Prospective study of vinorelbine and capecitabine combination therapy in chinese patients with metastatic breast cancer pretreated with anthracyclines and taxanes

Aims: This phase II study prospectively evaluated the feasibility of vinorelbine in combination with capecitabine in Chinese patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. Methods: Vinorelbine (25 mg/m² intravenous infusion on days 1 and 8) and capecitabine (1,000 mg/m² b.i.d., days 1-14) were administered to eligible MBC patients previously treated with anthracyclines and taxanes every 3 weeks for up to 6 cycles, until disease progression or unacceptable toxicity. The primary endpoint was objective response. Results: Seventy-two patients were enrolled. In total, 297 cycles were given (median 4 cycles, range 2-6). The overall response rate was 45.8% (95% CI 34.2-57.4%), including 5 complete (6.9%) and 28 partial responses (38.9%). With median follow-up of 22 months, median time to progression was 7.7 months (95% CI 5.5-10.0) and median survival was 26.1 months (95% CI 19.6-32.6). The response rate was 53.8% in patients resistant to anthracyclines and taxanes combination. The most common hematologic adverse events were leukopenia (81.9%) with grade 3/4 incidence of 41.7%; nausea was the most frequent non-hematologic toxicity (62.5%). Hand-foot syndrome occurred in 12.5% of patients, and diarrhea was rare. Conclusions: Capecitabine 1,000 mg/m² b.i.d. combined with vinorelbine 25 mg/m² is an effective and safe treatment for MBC patients, no matter if anthracycline and taxane pretreated or resistant.