Objectives: We conducted a multicenter phase II study to evaluate the clinical effi cacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabineas fi rst-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel35 mg/m 2 and gemcitabine 800 mg/m 2 i.v. on days 1, 8,15 every 28 days. Results: All patients were assessable for toxicity and 56 for effi cacy. Overall response rate was64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53–28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71–16.49). The most common hematological toxicity was neutropenia (no febrileneutropenia), which occurred in 28 patients (48.3%) but grade 3–4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experiencedgrade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule,in agreement with other published studies, need to befurther confirmed within a phase III study.
|Publication status||Published - 2005|