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  • 1
    Electronic Resource
    Electronic Resource
    Docetaxel (Taxotere®)–cisplatin (TC): An effective drug combination in gastric carcinoma (2000)
    Springer
    Annals of oncology 11 (2000), S. 301-306 
    Details
    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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008342013224
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  • 2
    Electronic Resource
    Electronic Resource
    The impact of adding low-dose leucovorin to monthly 5-fluorouracil in advanced colorectal carcinoma: Results of a phase III trial (1998)
    Springer
    Annals of oncology 9 (1998), S. 535-541 
    Details
    ISSN: 1569-8041
    Keywords: colorectal cancer ; fluorouracil ; low-dose leucovorin ; phase III trial ; survival benefit
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: A wide variety of fluorouracil (FU)-plus-leucovorin (LV) doseschedules are in clinical use for the treatment of advanced colorectalcancer. Only the monthly low-dose LV- plus-FU regimen, as used by the NorthCentral Cancer Treatment Group, has demonstrated a lasting survival benefitas opposed to FU alone (J Clin Oncol 1989; 7: 1407–1417). The SwissCancer Group adopted this regimen for a confirmatory phase III trial butused the same dose-intensity of fluorouracil in both treatment arms. Patients and methods: Patients with inoperable or metastatic colorectalcancer were randomized to receive monthly FU 400 mg/m2/dayplus LV 20 mg/m2/day as intravenous push daily for five days,or FU alone. Results: Three hundred nine of the 310 patients randomized were eligibleand included in the analysis. The objective response rate for patients withmeasurable disease was 9% with FU alone and 22% withFU-plus-LV (P = 0.0001). The median progression-free survival was 3.9 versus6.2 months (P = 0.003) and the overall survival 10 versus 12.4 months (P =0.02). The major prognostic factors for survival were performance status,weight loss, and disease symptoms. WHO 〉2 toxicity, consisting ofstomatitis (P = 0.001), diarrhea (P = 0.001), and nausea (P = 0.001), wasmore pronounced for FU-plus-LV, without fatal events. Conclusions: This is the largest published randomized trial to compareFU-plus-LV to FU alone in advanced colorectal cancer. It confirms the survivalbenefit obtained from biomodulating monthly FU with low-dose LV. The toxiceffects of FU-plus-LV were acceptable to most patients, and they respondedwell to FU dose reductions. In the absence of an ideal dose-intense FUmonotherapy regimen, monthly FU with low-dose LV provides a simple andeconomical means by which to achieve adequate FU efficacy in the treatment ofadvanced colorectal cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008270916325
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  • 3
    Electronic Resource
    Electronic Resource
    Clinical and pharmacokinetic study of oral NK611, a new podophyllotoxin derivative (1996)
    Springer
    Cancer chemotherapy and pharmacology 38 (1996), S. 541-547 
    Details
    ISSN: 1432-0843
    Keywords: Key words Podophyllotoxin derivative ; Bioavailability ; Pharmacokinetics.
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  NK611 is a novel water-soluble podophyllotoxin derivative that has comparable antitumour activity but higher potency and better bioavailability in animals as compared with etoposide. The primary objectives of this study were to determine, after both oral and intravenous administration in the same patient, the bioavailability and the pharmacokinetic profile of NK611. Secondary objectives involved evaluation of the toxicity and the antitumor activity. Patients were randomly assigned to receive oral or intravenous (30-min infusion) doses of 5, 10, and 20 mg/m2 on day 1, when pharmacokinetic studies were performed. A daily oral dose of 20 mg/m2 was then given from day 4 through day 7 for respective total doses of 85, 90, and 100 mg/m2. NK611 and its metabolites were determined in plasma and urine by two different high-performance liquid chromatography (HPLC) methods with UV detection. A total of 21 adult patients entered the study and received the complete first cycle and at least the 1st day of cycle 2; 17 of them received at least 2 complete cycles of treatment. After intravenous administration, the plasma decay curve of NK611 followed a two-exponential model, and after oral administration it declined monoexponentially in most cases. At all dose levels, bioavailability values were around 100%. At concentrations between 10 and 20 mg/m2 after both routes of administration, the pharmacokinetics were nonlinear; the terminal half-life, plasma clearance, and volume of distribution were significantly different; and the area under the plasma concentration-time curve was not correlated to the dose. The urinary excretion of NK611 corresponded to 10–15% of the dose after administration by both routes, whereas that of N-demethyl NK611 and its picroform was highly variable. The features of neutropenia were comparable with those noted for etoposide involving a high degree of interpatient variability and recovery within 1 month after treatment. A daily dose of 20 mg/m2 for 5 consecutive days every 4 weeks is the recommended regimen for phase II studies in patients who have never been treated or have undergone previous chemotherapy only once.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800050524
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  • 4
    Electronic Resource
    Electronic Resource
    The last 3 months of life of cancer patients: Medical aspects and role of home-care services in southern Switzerland (1996)
    Springer
    Supportive care in cancer 4 (1996), S. 180-185 
    Details
    ISSN: 1433-7339
    Keywords: Home-care services ; Cancer center ; Hospital stay ; Place of death
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The clinical data on terminal cancer patients who have died since the establishment of a program of collaboration between community services and the cancer center of Canton of Ticino, southern Switzerland, were retrospectively analyzed to describe the characteristics of patients seen and the effect on them of a home-care program coordinated by the cancer center. The home-care program is based on five geographically grouped community-based domiciliary services, with the addition of one nurse responsible for coordination and one physician from the oncology center. Selection criteria for participation in the home-care program are defined. The main outcome measures were: number of hospitalizations and median hospital stay during the last 3 months of life; reasons for and median length of last hospitalization; place of death of patients who had home care and those who did not. In the group of 993 patients analyzed, the median contact time with the cancer center was 9.5 months (10th percentile: 1 month, 90th percentile: 71 months); the most frequent neoplasm was lung cancer (22%) with the briefest contact time (7.5 months; 10th percentile: 1 month; 90th percentile: 21 months); 13.5% of patients were never hospitalized; half of the patients had a total hospital stay of 24 days or longer and 23% died at home. The sociodemographic and medical characteristics of home-care users were similar to those of the home-care nonusers and to those of the overall group. In the group of home-care users (32% of the total) 22% were never hospitalized, half of the patients had a total hospital stay of 17 days or longer, and 43.5% of them died at home. These values were significantly different (P〈0.001) from those reported in the group of home-care non-users. Palliative care, provided at home through community-based domiciliary services, is associated with less frequent and shorter hospitalizations in the last 3 months of life. Medical oncology and palliative treatments should be mutually complementary to improve patients care. Cancer centers should be involved in the planning and coordination of supportive-care domiciliary services.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01682337
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  • 5
    Electronic Resource
    Electronic Resource
    Parathyroid hormone-related protein in metastatic breast cancer induced hypercalcemia: A case report (2000)
    Springer
    Annals of oncology 11 (2000), S. 97-100 
    Details
    ISSN: 1569-8041
    Keywords: bisphosphonates ; malignant hypercalcemia ; metastatic breast cancer ; paraneoplastic syndrome ; parathyroid hormone-related protein
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008319323222
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  • 6
    Electronic Resource
    Electronic Resource
    Dose-finding study of epidoxorubicin and docetaxel as first-line chemotherapy in patients with advanced breast cancer (1999)
    Springer
    Annals of oncology 10 (1999), S. 539-545 
    Details
    ISSN: 1569-8041
    Keywords: advanced breast cancer ; docetaxel ; epidoxorubicin ; G-CSF
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Anthracyclines and taxanes are the most active drugs against breast cancer and the search after their optimal combination is under intensive investigation in both the advanced and early disease settings. A dose-finding study of epidoxorubicin (E) and docetaxel (D) was conducted in advanced breast cancer (ABC) to define the maximum tolerated dose (MTD) of the combination with and without granulocyte colony-stimulating factor (G-CSF) support and to characterise its toxicity and activity profile. Patients and methods: Forty-two patients who received neither palliative chemotherapy nor adjuvant anthracyclines (55% with dominant visceral disease and 66% with ≥2 sites involved) with measurable/evaluable lesions, were treated at four dose levels starting from E 75 mg/m2 and D 75 mg/m2 to E 120 mg/m2 and D 85 mg/m2. A maximum of four cycles of the combination was given every three weeks and four additional cycles of single agent D were allowed in responding patients. Cardiac function was monitored at baseline and at every second course by echocardiography. Results: Febrile neutropenia (two patients) and prolonged, severe neutropenia (absolute neutrophil count (ANC) 〈0.1 × 109/l for more than three days; one patient) defined the MTD of the combination without G-CSF support at E 90 mg/m2 and D 75 mg/m2. G-CSF was then routinely administered from the subsequent dose level of E 120 mg/m2 and D 75 mg/m2. The MTD with G-CSF support was established at E 120 mg/m2 and D 85 mg/m2 (one patient with neutropenic fever together with failure of ANC recovery at day 21, three patients with ANC less than 0.1 × 109/l for more than three days, one patient with both and one patient with grade 4 thrombocytopenia and toxic death from typhlitis while neutropenic). No severe neurotoxicity, mucositis, or fluid retention were observed and there were no clinical signs of cardiotoxicity. Antitumour activity was not a primary endpoint of the study: the overall response rate (ORR) in 40 evaluable patients was 60% (95% confidence interval: 43%–75%, 58% in liver disease, 84% in soft tissue) with no apparent dose-related effect. After a median follow-up of 19 months (range 2–30+), the overall time to progression (TTP) in nine patients without maintenance hormonal therapy was five months. Conclusions: The combination of E and D proved to be an effective and safe regimen in poor- prognosis patients with ABC. G-CSF support allowed higher doses to be delivered safely but dose escalation did not translate into improved response rates (RR). The MTD without growth factors support was used, in a phase II trial, which also included patients with previous anthracycline-containing adjuvant regimens.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1026437731354
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  • 7
    Electronic Resource
    Electronic Resource
    Ventricular arrhythmia and torsade de pointe: Dose limiting toxicities of the MDR-modulator S9788 in a phase I trial (1998)
    Springer
    Annals of oncology 9 (1998), S. 1233-1242 
    Details
    ISSN: 1569-8041
    Keywords: arrhythmia ; long QT ; MDR ; P-glycoprotein ; S9788 ; torsade de pointe ; triazineaminopiperidine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: S9788 is a triazineaminopiperidine derivative capable of reversing multidrug resistance (MDR) in vitro. In preclinical models S9788 was several fold more potent MDR inhibitor than verapamil or cyclosporine. At P-glycoprotein (Pgp) blocking concentrations, S9788 appeared to have only very little toxicity. Patients and methods: In a two step phase I trial we treated 39 patients with refractory cancer with S9788 and bolus doxorubicin. The steps differed mainly in the S9788 infusion duration; in the first part 23 patients received the MDR-reversing drug S9788 over 30 minutes, in the second step of the study 16 patients were administered S9788 over 150 minutes. The doses of S9788 were escalated in cohorts of three patients up to a dose level (DL) of 96 mg/m2 on the 30 minutes infusion, and to 144 mg/m2 on the 150 minutes infusion. The pharmacokinetics of S9788 were determined. Results: With the 30-minute infusion schedule symptomatic cardiac arrhythmia were found to be dose limiting. In all patients at the highest DL transient cardiac repolarization prolongation with a long QT-interval on ECG was demonstrated. With the 150-minute administration schedule, S9788 could be escalated up to 144 mg/m2 without subjective toxicity. However, transient QT prolongation was present in all patients. A third degree AV-block and a QT increase of about 40% occurred at the highest DL. Asymptomatic torsade de pointe (DL 96 mg/m2) was demonstrated on Holter recording in one patient. Theses repolarization disturbances with QT increase were considered dose limiting toxicity and the trial was closed. No arrhythmia related death was noted. Pharmacokinetics were similar with both infusion schedules with a mean alpha half life of 11.3 and 13.2 minutes, for the 30-minute and 150-minute infusion, and a terminal half life of 13.5 and 15 hours, respectively. QTc prolongation duration appeared to be dose-dependent. Conclusions: With the tested infusion schedules, cardiac toxicity, in particular AV-blocks and QT prolongation, leading to ventricular arrhythmia and torsade de pointe, are the dose limiting toxicities of S9788. Our experience together with the observation of asymptomatic torsade de pointe in two other phase I trials of S9788 infused over six hours precluded the further clinical development of S9788.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008495919071
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  • 8
    Electronic Resource
    Electronic Resource
    Phase I clinical and pharmacokinetic study of the oral platinum analogue JM216 given daily for 14 days (1998)
    Springer
    Annals of oncology 9 (1998), S. 1315-1322 
    Details
    ISSN: 1569-8041
    Keywords: oral chemotherapy ; oral platinum analogue ; phase I
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: The oral bis (acetate) ammine dichloro cyclohexylamine platinum (i.v.) analogue (BMS-182751) was brought into clinical development because it was shown to be cytotoxic against some human tumour cell lines and to have an antitumor activity in murine tumours at least comparable to that of parenteral cisplatin and carboplatin. In early clinical studies in which the optimal schedule of treatment was daily for five consecutive days, dose-dependent nausea and vomiting occurred in about two-thirds of patients. Patients and methods: To evaluate if the use of lower daily doses for longer periods of time could result in a better tolerability, JM216 was given once daily for 14 consecutive days every four to five weeks to adult patients with solid tumors. Oral antiemetics were given prophylactically only at the highest doses. The pharmacokinetics of total and ultrafiltrable platinum were studied on days 1 and 14 of the first cycle by Inductively Coupled-Mass-Spectrometry (ICP-MS). Results: Forty-six patients were treated at doses ranging from 10 mg/m2/d to 50 mg/m2/d and 39 were evaluable for hematologic toxicity over 74 cycles. MTDs were reached at 45 mg/m2/d and 50 mg/m2/d × 14 repeated every five weeks in patients with extensive, or limited/no prior treatment, respectively. The dose-limiting toxicity was neutropenia which was delayed and variable among patients. Other non-hematological toxicities were severe vomiting (22% of cycles), diarrhea (28% of cycles) and drug-associated fever (32% of patients), controlled with paracetamol. Subjective improvement with disappearance of tumour-related pain was observed in one patient with chemotherapy-resistant metastatic prostate cancer and in one previously untreated patient with malignant mesothelioma. Cmax and AUC values of both total and ultrafiltrable platinum on days 1 and 14 were highly variable among patients. Only Cmax on day 1 was linearly related to the dose. Total and ultrafiltrable platinum were still detectable two weeks after the last dose. No relationship could be established between AUC values and toxicities. Conclusions: Daily doses of JM216 of 40 mg/m2 and 45 mg/m2 for 14 consecutive days every five weeks with oral antiemetic prophylaxis are selected for phase II evaluation of single agent in patients with extensive or limited/no prior treatment, respectively. The administration of JM216 on a day × 14 schedule produced nausea and vomiting comparable to that observed with the day × 5 regimen but of longer duration. The variability of pharmacokinetics and pharmacodynamics, even though limited at the doses proposed for phase II evaluation of JM216 as single agent, recommend a careful monitoring of the patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008441416790
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  • 9
    Electronic Resource
    Electronic Resource
    Control of delayed nausea and vomiting with granisetron plus dexamethasone or dexamethasone alone in patients receiving highly emetogenic chemotherapy: A double-blind, placebo-controlled, comparative study (1998)
    Springer
    Annals of oncology 9 (1998), S. 661-666 
    Details
    ISSN: 1569-8041
    Keywords: cisplatin ; delayed emesis ; dexamethasone ; granisetron ; 5-HT3-receptor antagonist ; oral antiemetic
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: The efficacies of granisetron plus dexamethasone anddexamethasone alone in controlling delayed nausea and vomiting aftercisplatin chemotherapy (≥69 mg/m2) were compared in amulticentre, double-blind, placebo-controlled comparative study. Patients and methods: In all, 654 patients (of whom 619 were evaluable)received prophylactic granisetron plus dexamethasone before chemotherapy onday 0; on day 1 complete responders and non-responders were randomizedseparately to receive dexamethasone, 8 mg b.d. p.o., with eithergranisetron, 1 mg b.d. p.o., or matching placebo for six days. Results: Over days 1–6 the complete response rates were54.5% (dexamethasone group) and 52.1% (dexamethasone plusgranisetron group). Response rates were higher over days 4–6(71.8% and 70.7%, respectively) than over days 1–3(60.4% and 57.9%, respectively). Significantly more patientswho responded to antiemetic treatment during day 0 were responders over days1–6 (63% vs. 17%; P 〈 0.001). No othertreatment-related differences were found. Adverse events tended to be minor,with constipation and headache the most common. Overall, there were nosignificant differences in the safety profiles of the two regimens, butconstipation and abdominal pain were significantly more common in thedexamethasone plus granisetron group. Conclusions: Granisetron plus dexamethasone did not appear to conferadditional benefit over use of dexamethasone alone in controlling delayednausea and vomiting following cisplatin chemotherapy. Control of acute nauseaand vomiting, however, appeared to be an important factor influencing delayednausea and vomiting.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008256115221
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  • 10
    Electronic Resource
    Electronic Resource
    Dose-finding study of paclitaxel and cyclophosphamide in advanced breast cancer (1997)
    Springer
    Annals of oncology 8 (1997), S. 655-661 
    Details
    ISSN: 1569-8041
    Keywords: breast cancer ; cyclophosphamide ; G-CSF ; paclitaxel
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: The toxicity profile of prolonged infusions of paclitaxel incombination with cyclophosphamide in metastatic breast cancer has already beendefined. The objective of this dose-finding study was to determine the maximumtolerable doses (MTDs) of shorter (three-hour) infusions of paclitaxel incombination with i.v. bolus cyclophosphamide in patients who had previouslyreceived a maximum of one chemotherapy for advanced breast carcinoma. The MTDof the same regimen with granulocyte colony-stimulating factor (G-CSF) supportwas then established. Patients and methods: Eighty women with metastatic breast cancer receiveda total of 352 fully evaluable courses of therapy. The starting doses werepaclitaxel 135 mg/m2 and cyclophosphamide 750mg/m2 given every three weeks. At least three patients weretreated at each dose level and if there were dose-limiting toxic effectsduring the first cycles three additional patients were entered. G-CSF support(5µg/kg s.c.) was added to the second cycle if specific dose-limitingtoxicitieshad occurred during the first cycle. The MTD was defined as the dose level atwhich more than two of six patients presented dose-limiting toxicities duringthe first cycle. Results: Febrile neutropenia (n = 4) and severe thrombocytopenia (n = 1)defined the MTDs of paclitaxel as 200 mg/m2 and ofcyclophosphamide as 2,000 mg/m2, with or without G-CSF inpatients with and, respectively, without prior chemotherapy for advanceddisease. Non-hematologic toxicity was moderate. Recommended doses were 200mg/m2 of paclitaxel and 1,750 mg/m2 ofcyclophosphamide with or without G-CSF in patients with and, respectively,without prior chemotherapy. The overall response rate was 25% and50%, respectively, in patients with and without prior chemotherapy formetastatic disease. Complete remissions (9%) were reported only inpatients without prior chemotherapy; antitumour activity in women withanthracycline-resistant disease, with an 8% response rate (95%CI: 1%–26%), was poor. Conclusions: Paclitaxel at 200 mg/m2 and cyclophosphamideat 1,750 mg/m2 can be safely administered every three weeksto women with advanced breast cancer. The moderate antitumour activityobserved with the schedule tested argues against its use as initial therapyfor advanced breast cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008211629858
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