The effect of oral vinorelbine and capecitabine in patients with metastatic breast cancer

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10605 Background: Optimal chemotherapy (CT) for advanced breast cancer treatment should be effective, well tolerated and convenient. Although the optimum CT is not defined, oral chemotherapy is an attractive option for many patients. Methods: We report a phase II multicentric study, first and second line metastatic breast cancer (MBC) treatment, at least one measurable lesion, prospectively collected data between 2003 and 2005. Treatment schedule: vinorelbine 60 mg/m2 p.o. day 1 and 8, capecitabine 1000 mg/m2 twice daily, day 1–14 q 21 days. Patients: 84 patients with MBC have been registered. Mean age 58.1 years, ranges (39.7 years–71.9 years). All patients had received prior adjuvant anthracycline based chemotherapy (CT). No adjuvant or palliative CT within the last 12 months, no concomitant hormonal treatment. Results: The median number of oral chemotherapy cycles vinorelbine plus capecitabine was 6 cycles (ranges 1 cycle - 19 cycles), total number of cycles was 550. In 84 evaluable pts the objective tumor response was achieved in 46 pts 55%, (ORR = CR + PR), complete response CR was achieved in 11 (13%) pts, partial response in 35 pts (42%), stable disease in 26 pts (31%). Median follow up was 9.7 months. In the intent-to-treat analysis, median time to progression was 6.7 months, median survival not reached, 58 pts (69%) are still alive. Reported NCI grade 3 - 4 toxicities: neutropenia in 4 pts (5%), febrile neutropenia in 4 pts (5%), vomiting in 6 pts (7%) Conclusion: Oral vinorelbine-capecitabine combination shows very promising activity and low toxicity in the MBC treatment. No significant financial relationships to disclose.