To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer.

Patients with locally advanced or metastatic breast cancer, aged <= 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two sided alfa 0.05 and 80% power for 35% effect size, 130 patients per arm were needed.

From February 2004 to March 2008, 139 patients were randomized: 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p=0.03); patients treated with weekly schedules presented a significant worsening in role functioning and financial scores (p=0.02 and p<0.001). Neutropenia and stomatitis were worse in the 3-weekly arm, where two toxic deaths were observed. Overall response rate was 39.1% and 33.3% in 3-weekly and weekly arms; hazard ratio of progression was 1.29 (95% CI: 0.84-1.97) and hazard ratio of death was 1.38 (95% CI: 0.82-2.30) in the weekly arm.

In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly ones in terms of quality of life in patients with locally advanced or metastatic breast cancer.

Trial registration: ClinicalTrials.gov NCT00540800.

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