Phase II study of vinorelbine in the treatment of platinum-resistant ovarian carcinoma
2001 (English)In: Gynecologic Oncology, ISSN 0090-8258, Vol. 81, no 1, 58-62 p.Article in journal (Refereed) Published
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 cancer. Platinum-resistant disease was defined as disease refractory to or relapsing within 12 months after finishing platinum-containing chemotherapy. Methods. VRL (30 mg/m2) was administered intravenously as a bolus injection days 1 and 8 every 21 days. Initially, four courses of VRL were given. Patients 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. Toxicity was generally mild. Leukopenia was the dose-limiting toxicity. CALGB grade III/IV infection was observed in 15/0% of patients. The most important nonhematologic toxicities were nausea and constipation. Grade III/IV nausea 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 toxicity. 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 other second-line treatments. Further studies are required to define the role of VRL in combination chemotherapy for ovarian cancer.
Place, publisher, year, edition, pages
2001. Vol. 81, no 1, 58-62 p.
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:liu:diva-25271DOI: 10.1006/gyno.2000.6089Local ID: 9711OAI: oai:DiVA.org:liu-25271DiVA: diva2:245599