Treatment of metastatic breast cancer with alternative vinorelbine and gemcitabine

Abstract

800 Background: In Romania, most breast cancer cases are locally advanced or metastatic. Single agent therapy with gemcitabine or vinorelbine showed good tolerability and efficacy in advanced 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 October 2001 -October 2002. All patients had prior chemotherapy with antracicline or taxane. They had progression or recurrence within 6 month of prior treatment. They had measurable or evaluable disease. Median age was 52 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 1000 mg/m2 given on day 1, 15, 29, 43, 57, etc and vinorelbine 25 mg/m2 given on day 8, 22, 36, 50, etc. until disease progression; 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 (6.25%), grade 3 trombocitopenia -1 patient (3.12%). Grade 2 neurotoxicity was observed in 3 patients (9.37%). Grade 1–2 gastrointestinal toxicity (nausea/emesis) occurred in 13 patients (40.62%). Malaise or flu-like syndrome were mild and occurred in 9 patients (28.12%). 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 31.25% (2 patients (6.25%) complete response, 8 patients (25%) partial response); 12 patients had stable disease (37.5%) and 9 patients progressive disease (31.25%). The median time to progression was 8,3 month. Conclusion: Our results suggest that gemcitabine and vinorelbine alternative administration has an acceptable efficacy and a favorable safety profile. No significant financial relationships to disclose.