Abstract

ABSTRACT Background Most breast cancer cases are locally advanced or metastatic. Single agent therapy with gemcitabine or vinorelbine showed good tolerability and efficacy in metastatic breast cancer. Methods To evaluate safety profile and efficacy of alternatively gemcitabine and vinorelbine regimen in pretreated metastatic breast cancer, 32 patients were included between January 2009 and June 2010. All patients had prior chemotherapy with anthracycline or taxane. They had progression or recurrence within 6 month of prior treatment. They had measurable or evaluable disease. Median age was 47 years. Performance status was ECOG 0-2. Metastatic sites: liver - 9 patients, lung - 8 patients, bone - 17 patients, soft tissue - 6 patients. Treatment schedule: Gemcitabine 1250 mg/mÂ2 given on day 1, 8 and vinorelbine 25 mg/mÂ2 given on day 1, 8. The median duration of administration was six month. Results The treatment was well tolerated. Grade 1-2 myelosuppression was commonly observed; grade 3-4 neutropenia - 4 patients (12.5%), never complicated with septicaemia, grade 3 anemia - 2 patients (6.2 %), grade 3 thrombocytopenia - 1 patient (3.1 %). Grade 2 neurotoxicity was observed in 3 patients (9.3 %). Grade 1-2 gastrointestinal toxicity (nausea/emesis) occurred in 13 patients (40.6 %). Malaise or flu-like syndrome were mild and occurred in 9 patients (28.1 %). No treatment-related death was observed with gemcitabine - vinorelbine alternative regimen. No patients required dose reduction. One patient was not evaluable for tumor response. Overall response rate was 31.2 % (3 patients (9.3%) complete response, 7 patients (21.8 %) partial response; 14 patients had stable disease (43.7 %) and 8 patients progressive disease (25%). The median time to progression was 9 months. Conclusion Our results suggest that gemcitabine and vinorelbine alternative administration has an acceptable efficacy and a favorable safety profile. Disclosure All authors have declared no conflicts of interest.

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