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  • 1
    Electronic Resource
    Electronic Resource
    Untersuchungen zur Erfassung der Nephrotoxizität von humanem Alpha-2b-Interferon unter besonderer Berücksichtigung der Analyse von Harnenzymen bei Patienten mit chronischer myeloischer Leukämie (1987)
    Springer
    Journal of molecular medicine 65 (1987), S. 667-672 
    Details
    ISSN: 1432-1440
    Keywords: Interferon alpha-2b ; Nephrotoxicity ; Urinary enzymes
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary The nephrotoxic potential of alpha-interferon (IFN alpha-2b) was analysed in 21 patients with chronic myeloid leukemia. As particularly sensitive parameters in the detection of subclinical renal injury we measured the excretion of the following urinary enzymes: lactate dehydrogenase (LDH), gamma-glutamyltransferase (GGT), leucine arylaminidase (LAP), β-galactosidase (GAL) and N-acetyl-beta-glucosaminidase (NAG). Additionally, protein excretion and urinary sediment were analysed. In 18 of 21 patients a significant increase in the excretion of LDH, LAP, GGT and NAG was found, in 6 patients there was an additional rise in the output of GAL. Eleven patients developed proteinuria up to 2 g/l, one patient excreted up to 9 g/l. Enzymuria and protein excretion decreased in all patients after reduction of the IFN alpha-2b dosage and disappeared in two patients following cessation of therapy. The high incidence of nephrotoxic events in patients with CML during IFN alpha-2b therapy might be mostly due to immunological or substance-specific effects.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01875502
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  • 2
    Electronic Resource
    Electronic Resource
    Crossover comparison of the antiemetic efficacy of nabilone and alizapride in patients with nonseminomatous testicular cancer receiving cisplatin therapy (1986)
    Springer
    Journal of molecular medicine 64 (1986), S. 362-365 
    Details
    ISSN: 1432-1440
    Keywords: Antiemetic therapy ; Alizapride ; Cisplatin ; Nabilone
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Twenty nonseminomatous testicular cancer patients not pretreated with emetogenic chemotherapy were included in a crossover study of antiemetic therapy. Patients were randomly assigned to receive either nabilone (2×2 mg/day) or alizapride (3×150 mg/day) prior to beginning lowdose cisplatin chemotherapy. Patients on nabilone had significantly fewer episodes of emesis than those on alizapride (medians, 1.1 vs 2.9;p〈0.01). Nabilone was superior to alizapride in giving complete relief from nausea (medians, 65% vs 30%;p〈0.01), and was more effective in shortening the duration of nausea (medians, 1.3 h vs 5.1 h;p〈0.01); however, it caused more adverse effects. It is concluded that nabilone has greater antiemetic activity than alizapride in young patients receiving low-dose cisplatin chemotherapy. Nabilone dosage should be reduced to decrease the incidence and degree of adverse reactions while leaving the definite antiemetic activity unchanged.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01728184
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  • 3
    Electronic Resource
    Electronic Resource
    Sequentielle Induktionschemotherapie und Strahlenbehandlung inoperabler kleinzelliger Bronchialkarzinome (1989)
    Springer
    Journal of molecular medicine 67 (1989), S. 1182-1193 
    Details
    ISSN: 1432-1440
    Keywords: Small cell lung cancer ; Sequential chemotherapy ; Thoracic irradiation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary To study the potential benefit of sequential chemotherapy in inoperable small cell lung cancer (SCLC), from 1982 to 1986 ninety-one patients with histologically proven and previously untreated SCLC (median age: 53 years; median Karnofsky status: 80%) were randomly assigned to an initial therapy with adriamycin (since 1984 epirubicin), cyclophosphamide, vincristine (ACO resp. EPICO) or etoposide/cisplatin (VP16/DDP). Treatment courses were repeated every 3 weeks for a total of ≤6 courses with a crossover after a maximum of 3 cycles of either regimen. Limited disease (LD) patients with bronchoscopical, computertomographical and (re-) mediastinoscopical complete remission (CR) randomly received either a thoracic irradiation with 40 Gy or observation only. Overall, 60 out of 85 evaluable patients achieved an objective remission. A CR was observed in 24/51 patients (47%) with limited disease, and in 8/34 patients (24%) with extensive disease. Both, ACO (EPICO) and VP16/DDP were equally effective as initial and second-line therapy. Moreover, after failure to the initial therapy an objective remission could be achieved in 13% of the patients following the alternative second line combination. In 28% of LD patients with an otherwise complete remission residual tumor was detected by (re-) mediastinoscopy. Median survival times were 14 (CR: 16) months in LD patients and 10 (CR: 15) months in ED patients. At present, median survival is significantly improved in irradiated versus non-irradiated LD patients (25 vs. 13 months, p〈0.04). The remission rates and median survival times observed in this study are comparable to those of a historical control group treated with ACO plus radiotherapy alone.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01716205
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  • 4
    Electronic Resource
    Electronic Resource
    Zur Wirksamkeit von IFN-γ und IFN-α bei der Haarzellenleukämie (1987)
    Springer
    Journal of molecular medicine 65 (1987), S. 706-712 
    Details
    ISSN: 1432-1440
    Keywords: Hairy-cell leukemia ; Interferon gamma ; Interferon alpha-2b
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Zusammenfassung 6 Patienten mit einer Haarzellenleukämie wurden 3–35 Monate nach Splenektomie mit IFN-γ (4 × 106 E/m2/2. Tag sc) behandelt. Während einer Therapiedauer von 9–35 Wochen konnte bei keinem Patienten eine signifikante klinische oder hämatologische Befundbesserung erzielt werden. Nach einem therapiefreien Intervall von 0–13 Wochen erhielten alle Patienten IFN-α-2b (zunächst 4 × 106 E/m2/2. Tag, Erhaltungstherapie 1 × 106 E/2. Tag). Zum Zeitpunkt der Beendigung der jeweiligen IFN-α-2b-Gabe war bei 5 von 6 Patienten (1 Patient mit postthrombotischem Syndrom verstarb an einer Lungenembolie) eine deutliche Befundbesserung eingetreten. Nach einer Beobachtungszeit von jetzt 9–14 Monaten konnten 1 CR, 3 PR und 1 MR induziert werden. Die Nebenwirkungen beider Interferon-Präparationen unterschieden sich nicht signifikant.
    Notes: Summary Six patients with hairy-cell leukemia were treated with gamma-(IFN-γ) and alpha-(IFN-α-2b) interferon; 3–35 months following splenectomy, treatment was started with 4 × 106 U/m2 IFN-γ sc (iv) every second day for 9–35 weeks. Although the white blood cell counts decreased during therapy from 4.1–49 × 109/1 to 1.5–43 × 109/1, no hematological or clinical improvement was obtained. Subsequently (interval 0–13 weeks), IFN-α-2b was given at an initial dose of 4 × 106 U/m2 sc every second day to all patients. After a treatment period corresponding to that of IFN-γ administration, a significant hematological improvement was observed in five patients (one early death due to pulmonary embolism). At the last follow-up (9–14 months after start of treatment; maintenance therapy, 1 × 106 U every second day), these patients exhibited normal peripheral blood cell counts, and in bone marrow biopsy specimens a marked decrease of hairy cells was seen (1 CR, 3 PR, 1 MR). Adverse reactions including fever, headache, nausea, dryness of the mouth, myalgia, and fatigue did not significantly differ between the two interferon preparations. Whereas IFN-γ is unlikely to have any significant impact on the course of hairy cell leukemia, IFN-α-2b does result in improvement of hematological values and well-being in almost all patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01875510
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  • 5
    Electronic Resource
    Electronic Resource
    Treatment of chronic myelogenous leukemia with interferons alpha and gamma (1990)
    Springer
    Annals of hematology 61 (1990), S. 45-46 
    Details
    ISSN: 1432-0584
    Keywords: Interferon alpha ; Interferon gamma ; Chronic myelogenous leukemia
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary A 23-year-old male patient with Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) was treated with both IFN alpha and IFN gamma. Normalization of leukocyte counts was reached after 3 months of treatment. Southern blot analysis failed to detect the neoplastic cell clone after 19 months of therapy. Cytogenetically, complete suppression of Ph positive cells in the patient's bone marrow and blood was observed after 20 months and 25 months, respectively. This response was achieved with doses of IFN alpha and IFN gamma which were considerably lower than the dosage of IFN used in single agent therapy of CML.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01739433
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  • 6
    Electronic Resource
    Electronic Resource
    Phase I study of recombinant human tumor necrosis factor α in advanced malignant disease (1989)
    Springer
    Cancer immunology immunotherapy 29 (1989), S. 144-150 
    Details
    ISSN: 1432-0851
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary A phase I study with recombinant human tumor necrosis factor α (rhuTNF-α; Knoll AG, Ludwigshafen, FRG) in patients with advanced malignant disease was undertaken to evaluate drug toxicity (organ specifity, time course, predictability, reversibility, maximal tolerated dose), effectiveness, antigenicity and pharmacokinetics. TNF was administered as a test dose followed by daily i.v. infusions for 5 days, every 3 weeks (single i.v. infusion lasting 10 min, TNF dissolved in 50 ml 5% human albumin). Dosage was increased in groups of 3 or 4 patients from 0.04 mg/m2 to 0.28 mg/m2. A total of 19 patients with different cancers, including seven large-bowel carcinomas, three chronic myelogenous leukemias, three hypernephromas, two small-cell lung cancers, one malignant melanoma, one malignant lymphoma, one rhabdomyosarcoma and one fibrosarcoma were treated. Major side-effects were chills and fever (maximum 40.4°C, median 38.7°C, 19/19), headache (12/19), nausea and vomiting (12/19) and pronounced (〉20%) hypotension (4/19). Acute side-effects could be diminished by paracetamol or indomethacin pretreatment, and with one possible exception no tachyphylaxis to TNF was noted. Mild renal toxicity was seen during TNF treatment. Pharmacokinetic studies showed a serum half-life (t 1/2) ranging from 11 min to 17 min for doses from 0.04 mg/m2 to 0.16 mg/m2 and prolonged clearance with t 1/2 ranging from 54 min to 70 min in the 0.20–0.28 mg/m2 dose range. No objective antitumor effects were observed in this phase I study.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00199290
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  • 7
    Electronic Resource
    Electronic Resource
    Relation between leukocyte counts and cortisol secretion in CML patients undergoing combined TNF α/IFN α therapy (1992)
    Springer
    Annals of hematology 65 (1992), S. 116-120 
    Details
    ISSN: 1432-0584
    Keywords: TNF α ; IFN α-2b ; Leukocytes ; Cortisol ; ACTH ; CML
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary During long-term interferon α-2b (IFN) therapy of Philadelphia chromosome-positive chronic myelogenous leukemia (CML) patients, short-term effects of tumor necrosis factor α (TNF) on peripheral leukocyte counts, as well as cortisol and corticotropin (ACTH) release were studied. TNF (40–160μg/m2) was given as a 2-h infusion on 5 consecutive days every 3 weeks, in addition to s.c. daily IFN injections (4 mio U/m2), to four (two male/two female) patients, who had been treated for more than 8 months with IFN and additionally for 0–7 months with TNF. Leukocyte counts, cortisol, and ACTH were determined at 30-min intervals between 4 p.m. and midnight. Profiles were determined the day before and on day 1 of TNF therapy. Leukocyte numbers decreased 30 min after start of TNF administration and increased 30–60 min later with a rebound until the next TNF application. The increase of leukocyte counts was due mostly to neutrophil granulocytes. ACTH levels increased 30 min, cortisol 60 min, and leukocyte counts 90 min after start of TNF infusion. Metopirone, an inhibitor of cortisol synthesis given to one patient, suppressed the TNF-induced stimulation of cortisol secretion and subsequent increase of leukocyte counts, while ACTH blood levels were enhanced. It was concluded that leukocyte count increases after TNF/IFN administration might be related to TNF-evoked cortisol secretion.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01695809
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  • 8
    Electronic Resource
    Electronic Resource
    Etoposide in patients with previously untreated non-small-cell lung cancer: a phase I study (1991)
    Springer
    Cancer chemotherapy and pharmacology 28 (1991), S. 59-62 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary In a phase I study, a range of doses of etoposide (200–370 mg/m2 given i. v. daily on 3 consecutive days) were evaluated for tolerance and response as first-line treatment in 26 patients with non-small-cell lung cancer. The dose-limiting toxicity was myelosuppression, especially leukopenia. At dose levels of 350 and 370 mg/m2 ctoposide per day, leukopenia of WHO grade 4 occurred in two and one of seven patients, respectively. No thrombocytopenia of this degree was observed. Myelosuppression was quickly reversible and noncumulative. Apart from alopecia, nonhematologic organ toxicities above WHO grade 2 were not seen. Toxicity analysis suggests that the recommended dose of single-agent etoposide for phase II studies in untreated patients is 330–370 mg/m2 given i. v. daily for 3 days. At the dose levels tested, 6 (23%) major responses could be induced. All responses were seen at a starting dose of 〉300 mg/m2 per day. The median duration of response was 4 months. The median survival for all patients was 8 months and that for responding patients was 15 months.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00684958
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  • 9
    Electronic Resource
    Electronic Resource
    Two randomised phase II trials of intermittent intravenous versus subcutaneous alpha-2 interferon alone (Trial 1) and in combination with 5-fluorouracil (Trial 2) in advanced colorectal cancer (1987)
    Springer
    International journal of colorectal disease 2 (1987), S. 26-29 
    Details
    ISSN: 1432-1262
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Sixty-five patients with advanced colorectal cancer were randomised to one of two schedules of recombinant alpha-2 interferon (IFN). In the first study, 36 patients received single-agent IFN, either 50×106 U/m2 intravenously on 5 consecutive days every 4 weeks, or 20×106 U/m2 subcutaneously three times per week. No tumour responses were seen and toxicity was unacceptable. In the second study, 29 patients received IFN in two similar schedules, but the dose of IFN was reduced to 20×106 U/m2 per day in the intravenous arm and to 5×106 U/m2 per day in the subcutaneous arm. In addition these patients were administered intravenous 5-Fluorouracil (5-FU), 250–500 mg/m2 per day on the first 5 days of each 4-weekly cycle. Although the toxicity of this second study was tolerable, only one short-lived partial remission was observed. Alpha-2 interferon, alone or in combination with 5-FU, is ineffective in advanced colorectal cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01648994
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  • 10
    Electronic Resource
    Electronic Resource
    The concept of dose intensification in the treatment of neoplastic disease (1992)
    Springer
    Infection 20 (1992), S. S107 
    Details
    ISSN: 1439-0973
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Zusammenfassung In der vorliegenden Arbeit werden unterschiedliche theoretische und klinische Ansätze, die zu dem Konzept der Dosisintensivierung beigetragen haben, beschrieben. Dieses Konzept beinhaltet, daß die Dosierungen von verabreichten Zytostatika pro Zeiteinheit mitbestimmend für die erfolgreiche Behandlung von Patienten mit malignen Tumorerkrankungen sind. Durch den klinischen Einsatz von rekombinanten hämatopoetischen Wachstumsfaktoren können Nebenwirkungen auf das Knochenmark verringert werden, so daß das Konzept der Dosisintensivierung klinisch besser realisierbar wird. Prospektive randomisierte Studien, bei denen nur die Dosis-Intensität verändert wird, werden vermehrt erforderlich. Es wird sich dann erweisen, ob die Dosisintensivierung zu einer Lebensverlängerung beitragen kann.
    Notes: Summary This paper summarizes different theoretical and clinical approaches contributing to the concept of dose intensification. According to this concept, the amount of antineoplastic drug delivered per time predominantly determines the clinical outcome in patients with neoplastic disease. With the availability of recombinant haemopoietic growth factors haematotoxic side effects might be reduced, making this concept more feasible for clinical use. However, more prospective randomized studies, in which dose-intensity is the only treatment variable, are needed to prove that dose intensification will lead to higher survival rates.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01705028
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