Gemcitabine plus paclitaxel as first-line chemotherapy for patients with advanced breast cancer

Objectives: To assess the efficacy and tolerability of gemcitabine and paclitaxel as first- line treatment in advanced breast cancer. Methods: Patients with histologically confirmed metastatic or metastatic plus locally advanced breast cancer received gemcitabine 1,200 mg/ m(2) on days 1 and 8 and paclitaxel 175 mg/ m(2) on day 1 every 21 days for 8 cycles. Results: From December 1999 to August 2001, 45 patients, with a median age of 53.5 years ( range, 22 - 77), received a total of 260 cycles. All were assessable for response and toxicity. Twenty- seven patients had prior adjuvant therapy. Hormonal receptor status was positive in 31.1% and negative in 40.0% of patients. Main metastatic sites included soft tissue ( 62.2%) and lung ( 53.3%). The objective response rate was 66.7%; complete response, 22.2%; partial response, 44.4%; stable disease, 15.6%; progressive disease, 17.8%. Median duration of response was 18 months and median time to tumor progression was 11 months. Grade 3/ 4 leukopenia, neutropenia, and thrombocytopenia developed in 13.3% of patients, and 15.5% developed grade 3/ 4 mucositis. No treatment- related deaths occurred. Median overall survival was 19 months. Conclusion: Gemcitabine plus paclitaxel is an active combination with a favorable toxicity profile as first- line treatment for patients with advanced breast cancer. Copyright (C) 2004 S. Karger AG, Basel.