Seminars in oncology
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Seminars in oncology · Apr 1995
ReviewSummary of phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of advanced non-small cell lung cancer.
Six phase II studies have been conducted in the United States and Europe using docetaxel (Taxotere; Rhone-Poulenc Rorer, Antony, France) for advanced non-small cell lung cancer. One hundred eighty chemotherapy-naive patients in four studies and 88 patients who failed prior platinum-containing chemotherapy in two studies were treated with docetaxel 75 to 100 mg/m2 intravenously over 1 hour every 3 weeks. Fifty-nine percent of patients had adenocarcinoma and 82% had stage IV disease. ⋯ Fluid retention, which occurred in patients who received multiple courses of treatment, was common but rarely dose-limiting, and may be ameliorated with prophylactic corticosteroids. Other toxic effects were relatively mild. Docetaxel has significant activity against advanced non-small cell lung cancer, producing a major response in both chemotherapy-naive patients and patients who had failed prior platinum-containing chemotherapy.
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Seminars in oncology · Apr 1995
ReviewReview of docetaxel (Taxotere), a highly active new agent for the treatment of metastatic breast cancer.
Phase II studies have demonstrated that docetaxel (Taxotere; Rhône-Poulenc Rorer, Collegeville, PA) is one of the most active single agents in the treatment of metastatic breast cancer. The overall response rate as front-line therapy for metastatic disease was 59% (95% confidence interval, 51% to 67%) in five phase II trials (four of which were multicenter) when 100 mg/m2 docetaxel was infused over 1 hour every 3 weeks. In the three phase II trials reported to date of patients with metastatic cancer who had failed previous frontline therapy, 100 mg/m2 docetaxel infused over 1 hour every 3 weeks produced an objective response rate of 49% (95% confidence interval, 40% to 58%). ⋯ A novel toxicity observed in many patients was fluid retention syndrome, with onset at a median of four to five cycles. The fluid retention was of noncardiac or renal origin, was slowly progressive with additional cycles of therapy, was reversible after cessation of the drug, and could be largely ameliorated by oral diuretics and glucocorticoid premedication. Phase III studies to further define docetaxel's role in the treatment of breast cancer are now under way.
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Seminars in oncology · Apr 1995
Clinical TrialDose intensification--a phase I study of ifosfamide with vinorelbine (Navelbine): rationale and study design in advanced non-small cell lung cancer.
A phase I trial of a combination of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) and ifosfamide given on a novel schedule on 3 consecutive days with granulocyte colony-stimulating factor was conducted to establish the maximum tolerated dose of vinorelbine and the dose-limiting toxicities of this regimen. Doses of vinorelbine were escalated in cohorts of patients. Of the 29 patients enrolled at the time of data analysis, 26 were evaluable for toxicity. ⋯ The recommended phase II doses were established as 1.6 g/m2/d ifosfamide for 3 days and 30 mg/m2/d vinorelbine for 3 days. This study established that granulocyte colony-stimulating factor was needed for approximately 8 days. We are currently examining the feasibility of two dose levels of vinorelbine (25 mg/m2 and 30 mg/m2/d for 3 days) in combination with ifosfamide (1.6 g/m2/d) given every 2 weeks.
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Seminars in oncology · Feb 1995
Clinical TrialUse of high-dose etoposide/ifosfamide/carboplatin/epirubicin and peripheral blood progenitor cell transplantation in limited-disease small cell lung cancer.
Conventional-dose chemotherapy for limited-disease small cell lung cancer has resulted in high response rates, but rarely in a cure. In an ongoing phase I-II trial, limited-disease small cell lung cancer patients received high-dose chemotherapy and autologous peripheral blood progenitor cell (PBPC) transplantation as part of an early intensification strategy after two cycles of induction chemotherapy. Eligible patients (n = 18) were initially treated with two cycles of etoposide (500 mg/m2), ifosfamide (4 g/m2), cisplatin (50 mg/m2), epirubicin (50 mg/m2) and granulocyte colony-stimulating factor to combine an effective, standard-dose chemotherapy regimen with simultaneous mobilization of PBPCs. ⋯ The median survival time was not yet reached. These preliminary data demonstrate that early, high-dose chemotherapy and PBPC transplantation followed by local radiotherapy is safe and may lead to prolonged disease-free survival in some patients. Prospective, randomized studies in a larger series of patients will be required to provide definitive proof of the role of early high-dose chemotherapy in the management of limited-disease small cell lung cancer.