and communicative competences.
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  • 16
    ISSN: 1530-0358
    Keywords: Recurrent rectal cancer ; Cost-effectiveness analysis ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract PURPOSE: This study was performed to determine the quality of life and cost-effectiveness of therapeutic options for patients with locally recurrent rectal carcinoma, determined from the perspectives of patients and health care providers. METHODS: We reviewed the records of patients (N=68) with locally recurrent rectal carcinoma evaluated from 1992 through 1995. We constructed a decision-analytic model incorporating outcomes, survival, and costs. Utilities were elicited from convenience samples of health care providers and patients using the standard gamble technique. RESULTS: The median survival for patients undergoing surgical resection (n=40) was 42 months, compared with 16.8 months for patients undergoing diagnostic or palliative surgery (n=16) and 18.3 months for patients treated nonoperatively (n=12;P〈0.005). The mean cost of treatment per patient was $19,283 for the nonoperative group, $45,647 for the diagnostic or palliative surgery group, and $70,878 for the surgical resection group. The diagnostic or palliative surgical strategy was dominated by the nonoperative strategy because the former had greater costs with fewer health benefits. The incremental cost-utility ratio of surgical resection compared with nonoperative management using health care provider utilities was $109,777 per quality-adjusted life year gained; it was reduced to $56,698 using per quality-adjusted life year using mean patient utilities. CONCLUSIONS: Patients with recurrent rectal carcinoma view surgery and morbidity to be less severe than health care providers. Diagnostic or palliative surgery is expensive and affects quality-adjusted survival adversely compared with nonoperative therapy. Surgical resection may be a cost-effective use of resources, particularly when cost-effectiveness is calculated using patient preferences.
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  • 17
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    Diseases of the colon & rectum 43 (2000), S. 650-655 
    ISSN: 1530-0358
    Keywords: Loop ileostomy ; Loop colostomy ; Quality of life ; Stoma complications
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract PURPOSE: The hypothesis is that the impact of a temporary stoma on a patient's daily life is determined by complications and related stoma care problems. METHOD: A prospective clinical trial was performed, studying complications and social well-being of 37 patients with loop ileostomy and 39 patients with a loop colostomy (randomly assigned comparison). Patients were categorized according to degree of social restriction. The association between the degree of social restriction and the presence of stoma care problems and complications was assessed. Follow-up was scheduled every three months until the stoma was closed (94 percent). RESULTS: There is no relation between stoma type (ileostomy or colostomy) and degree of social restriction (chi-squared test,P=0.42). The more stoma care problems or complications seen, the higher the degree of social restriction: significantly more stoma care problems were seen in the completely isolated group of patients when compared with the patients who were less socially restricted (Spearman correlation coefficient 1=0.35,P=0.003). Especially stoma leakage, peristomal skin irritation, dietary prescriptions, retraction, and prolapse of the stoma have significant impact on the patient's daily life. CONCLUSION: Stoma surgery has a great influence on a patient's daily life. There is a clear relation between the number of stoma care problems and the degree of social restriction. Follow-up of stoma patients under close surveillance of stoma care nurse to minimize stoma care problems and a careful surgical technique are advocated for good stoma care.
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  • 18
    ISSN: 1530-0358
    Keywords: Rectal cancer ; Sphincter preservation ; Functional outcome ; Quality of life ; Intraoperative radiation therapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract PURPOSE: Locally advanced primary and recurrent rectal cancers treated with external beam radiation therapy, intraoperative radiation therapy, and chemotherapy represent a complex group of patients in the setting of extensive pelvic surgery and sphincter preservation. We sought to define functional outcome and quality of life in this subset of patients. METHODS: We retrospectively reviewed our experience with locally advanced primary and recurrent rectal cancer patients who underwent intraoperative radiation therapy with either low anterior resection (n=12) or coloanal anastomosis (n=6) between 1991 and 1998. Current functional outcome and quality of life were evaluated by a detailed questionnaire. RESULTS: Median time from operation to assessment was 24 (range, 6–93) months. Using a standardized Sphincter Function Scale, incorporating the number of bowel movements per day and degree of incontinence, patients were graded as poor, fair, good, or excellent function. Of all patients, 56 percent reported unfavorable (poor or fair) function. Of the subset of patients with coloanal anastomosis or very low low anterior resection, 88 percent had unfavorable function as compared with 30 percent with standard low anterior resection. (P=0.02; Fisher's exact probability test). A quality-of-life satisfaction score based on social, professional, and recreational restrictions demonstrated 56 percent of patients to be dissatisfied with their bowel function. CONCLUSIONS: The majority of patients with advanced rectal cancers who require external beam radiation therapy, extensive pelvic surgery, and intraoperative radiation therapy report unfavorable functional and quality-of-life outcomes after sphincter preservation. In this setting patients being considered for coloanal anastomosis or very low anterior resection may be better served by permanent diversion.
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  • 19
    ISSN: 1534-4681
    Keywords: Quality of life ; Cystectomy ; Urinary diversion
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: In this study, we used a previously well-validated survey to assess the impact of different forms of urinary diversion on overall quality of life in patients with bladder cancer. Methods: A total of 92 patients, having three different forms of urinary diversion after radical cystectomy, completed by mail the SF-36, a validated quality-of-life survey. All patients had local(regional disease at the time of cystectomy and are currently without evidence of disease. Completed surveys were then analyzed into physical (PCS) and mental (MCS) component quality-of-life scores per published protocols. Results were then compared with published age-based norms. Results: A total of 38 men who had cystectomy and ileal neobladder had a mean PCS (6SD) of 48.4 (7.8) and a mean MCS of 51.0 (7.4); 16 men and women who had cystectomy and Indiana Pouch had a mean PCS of 48.4 (8.9) and a mean MCS of 55.7 (3.8). None of these results is statistically different from published age- and sex-based population norms. Thirty-eight men who had cystectomy and ileal conduit had a mean PCS of 41.4 (8.5) and a mean MCS of 48.2 (10.7). The PCS is not statistically different from the population-based norm; however, the MCS is significantly decreased from the published norm (P 5.01). Conclusions: Patients with ileal conduits have significantly decreased mental health quality of life whereas patients with continent urinary diversions do not. Therefore, when not medically contraindicated, patients should be offered a continent diversion as the diversion of choice after cystectomy.
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  • 20
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    Annals of surgical oncology 7 (2000), S. 367-375 
    ISSN: 1534-4681
    Keywords: Outcomes ; Surgical oncology ; Review ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: There have been significant developments and advances in the area of outcomes research in the past 25 years. Unfortunately, many surgical oncologists may not have a clear concept of outcomes research and the methodology involved. Methods: A literature-based review article was done that included an overview of outcomes research, and study design and types, outcome measures, outcome instruments, and sources of outcome data were examined. In addition, we reviewed small area variation(volume outcome analysis as well as quality-of-life studies and their applications in surgical oncology clinical investigation. Specific examples from surgical oncology were identified. Results: As the costs of health care have increased, so has the emphasis on measuring outcomes of medical and surgical care to determine the quality and appropriateness of care. Marked variations in a variety of outcomes after oncological procedures have been attributed to individual surgeon and institution characteristics. Because much of the clinical surgical oncology literature deals only with the traditional mortality and morbidity outcomes, a more comprehensive examination of patient outcomes is required to fully evaluate the impact of patient management decisions. Health-related quality of life can be measured and analyzed in several ways and decisions regarding the use of such methodology are dependent on multiple factors. Conclusions: Surgical oncologists should recognize that the true value of their interventions requires systematic and comprehensive examination of patient outcomes.
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  • 21
    ISSN: 1569-8041
    Keywords: Charcot–Marie–Tooth disease ; chemotherapy ; hereditary motor and sensory neuropathy ; PMP22 ; vincristine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Severe up to life-threatening neuropathy has beenobserved in patients with hereditary neuropathies receiving vincristine. Case report:A 52-year-old female painter suffering fromhigh-grade non-Hodgkin's lymphoma (stage IVB) was treated with a total of 4mg of vincristine during two courses of CHOP chemotherapy (cyclophosphamide,vincristine, adriamycin, prednisone). At onset of treatment no neurologicalproblems were reported. There was good lymphoma response to chemotherapy. Atthe same time, however, the patient gradually developed dysphagia, dysarthria,muscular weakness of both lower and upper extremities, areflexia, paraesthesiaof the fingertips and bilateral sensory impairment of feet and lower legs.These symptoms continually worsened over a period of seven weeks until she wasunable to walk or to perform her work. Electrophysiological studies showedperipheral axonal and demyelinative sensorimotor neuropathy in correlation tohistological findings. Molecular analysis revealed 17p11.2 duplication typicalfor Charcot–Marie–Tooth disease IA. While continuing chemotherapywithout the use of vincristine the patient's neurologic symptoms slowlyrecovered within six months. Conclusion:Prior to administration of vincristine family andpatient history as well as physical examination should be performed carefullyto look for underlying hereditary neuropathy. For those patients with aclinical history or symptoms suggestive for CMT nerve conduction velocitystudies and on an individual base even molecular genetic analysis areneccessary to prevent serious neurologic complications.
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  • 22
    ISSN: 1569-8041
    Keywords: carboplatin ; chemotherapy ; gemcitabine ; non-small-cell lung cancer ; paclitaxel
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:The combination of paclitaxel (P) and carboplatin (C)is an effective treatment for advanced NSCLC. Gemcitabine (G) is an active newdrug. We planned a phase I study to find the maximum tolerated dose (MTD) ofthe PCG combination. A phase II study was subsequently conducted to evaluatethe activity and toxicity of PCG. Patients and methods:Forty-five patients entered the study.Twenty-eight had stage IIIA–B disease, 17 stage IV. In the phase Istudy, with a fixed dose of C at AUC = 6 on day 1, P was escalated usingincrements of 25 mg/m2 starting from 175 mg/m2 on day1 and G with increments of 200 mg/m2 starting from 800mg/m2 on day 1 and 8. Results:Fourteen patients entered the phase I study. The MTD wasreached at P 200 mg/m2, C AUC = 6 and G 1000 mg/m2.Neutropenic fever and grade 3 diarrhea were the dose limiting toxicities.Thirty-one patients were treated in the phase II study with P 175mg/m2, C AUC = 6 and G 1000 mg/m2. Response rate was57% (68% in stage III and 47% in stage IV).Myelosuppression was the main toxicity, with grade 3–4 leukopeniaoccurring in 35% of cases. Grade 3 anemia was observed in 24%of cases and grade 3–4 thrombocytopenia occurred in 34% ofpatients. Non-hematological toxicity was mild. Median survival and one-yearactuarial survival were 20.5 months and 74% for stage III and 11.5months and 47% for stage IV. Conclusions:PCG is a promising regimen for treating advancedNSCLC. A phase III study comparing PCG to paclitaxel plus carboplatin inadvanced NSCLC is ongoing. On the other hand, we are planning to introduce thePCG regimen in the treatment of stage II–III patients in the setting ofa multimodality treatment.
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  • 23
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    Annals of oncology 11 (2000), S. 1615-1616 
    ISSN: 1569-8041
    Keywords: chemotherapy ; gemcitabine ; radiotherapy ; radiation myositis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
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  • 24
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    Annals of oncology 11 (2000), S. 1523-1530 
    ISSN: 1569-8041
    Keywords: androgen-independent prostate cancer ; chemotherapy ; metastatic prostate cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background and purpose:A great number of clinical researchstudies have been reported in the field of chemotherapy for advancedandrogen-independent prostate cancer during the last ten years. The aims ofthe present review were to assess their impact on management of the diseaseand on survival of patients. Methods:The review of full published reports was facilited by theuse of a MEDLINE computer search. Results:Clinical research studies have focused on definingguidelines for eligibility criteria and accurate endpoints for patients to beenrolled onto clinical trials and developing new agents or combinationof drugs including estramustine phosphate. Any combination of currentchemotherapy has no impact on overall survival of patients. Among drugs indevelopment, only the promising activity observed with docetaxel deservesrandomized trials to assess its impact on survival. The major innovativeadvance of the 90s is the demonstration of the impact of chemotherapy(mitoxantrone + prednisone) on quality of life as compared to prednisonealone. A greater and longer-lasting improvement in quality of life along witha concomitant decrease in costs was observed. Conclusions:At the present time, chemotherapy should beconsidered as a palliative treatment in patients with symptomaticandrogen-independent disease. The enrollment of patients into clinical trialsdealing with quality of life as primary endpoint is strongly solicited. Astandard methodology should be used in phase II trials with a primary goal ofselection of agents which should progress to randomized trials using survivalas an endpoint. Hopefully new specific strategies targeted to reverse themolecular changes that underlie prostate tumorigenesis should rapidly impactthe multimodality management of AIPC in the third millenium.
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  • 25
    ISSN: 1569-8041
    Keywords: cancer ; chemotherapy ; pleuropulmonary blastoma ; PPB ; soft tissue sarcoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Pleuropulmonary blastoma (PPB) is a rare dysontogenetic tumor that usuallydevelops in the first decade of life and has been recognized as a distinctclinico-pathological entity different from the ordinary pulmonary blastoma ofadulthood. Since the tumor grows aggressively and tends to metastasize early,physicians have to be aware of late onset of symptoms and uncommonmanifestations. We report a case of PPB in a young adult and its recurrencein the pancreas after primary surgical treatment and adjuvant chemotherapy.Keeping in mind the moderate prognosis of PPB in children, accurate assessmentand treatment of PPB require a team approach of oncology, radiology andsurgery to establish new therapeutic guidelines in the future.
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  • 26
    ISSN: 1569-8041
    Keywords: 5-fluorouracil ; arterial access device ; chemotherapy ; colorectal cancer ; hepatic arterial chemotherapy ; liver metastases ; port-a-cath
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Hepatic arterial chemotherapy for liver metastases ofcolorectal cancer is still under discussion. Mainly because of the technicalcomplications of this mode of treatment and the lack of a survival benefit inrandomized studies. We performed an analysis of hepatic arterial5-fluorouracil (5-FU) chemotherapy in 145 consecutive patients treated at asingle institution. Patients and methods:One hundred forty-five patients withinoperable liver metastases from colorectal cancer were included. 5-FU, 1000mg/m2/day continuous infusion for five days every three weeks, wasdelivered in the hepatic artery by percutaneous catheter or arterial accessdevice. Results:The response rate was 34% for all patients,40% in patients with extrahepatic disease, and 15% in patientswith i.v. 5-FU-based pretreatment. TTP and OS for all patients were 7.5 and14.3 months, respectively. In patients with extrahepatic disease or i.v.5-FU-based pretreatment, OS was significantly shorter compared to patientswithout extrahepatic disease or 5-FU-based pretreatment (9.7 vs. 19.3 monthsand 10.1 vs. 17.4 months, respectively). forty-seven percent of patientsstopped treatment because of a complication. Complications most often seen inpatients with arterial ports were hepatic artery thrombosis (48%) anddislocation of the catheter (22%). Conclusions:The results of our analysis are in line with previousphase III studies. Extrahepatic disease and i.v. 5-FU-based pretreatment wereprognostic for reduced OS. The complication rate of hepatic arterial deliverywas worrisome, although, no negative impact on survival could be established.There is a strong need for improvement of hepatic arterial delivery methodsbefore further evaluation of hepatic arterial 5-FU will be worthwhile.
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  • 27
    ISSN: 1569-8041
    Keywords: advanced ovarian cancer ; chemotherapy ; docetaxel ; phase II trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:This phase II study was conducted to evaluate theefficacy and toxicity of docetaxel in Japanese patients with advanced ovariancancer. Patients and methods:Docetaxel was administered at a dose of 70mg/m2 intravenously to patients with platinum pre-treated advancedovarian cancer. Treatment was repeated every three weeks. No routinecorticosteroid premedication was given. Results:Ninety patients with advanced ovarian cancer were enteredand sixty were assessable for response. The overall response rate was28% in the assessable patients (95% confidence interval(95% CI): 17.5%–41.4%). CA125 responses were seenin 8 (24%) of 34 assessable patients for CA125 criteria. The 36platinum-refractory patients had a response rate of 25% compared with33% in the platinum-sensitive patients. The predominant toxicity wasneutropenia, with 86% of the patients experiencing grade 3 or 4.Hypersensitivity reactions occurred in 37% of the patients and were notlife threatening. Edema was mild and infrequent. Conclusion:Docetaxel at 70 mg/m2 demonstratedeffectiveness as a treatment of both platinum-sensitive andplatinum-refractory ovarian cancer patients, with a low incidence of severehypersensitivity reactions and edema.
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  • 28
    ISSN: 1569-8041
    Keywords: autologous stem-cell transplantation ; chemotherapy ; follicular lymphoma ; progression
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Among the 566 patients with follicular lymphomas (FL)included in the GELF 86 prospective trials from October 1986 to September1995, 372 with progressive/relapsing disease were analyzed retrospectively toidentify prognostic factors at first relapse. Patients and methods:For progressive FL, patients received mono-(22%) or polychemotherapy (78%) followed by high-dose therapy(HDT) with ASCT for 83 patients (22%). The median time toprogression from initial treatment was 23 months (range 3–102 months)and 24% of documented patients (52 of 217) had histologicaltransformation (HT). Salvage therapy produced an overall response in64% of patients and the five-year survival from progression was42%. Results:For patients who underwent HDT with ASCT compared tostandard treatment, five-year freedom from second failure was at 42%vs. 16% (P = 0.0001) and five-year survival was58% vs. 38% (P = 0.0005), respectively. Thebenefit of HDT and ASCT remained if we consider only patients less than 65years (five-year survival at 60% vs. 40%; P =0.001). Multivariate analysis of parameters significant according tounivariate analysis found that no ASCT at first progression, age at relapse〉50 years, progression on-therapy were adversely significant onsurvival. Conclusions:HDT with ASCT compared to standard treatmentprolonged remission and survival after first progression of FL patients.
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  • 29
    ISSN: 1569-8041
    Keywords: 5-fluorouracil ; chemotherapy ; colorectal cancer ; cost/effectiveness analysis ; irinotecan
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:It has been shown that irinotecan is superior toinfusional 5-fluorouracil (5-FU) in patients with advanced colorectal cancerafter 5-FU failure. In a recent trial, median survival was 10.8 months forpatients treated with irinotecan, compared to 8.5 months in patients receivinginfusional 5-FU. Considering the statistically significant but clinicallyrelatively small advantage of irinotecan over 5-FU, cost effectiveness shouldalso be part of treatment decision. Purpose:To relate the costs of each management approach tooverall survival in patients with metastatic colorectal cancer. Patients and methods:The healthcare costs and medical benefits(treatment-added survival) of second-line chemotherapy in patients (infusional5-FU: 129, irinotecan: 127) were compared. Data on overall survival were drawnfrom a multicenter randomised trial that compared infusional 5-FU (continuousinfusion, AIO, or LV5-FU2 regimens) to irinotecan alone. Costs were derivedfrom the accounting system in two university hospitals in Paris, France. Results:The range in total healthcare costs was 14,135 to 12,192US$ patient between management approaches, with irinotecan chemotherapycosting most and 5-FU-continuous infusion least. If survival was included asa treatment benefit, the cost-effectiveness ratio of irinotecan over 5-FUranged from 9,344 to 10,137 US$ per year of added survival. Conclusions:The least expensive management for metastaticcolorectal was 5-FU infusion but the additional cost of irinotecan wasbalanced by the added months of survival, with a cost-effectiveness ratioclose to that of other cancer treatments.
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  • 30
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    Annals of oncology 11 (2000), S. 81-85 
    ISSN: 1569-8041
    Keywords: ABVD ; BEACOPP ; chemotherapy ; clinical trials ; COPP ; dose intensification ; Hodgkin's disease ; radiotherapy ; risk factors
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Treatment strategies in Hodgkin's disease (HD) arechanging fundamentally over the last decades. Both radiotherapy andcombination chemotherapy are effective treatment modalities. However, theoptimal choice of treatment or combinations of treatment is still debated fordifferent prognostic groups. Patients and methods:The German Hodgkin's Lymphoma Study Group(GHSG) initiated randomized clinical trials since 1978. Over the past 20years, more than 6000 patients with HD in all stages were randomized, treatedand followed by the GHSG. Patients are now being recruited from more than 300clinical centers. Results:As a consequence of different clinical trials, it is nowthe policy of the GHSG to tailor treatment to the individual risk of patients,giving favorable patients less intensive and less toxic therapy thanunfavorable patients. The treatment for early and intermediate stage HDbecomes quite similar with few cycles of polychemotherapy followed by involvedfield irradiation. In advanced stage HD, the introduction of dose intensifiedchemotherapy (BEACOPP), has improved treatment results and thus willsubstitute the MOPP or ABVD regimens. Conclusions:Although most of the patients with HD will be curedby modern treatment stategies, several questions are still subjects of ongoingclinical trials: 1) which chemotherapy regimen in which quantity will be thebest with respect to efficacy and toxicity and 2) which dose and field sizeof radiotherapy is adequate within the combined modality.
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  • 31
    ISSN: 1569-8041
    Keywords: chemotherapy ; docetaxel ; gastric cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose:A multi-centric trial was performed to explore theclinical activity, in terms of response and toxicity (primary objectives),duration of response and survival (secondary objectives), of docetaxel withcisplatin in advanced gastric cancer (AGC). Patients and methods:Patients with measurable unresectable and/ormetastatic gastric carcinoma, performance status ≤1, normal hematological,hepatic and renal functions and not pretreated for advanced disease bychemotherapy received up to eight cycles of TC (docetaxel 85 mg/m2d1, cisplatin 75 mg/m2 d1) q3w. Dose escalation to 100mg/m2 was performed in five patients and was discontinued forexcessive toxicity. Results:Forty-eight patients were accrued. A median of 5cycles/patient was given. We observed 2 complete and 25 partial responses foran overall intent to treat response rate of 56% (95% CI:41%–71%). Twelve patients had stable disease for ≥9weeks (3 cycles). The median time to progression and overall survival were 6.6and 9 months, respectively. Grade ≥3 toxicities were neutropenia81%, anemia 32%, thrombocytopenia 4%, alopecia36%, fatigue 9%, mucositis 9%, diarrhea 6%,nausea/vomiting 4%, neurologic 2%, and one anaphylaxisprecluding treatment administration. We recorded nine episodes of non-fatalfebrile neutropenia in eight patients, two of them with docetaxel at 100mg/m2. There were no direct treatment-related deaths. Conclusions:TC is active in AGC with a high response rate in amulticentric trial. Despite its hematotoxicity, this regimen is well toleratedand can be recycled as originally planned in 78% of the cases. Theseresults may serve as basis for further developments of docetaxel containingregimens in this disease.
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  • 32
    ISSN: 1569-8041
    Keywords: chemotherapy ; concomitant chemoradiotherapy ; head and neck cancer ; paclitaxel ; radiation ; reirradiation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Concomitant chemoradiotherapy is an effectivetreatment modality for advanced head and neck cancer, but improved regimensare needed. We sought to define the toxicities, recommended phase II dose, andoutcome of a combination chemotherapy regimen with concomitanthyperfractionated radiotherapy in patients with poor prognosis cancers of thehead and neck, including those having received prior curative intentradiotherapy. Patients and methods:From 1995 until 1997, 54 patients weretreated, 25 of whom had received a prior full course of radiotherapy to thehead and neck. Patients were treated with 5-fluorouracil (5-FU) 600mg/m2/day continuous infusion × 5 days (days 1–5),hydroxyurea, 500 mg p.o. bid × 11 doses (days 1–6) and paclitaxel(60–150 mg/m2) by one-hour infusion on day 2 using a doseescalation strategy. Radiotherapy was given concomitantly on days 2–6,150 cGy bid. Each of 4–5 cycles was delivered every other week. Results:The MTD of paclitaxel was 100 mg/m2. Theregimen was feasible; radiotherapy was delivered at a median of 7300 cGy and83% of patients received ≥80% planned dose intensity.Hematological toxicity, with granulocyte colony stimulating factor, was verymild. Dose limiting toxicities were mucositis and dermatitis. Despite poorprognosis, two-year survival was 45%. Conclusions:The recommended phase II dose of this regimen is 5-FU600 mg/m2/day × 120 hours (days 1–5), hydroxyurea 500mg p.o. b.i.d. × 11 doses (days 1–6), paclitaxel 100mg/m2 over one hour on day 2, and radiotherapy 150 cGy b.i.d. days2–6. Concomitant chemotherapy and re-irradiation was feasible on thisprotocol and resulted in long-term survival in patients without other curativeintent options.
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  • 33
    ISSN: 1569-8041
    Keywords: alkylating agents ; bendamustine ; chemotherapy ; phase I study ; solid tumours ; weekly chemotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:The cytotoxic agent bendamustine combines apurine-like benzimidazol and alkylating nitrogen mustard group. The clinicallytolerated dose for single bolus bendamustine is 215 mg/m2, forfractionated therapy on four consecutive days 85 mg/m2. The maximumtolerated dose of a day 1 and 8 (q4w) 30 min infusion schedule was recentlyfound to be 160 mg/m2, mouth dryness and fatigue weredose-limiting. Our current phase I trial was designed to define therecommended dose of a new weekly short infusion schedule. Patients and methods:Patients with refractory malignant tumoursqualified for the trial after written informed consent was obtained.Bendamustine was given as a 30-min i.v. infusion weekly for up to eightconsecutive weeks. Results:Twelve patients (8 male, 4 female, median age 57.5 years,range 42–64) were enrolled in this trial. At the starting dose of 80mg/m2, two patients had dose-limiting toxicity (fatigue grade 3,mouth dryness grade 3, fever grade 4 Common Toxicity Criteria). Nodose-limiting events were observed in six patients treated at 60mg/m2. An intermediate dose level of 70 mg/m2 wasstudied in three younger, less heavily pre-treated patients, was welltolerated and not associated with dose-limiting events. Haematologicaltoxicity was mild except for grade 3–4 lymphocytopenia, occurring in 11of 12 patients. Bendamustine was found to induce long-lastingpanlymphocytopenia with predominant B-cell cytotoxicity. Conclusions:The maximum tolerated dose of weekly bendamustinegiven as a 30-min i.v. infusion is 80 mg/m2, mouth dryness, fatigueand fever are dose-limiting. The recommended dose for phase II trials is 60mg/m2.
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  • 34
    ISSN: 1569-8041
    Keywords: anthracycline ; chemotherapy ; liposomal daunorubicin ; lymphoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Standard therapy for lymphoma consists of acyclophosphamide (C), doxorubicin, vincristine (V), and prednisone (P) (CHOP)combination regimen. Liposomal daunorubicin (DaunoXome®) is an alternativeto doxorubicin for patients with lymphoma because of its more favorable safetyprofile and potentially more selective uptake in lymphoma. The objectives ofthis study were to determine the maximum tolerated dose (MTD) of liposomaldaunorubucin with CVP (COP-X) and the tolerability of the regimen in patientswith indolent lymphoma. Patients and methods:Patients with low-grade andintermediate-grade lymphoma having adequate cardiac, hepatic, and renalfunction were enrolled. Patients received C 750 mg/m2, V 1.4mg/m2 (maximum 2.0 mg), and liposomal daunorubicin 50–100mg/m2 i.v. on day 1 and P 100 mg p.o. on days 1–5. MTD wasthe liposomal daunorubicin dose associated with 20% dose-limitingtoxicity (ANC 〈500/mm3 for 〉5 days or febrile neutropenia). Results:Twenty patients, median age 59 years, were treated. Theliposomal daunorubicin MTD combined with CVP was 70–80 mg/m2,depending on patient population. No significant non-hematologic toxicityoccurred. Response rate was 44% (2 complete and 5 partial responses). Conclusions:A liposomal daunorubicin dose of 80 mg/m2in the COP-X regimen was well tolerated with little non-hematologic toxicity.
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  • 35
    ISSN: 1569-8041
    Keywords: chemotherapy ; chromosome aberrations ; malignant germ-cell tumours
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
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  • 36
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    Annals of oncology 11 (2000), S. 11-16 
    ISSN: 1569-8041
    Keywords: chemotherapy ; gene therapy ; head and neck cancer ; immunotherapy ; radiotherapy ; recurrent ; surgery
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Locoregional recurrence is the most common cause of failure after head andneck cancer surgery. It is a disease which causes significant morbidityespecially on speech and swallowing. There are many different treatmentsavailable including surgery, reirradiation and chemotherapy. However, none ofthese have produced any significant survival benefit. Because of this, therehas been considerable interest in the development of new biological therapiessuch as gene therapy and immunotherapy for this disease. The objectives ofthis article are to provide an overview of the currently available therapiesfor recurrent head and neck cancer including gene therapy and immunotherapy.Prevention of recurrent disease by the detection and treatment of minimalresidual disease is also discussed.
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  • 37
    ISSN: 1569-8041
    Keywords: chemotherapy ; hepatocellular carcinoma ; liposomal doxorubicin ; phase II
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Pegylated liposomal doxorubicin has an enhancedefficacy and reduced toxicity compared with free doxorubicin. The efficacy andtoxicity of pegylated liposomal doxorubicin was investigated in patients withhepatocellular carcinoma. Patients and methods:Patients with histologically confirmed,locally advanced or metastatic hepatocellular carcinoma and a Karnofsky index〉60% were included in this prospective single-arm study. Exclusioncriteria were liver cirrhosis stage Child–Pugh C, previous chemotherapy,or chemoembolization. Pegylated liposomal doxorubicin was given in a dose of30 mg/m2 every three weeks until progression of disease. Afterinclusion of five patients the dose could be escalated to 40 mg/m2in absence of toxicity grade 3 and 4. Results:Sixteen patients were evaluable for response. Noobjective response was achieved. The median survival time was 140 days(95% confidence interval: 126–154 days). Treatment toxicitiesgrade ≥3 comprised increased liver enzymes in patients with preexistinggrade 1 or 2 elevation (n = 6), hematologic toxicity (n =5), and hypersensitivity (n = 2). Conclusions:Pegylated liposomal doxorubicin is not effective fortreatment of advanced hepatocellular carcinoma. The favorable toxicity profilewas confirmed even in patients with underlying liver disease.
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  • 38
    ISSN: 1569-8041
    Keywords: chemotherapy ; gemcitabine ; non-small-cell lung cancer ; paclitaxel
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Thirty patients with chemotherapy-naïve advanced non-small-cell lungcancer (NSCLC) were given escalating doses of paclitaxel (150, 175, 200mg/m2) on day 1 in three consecutive cycles, together with a fixeddose of gemcitabine 1000 mg/m2 on days 1 and 8; cycles wererepeated every three weeks. The dose escalation of paclitaxel was feasible inthe majority of patients. Subsequently, 30 other NSCLC patients received adose of 200 mg/m2 paclitaxel with gemcitabine 1000 mg/m2in a phase II study. The major side effect was mild myelosuppression. Aresponse rate of 24% was achieved in 49 fully evaluable patients. Thisregimen proved to be safe and easy to administer on an out-patient setting,and constitutes now one of the arms of the current EORTC randomized study foradvanced NSCLC.
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  • 39
    ISSN: 1569-8041
    Keywords: breast cancer ; carboplatinum ; chemotherapy ; continuous 5-fluorouracil
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract We performed a trial using the combination of epirubicin 50mg/m2/day 1, carboplatinum AUC 5/day 1 and continuous5-fluorouracil (5-FU) 200 mg/m2/day (every 4 weeks for6 months) to confirm the efficacy and low toxicity profile of thisregimen in breast cancer. In 51 patients with metastatic(n = 33) or locally advanced (n = 18)breast cancer the overall response rate was 86% (95% confidenceinterval (95% CI): 73%–94%): 94% in locallyadvanced and 81% metastatic disease. Grade 3–4 toxicity was low:4% of patients presented with febrile neutropenia, 16% withsevere palmar-plantar syndrome, 10% with Port-a-cath thrombosis. This study confirms the high efficacy of infusional 5-FU-based regimens andjustifies further research into novel promising oral 5-FU derivatives.
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  • 40
    ISSN: 1569-8041
    Keywords: chemotherapy ; ovarian cancer ; second-line
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Gemcitabine is active in patients with otherwiseresistant or refractory ovarian cancer. As the drug is well tolerated, studiesusing gemcitabine combined with other antineoplastic agents are needed. Theaim of the study was to determine the maximum tolerated dose (MTD) ofepirubicin combined with gemcitabine, with and without support of G-CSF. Patients and methods:Patients with platinum-resistant orrefractory ovarian cancer were eligible. Gemcitabine (G) (starting dose 800mg/m2 day 1 and 8; 200 mg/m2 escalation per level) andepirubicin (E) (starting dose 60 mg/m2 day 1; 15 mg/m2escalation per level) were given every 21 days for four to six cycles. G-CSF(filgrastim 5 µg/kg/die) was given in case of grade 4 neutropenia(levels without support) or from day 9 up to leukocyte count〉10,000/mm3 after nadir (levels with support). Cohorts of threepatients were enrolled at each level, and another three patients were planned,if one dose-limiting toxicity (DLT) was registered. MTD was determined firstwithout and then with G-CSF. Results:Four levels were studied (G 800 + E 60; G 1000 + E 60;G 1000 + E 75; G 1000 + E 75 + G-CSF) with four, four, three and threepatients enrolled, respectively. DLT (grade 4 febrile neutropenia) wasobserved in two patients at level 3. Thus, G1000 + E 60 mg/m2 wasthe MTD without G-CSF. The addition of prophylactic G-CSF did not allow afurther increase of the dose and grade 4 thrombocytopenia was the DLT at level4. Non-hematological toxicity was mild. Grade 2 mucositis was reported in fourpatients. Among the 13 patients with measurable or evaluable disease, 3partial responses were observed for an overall response rate of 23.1%. Conclusions:The combination of gemcitabine 1000 mg/m2(day 1, 8) and epirubicin at 60 mg/m2 (day 1) is a feasibletherapy. Grade 4 neutropenia is frequent and G-CSF support is often required.With prophylactic support of G-CSF, the DLT is thrombocytopenia.
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  • 41
    ISSN: 1569-8041
    Keywords: chemotherapy ; intra-arterial ; liver metastasis ; unresectable pancreatic cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:A phase II trial of a new intra-arterial chemotherapyregimen for unresectable pancreatic cancer (UPC). Patients and methods:Ninety-six patients with UPC were treatedwith intra-arterial chemotherapy at three-weekly intervals. The schedule usedwas FLEC: 5-fluorouracil 1000 mg/m2, folinic acid 100mg/m2, carboplatin 300 mg/m2; epirubicin 60mg/m2. Results:The overall response rates by CT-scan evaluation were:15% partial response (PR), 44% stable disease (SD), 17%progressive disease (PD). The overall median survival was 9.9 months, and 10.6and 6.8 for UICC stage III and IV, respectively. Pain reduction occurred in42% of patients. A weight gain 〉7% from baseline occurred in8% of patients. A total of 341 courses of FLEC were administered. Grade3–4 hematological toxicity was seen in 25% of patients;ematemesis in 4%; grade 3 gastrointestinal toxicity in 3%; andgrade 3 alopecia in 16%. One sudden death, a pre-infarction angina, anda transitory ischemic attack were observed. The only complication related tothe angiographic procedure was an intimal dissection of the iliac artery. Conclusions:The intra-arterial FLEC regimen was well toleratedand active. It requires only one day of hospitalization. Efficacy could onlybe assessed in a randomized study against a gemcitabine containing regimen.
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  • 42
    ISSN: 1569-8041
    Keywords: chemotherapy ; combination ; etoposide ; ifosfamide ; ovarian cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:The prognosis of platinum resistant ovarian cancer isvery poor and the treatment of choice has not been clearly defined. Patients and methods:We conducted a phase II study with thecombination of ifosfamide i.v. at 2.25 g/m2 (days 1, 2) andetoposide per os at 100 mg daily (days 1–10) every four weeks. To beeligible for the study patients had to be resistant to platinum and paclitaxelpretreated. Results:Forty-one patients entered the study. The median intervalfrom the previous chemotherapy was 3.9 months. The median number of previouschemotherapeutic regimens was 2. Severe toxicities included neutropenia(41% of patients), leukopenia (29%) and thrombocytopenia(13%). Thirty-five patients are assessable for response. Nine patientsresponded (22% of the eligible, 26% of the assessable), four ofthemdemonstrated complete response to chemotherapy (10% and 12%,respectively), while three patients demonstrated stabilization of theirprogressive disease. After a median follow-up of 18 months, time toprogression is 3 months (range 0.9–14.4), duration of response is 9months (2.5–11) and median survival is 13 months (2.5–37.4+). Conclusions:The combination of ifosfamide with oral etoposideappears to have significant but manageable toxicity and encouraging efficacyin platinum resistant ovarian cancer.
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  • 43
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    Journal of gastroenterology 35 (2000), S. 907-911 
    ISSN: 1435-5922
    Keywords: Key words: gastric cancer ; liver neoplasms ; secondary ; interventional radiology ; chemotherapy ; chemoembolization ; therapeutic
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract: Little is known about the effectiveness of transcatheter chemotherapy in liver metastases from gastric cancer. The aim of this study was to evaluate the initial results of hepatic artery infusion and oily chemoembolization in these liver secondaries. Courses of transcatheter arterial infusion with 5-fluorouracil/doxorubicin (12 patients) and oily chemoembolization with doxorubicin-in-iodized oil and gelatin sponge (12 patients) were performed in 24 patients with histologically proven unresectable gastric cancer liver metastases. A positive effect of treatment (partial response + stabilization) was seen in 92% of the patients after chemoinfusion and in 50% after chemoembolization. The 1- and 2-year actuarial survival rates were 92% and 53% for infusion vs 50% and 17% for chemoembolization, respectively (log-rank test, P = 0.0009). For patients who had already died, the mean survival was 19.2 months vs 9.5 months (Student's t-test, P 〈 0.05) with median survivals of 23 months vs 8 months, respectively. The results with arterial infusion were very close to those reported for liver resection. Transcatheter therapy appears to be useful for the palliation of unresectable liver metastases from gastric cancer. If regional chemotherapy is used, arterial infusion should be the first-choice treatment, with oily chemoembolization being reserved for patients who do not respond to infusion.
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  • 44
    ISSN: 1432-1459
    Keywords: Key words Motor neurone disease ; Amyotrophic lateral sclerosis ; SF-36 ; Carer Strain Index ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The measurement of functioning and well-being from the perspective of the patient has in recent years become central to the assessment of health and the evaluation of treatment regimes. The past decade has seen an enormous growth in the application of measures designed to assess quality of life in a vast array of medical specialities. However, the use of such measures in neurology has been relatively limited, and this has certainly been the case in amyotrophic lateral sclerosis (ALS). The European ALS Health Profile Study is a longitudinal survey of patients diagnosed with ALS or other motor neurone diseases in which patients are aksed to complete questionnaires concerning their subjective health status. Data from clinical assessments are also collected. It is intended that the information collected will provide more systematic and detailed evidence of the impact of the disease from the perspective of the patient. This contribution documents results from baseline assessment obtained from data supplied by clinicians, carers and patients themselves. Three outcome measured are assessed in this paper: the SF-36, a generic measure of well being and functioning, the ALS Functinal Rating Scale and the Carer Strain Index. The evidence presented here suggests that these measures provide a meaningful and valid picture of the impact of the disease. The data indicate that ALS has substantial adverse effects both upon the functioning and well being of patients and carers, as well as an association between the emotional health status of patients and carers, and between the physical health status of patients and carers.
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  • 45
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    Annals of oncology 11 (2000), S. 927-937 
    ISSN: 1569-8041
    Keywords: brain lymphomas ; chemotherapy ; intrathecal chemotherapy ; methotrexate ; primary central nervous system lymphoma ; radiotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Primary central nervous system lymphomas (PCNSL) are aggressivemalignancies, exhibiting one of the worst prognoses among lymphomas. The besttreatment modality for PCNSL has not yet been identified. Several therapeuticquestions still remain unanswered, and some methodological pitfalls inclinical trials prevent definitive conclusions from being drawn. In thisreview, certain aspects of trial design as well as emerging therapeuticguidelines are analyzed, and future perspectives are discussed. In the vast majority of prospective trials, general criteria for treatmentof aggressive lymphomas were adopted, choosing primary chemotherapy (CHT)followed by radiotherapy (RT) as therapeutic modality. This strategy produceda five-year survival of 22%–40% in comparison to the3%–26% reported with RT alone. Systemic high-dosemethotrexate (HD-MTX) seems to be the most effective drug, producing aresponse rate of 80%–90% and a two-year survival of60%–65%. To date, the addition of other drugs atconventional doses have not consistently improved outcome. With a fewexceptions, any regimen without HD-MTX comprehensively performed no betterthan RT alone. In combined treatment, RT doses should be decided on the bases of responseto primary CHT and the number of lesions, and, until definitive conclusionsfrom well-designed trials are available, RT parameters should follow thewidely accepted principles used for other aggressive lymphomas. CHT asexclusive treatment, keeping RT for relapses or persistent disease, appearsto be an attractive strategy. However, the worldwide experience with thismodality is still limited, and corroborating data are needed. Intrathecal CHTstill has not found a defined role in PCNSL management. Preliminary data seemto indicate that adequate meningeal treatment with HD-MTX, but withoutintrathecal CHT, could also be suitable in positive-cerebrospinal fluidpatients. Future efforts should be addressed to identify new active drugs and moreefficient CHT combinations, to evaluate the efficacy of high-dose CHTsupported by autologous peripheral blood stem cells transplantation, and toclarify the impact of RT delay in complete responders, the usefulness ofintrathecal CHT, and the best management for elderly patients. The assessmentof impact of treatment on neuropsychological functions and quality of life isa mandatory endpoint in clinical trials.
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  • 46
    ISSN: 1569-8041
    Keywords: antifolate ; chemotherapy ; pancreatic cancer ; thymidylate synthase inhibitor
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose:To determine the safety and activity of LY231514(ALIMTA™, MTA, pemetrexed disodium, Eli Lilly and Co.,Indianapolis, IN) in chemotherapy-naïve patients with advanced pancreaticcancer. Patients and methods:Patients with unresectable or metastaticpancreatic cancer received LY231514 600 mg/m2 as a 10–minuteinfusion every three weeks. Results:Forty-two patients were enrolled in this phase II trial.The median age was 60.3 (range 37–77) years; 79% had metastaticdisease. Neutropenia was common (40% of patients ≥ grade 3) butinfectious complications were rare. Significant anemia or thrombocytopeniaoccurred in 〈20% of patients. Non-hematologic toxicities includedgrade 2 or 3 skin reaction which was ameliorated by dexamethasone. Elevationsof bilirubin or transaminases were infrequent (〈25% of patients) anddid not require dose reductions or treatment delays. Thirty-five patientsreceived two cycles of therapy and were evaluable for response. One complete(duration 16.2 months) and one partial (duration 6.9 months) were observedresulting in an objective response rate of 5.7% for evaluable patients.In addition, 17 patients (40%) had stable disease that lasted ≥6months in 5 patients. The median survival was 6.5 months, with 28% ofpatients alive at one year. Conclusions:LY231514 is a well-tolerated agent with minimalobjective antitumor activity in pancreatic cancer. The median and one yearsurvival times, which may be important indicators in phase II trials of newagents, are of interest. Combination trials of LY231514 in pancreatic cancerare planned.
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  • 47
    ISSN: 1569-8041
    Keywords: chemotherapy ; doxorubicin ; hepatocellular carcinoma ; liposome ; pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:There is lack of effective and safe chemotherapy foradvanced hepatocellular carcinoma. Polyethylene glycol-coated (pegylated)liposomal doxorubicin (PLD) has long circulation time and enhanced drugaccumulation in the tumor tissues. It has significant activity in Kaposi'ssarcoma, breast and ovarian cancers and the acute adverse effects of free drugare reduced. Patients and methods:A patient with advanced hepatocellularcarcinoma was treated with PLD and a pharmacokinetic study was performed.Initial serum total and direct bilirubin were 3.6 and 6.8 folds of uppernormal, respectively, and an indocyanine green clearance test at 15 minuteswas 26.3% (normal 〈 15%). Results:Compared to cases with normal liver function, increasedvolume of distribution of doxorubicin correlated with a large amount ofascites (P〈 0.05). The clearance of drug was unexpectedly higherthan in cases with normal liver function (P〈 0.05). According tothe pharmacokinetic studies, the disposition of PLD in this case has not beenretarded even in the presence of severe liver dysfunction. Only minimaltoxicities including grade 2 stomatitis and moderate leukopenia were observed.The tumor had a partial remission and the patient survived nine months afterPLD treatment. Conclusion:PLD could serve as a safe and effective treatment forhepatocellular carcinoma even in the presence of impaired liver function. Itsrole in treating advanced hepatocellular carcinoma is worthy of further study.
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  • 48
    ISSN: 1569-8041
    Keywords: chemotherapy ; gemcitabine ; non-small-cell lung cancer ; phase II trial ; vinorelbine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose:The purpose of the present phase II trial was todetermine the efficacy and toxicity of vinorelbine–gemcitabine inpatients with advanced non-small-cell lung cancer (NSCLC). Patients and methods:From December 1997 to February 1999, 78chemotherapy-naive patients (median age 60 years, Karnofsky performance statusof 100, 90, 80 and 70 present in 5%, 41%, 36% and18% of the patients, respectively) with stage IIIB (17%) or IV(83%) NSCLC (65% adenocarcinomas, 22% squamous-cellcarcinomas, 10% large-cell carcinomas, 3% mixed-cell carcinomas)received 25 mg/m2 vinorelbine and 1200 mg/m2 gemcitabineon days 1, 8 and 15 of a four-week cycle. Results:In an intent-to-treat analysis, partial responses wereseen in 19% of the patients. The median duration of response was 4.4months. The median survival time was seven months and the one-year survivalrate was 32%. Myelosuppression was the main side effect with WHO grade3/4 neutropenia and thrombocytopenia in 35% and 11% of thepatients, respectively. Other side effects were usually mild to moderate. Conclusions:Vinorelbine–gemcitabine is active, welltolerated and easy to administer on an outpatient basis in advanced NSCLC.Thus a randomized comparison of this combination with platinum-based protocolsis warranted in patients with advanced NSCLC.
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  • 49
    ISSN: 1569-8041
    Keywords: chemotherapy ; esophageal cancer ; gemcitabine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:There were approximately 12,500 cases of esophageal carcinoma diagnosed in the US in 1992 and 12,200 deaths. The impact of chemotherapy on patients with metastatic disease is marginal with a median survival of only five months. Gemcitabine (LY188011,2,2,–difluorodeoxycytidine: dFdC), an analog of cytosine arabinoside (ara-C), is a pyrimidine antimetabolite. Gemcitabine has shown interesting clinical activity in initial phase II clinical trials in a variety of malignancies, including the aerodigestive malignancies, squamous-cell carcinoma of the head/neck and both non-small-cell and small-cell lung cancer. Patients and methods:A total of 21 patients with chemotherapy-naïve metastatic esophageal carcinoma were entered. Nineteen patients were evaluable for toxicity and seventeen patients were evaluable for response. Gemcitabine was administered intravenously at 1250 mg/m2 over 30–60 minutes on days 1, 8, and 15 followed by 1 week of rest. This four-week schedule defined a cycle of treatment. Patients may have received a maximum of six cycles. Results:Gemcitabine was well tolerated with minimal non-hematologic toxicity and grade 3–4 anemia, granulocytopenia, and thrombocytopenia occurring in 10.5%, 21%, and 0% of patients, respectively. No responses were seen in the seventeen evaluable patients. Conclusions:At the dose and schedule studied it would appear that gemcitabine has no activity in patients with chemotherapy-naïve esophageal carcinoma.
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  • 50
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    Annals of oncology 11 (2000), S. 133-149 
    ISSN: 1569-8041
    Keywords: chemotherapy ; dose ; dose-density ; dose-intensity ; high-dose chemotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Shortening the interval between cycles is one meansof increasing the dose intensity of chemotherapy, and can be supported bybiological and mathematical rationales. Our objective was to assess theclinical relevance of the rapid repetition of regimens (so-called `dose-densechemotherapy') in various solid neoplasms. Design:The medical literature was reviewed in accord withMulrow's recommendations. Randomised studies comparing frequently-repeatedchemotherapy to standard regimens as well as open studies are described andcritically examined. Results:Dose-dense regimens were widely found to be feasible. In small-cell lung cancer, survival of patients receiving dose-denseregimens was better than that of patients treated by standard chemotherapy inthree trials, two of which reached significance, when these intensive regimensallowed better dose intensity. In poor-prognosis germ-cell tumors, a dose-dense regimen was not betterthan standard therapy, perhaps because of an excessively high toxicity-relateddeath rate. However, recent phase II studies have provided encouragingresults. In early breast cancer, the one published randomized study in the adjuvantsetting showed only a trend towards better disease-free survival innode-positive women receiving a weekly-repeated regimen. Two randomized trialsfailed to show any benefit in the neoadjuvant setting with a dose-denseregimen. No evidence of a benefit was provided in metastatic breast cancer. In advanced colorectal cancer, evidence of an improvement in survival withweekly or bi-weekly 5-FU–leucovorin compared to a classic monthlyschedule has recently been shown in two randomized trials, and dose-denseregimens are recognized as standard therapy in many countries. Phase II studies of dose-dense regimens have also shown high response ratesand long survival in many neoplasms, including Ewing's sarcoma, gestationaltrophoblastic disease, ovarian carcinoma and gastric cancer. Conclusions:A considerable amount of experience has been gainedwith frequently-repeated regimens. A few randomized trials have demonstrateda benefit for survival on standard chemotherapy in small-cell lung cancer andadvanced colorectal cancer. However, this benefit appears to be weak. Thecombination of dose-dense chemotherapy regimens with new anti-cancerstrategies based on our insights into the mechanisms of oncogenesis is achallenge on the eve of the millennium.
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  • 51
    ISSN: 1569-8041
    Keywords: chemotherapy ; colorectal cancer ; oxaliplatin ; phase II
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Backround:Oxaliplatin is a novel platinum derivative, which,combined with 5-fluorouracil (5-FU), and folinic acid (FA), demonstratessynergistic activity in metastatic colorectal cancer (MCC). The HeCOGperformed a multicenter phase II study of a weekly oxaliplatin administrationschedule in patients with previously treated MCC to evaluate the antitumorefficacy and toxicity of this combination. Patients and methods:Eligible patients included those whorelapsed after or during chemotherapy with 5-FU and FA and/or irinotecan.Prior radiotherapy was accepted provided that measurable disease was outsidethe radiation fields. Other eligibility criteria included written informedconsent, a WHO performance status ≤2 and adequate bone marrow, liver andrenal function. Treatment consisted of Oxaliplatin 50 mg/m2 bytwo-hour intravenous (i.v.) infusion followed by FA 500 mg/m2(two-hour i.v. infusion) and 5-FU 2500 mg/m2 (24-hour continuousi.v. infusion) on days 1, 8, 15, 22, 29, 36. The regimen was repeated every50 days. Results:Thirty-two patients (Median age 61 years, range25–76) entered the trial. The majority (75%) had progressed afterreceiving first-line chemotherapy. Diarrhea was the main non-hematologic toxicity. More than half of thepatients (53%) developed grades 3 or 4 diarrhea. Due to this sideeffect only 29% of cycles were given with at least 90% of theplanned dose of 5-FU. Hematologic toxicity included grade 3 neutropenia andthrombocytopenia (10% for each), and grade 4 thrombocytopenia(3%). Two patients (6%) died of sepsis, one related toneutropenia and one due to urinary tract sepsis. Sixteen patients (50%)developed grades 1 and 2 neurotoxicity in the form of sensory neuropathy,which was mild and transient. The objective response rate was 13%(95% CI: 3%–29%). All four responses were partial.Twelve patients (38%) had stable disease and 8 (25%) progressivedisease. The median time to progression was three months and the mediansurvival was nine months from the start of therapy. The Kaplan–Meierestimated probability of one-year survival for the group as a whole was32%. Conclusions:The weekly administration of oxaliplatin with 5-FUand FA was associated with considerably less neurotoxicity than otherschedules. However, the high percentage of diarrhea suggests that a dosereduction of 5-FU in this regimen may result in better therapeutic synergy.
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  • 52
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    Annals of oncology 11 (2000), S. 887-889 
    ISSN: 1569-8041
    Keywords: chemotherapy ; lung metastases ; spontaneous pneumothorax
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Pneumothorax occurring in the absence of obvious lungdisease is defined as spontaneous pneumothorax. Spontaneous pneumothoraxoccurs in a variety of settings in patients with malignancies. Patients and methods:We present a case report of spontaneouspneumothorax in malignancy and review the literature. Results:No correlation was found between the occurrence ofpneumothorax with age, sex or smoking history. Pneumothorax occurred with avariety of primary tumors. However it was always associated with lungmetastases or lung involvement with tumor. In certain cases the metastaseswere detected after the occurrence of pneumothorax. Conclusions:The occurrence of pneumothorax in a patient withmalignancy should prompt a search for lung metastases.
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  • 53
    ISSN: 1569-8041
    Keywords: adjuvant ; chemotherapy ; gastric cancer ; meta-analysis ; randomised clinical trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Several studies have investigated the possible roleof the adjuvant chemotherapy after curative resection for gastric cancerfailing to show a clear indication; previous meta-analyses suggested smallsurvival benefit of adjuvant chemotherapy, but the statistical methods usedwere open to criticisms. Materials and methods:Randomised trials were identified by meansof Medline and CancerLit and by selecting references from relevant articles.Systematic review of all randomised clinical trials of adjuvant chemotherapyfor gastric cancer compared with surgery alone, published before January 2000,were considered. Pooling of data was performed using the fixed effect model.Death for any cause was the study endpoint. The hazard ratio and its95% confidence intervals (95% CI), derived according to themethod of Parmar, were the statistics chosen for summarising the relativebenefit of chemotherapyversuscontrol. Results:Overall 20 articles (21 comparisons) were considered foranalysis. Three studies used single agent chemotherapy, seven combination of5-fluorouracil (5-FU) with anthracyclin, ten combination of 5-FU withoutanthracyclines. Information on 3658 patients, 2180 deaths, was collected. Chemotherapy reduced the risk of death by 18% (hazard ratio 0.82,95% CI: 0.75–0.89, P 〈 0.001). Association ofAnthracyclines to 5-FU did not show a statistically significant improvementwhen compared with the effect of the other regimens. Conclusions:Chemotherapy produces a small survival benefit inpatients with curatively resected gastric cancer. However, taking into accountthe limitations of literature based meta-analyses, adjuvant chemotherapy isstill to be considered as an investigational approach.
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  • 54
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    Annals of oncology 11 (2000), S. 1343-1347 
    ISSN: 1569-8041
    Keywords: chemotherapy ; Her2/neu ; indolent ; malignant ; palliative care ; secretory breast cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Secretory carcinoma of the breast is a rare and indolent tumour originallydescribed in children but occurring equally in the adult population. Theprincipal management problems following primary surgical treatment are localrecurrence and axillary lymph node metastases. Distant metastases areextremely rare. We present the case of a 27-year-old woman with pulmonary metastases froma secretory breast cancer treated by mastectomy and axillary lymph nodedissection 12 years previously. There was no response to chemotherapy; however, the patient remained aliveand active two years from presentation with metastatic disease and one yearfrom cessation of all cytotoxic chemotherapy. She eventually died ofrespiratory failure two and a half years after presentation. To our knowledge, this is only the fourth reported case of distantmetastases from secretory breast cancer and the second reported case in whichcurrent active chemotherapy has been used. We review the literature anddiscuss the apparent chemoresistance of this tumour including the lack ofmembrane staining for Her2/neu. In the absence of any proven effective chemotherapy we believe that symptomcontrol becomes the focus of management and offers patients with metastaticsecretory breast cancer the greatest chance of a functional and good qualityexistence.
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  • 55
    ISSN: 1569-8041
    Keywords: chemotherapy ; drug interaction ; in vitroassay
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Chemotherapy using multi-drug regimens is consideredmore active than single-agent therapy. This may be due to synergisticinteractions or, simply, a higher probability of administering an activeagent. We investigated in vitrothe type of drug interactions in arecognized regimen in relationship to tumour type and drug sensitivity. Patients and methods: The possibility of synergistic and additiveinteractions between individual cytotoxic drugs was investigated for thecomponent drugs of the established FEC regimen, i.e., 5-fluorouracil,epirubicin and cyclophosphamide, in 243 patient tumour samples representingvarious drug sensitivity using the non-clonogenic fluorometric microculturecytotoxicity assay. Results: Using a cell survival of ≤50% as a limit fordrug activity and sample sensitivity, the overall response rates to the mostactive single drug (Dmax) and the combination were 56% and64%, respectively, with a distribution among diagnoses similar to thatin the clinic. For 86% of the samples there was concordance withrespect to judgement of activity using either Dmax or thecombination. For samples being sensitive to at least one single drug,95% were also sensitive to the combination whereas for samples withinsignificant Dmax effect, only 2% were sensitive to thecombination. In samples with modest Dmax effects, i.e., cellsurvival in the range 〉50%–≤80%, 45%responded to the combination. The effect of the combination was generally wellpredicted from the Dmax effect. Conclusions:The superior antitumour effect of drug combinationscompared with single drugs may be due to the higher chance of selecting anactive agent. However, for intermediately sensitive tumours, additionalinteraction effects of a combination may be of clinical significance.
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  • 56
    ISSN: 1569-8041
    Keywords: carcinosarcoma ; chemotherapy ; thyroid
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Thyroid carcinosarcoma is a rare and aggressive thyroid tumor. Histologicalexamination of a tumor showed the characteristic of epithelial carcinoma andmesenchymal differentiation. We retrospectively analyzed the course of thepatient and reviewed the literature in which only 19 other cases aredescribed. Carcinosarcoma of the thyroid is a very aggressive tumor with aclinical course similar to anaplastic thyroid carcinoma. Survival is veryshort despite aggressive multimodal treatment.
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  • 57
    ISSN: 1569-8041
    Keywords: acute myeloid leukemia ; chemotherapy ; chronic lymphocytic leukemia ; immunosuppression ; second neoplasms
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract An increased incidence of different malignancies associated to chroniclymphocytic leukemia (CLL) has been reported. The association of CLL and acuteleukemia is a rare event described in 〈1% of CLL, the type of acuteleukemia being either from the lymphoid or more often from the myeloidlineage. The coexistence of acute myeloid leukemia (AML) and CLL in the samepatient has been occasionally reported. Most of these cases have beenassociated with the administration of chemotherapy or radioterapy for CLL,suggesting that the former may be a secondary leukemia. On the other hand, CLLcould precede, but could also be diagnosed at the same, or delayed time asAML, suggesting the presence of other leukemogenic factors. We describe theexceptional development of AML and lung cancer in a patient with previouslydiagnosed CLL in minimal residual disease status after fludarabine treatmentfollowed by autologous peripheral blood stem-cell transplantation.
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  • 58
    ISSN: 1569-8041
    Keywords: chemotherapy ; interferon ; transitionall-cell carcinoma ; urothelial tract
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Based on the favorable results of the combination5-fluorouracil (5-FU), cisplatin and interferon-α as second-line treatmentin advanced metastatic transitional-cell carcinoma of the urothelial tract aconfirmatory study was executed in a multicenter setting. Patients and methods:In this open label phase II study 43patients failing adequate previous chemotherapy were treated with IFN-α2b5 MU/m2 subcutaneously for 5 consecutive days starting on day 1 and22 simultaneous with 5-FU 500 mg/m2 daily as a continuous infusion.In between the same dose of IFN-α2b was given 3 times weekly with CDDP 25mg/m2 on days 1, 8, 15 and 22. This cycle was repeated every sixweeks. Results:In 40 eligible patients 5 PR were seen (12.5%;95% confidence interval (95% CI):4.1%–26.8%). The major toxicity was hematological. Twotoxic deaths were seen due to gastro-intestinal hemorrhage. Conclusions:In view of these results this combination can not berecommended as second line treatment for metastatic transitional-cellcarcinoma of the urothelial tract.
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  • 59
    ISSN: 1569-8041
    Keywords: chemotherapy ; docetaxel ; gemcitabine ; non-small-cell lung cancer ; phase I trials ; taxanes
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Docetaxel and gemcitabine are active in a broad rangeof malignancies. The objective of this phase I trial was to determine themaximally tolerated doses of the combination of docetaxel and gemcitabine. Patients and methods:Patients with advanced cancer, WHOperformance status 0–2, who had received up to one prior chemotherapyregimen were treated with gemcitabine on days 1 and 8 and docetaxel on day 8repeated every 21 days. Prophylactic ciprofloxacin was commenced on day 11 ofeach cycle and continued until the neutrophil count reached 1.0 ×109/l. G-CSF was not administered. Dose levels studied weredocetaxel/gemcitabine: 60/800, 60/1000, 75/1000, 75/1200, 85/1200 and 100/1200mg/m2. Results:Thirty-nine patients were entered and all were assessablefor toxicity. The highest administered dose level was 100 mg/m2docetaxel and 1200 mg/m2 gemcitabine with dose limiting toxicitiesof febrile neutropenia, grade 4 neutropenia ≥7 days, grade 4thrombocytopenia, grade 3 stomatitis and/or grade 3 fatigue in three out ofsix patients. Treatment was well tolerated (40 cycles) in the 10 patientstreated at the recommended dose level (85/1200) with only a single episode offebrile neutropenia and grade 3 or 4 non-hematologic toxicity was infrequent.There was no significant pulmonary toxicity. Responses were seen in a rangeof malignancies including non-small-cell lung cancer. Conclusions:The recommended dose level of 85 mg/m2docetaxel and 1200 mg/m2 gemcitabine has a favourable toxicityprofile and is suitable for further investigation in phase II trials. Thisnon-platinum containing regimen warrants further investigation as a potentialalternative to platinum containing regimens in non-small-cell lung cancer andother malignancies.
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  • 60
    ISSN: 1569-8041
    Keywords: cervical cancer ; chemotherapy ; phase I ; radiotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background.Cisplatin and paclitaxel are active in cervical cancerand both are able to potentiate the effects of radiotherapy. In this study weevaluated the maximum-tolerated dose (MTD) of paclitaxel in combination witha fixed dose of cisplatin when given weekly concurrently with pelvicradiotherapy to patients with carcinoma of the cervix uteri. Patients and methods:Eighteen patients with cervical cancer wereenrolled in this study. Cisplatin (30 mg/m2) and paclitaxel(starting dose 40 mg/m2; 5 mg/m2 escalation per level)were given on day 1 of radiotherapy and then weekly for six times.Radiotherapy was given to the pelvis with a four-field box technique for fivedays each week. Patients received 65 Gy in 1.8 Gy fractions. Cohorts of threepatients were enrolled at each level and three further patients were includedif one or two dose-limiting severe adverse events (SAE) were recorded. SAE wasdefined as grade 3 or 4 nonhematologic toxicity, excluding nausea or vomitingand alopecia, grade 4 neutropenia or thrombocytopenia, and prolonged (〉1week) neutropenia or thrombocytopenia. Results:Four levels were studied (paclitaxel 40, 45, 50, 55mg/m2) with three, five, four and six patients enrolled,respectively. The MTD of paclitaxel was found at 50 mg/m2/wk andcisplatin 30 mg/m2/wk. Diarrhea was the dose-limiting toxicity.Thirteen patients were evaluable for response: seven complete and five partialresponses were obtained with an overall response rate of 92.3%. Conclusions:The MTD of paclitaxel is 50 mg/m2/wk whenassociated to cisplatin 30 mg/m2/wk and concurrent pelvicradiotherapy. Diarrhea is the dose limiting side effect. Preliminary datasuggest that concurrent chemoradiotherapy with paclitaxel and cisplatin couldbe a very active treatment for patients with locally advanced carcinoma of thecervix.
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  • 61
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    Annals of oncology 11 (2000), S. 509-513 
    ISSN: 1569-8041
    Keywords: assessment ; chemotherapy ; eripheral neuropathy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
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  • 62
    ISSN: 1569-8041
    Keywords: advanced breast cancer ; chemotherapy ; gemcitabine ; vinorelbine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Gemcitabine and vinorelbine have shown activity inbreast cancer. A phase II trial was initiated in order to evaluate theresponse rate (RR) and time to progression (TTP) of the combination of the twodrugs in patients with metastatic breast cancer progressing after first-linetaxane-based chemotherapy. Patients and methods:Thirty-one patients were treated with thecombination of gemcitabine 1000 mg/m2 days 1 + 8 and vinorelbine30 mg/m2 days 1 + 8. The cycles were repeated every three weeks. Results:Of 27 evaluable patients 1 (4%, 95%confidence interval (95% CI): 0.1%–19%) achievedcomplete remission (CR), five (18%; 95% CI:6%–38%) partial remission (PR), eleven (40%;95% CI: 22%–61%) stable disease and ten patientsprogressed. The median duration of response was six months (range 4–10+)and the median duration of disease stabilization was five months (range2–22+). With a median follow-up of 16 months (range 0.4–22+) themedian TTP was 3.5 months (range 0.4–22+) and the median survival was9.5 months (range 0.4–22+). Grade 3–4 toxicities weregranulocytopenia 15 patients (48%), rash 3 patients (10%),neuropathy 1 patient (3%) and thrombocytopenia 1 patient (3%).In conclusion the combination of gemcitabine/vinorelbine in the dosesadministered in this group of patients had a response rate of 22% andneeds to be further evaluated in metastatic breast cancer.
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  • 63
    ISSN: 1569-8041
    Keywords: chemotherapy ; gemcitabine ; malignant glioma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose:We conducted a phase II multicentre study of gemcitabinein patients with anaplastic astrocytoma and glioblastoma multiforme at firstrelapse. Patients and methods:Patients with anaplastic astrocytoma orglioblastoma multiforme receiving a stable dose of steroids and ECOGperformance status ≤3 were eligible for this study at the time of firstrelapse. One adjuvant chemotherapy regimen was permissible. Patients receivedgemcitabine 1000 mg/m2 i.v. weekly × 3, repeated on afour-weekly cycle. Results:Of 20 patients enrolled, 15 were evaluable for response,19 for non-hematological toxicity and 18 for hematological toxicity. Sevenpatients had anaplastic astrocytoma (AA) and twelve glioblastoma multiforme(GBM). Age ranged from 28–71 years (median 50). Fifteen patientsdiscontinued therapy due to disease progression. The median number of cyclesadministered was 1 (range 1–11); only two patients received more thanthree cycles. Hematologic toxicity was acceptable and no grade 4 toxicity wasseen. One patient developed Pneumocystispneumonia and eventualpulmonary embolism; one died of gastric hemorrhage related to steroid therapy.No objective responses were seen. Nine patients had stable disease (medianduration 2.7 months, range 0.9–11.2). Conclusions:Gemcitabine given in this dose and schedule seemswell tolerated but is not active in patients with recurrent high-gradegliomas.
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  • 64
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    Reviews in endocrine & metabolic disorders 1 (2000), S. 225-231 
    ISSN: 1573-2606
    Keywords: thyroid neoplasms ; chemotherapy ; anaplastic carcinoma ; lymphoma ; therapeutics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
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  • 65
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    Quality of life research 9 (2000), S. 129-137 
    ISSN: 1573-2649
    Keywords: EORTC QLQ-C30 ; Gynecological cancer ; Psychometric property ; Quality of life ; Standard Chinese
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The majority of quality of life (QOL) questionnaires have been developed and used in English-speaking or Western European countries. The aims of this study were to provide the Standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30 version 2.0), and evaluate its psychometric properties. The translation process included independent translation, back translation, a pilot test with gynecological cancer patients, and a review and approval by the original developers. Participants in the major study included gestational trophoblastic disease patients (n = 68), ovarian cancer patients (n = 105), and other types of gynecological cancer patients (n = 18). The average completion time of the Standard Chinese version was 8.1 ± 2.9 min. All item-subscale correlation coefficients exceeded the criterion of item-convergent validity (r 〉 0.40) except item 1, 5, 20, and 25, and all items correlated significantly higher with their own subscale than with other subscales except item 1, 20, and 25. The correlation coefficients among all subscales were significant but modest (r = 0.40–0.70). Seven out of nine subscales met the minimal standards of reliability (Cronbach's α 〉 0.70). In conclusion, the Standard Chinese version of the EORTC QLQ-C30 is a valid instrument overall in assessing the QOL of Chinese gynecological cancer patients.
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  • 66
    ISSN: 1573-2649
    Keywords: Proxy measures ; Quality of life ; Surrogacy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract In studies of the effect of cancer treatment in the advanced disease setting, researchers have attempted to avoid missing data for quality of life (QOL) assessments by either substituting proxy for patient assessments from the outset or by interspersing proxy measures when patients are unable to respond. Although poor agreement between patient and proxy assessments has been amply demonstrated in the literature, interest in using proxy measures persists. Completion of the Spitzer QL-Index by a small sample of patients with brain metastases and family member proxies provided data for evaluating the ability to substitute proxy for patient QOL assessments. These data cannot address treatment efficacy due to the modest sample size. Rather, the analyses serve to alert researchers to the important distinction (in a clinical trial setting) between agreement and the use of the proxy as a surrogate. We present several methods for evaluating the accuracy of proxy measures and for identifying other sources of error and bias that may vary with time or with treatment arm. Lin's concordance correlation coefficient suggests that proxies are generally a poor substitute for capturing a patient's perspective of his/her QOL. A longitudinal analysis suggests that the use of proxy rather than patient responses could lead to different conclusions concerning radiation therapy's effect on QOL.
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  • 67
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    Quality of life research 9 (2000), S. 207-218 
    ISSN: 1573-2649
    Keywords: Diabetes ; DTSQ ; LQD ; Non-insulin-dependent diabetes ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The purpose of the study was to find out which of five Quality of life (QoL) questionnaires are reliable and valid for evaluating the QoL in German patients with type 2 diabetes: the Diabetes Treatment Satisfaction Questionnaire (DTSQ), the Well-Being Questionnaire (WBQ), the Short Form SF36 of the Medical Outcome Study (SF36), the Diabetes39 and the Quality of Life with Diabetes (LQD) questionnaire. A stratified sample of 144 patients who were attending one of nine special hospitals for people with diabetes at the time of the study were given the questionnaires twice. Most of the scales of the questionnaires had internal consistencies (α) of above 0.80 as recommended; the retest reliabilities were lower, especially for scales evaluating satisfaction with levels of blood sugar and treatment in general. A factor analysis of all scale scores yielded four factors: (1) physical aspects, (2) well-being and satisfaction, (3) diabetes-specific stress, and (4) treatment satisfaction. Construct validity showed frequency of hypoglycemias, neuropathies, treatment with insulin and number of late complications to have a negative impact on QoL scores. No single questionnaire covered all relevant aspects of the QoL of subjects with type 2 diabetes. Thus, quality of life in diabetic people should be evaluated with scales representing the cognitive dimensions found in this study so as not to miss significant aspects.
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  • 68
    ISSN: 1573-2649
    Keywords: Coronary artery bypass grafting (CABG) ; Ejection fraction ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Aim: To describe the relief of symptoms and improvement in Quality of Life (QoL) 5 years after coronary artery bypass grafting (CABG) in relation to preoperative ejection fraction (EF). Methods: Patients who underwent CABG between 1988 and 1991 in western Sweden were approached with an inquiry prior to surgery and 5 years after the operation. Quality of Life was estimated with three different instruments: Physical activity score, Nottingham Health Profile and Psychological General Well-being Index. Results: Among all patients who underwent CABG (n = 1904) the 5-year mortality rate was 27% in those with EF 〈 0.40 and 12% in those with EF ≥ 0.40 (p 〈 0.0001). In all, 849 patients, of whom 58 (7%) had EF 〈 0.40 participated in the evaluation. Neither physical activity, symptoms of chest pain, dyspnea nor any indices of QoL were significantly associated with preoperative EF. Improvement in physical activity, symptoms of chest pain and dyspnea and various estimates of QoL appeared similar and marked regardless of preoperative EF. Conclusion: Among survivors there was no association between preoperative EF and symptoms or various estimates of QoL 5 years after CABG. Improvement in symptoms and QoL were not dependent on preoperative EF.
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  • 69
    ISSN: 1573-2649
    Keywords: Captopril ; Heart failure ; Losartan ; Missing data ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective: To measure health-related quality-of-life (HRQoL) in elderly symptomatic heart failure patients following treatment with an angiotensin II receptor antagonist (losartan) vs. an angiotensin-converting-enzyme (ACE) inhibitor (captopril). Methods: Patients (age ≥65 years) were randomised to losartan, titrated to 50 mg once daily, or captopril, titrated to 50 mg three times daily, as tolerated. Sickness Impact Profile (SIP) and Minnesota Living with Heart Failure (LIhFE) questionnaires were administered at baseline, weeks 12 and 48. Composite hypothesis testing of change in HRQoL from baseline for completers, and withdrawal for unfavourable events (death, clinical/laboratory adverse experience) was used to account for differential dropout rates. Results: In 203 patients completing the substudy (week 48), significant and comparable improvements in HRQoL from baseline were observed for both treatment groups (p ≤ 0.001). Although there was a trend favouring losartan vs. captopril for the composite HRQoL endpoint (unadjusted p = 0.018, one-sided), this was not considered significant after adjusting for multiple testing. Significantly more captopril patients in the substudy subset withdrew for unfavourable reasons (19.6 vs. 10.9%, p = 0.038). Conclusions: Significant improvements in HRQoL were observed in elderly patients with symptomatic heart failure treated with losartan and captopril long-term. A trend favouring losartan in the composite measure of drug tolerability/quality of life was not significant, but losartan was generally better tolerated than captopril in that significantly fewer losartan patients discontinued therapy.
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  • 70
    ISSN: 1573-2649
    Keywords: Accommodation processes ; Quality of life ; Satisfaction ; Schizophrenia ; Social comparison
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract In schizophrenic patients, quality of life (QoL) studies often find high levels of general life satisfaction and satisfaction in various life domains despite deprived living conditions. Therefore, the usefulness of QoL as an outcome indicator has been questioned. Since social comparison processes have been postulated to be related to the level of satisfaction, this hypothesis was analysed empirically by the present study in schizophrenic patients. Satisfaction and social comparisons of 148 schizophrenic inpatients and 66 mentally healthy controls were examined with regard to the domains ‘health’ and ‘family’ by means of a standardised interview. The schizophrenic patients had a history of either long-term (n = 75) or short-term (n = 73) restricted and deprived living conditions. Long-term patients showed significantly higher satisfaction levels than short-term patients. They compared themselves predominantly laterally or downwards with fellow inpatients. Significant relationships between the direction of social comparisons and satisfaction ratings were found in all three samples. Social comparisons proved to be important for the level of satisfaction in schizophrenic patients. Results indicate that experiences of restricted and deprived living conditions induce accommodation processes and response-shifts that should be taken into account in the interpretation of quality-of-life data.
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  • 71
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    Quality of life research 9 (2000), S. 509-520 
    ISSN: 1573-2649
    Keywords: Arthritis impact measurement scales ; Elderly ; Patient generated index ; Quality of life ; Validity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The purpose of this study was to determine the validity of the recently modified patient generated index (PGI) when used as a self-completed postal questionnaire by older people with arthritis. Two postal surveys were used, followed by interviews with a theoretically chosen sub-sample of respondents to both. Data from the self-completed modified PGI and the arthritis impact measurement scales (AIMS) and the interviews were assessed against 10 pre-defined validity criteria. A total number of 1027 people over 65 years old and with arthritis were surveyed and 53 were selected for interview. The response rates to the two-part survey were 78 and 83%. Complete data for the validity analysis were available from 47% of the respondents. The modified PGI met four and failed to meet six validity criteria. Pre-defined correlations were found with the AIMS and differentiation was possible between respondents with mild, moderate and severe arthritis and between those who had recently sought medical attention and those who had not. The areas that had been chosen for inclusion in the modified PGI were affected by arthritis but may not have been the ‘most important’ areas. The measurement method could not detect changes in health nor differentiate between respondents taking and not taking analgesics. There were several problems in the respondents' interpretation of the instructions, which were only revealed during the interviews. These data should help inform further modification of the PGI.
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  • 72
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    Quality of life research 9 (2000), S. 667-674 
    ISSN: 1573-2649
    Keywords: Eating disorders ; Quality of life ; Patient outcomes
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective: This study investigated the perception of health-related quality of life (HRQoL) in ambulatory patients with eating disorders in relation to the severity of eating symptomatology and psychological comorbidity. Methods: One hundred ninety-seven study patients were consecutively recruited at the Eating Disorders Outpatient Clinic. Short Form-36 items (SF-36), a generic HRQoL questionnaire, the Eating Attitudes Test (EAT-40), and the Hospital Anxiety and Depression Scale (HAD) were used to measure different aspects of HRQoL. The results of the SF-36 were compared with the norms of the Spanish general population for women 18–34 years of age. Results: Patients with eating disorders were more dysfunctional in all areas of the SF-36 compared with women in the general population. There were no differences among the eating disorder diagnostic groups. Higher scores on the EAT-40 and the HAD were associated with a perception of greater impairment on all SF-36 subscales. Conclusion: The evaluation of HRQoL in these patients confirms the impact of these disorders on daily life in areas not directly related to eating disorders. The SF-36 is useful for discriminating among different levels of severity of eating disorders and other psychological comorbidities of these patients.
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  • 73
    ISSN: 1573-2649
    Keywords: Asthma ; Chronic obstructive pulmonary disease ; Epilepsy ; Health-related quality of life ; Health status ; Ischemic coronary disease ; Quality of life ; Rheumatoid arthritis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The objective of this study was to compare the health-related quality of life (HRQL) of patients with epilepsy with populations suffering from different chronic diseases, using the short form 36 (SF-36) health profile measure. The populations to be compared were adult patients drawn from hospital based registers, with confirmed epilepsy (n = 397), angina pectoris (n = 785), rheumatoid arthritis (n = 1030), asthma (n = 117) and chronic obstructive pulmonary disease (COPD) (n = 221). Health-related quality of life scores were compared using analysis of covariance (ANCOVA) for predicting mean scores adjusted for age, gender, education and comorbidity. Patients with epilepsy on average scored highest on all scales, reflecting that in our sample the majority had well-controlled epilepsy. Our results indicate that the HRQL of a representative sample of patients with epilepsy is good, when compared with other chronic disorders, although reduced in several dimensions compared with a general reference population. Patients with rheumatoid arthritis (RA) and COPD scored lowest on the physical function scales, while rheumatoid arthritis patients reported most pain.
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  • 74
    ISSN: 1573-2649
    Keywords: Asthma ; Quality of life ; Questionnaire ; Satisfaction ; Validation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The Patient Satisfaction with Asthma Medication (PSAM) questionnaire was developed because no treatment satisfaction questionnaire could be identified that was comprehensive yet brief enough for use in clinical trials. Adult moderate asthmatics residing in Canada using an inhaled medication (either salmeterol, formoterol, or albuterol) self-administered the questionnaire, which also included the Asthma Quality of Life Questionnaire (AQLQ). A total of 53 asthmatics (70% female, 45% married, mean age: 47 years) completed the questionnaire. Using variable clustering, four PSAM scales were identified: Inhaler Properties, Comparison with Other Medications, Overall Perception of Medication, and Relief. Internal-consistency reliability provided evidence of reliability and lack of redundancy (Cronbach's Alpha: 0.82–0.88). Test-retest reliability was acceptable (ICC values at or near 0.70). As expected, interscale PSAM correlations were moderate to high; correlations between the PSAM and the AQLQ were low to moderate. To assess known groups validity, respondents were categorized by self-reported degree of asthma control: ‘very well controlled’ ‘somewhat controlled’, and ‘not well controlled’. Significant between-groups differences were found on all PSAM scales except Inhaler Properties. Patients categorized as ‘very well controlled’ tended to report highest PSAM scale scores. The PSAM questionnaire demonstrated reliability and validity in moderate asthmatics. Responsiveness should be assessed in future, prospective studies.
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  • 75
    ISSN: 1573-2649
    Keywords: Diabetes mellitus ; Functional insulin treatment ; Lifestyle ; Quality of life ; Randomised cross-over study ; Treatment satisfaction
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Even a small improvement in satisfaction with treatment for a chronic disease can be valuable. However, sensitive measurements instruments are needed to assess the effects of treatment changes in patients already well satisfied with baseline treatment. Such instruments were thought to be necessary to deal with ceiling effects in scores of satisfaction with functional insulin treatment (FIT) accommodating full flexibility of food intake and lifestyle in diabetes by manipulation of insulin (FIT; Howorka etal. 2000). The Status(S) version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ, Bradley 1994) was extended with items measuring specific components of FIT and its psychometric properties investigated in a validation study with 171 FIT patients with diabetes. A new Change(C) version of DTSQ extended for FIT was used together with the DTSQ(S) by 52 participants in a subsequent randomised cross-over study involving new fast-acting lispro vs. regular insulin, where treatment satisfaction was the primary outcome variable. Insulin lispro use improved satisfaction (p ≤ 0.001) both, on classical and extended versions of DTSQ(S) and (C), despite high baseline levels of satisfaction. However, the DTSQ(C) augmented the effects of lispro (p = 0.0001) apparent on DTSQ(S) scores and revealed significant treatment effects (p ≤ 0.01) not significant with DTSQ(S). In parallel, glycaemic control improved with lispro (e.g., HbA1c, p = 0.023). Improved satisfaction with treatment was more apparent with DTSQ(C) than DTSQ(S) in patients who at baseline were at or near ceiling for treatment satisfaction.
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  • 76
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    Quality of life research 9 (2000), S. 931-940 
    ISSN: 1573-2649
    Keywords: HIV/AIDS ; Measurement ; Quality of life ; Women
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Although women had been under recognized in the literature on HIV/AIDS, increasing numbers of studies have focused on the lives and experiences of women living with HIV/AIDS. Areas of research in which the study of women and HIV continues to be noticeably lacking include health related quality of life (HRQOL). This paper describes HRQOL in an inner city sample of 287 HIV positive non-pregnant women, interviewed as part of a larger multi-site CDC funded study of the reproductive health of women. The average age of the respondents was 33 years and women had known their HIV status an average of 41 months. HRQOL was assessed using a 17-item modified version of the Medical Outcomes Study-HIV Health Survey and demonstrated acceptable internal consistency (0.64-0.89) and variability. Women in our study were similar to other HIV-positive female samples and reported lower levels of well-being and functioning than some HIV-positive male samples. Women's responses to individual items and areas of potential need for health care are discussed. Examination of HRQOL in women with HIV can aid in the comparison of how women and men are affected by HIV and can help health care professionals identify needed services and include possible interventions to promote quality of life.
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  • 77
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    Quality of life research 9 (2000), S. 1041-1052 
    ISSN: 1573-2649
    Keywords: Cancer ; Proxy ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The objective of the study was to determine possible differences in perception of quality of life (QoL) between patients with metastatic breast or prostate cancer, their partners, and the treating physician. Patients with metastatic breast cancer (n = 71), and metastatic prostate cancer (n = 29), a partner, and the physician each completed the same QoL questionnaire indicating how they perceived the patient's QoL. The European organization for research and treatment of cancer (EORTC) QLQ-C30 questionnaire was used to assess patients with breast cancer and the modified prostate cancer specific quality of life instrument (PROSQOLI) for patients with prostate cancer. There was reasonable agreement in mean scores between patients, and physicians or partners, for many domains of QoL; however, there was substantial discordance between scores when considering individual patients. For patients with metastatic breast cancer, physicians systematically underestimated overall QoL (p = 0.0002), social functioning (p = 0.001), and role functioning (p = 0.008), while partners showed better agreement. With prostate cancer physicians tended to underestimate pain, while mean scores for spouses were more concordant. There is substantial variability between ratings of QoL by physicians or partners, as compared to patient ratings. Medical decisions should be based on information about QoL provided by patients using validated methods.
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  • 78
    ISSN: 1573-2649
    Keywords: Prostate cancer ; Psychometrics ; Quality of life ; Questionnaire
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Quality of life in prostate cancer patients with clinically localized disease has become the focus of increasing attention over the past decade. However, few instruments have been developed and validated to assess quality of life specifically in this patient population. Objective: The purpose of this investigation was to create a comprehensive, multi-scale quality of life instrument that can be tailored to the needs of the clinician/investigator in multiple settings. Design, subjects, and measures: Patients diagnosed with clinically localized prostate cancer were mailed a questionnaire consisting of new and previously validated quality of life items and ancillary scales. Data from returned questionnaires were analyzed and used to create a multi-scale instrument that assesses the effects of treatment and disease on urinary, sexual, and bowel domains, supplemented by a scale assessing anxiety over disease course/effectiveness of treatment. The instrument was then mailed to a second sample of prostate cancer patients once and then again two weeks later to assess test-retest reliability. To assess feasibility in clinical settings, the instrument was self-administered to a third patient sample during a urology clinic visit. Results: All scales exhibited good internal consistency and test-retest reliability, convergent and discriminant validity, and significant correlations with disease specific, generic health-related, and global measures of quality of life. Men with greater physiologic impairment reported more limitations in role activities and more bother. Scales were also able to differentiate patients undergoing different therapies. All scales exhibited negligible correlations with a measure of socially desirable responding. Additionally, the instrument proved feasible when used as a self-administered questionnaire in a clinical setting. Conclusions: The current instrument possesses brief multi-item scales that can be successfully self-administered in multiple settings. The instrument is flexible, relatively quick, psychometrically reliable and valid, and permits a more comprehensive assessment of patients' quality of life.
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  • 79
    ISSN: 1573-2649
    Keywords: Fluctuations ; Health state utilities ; Parkinson's disease ; Preference measurement ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The purpose of this study was to derive patient preferences and utilities for outcomes associated with treatment of motor fluctuations, or ‘off-time’ for patients with Parkinson's disease (PD). Visual analog scale (VAS) and standard gamble (SG) approaches were used with 60 patients to determine patient preferences and utilities for 10 health state descriptions. Health state descriptions were categorized according to two factors: disease severity, and proportion of the day with ‘off-time’. There were two representative levels of disease severity, based on Hoehn and Yahr stages 1.5 and 2.5: unilateral disease with no postural instability, and bilateral disease with some postural instability. These severity levels were combined with five levels of ‘off-time’ per day ranging from none to 〉 75% of the day. Patients' mean preference or utility for their own current health ranged from 0.65 ± 0.20 (VAS) to 0.74 ± 0.22 (SG). Patients assigned the lowest mean values to the health state description for Hoehn and Yahr stage 2.5 with ‘off-time’ for 〉 75% of the day (VAS: 0.17 ± 0.17; SG: 0.49 ± 0.27). The highest mean values were assigned to Hoehn and Yahr stage 1.5 with no ‘off-time’ (VAS: 0.83 ± 0.17; SG: 0.85 ± 0.18). The results of this study indicated patients with PD would likely seek treatment that would minimize the amount of ‘off-time’ experienced per day, and that patients were relatively risk averse.
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  • 80
    ISSN: 1573-689X
    Keywords: bedside wellness system ; chemotherapy ; fatigue ; emesis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: The bedside wellness system (BSW) is effective for decreasing stress and improving mental well-being and should help relieve the side effects and mental disorders of patients during cancer chemotherapy. Methods: The study was a randomized clinical trial. After giving informed consent, patients were randomly assigned to the BSW intervention or control groups. The patients were given the Hospital Anxiety and Depression Scale (HADS) test before the trial to evaluate their emotional baseline. The Cancer Fatigue Scale, which was developed at our institute, and face visual analog scale were used to measure the emotional state and subjective feelings before and after the trial. The degree of emesis was measured using a visual analogue scale after the experience. We set up the system in a room in the outpatient clinic of the National Cancer Center New Hospital Building. Results: The decreases in the fatigue score and emesis score 3–5 days after chemotherapy were statistically significant (both p 〈 0.05) and carry-over effects were detected. Conclusions: BSW intervention therapy is an effective way to treat fatigue and emesis. This virtual reality system is a new therapeutic method that can be used in palliative medicine.
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  • 81
    ISSN: 1573-7284
    Keywords: GHQ-28 ; Ischaemic heart disease ; Mental health ; Quality of life ; SF-36 ; Validity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective: To assess the mental health of patients admitted to hospital with suspected ischaemic heart disease, by means of two instruments, the General Health Questionnaire (GHQ-28) and the MH (1–5) dimension of the SF-36 Health Survey Questionnaire, and to compare the psychometric properties of both questionnaires in this population. Methods: A study was conducted of 185 patients consecutively admitted to hospital with suspected ischaemic heart disease, classified into four groups: Acute Myocardial Infarctus (AMI), unstable angina, non-ischaemic cardiologies, and non-cardiological conditions. Their mental health was assessed by means of the GHQ-28 and the MH 1–5 sub-scales of the SF-36; the validity of the results were analysed by the association of each instrument with socio-demographic (age, sex, social class, and educational level) and clinical (co-morbidity, risk factors, diagnostic groups and background to the illness) variables. The correlation of each instrument with other sub-scales of the SF-36 was studied. The internal consistency was measured by Cronbach's α, together with the item-internal consistency and item-discriminant validity. Results: Of the population studied, 71.9% were males and the mean age was 60.2 years (SD: 10.4). The diagnosis for 33.5% was AMI and for 37.8% unstable angina. For all the variables studied, the scores in the two instruments were ordered in the same way, and were significantly worse for females and for the most disadvantaged social class. None of the scales discriminated in respect of the diagnostic group or the presence of comorbidity. However, a linear relationship was observed with risk factors. Cronbach's α was 0.95 for the GHQ-28 and 0.80 for the MH 1–5. Correlations with the other dimensions showed ranges of −0.35 to −0.61 for the GHQ-28 and of 0.26 to 0.61 for the MH 1–5. These were highest for the Vitality and Social Functioning sub-scales in both instruments. Conclusions: The subjective perception of mental health is measured in a similar way by both the MH 1–5 scale of the SF-36 and the GHQ-28. However, since the MH 1–5 questionnaire is shorter, it should be administratively easier to introduce into routine cardiological practice.
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  • 82
    ISSN: 1573-7217
    Keywords: cerbB2 ; chemotherapy ; neoadjuvant ; prognosis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Recent advances in the detection and treatment of breast cancer have led to an intensive search for new markers of both prognosis and chemoresponsiveness. The oncogene cerbB2 has proved to be one of the most promising markers currently under study, both as a predictor of chemoresponsiveness and as a marker of poor prognosis. In addition the increasing use of neoadjuvant chemotherapy has led to the loss of standard prognostic criteria. In order to study the potential role of cerbB2 expression as an indicator of chemoendocrine resistance and poor prognosis, both before and after chemotherapy, we obtained tumour sections from 283 women enrolled onto a neoadjuvant trial. In this trial patients were randomised to receive either primary surgery followed by adjuvant chemoendocrine treatment or neoadjuvant chemoendocrine therapy followed by surgery. CerbB2 status was determined immunohistochemically on all of these patients. Thirty-eight percent of the tumours were cerbB2 positive. There was no significant difference in expression between the adjuvant (41%) and neoadjuvant arms (35%). CerbB2 positive patients were much more likely to have shown non-response to chemoendocrine therapy (p〈0.001) and had a worse DES (p〈0.05). The best prognosis was seen in cerbB2 negative patients receiving neoadjuvant chemoendocrine therapy who showed a significantly better DFS (p〈0.05), than the cerbB2 negative patients receiving adjuvant therapy.
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  • 83
    ISSN: 1573-7217
    Keywords: breast cancer ; chemotherapy ; cohort study ; radiotherapy ; second primary cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objectives and methods.The risk of second primary malignancies (SMN) was studied in a cohort of 4,416 one-year survivors of a breast cancer. The role of the menopausal status and of the initial treatment modalities (surgery, radiotherapy, and chemotherapy) was investigated. Results.Excluding second primary breast cancer and non-melanoma skin cancer, a total of 193 (4.4%) patients developed a SMN between 1973 and 1992, compared with 136 expected (Standardised Incidence Ratio, SIR = 1.4, 95% CI (1.2–1.6)). No trend towards either an increase or a decrease was noted in the SIR with time after treatment (p = 0.2). The greatest increase in the relative risk concerned soft tissue cancers (SIR = 13.0, 95% CI: 6.8–22.3), followed by leukaemia (SIR = 3.1, 95% CI: 1.7–5.0), melanoma (SIR  =  2.7, 95% CI: 1.4–4.8), kidney (SIR = 2.5, 95% CI: 1.2–4.5), ovary (SIR = 2.0, 95% CI: 1.2–3.1) and uterine tumours (SIR = 1.9, 95% CI: 1.4–2.5). The SIR was 3.0 (95% CI 1.8–4.7) in women under 40 at the time of the breast cancer, 1.9 (95% CI : 1.4 – 2.4) in those aged 40–49 and 1.2 (95% CI 1.0–1.4) in those aged 50 or more. In the 2,514 women who had received radiotherapy as initial treatment without chemotherapy, the SIR for all SMN was 1.6 (95% CI: 1.1–2.3) fold higher than in those who had not received radiotherapy as initial treatment. Conclusion.In conclusion, this study confirms the increased risk of second malignancies in women treated for a breast cancer, and particularly in those who were younger at the time of treatment for breast cancer. Our results also suggest that radiotherapy may play a role in the onset of these second lesions.
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  • 84
    ISSN: 1573-7217
    Keywords: breast cancer ; locally advanced ; neoadjuvant ; chemotherapy ; paclitaxel ; cisplatin
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background.In an earlier study, we have demonstrated a high response rate in metastatic breast cancer using paclitaxel (P) and cisplatin (C). A phase II study using the same regimen (PC) has been conducted in locally advanced breast cancer (LABC). Methods.A total of 72 consecutive patients with non-inflammatory LABC (T2 ≥ 4 cm, T3 or T4, N0–N2, M0). Patients were scheduled to receive 3–4 cycles of the neoadjuvant PC (paclitaxel 135 mg/m2 and cisplatin 75 mg/m2 on day 1) every 21 days. Patients were then subjected to surgery and subsequently received 6 cycles of FAC (5-fluorouracil 500 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2) or 4 cycles of AC (doxorubicin 60 mg/m2, and cyclophosphamide 600 mg/m2). Patients then received radiation therapy, and those with hormone receptor positive tumors were given adjuvant tamoxifen intended for 5 years. Results.The median age was 39 years (range, 24–78). Clinically, 7%, 58%, and 35% of patients had T2 ≥ 4 cm, T3, and T4, respectively. Disease stage at diagnosis was IIB (33%), IIIA (27%), and IIIB (40%). Complete and partial clinical response to PC was demonstrated in 13 (18%), and 52 (72%) patients, respectively. Of those patients with evaluable pathologic response (68 patients), complete pathologic response (pCR) was achieved in 15 (22%) patients. At a median follow-up of 22 (± 3.5) months, 58 (81%) were alive with no recurrence, nine (12%) were alive with evidence of disease, and five (7%) were dead. None of the patients achieving pCR has developed any relapse. The median overall survival has not been reached for all 72 patients with a projected 3-year survival (± SE) of 90% (± 4%). The median progression-free survival (PFS) was 42.1 (± 4.8) months with a projected PFS of 74% ± 7% at 3-years (for 68 patients). Conclusions.PC regimen in LABC produced a high pCR. The contribution of the other added modalities to survival could not be assessed.
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  • 85
    ISSN: 1573-7217
    Keywords: adjuvant treatment ; breast cancer ; chemotherapy ; immunotherapy ; radiotherapy ; randomized trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract With a median follow-up of 14 years, the combination of polyadenylic–polyuridylic acid plus locoregional radiotherapy (257 patients) has significantly improved disease-free survival (p = 0.03) and significantly reduced the incidence of metastases (p = 0.04) when compared to CMF alone (260 patients), in women with operable breast cancer. The trial does not, however, permit an appreciation of the respective role of radiotherapy and PolyAU in these results.
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  • 86
    ISSN: 1573-7225
    Keywords: breast neoplasms ; chemotherapy ; female ; hormonal therapy ; invasive carcinoma ; multiple primary neoplasms ; radiation therapy ; thyroid neoplasms
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Breast and thyroid cancer have been observed to occur more frequently than expected as multiple primary tumors in women. The study presented herein focuses on the effects of age at diagnosis and treatment for the first cancer on the development of the second cancer. Methods:This retrospective cohort study used a study population consisting of 38,632 women diagnosed with primary invasive breast cancer and 2189 women diagnosed with primary invasive thyroid cancer between 1974 and 1994. Cases were identified from records of the Cancer Surveillance System of western Washington and followed for subsequent cancer development through 1995. Results:Seventy-one women were diagnosed during their lives with both breast and thyroid cancers. Including cancers diagnosed during the same month as or after the initial cancer, the relative risk (RR) of breast cancer among women with thyroid cancer was 1.5 (95% confidence interval [CI] 1.1–2.0), and the RR of thyroid cancer among women with breast cancer was 1.5 (95% CI 1.1–2.2). Among women with thyroid cancer, risk of breast cancer was greatest when the latter cancer was diagnosed under 45 years of age (RR = 2.3, 95% CI 1.1–4.4). First course of treatment, including radiation or hormonal therapy to treat thyroid cancer, and radiation, chemotherapy, or hormonal therapy to treat breast cancer, did not alter a woman's risk of developing the second cancer. Conclusions:The data suggest that the incidence of breast and thyroid cancer may be related, and that in particular women with thyroid cancer may be at a moderately increased risk of developing breast cancer before age 45.
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  • 87
    ISSN: 1433-8726
    Keywords: Key words Bladder neoplasm ; Quality of life ; QLQ-C30 ; Cystectomy ; Ileal conduit ; Orthotopic neobladder ; Urinary diversion
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The impact of bladder removal and urinary diversion for patients' everyday life is largely unknown. The aims of this study were to compare subjective morbidity of ileal neobladder to the urethra versus ileal conduit urinary diversion and to elucidate its influence on quality of life. A total of 102 patients who underwent cystectomy due to a bladder malignancy were included in the study. In 69 patients (67.6%) an orthotopic neobladder and in 33 patients (32.4%) an ileal conduit was performed as urinary diversion. The compliance was 99% and mean follow-up was 37 months. All patients completed two retrospective quality of life questionnaires, namely the QLQ-C30 and a questionnaire developed at our institution to ask for urinary diversion specific items. The questioning and assessment was performed by non-urologists. The results obtained from the validated (QLQ-C30) and our own specially compiled questionnaire clearly demonstrate that patients with an orthotopic neobladder are more able to adapt to the new situation than patients with an ileal conduit. In addition, neobladder to the urethra improves the quality of life because it improves self-confidence, causes better rehabilitation as well as the restoration of leisure, professional, travelling, and social activities, and reduced risk of inadvertent loss of urine. For example, 92.8% of neobladder patients did not feel handicapped at all, and 87% did not feel sick or ill, in contrast to 51.5% and 66.7% of ileal conduit patients, respectively. Of the neobladder patients, 74.6% felt absolutely safe with the urinary diversion in contrast to 33.3% in the ileal conduit group. Only 1.5% of neobladder patients had wet clothes caused by urine leakage during the day, versus 48.5% of ileal conduit patients. Moreover, 97% of our neobladder patients would recommend the same urinary diversion to a friend suffering from the same disease, but only 36% of ileal conduit patients would do so. These results demonstrate that the quality of life is preserved to a higher degree after orthotopic neobladder than after ileal conduit urinary diversion.
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  • 88
    ISSN: 1433-8491
    Keywords: Key words Obsessive-compulsive disorder ; Subclinical OCD ; Epidemiology ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Despite the worldwide relevance of obsessive-compulsive disorder (OCD) there are considerable differences in prevalence rates and gender ratios between the studies and a substantial lack of prevalence data on subclinical OCD. Moreover, data on quality of life and on psychosocial function of subjects with OCD and subclinical OCD in the general population are missing to date. Methods: German versions of the DMS-IV adapted Composite International Diagnostic Interview were administered to a representative sample of 4075 persons aged 18–64 years living in a northern Germany region. Specific DSM-IV based criteria for subclinical OCD were used. Results: The life-time prevalence rates for OCD and subclinical OCD were 0.5% and 2%, respectively. Twelve month prevalence rates were 0.39% and 1.6%, respectively. The gender female:male ratio was 5.7 in OCD and 1.2 in subclinical OCD. In various measures of psychosocial function and quality of life, OCD and subclinical OCD were significantly impaired. However, subclinical OCD subjects did not visit mental health professionals more often than controls. Conclusion: Due to different epidemiological characteristics subclinical OCD might represent a syndrome distinct from OCD which is also associated with significant impairments in personal and interpersonal functions and in quality of life.
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  • 89
    ISSN: 1433-7339
    Keywords: Key words Cancer ; Fatigue ; Depression ; Symptom management ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  Fatigue is one of the most frequent symptoms in cancer patients. However, the precise causes of this fatigue are still unknown, and this situation makes it difficult to combat the problem. The present study was conducted to investigate factors correlated with fatigue in disease-free breast cancer patients. A group of 134 randomly selected ambulatory breast cancer patients who had undergone successful surgical treatment participated. They completed the Cancer Fatigue Scale, the Hospital Anxiety and Depression Scale, the Mental Adjustment to Cancer Scale, and an ad hoc questionnaire detailing physical symptoms, social support, and demographic variables at home and returned them by mail the following day. Multiple regression analysis revealed that fatigue was significantly correlated with dyspnea, insufficient sleep, and depression, and that these three variables accounted for a total of 46% of variance in fatigue. Factors concerned with the cancer and treatment, such as disease stage, lymph node metastasis, number of days since operation, past intravenous chemotherapy, radiotherapy, current use of fluoropyrimidine compounds, and current use of tamoxifen citrate were not correlated with fatigue. The results suggest that fatigue in this population is determined by current physical and psychological distress rather than by the cancer itself and prior cancer treatments, and that the management of dyspnea, insomnia, and depression might be important in reducing fatigue in this population.
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  • 90
    ISSN: 1573-2649
    Keywords: Acquired immune deficiency syndrome (AIDS) factor analysis ; Functional status ; Health status ; Health status indicators ; Human immunodeficiency virus (HIV) ; Mental health ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract To examine the effect of HIV status, symptomatology and CD4+ lymphocyte level on health-related quality of life, the Medical Outcomes Study Short-Form Health Survey (SF-36) was administered to 2,295 gay men enrolled in the Multicenter AIDS Cohort Study (MACS) in 1994. Distinct physical and mental health factors of the SF-36 were found. Seropositive asymptomatic individuals and seropositive individuals with CD4+ lymphocytes ≥ 500/mm3 scored as well as seronegative participants on all of the mental health domain scales, but lower on the general health perceptions and physical health composite score. Seropositive individuals with at least one symptom or with CD4+ lymphocytes below 200/mm3 scored significantly lower on all of the SF-36 scales and summary scores than seronegative controls. The SF-36 was found to exhibit similar mental and physical health factors for an adult gay male population to that previously seen in general population samples and in patient groups with other diseases. In conclusion, HIV-positive men who are asymptomatic or have CD4+ lymphocytes above 500/mm3 have similar perceived mental health but worse perceived physical health than seronegative men. HIV-positive men who are symptomatic or have CD4+ lymphocytes below 200/mm3 have worse perceived mental and physical health than seronegative men.
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  • 91
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    Quality of life research 9 (2000), S. 29-38 
    ISSN: 1573-2649
    Keywords: Child ; EuroQol ; Imperforate anus ; Proxy ; Quality of life ; TACQOL
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective: To investigate the feasibility and validity of a proxy version of the EuroQol in children treated for imperforate anus. Methods: Patients included were between 1 and 51 years of age. Instruments included were the EuroQol, the TACQOL and a disease specific questionnaire, the Langemeijer Stool Questionnaire. Patients older than 15 years filled in all questionnaires themselves, in the age groups 5–10 and 11–15 a parent administered the questionnaires. Feasibility was judged on the number of missing values. In search of validity, EuroQol scores were compared with the prevalence of disease symptoms (convergent validity) and with the TACQOL (construct validity). Results: The number of missings was not related to age. The disease specific questionnaire correlated significantly with the EQvas from 11 years on and with the EQ-5Dindex from 5 years on. The mean correlation between contextual similar domains of the EuroQol and the TACQOL was −0.55. The correlation between different domains was −0.32. Conclusion: The results support the idea that the use of a proxy version of the EuroQol is feasible and valid. The convergent validity of the EQvas was supported from 11 years on. The EQ-5D showed good construct and convergent validity from 5 years on.
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  • 92
    ISSN: 1573-2649
    Keywords: Health status ; Mode of administration ; Parkinson's disease ; Psychometrics ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract This study evaluated the feasibility and psychometric properties of self-completed and telephone interview versions of a patient health-related quality-of-life (HQL) questionnaire for Parkinson's disease that included the SF-36 Health Survey (SF-36), the Parkinson's Disease Questionnaire (PDQ-39), and the Medical Outcomes Study Sexual Function Survey. Parkinson's disease patients (n = 150) completed the questionnaire twice: once at the study site and once over the telephone in a randomized order. Ninety-four percent of enrolled patients completed the first HQL assessment and 88% completed both assessments. Cronbach's α exceeded 0.70 for all scales except for the self-completed PDQ-39 Social Support subscale (0.57) and the telephone interview PDQ-39 Social Support (0.60) and Cognitions (0.67) subscales and the SF-36 General Health (0.60) and Social Function (0.61) subscales. There were no statistically significant differences in mean HQL scale scores across the two modes of administration. Mean scores for 3 of the PDQ-39 subscales and the Summary Index were significantly poorer (p 〈 0.05) for patients at later clinical stages. Similarly, patients with dyskinesias reported significantly poorer scores for 4 of the PDQ-39 subscales and the Summary Index and patients with self-reported comorbidities reported poorer SF-36 Physical Function and General Health subscale scores than patients without dyskinesias and comorbidities, respectively. This study suggests that the self-completed and telephone interview versions of the patient HQL questionnaire are feasible and valid for future clinical trial applications.
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  • 93
    Electronic Resource
    Electronic Resource
    Springer
    Quality of life research 9 (2000), S. 65-73 
    ISSN: 1573-2649
    Keywords: Cancer patients ; EORTC QLQ-C30 ; Longitudinal assessments ; Prognosis groups ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The present study examines differences in quality of life between two points in time in a heterogeneous sample of cancer patients with different prognoses. The original sample comprised 253 patients, while the follow-up data obtained 3–4 years later included 75 patients, that is, 92% of the survivors. All the patients completed a questionnaire including the EORTC QLQ-C30. The research questions focus on overall changes in quality of life, and whether patients with a good prognosis would show less negative changes in quality of life than patients with a poor prognosis. The overall observed changes in quality of life were surprisingly small over a 3–4 year period. This study shows that prognoses do predict changes in social functioning and in some physical aspects of quality of life over a 3–4 year period after the assessment of prognoses by physicians. Prognoses did not, however, predict changes in psychological aspects of quality of life.
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  • 94
    ISSN: 1573-2649
    Keywords: Bladder cancer ; Cystectomy ; Postoperative adjustment ; Prospective study ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract This study reports the changes in the quality of life (QoL) of 44 patients observed prospectively from pre-surgery to one year post-surgery. Two kinds of surgeries were compared: continent and incontinent urinary diversion. In most areas the QoL returned to the prior level within one year after surgery. However, patients were restricted in their physical activity, sexual activity, and emotional well-being. Using individual weights for different aspects of life (Fragen zur Lebenszufriedenheit – Module FLZM), QoL was higher than when using an unweighted measurement (Short Form 36, MOS). Two trends for the different developments in the QoL were established: general life satisfaction and social functioning tended to improve after a continent diversion but decreased after an incontinent diversion. The perceived global satisfaction with both kinds of diversion was high – 75% of the patients would choose the same kind of diversion again.
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  • 95
    ISSN: 1573-2649
    Keywords: Coping style ; Personality ; Quality of life ; Statistical-modelling
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective: To determine the role of health status, personality and coping style, on self-report health-related quality of life (QoL). Methods: Participants were HIV seropositive individuals at all disease stages from three samples (a) gay/bisexual men from the UK, (b) injecting drug users from the UK, (c) injecting drug users from Italy. All participants completed questionnaires evaluating QoL, personality, coping style and social support. Explicit models of the relationships between the measured variables based on a review of the literature were tested using structural equation modelling. Results: Health status was modestly associated with the physical but not the psychological aspects of QoL (β = 0.44). Neuroticism was strongly associated with psychological QoL (β = −0.73) but only weakly with physical QoL (β = −0.21). The samples did not differ in either the pattern or the magnitude of these relationships. Mediating factors such as coping style, social support and other personality variables had only a weak influence on the role of Neuroticism. Conclusions: Neuroticism had a strong influence on health-related QoL that was independent of health status. Neuroticism was more strongly associated with the psychological aspects of QoL than health status. Coping styles and the other psychological variables assessed had only a weak mediating influence on this relationship.
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  • 96
    ISSN: 1573-2649
    Keywords: Factor analysis ; Germany ; New Zealand ; Oral health ; Poland ; Quality of life ; Reliability
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract A questionnaire designed to measure oral health-related quality of life (OHRQOL) in adults and children was assessed for its factorial structure and reliability using data from the Second International Collaborative Study on Oral Health Outcomes in New Zealand, Poland and Germany. Principal component analysis with orthogonal and oblique rotation was applied. The three-factor structure hypothesized for the children's questionnaire (self-reported oral disease symptoms, perceived oral well-being, social and physical functioning) was confirmed in New Zealand and Poland, and two self-reported oral disease symptom dimensions emerged in Germany. Five factors instead of the three hypothesized were identified for adults: two dimensions of symptoms were identified, and social and physical functioning appeared to be independent dimensions of OHRQOL. Similarity between the factors was demonstrated in all three countries. The reliability of the questionnaire ranged from moderate to excellent depending on the dimension and the country. These findings provide preliminary evidence of the cross-cultural stability of the OHRQOL questionnaire in New Zealand, Poland and Germany, for both children and adults. Further investigations by the present authors of the properties of the instrument in other samples will focus on demonstrating the stability and replicability of the factor structure identified here.
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  • 97
    ISSN: 1573-2649
    Keywords: Chronic bronchitis ; EuroQoL (EQ-5D) ; Health outcomes ; Medical outcomes study 6-item general health survey (MOS-6A) ; Measure yourself medical out come profile (MYMOP) ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract There is little published information on the measurement of health status or quality of life in acute exacerbations of chronic bronchitis. The measure yourself medical outcome profile (MYMOP), the medical outcomes study 6-item general health survey (MOS-6A), and EuroQoL (EQ-5D) were evaluated in 81 patients with acute exacerbations of Type-1 chronic bronchitis presenting at a single general practice centre in Glasgow. The questionnaires were administered at the first clinic visit and at a second visit within 1 week of treatment completion. Item scores for MYMOP were generally more responsive than those for the other instruments, as assessed by standardised response means and an index of responsiveness for those patients reporting minimal change between visits. Construct validity was demonstrated for the MYMOP by the gradient in score change with the patient's perceived change in clinical condition and by the relationship between score change and the physician's assessment of clinical outcome. This study demonstrated that the MYMOP is a valid and potentially useful instrument for the assessment of patient outcomes in acute exacerbations of chronic bronchitis and is more responsive than the MOS-6A or EQ-5D in this setting. The choice of instrument will vary according to the objective of the study.
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  • 98
    ISSN: 1573-2649
    Keywords: Children ; Population sample ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract This study aimed to assess the quality of life of a population sample of schoolchildren. The Generic Children's Quality of Life Measure (GCQ) has been developed to allow comparison between chronically ill children and the general child population. The measure assesses how the child views his or her life and also how they would like it to be. Quality of life is measured as the discrepancy between the two viewpoints. This large community-based survey aimed to establish GCQ norm values for children aged 6–14 years. The children were from a sample of schools stratified by geographical location and social need: rural affluent, rural low affluence, urban affluent and urban low affluence. 720 completed questionnaires were analysed. The scores were normally distributed with a wide range. The GCQ showed an acceptable reliability with a Cronbach's α of 0.75. The quality of life score was not correlated with age (r = −0.02, p = 0.64) nor with the deprivation score of the area in which the children lived (r = −0.026, p = 0.49). There were no significant differences between the scores by gender (p = 0.22) nor by rural/urban location (p = 0.60). Normative values were established. The GCQ is suitable for using with children over a large age range (6–14 years) without the scores being confounded by the age, gender, affluence or geographical location.
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  • 99
    ISSN: 1573-2649
    Keywords: Quality of life ; Radiotherapy ; Response shift
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract In medicine, response shift refers to a change — as a result of an event such as a therapy — in the meaning of one's self-evaluation of quality of life. Due to response shift, estimates of side effects of radiotherapy may be attenuated if patients adapt to treatment toxicities. The purpose of our study was to assess to what extent two components of response shift, scale recalibration and changes in values, occur in early-stage breast cancer patients undergoing radiotherapy and to examine what the implications would be for treatment evaluation. In the week before start of post-operative radiotherapy, 46 patients filled out a questionnaire consisting of quality of life items of the SF-36 and the Rotterdam symptom checklist (RSCL) (pretest). During radiotherapy, patients were asked to fill out the questionnaire twice: a posttest (quality of life at that moment) and a thentest (quality of life before treatment, retrospectively), supposedly using the same internal standard. Changes in values were studied by asking the patients on the two occasions to rate the importance of seven attributes representing various domains of quality of life. Patients were also asked whether their quality of life with respect to the measured aspects had changed since the pretest (subjective transition scores). Significant scale recalibration effects were observed in the areas of fatigue and overall quality of life. When the groups were divided according to their subjective transition scores, significant scale recalibration effects were found in case of worsened quality of life for fatigue and overall quality of life, and in case of improved quality of life for fatigue and psychological well-being. The mean importance ratings remained fairly stable over time, except for ‘skin reactions’, which obtained less importance at the end of radiotherapy than before. In conclusion, effects of scale recalibration were observed that would have significantly affected quality of life evaluations, in that the impact of radiotherapy on fatigue and overall quality of life would have been underestimated. Changes in internal values were observed only for ‘skin reactions’.
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  • 100
    ISSN: 1573-2649
    Keywords: Determinants ; Head and neck cancer ; Optimism ; Outcome ; Quality of life
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The aim of this study was to investigate the role of dispositional optimism (DO) as a predictor of health-related quality of life (HRQL) in a sample of upper aerodigestive tract cancer (UADT) patients. A prospective observational study design was used with a cohort of patients from one centre. DO was evaluated using a French version of the Life Orientation Test (the FLOT) translated and validated for this study. HRQL was evaluated using the EORTC QLQ-C30 prior to and 3 months following treatment. The association between FLOT ratings and HRQL was evaluated using linear multiple regression analysis and a two-way ANOVA with repeated measures. Baseline data were gathered on 101 subjects and follow-up data on 88 of these. The sample was dichotomized around the median FLOT score creating ‘optimist’ and ‘pessimist’ groups. Before treatment, optimists reported better role, cognitive and emotional function, less pain and fatigue and a better global rating of HRQL than did pessimists. Following treatment, optimists reported better role and cognitive functioning, less pain and better global HRQL than did pessimists. Pessimists reported a greater deterioration in the role domain following treatment than did optimists. At no point did pessimists rate HRQL better than optimists. The results suggest that optimism is associated with better HRQL in French UADT cancer patients.
    Type of Medium: Electronic Resource
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