TY - JOUR
T1 - Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer
T2 - Results of a single-centre randomized phase 3 trial
AU - Nuzzo, Francesco
AU - Morabito, Alessandro
AU - Gravina, Adriano
AU - Di Rella, Francesca
AU - Landi, Gabriella
AU - Pacilio, Carmen
AU - Labonia, Vincenzo
AU - Rossi, Emanuela
AU - De Maio, Ermelinda
AU - Piccirillo, Maria C.
AU - D'Aiuto, Giuseppe
AU - Thomas, Renato
AU - Rinaldo, Massimo
AU - Botti, Gerardo
AU - Di Bonito, Maurizio
AU - Di Maio, Massimo
AU - Gallo, Ciro
AU - Perrone, Francesco
AU - de Matteis, Andrea
PY - 2011/2/16
Y1 - 2011/2/16
N2 - 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.
AB - 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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U2 - 10.1186/1471-2407-11-75
DO - 10.1186/1471-2407-11-75
M3 - Article
C2 - 21324184
AN - SCOPUS:79951549835
VL - 11
JO - BMC Cancer
JF - BMC Cancer
SN - 1471-2407
M1 - 75
ER -