Monthly docetaxel and weekly gemcitabine in metastatic breast cancer: A phase II trial

Background: Docetaxel and gemcitabine are active against breast cancer. The purpose of this phase II study was to evaluate the efficacy and safety of monthly docetaxel combined with weekly gemcitabine in patients with chemoth erapy-pretreated metastatic breast cancer. Patients and methods: Thirty-nine patients were enrolled, of whom thirty ha d received prior chemotherapy in the adjuvant setting, seven for metastatic disease, and two for both, including prior anthracycline in 33 patients. T reatment was gemcitabine 800 mg/m(2) days 1, 8, 15 and docetaxel 100 mg/m(2 ) on day 1, with cycles repeated every four weeks. Results: Response rate was 79% (95% confidence interval (CI): 63%-91%), wit h 2 complete and 29 partial responses. Twenty-five of the responders remain ed progression-free for more than six months. Median survival was 24.5 mont hs. Delivered dose intensity of gemcitabine was lower than expected (63% of planned). The predominant hematologic toxicity was grade 4 neutropenia in 36 patients, complicated by fever in three patients. With the exception of asthenia, severe non-hematological toxicities were infrequent. Conclusions: Monthly docetaxel, combined with weekly gemcitabine, has signi ficant but manageable hematologic toxicity. Despite frequent dose adjustmen ts, this doublet is very active in metastatic breast cancer, producing a hi gh proportion of durable responses associated with favorable survival.