Phase II trial of weekly docetaxel/gemcitabine as first-line chemotherapy in patients with locally recurrent or metastatic breast cancer

Purpose: A phase 11 study evaluated weekly docetaxel/gemcitabine as first-line chemotherapy for locally recurrent or metastatic breast cancer in a multicenter community oncology practice setting. Patients and Methods: Eligible patients who had not received chemotherapy for metastatic disease received docetaxel 30 mg/m(2) followed by gemcitabine 800 mg/m(2), each administered weekly for 3 weeks (days 1, 8, and 15), followed by a 1-week rest period (28-day cycle). Patients also received oral dexamethasone to reduce the incidence/severity of fluid retention and hypersensitivity reactions. Of the 46 enrolled patients, 45 were treated as part of the intent-to-treat (ITT) population and were evaluable for safety. Results: There were 3 complete responses and 12 partial responses among the 39 evaluable patients, for an objective response rate (ORR) of 39% (95% confidence interval [CI], 24%-54%). The ORR in the ITT population was 33% (95% Cl, 18%-48%). Median time to response was 3.4 months, with a median response duration of 6.7 months. Median survival was 15.8 months, and median time to progression was 5.8 months. The most common grade 3/4 hematologic toxicity was neutropenia (13.3%); there was a low incidence of other grade 3/4 hematologic toxicities. Grade 3 fatigue (15.6%) was the most common grade 3/4 nonhematologic toxicity and grade 2 alopecia occurred in 47% of patients. One patient who had been receiving chronic corticosteroid therapy died from treatment-related neutropenia and acute respiratory distress syndrome. Conclusion: These phase 11 results suggest that weekly docetaxel/gemcitabine is moderately active and well tolerated as first-line therapy for locally recurrent or metastatic breast cancer. No clear advantage for combined weekly clocetaxel/gemcitabine was observed compared with published results on the efficacy of docetaxel and gemcitabine given as single agents.