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

✍ Scribed by Edgardo Rivera; Jaime A. Mejia; Banu K. Arun; Rosnie B. Adinin; Ronald S. Walters; Abenaa Brewster; Kristine R. Broglio; Guosheng Yin; Bita Esmaeli; Gabriel N. Hortobagyi; Vicente Valero

• Publisher: John Wiley and Sons
• Year: 2008
• Tongue: English
• Weight: 120 KB
• Volume: 112
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.23321

✦ Synopsis

Abstract

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/m^2^ every 3 weeks or 35 mg/m^2^ 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.