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

BACKGROUND AND OBJECTIVESVinorelbine and capecitabine are both active in breast cancer with moderate toxicity.DESIGN AND SETTINGA pilot study conducted from December 2007 to January 2010 in patients with metastatic breast cancer (MBC) to the evaluate efficacy and safety of combination therapy with vinorelbine and capecitabine.PATIENTS AND METHODSThe 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.RESULTSOf 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 1 5 patients (48.4%) had a partial response giving an overall response rate of 54.8% (95% Cl, 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 1 0 months for the two groups, respectively.CONCLUSIONSThe 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 anthracy-cline failure or as first-line chemotherapy requires further study.