Gemcitabine-oxaliplatin combination in heavily pretreated metastatic breast cancer: a pilot study on 43 patients.

To investigate the efficacy and the safety of gemcitabine and oxaliplatin combination in metastatic breast cancer (MBC), in patients heavily treated with anthracycline and taxane. A retrospective study including all MBC patients, treated by two different schedules of GemOx between February 2001 and December 2003 in the medical oncology department of Saint-Louis hospital. Forty-three consecutive patients were included. Median involved organs was 2. The median number of regimen of previous metastatic chemotherapy administered was 3. The median number of cycle administered was 5, with a median dose by cycle of 1,000 or 2,000 mg/m(2) of gemcitabine (D1D2 or D1D8 schedule, respectively) and 100 mg/m(2) of oxaliplatin. Of the 40 evaluable patients, three achieved a partial response giving an overall response rate of 7.5% and 11 demonstrated stable disease, giving a stabilization rate of 27.5%. Median overall survival in all treated patients was 10.6 months and median progression-free survival in all evaluated patients was 3.0 and 10.5 months for the partial responders. Hematotoxicity was prevalent, sometimes severe, with grades 3 and 4 neutropenia, thrombocytopenia, and anemia in 42%, 19%, and 14% of the patients. Grades 3 and 4 peripheral neuropathy were developed by 9% of the patients, but was not limiting. The present study reports the results of two exploratory schedules of the GemOx combination in advanced breast cancer patients. The D1D8 schedule was the most promising and deserves further clinical studies.