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 withdocetaxel 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.
RCT Entities:
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.
Authors: Stacy Moulder; Gregory Gladish; Joe Ensor; Ana Maria Gonzalez-Angulo; Massimo Cristofanilli; James L Murray; Daniel Booser; Sharon H Giordano; Abeena Brewster; Julia Moore; Edgardo Rivera; Gabriel N Hortobagyi; Hai T Tran Journal: Cancer Date: 2011-10-17 Impact factor: 6.860
Authors: Ricardo Fernandes; Sasha Mazzarello; Habeeb Majeed; Stephanie Smith; Risa Shorr; Brian Hutton; Mohammed Fk Ibrahim; Carmel Jacobs; Michael Ong; Mark Clemons Journal: Support Care Cancer Date: 2015-09-19 Impact factor: 3.603
Authors: Stacy Moulder; Hailun Li; Molin Wang; William J Gradishar; Edith A Perez; Joseph A Sparano; Michael Pins; Ximing Yang; George W Sledge Journal: Breast Cancer Res Treat Date: 2010-02 Impact factor: 4.872