Phase II study of docetaxel-vinorelbine in platinum-resistant, paclitaxel-pretreated ovarian cancer
Date
2003Author
Aravantinos, GerasimosBafaloukos, Dimitrios
Fountzilas, George
Christodoulou, C.
Papadimitriou, C.
Pavlidis, Nicholas
Kalofonos, H. P.
Gogas, H.
Kosmidis, Paraskevas A.
Dimopoulos, M. A.
Source
Annals of OncologyVolume
14Issue
7Pages
1094-1099Google Scholar check
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Background: This multicenter, prospective phase II study evaluated the safety and efficacy of the combination of docetaxel and vinorelbine in patients with platinum-resistant, paclitaxel-pretreated recurrent ovarian cancer. Patients and methods: Treatment consisted of vinorelbine 25 mg/m2 as a 20-min i.v. infusion (days 1 and 8), and docetaxel 70 mg/m2, as a 1-h i.v. infusion (day 8). Granulocyte colony-stimulating factor support was administered prophylactically on days 12-16. Treatment was repeated every 21 days. Results: Forty-six patients were enrolled. The median number of previous chemotherapeutic regimens was one (range 1-3) with a median treatment-free interval of 4.3 months. Four chemotherapy cycles per patient were administered. Almost 75% of the planned doses for both drugs were given. Forty-one patients are evaluable for response. Three patients (6.5% of all patients; 7.3% of evaluable patients) achieved complete response and eight (17.4% and 19.5%, respectively) a partial response to chemotherapy leading to overall response rates of 23.9% and 26.8%, respectively. Another 34.8% (39.0%) had stable disease. At a median follow-up of 30 months, the median disease-free survival was 13 months, relapse-free survival was 5 months, time to progression was 4.5 months, and overall survival was 9.3 months. Severe toxicities included leukopenia (31%), neutropenia (35%) and febrile neutropenia (20%). Conclusions: The combination of docetaxel/vinorelbine is an effective regimen with manageable toxicity for the treatment of platinum-resistant, paclitaxel-pretreated ovarian cancer.
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