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Clinical Trial
. 2011 Feb 16:11:75.
doi: 10.1186/1471-2407-11-75.

Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial

Francesco Nuzzo  1 , Alessandro Morabito, Adriano Gravina, Francesca Di Rella, Gabriella Landi, Carmen Pacilio, Vincenzo Labonia, Emanuela Rossi, Ermelinda De Maio, Maria Carmela Piccirillo, Giuseppe D'Aiuto, Renato Thomas, Massimo Rinaldo, Gerardo Botti, Maurizio Di Bonito, Massimo Di Maio, Ciro Gallo, Francesco Perrone, Andrea de Matteis
Affiliations
Clinical Trial

Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial

Francesco Nuzzo et al. BMC Cancer. .

Abstract

Background: 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.

Methods: 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 alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed.

Results: 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 significantly 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.

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

Trial registration: ClinicalTrials.gov NCT00540800.

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Figures

Figure 1
Figure 1
The CONSORT flowchart.
Figure 2
Figure 2
Pattern of worst scores reported by the Daily Diary Card during the first 6 weeks of treatment. Gray lines represent weekly schedules of docetaxel; red lines represent 3-weekly schedules of docetaxel.
See this image and copyright information in PMC

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