Phase 3 study comparing the use of docetaxel on an every‐3‐week versus weekly schedule in the treatment of metastatic breast cancer

BACKGROUND Previous studies have evaluated 3‐week and weekly docetaxel schedules in patients with metastatic breast cancer (MBC). The varying efficacy results and toxicity profiles noted in these earlier studies led to a comparison of the schedules to determine which was safer and more efficacious. METHODS A phase 3 clinical trial was conducted in patients with MBC who were treated with docetaxel either every 3 weeks or once weekly to determine and compare response rate and duration, time to disease progression, progression‐free survival (PFS), overall survival (OS), and toxicity. Patients were randomized to receive docetaxel at a starting dose of either 75 mg/m2 every 3 weeks or 35 mg/m2 weekly for 3 consecutive weeks followed by 1 week of rest. RESULTS A total of 118 patients underwent efficacy analysis; 59 patients were randomized to the every‐3‐week treatment arm and 59 to the weekly arm. The response rate was 35.6% (95% confidence interval [95% CI], 23.6–49.1%) for the every‐3‐week arm versus 20.3% (95% CI, 11.0–32.8%) for the weekly arm. There was no statistical difference between the every 3‐week and the weekly treatment arms with regard to median PFS (5.7 months vs 5.5 months; P = .46) or OS (18.3 months vs 18.6 months, respectively; P = .34). There was a higher overall toxicity rate (grades 3 and 4, according to the National Cancer Institute Common Toxicity Criteria [version 2.0]) in the every‐3‐week treatment arm versus the weekly treatment arm (88.1% vs 55.9%, respectively; P = .0001). CONCLUSIONS Compared with patients who received weekly docetaxel, those who received docetaxel every 3 weeks had a higher response rate but experienced similar PFS and OS and a more pronounced toxicity. Cancer 2008. © 2008 American Cancer Society. A phase 3 clinical trial was conducted in patients with metastatic breast cancer who were treated with docetaxel either once every 3 weeks or once a week to determine and compare response rate (RR), time to disease progression, progression‐free survival (PFS), overall survival (OS), and safety profile. The RR was 35.6% versus 20.3%, the PFS was 5.7 months versus 5.5 months, and the OS was 18.3 months versus 18.6 months for the 3‐week and weekly arms, respectively. There was a significantly higher overall toxicity rate (grades 3 and 4) in the every‐3‐week treatment arm versus the weekly treatment arm (88.1% vs 55.9%, respectively).