Combination of oral vinorelbine and capecitabine in the treatment of metastatic breast cancer patients previously exposed to anthracyclines: a pilot study.

Background And Objectives: Vinorelbine and capecitabine are both active in breast cancer with moderate toxicity.

Design And Setting: A pilot study conducted from December 2007 to January 2010 in patients with metastatic breast cancer (MBC) to evaluate efficacy and safety.

Patients And Methods: The study included patients with MBC who were previously treated by anthracyclines either during the adjuvant phase or the metastatic phase. Patients were treated with oral vinorelbine (60 mg/m2) on day 1+8 and capecitabine (1000 mg/m2) twice daily (VC) from day 1 to day 14 with both repeated every 3 weeks until progression, refusal or for a maximum of 8 cycles. A dose reduction was made in case of grade 3 and 4 toxicities.

Results: Of 31 women (median age, 51 years), 12 cases were first-line therapy and 19 cases were second-line therapy or greater, and 30 were evaluable for response. Two patients (6.4%) achieved complete response and 15 patients (48.4%) had a partial response giving an overall response rate of 54.8% (95% CI, 42%-68%). Time- to-disease progression was 7.8 months for patients receiving VC as first-line therapy versus 6 months for patients receiving VC as second-line therapy or more, while median survival time was 22 months and 10 months for the two groups, respectively.

Conclusions: The oral VC regimen is effective and safe in patients with MBC previously exposed to anthracyclines, and offers a promising alternative to the intravenous route. Its role as a salvage therapy following anthracycline failure or as first-line chemotherapy requires further studies.