Phase II study of vinorelbine in the treatment of platinum-resistant ovarian carcinoma

Objective. The purpose of this phase II study was to evaluate on an intent- to-treat basis the activity and toxicity of single-agent vinorelbine (VRL) as second-line chemotherapy of patients with platinum-resistant ovarian can cer. Platinum-resistant disease was defined as disease refractory to or rel apsing within 12 months after finishing platinum-containing chemotherapy. Methods. VRL (30 mg/m(2)) was administered intravenously as a bolus injecti on days 1 and 8 every 21 days. Initially, four courses of VRL were given. P atients with responding or stable disease received four more courses of VRL to a maximum of eight courses. Results. Twenty-eight of 33 eligible patients were considered evaluable for response. The overall response rate was 21% (7/33) (95% CI: 7-35), Median time to progression was 3.1 months and median survival was 10.1 months. Tox icity was generally mild. Leukopenia was the dose-limiting toxicity. CALGB grade III/IV infection was observed in 15/0% of patients. The most importan t nonhematologic toxicities were nausea and constipation. Grade III/IV naus ea was observed in 6/0% and grade III/IV constipation in 3/3% of patients, Peripheral neurotoxicity was only a minor problem with no grade III/IV toxi city. No patients stopped treatment because of toxicity and no toxic death was reported. Conclusion. VRL was generally well tolerated, but the activity in platinum- resistant ovarian cancer was only modest, although fully comparable to othe r second-line treatments. Further studies are required to define the role o f VRL in combination chemotherapy for ovarian cancer. (C) 2001 Academic Pre ss.