A PHASE-II, MULTICENTER, UK STUDY OF VINORELBINE IN ADVANCED BREAST-CANCER

Thirty-four evaluable patients were treated with vinorelbine, a novel, semisynthetic vinca alkaloid, as first-line chemotherapy for advanced breast cancer. They received vinorelbine 25 mg m(-2) i.v. given weekl y for a maximum of 16 cycles. Two patients achieved a complete remissi on and 15 a partial remission, giving a response rate of 17/34 (50%; 9 5% CI of 34-66%); median response duration was 5.8 months. The median progression-free interval was 4.4 months and median survival 9.9 month s. Treatment was generally well tolerated. Fatigue was the most common side-effect. The main reason for dose adjustments was myelosuppressio n; 68% of patients had WHO grade 3 or 4 neutropenia and there was one death attributed to neutropenic sepsis. Nausea/vomiting and neuropathy were mild and alopecia was uncommon. This study confirms vinorelbine as a highly active, well-tolerated agent in advanced breast cancer wor thy of evaluation in combination chemotherapy regimens.