Multicenter phase II trial of first-line docetaxel/gemcitabine in advanced breast cancer pretreated with adjuvant anthracyclines.

The aim of this study was to evaluate activity and tolerability of docetaxel-gemcitabine combination as first-line treatment in patients with metastatic breast cancer previously treated with adjuvant anthracyclines. Patients and Methods: Sixty-eight women received gemcitabine 1,000 mg/m 2 as 30- minute infusion on days 1 and 8, and docetaxel 80 mg/m 2 as 1-hour infusion on day 8, with cycles repeated every 3 weeks. Results: Objective responses were observed in 32 out of 68 evaluable patients (45% ; 95% confidence interval, 35.2- 58.8% ). Responses were 44% , 42% , 49% in soft tissue, bone and visceral lesions, respectively, 50% /52% in HER2- positive/-negative tumors, and 50% in both ER- positive/- negative tumors. Median time to progression and overall survival were 6 and 16 months, respectively. Treatment was usually well tolerated, with grade 3-4 neutropenia in 32% - 7% of the patients, and neutropenic fever, grade 3 vomiting, mucositis and peripheral neurotoxicity in 3% of the patients. Conclusion: Gemcitabine-docetaxel combination is effective and well tolerated as first-line treatment in advanced breast cancer previously treated with adjuvant anthracyclines. Anthracyclines and taxanes are the cytotoxic drugs affording the best therapeutic results in women with breast cancer, and an increasing number of patients receive anthracyclines as adjuvant chemotherapy, becoming resistant to these agents at