title: 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.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00540800.
authors.affiliation: National Cancer Institute, via M, Semmola, 80131 Napoli, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Nuzzo
authors.forename: Alessandro
authors.initials: A
authors.lastname: Morabito
authors.forename: Adriano
authors.initials: A
authors.lastname: Gravina
authors.forename: Francesca
authors.initials: F
authors.lastname: Di Rella
authors.forename: Gabriella
authors.initials: G
authors.lastname: Landi
authors.forename: Carmen
authors.initials: C
authors.lastname: Pacilio
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Labonia
authors.forename: Emanuela
authors.initials: E
authors.lastname: Rossi
authors.forename: Ermelinda
authors.initials: E
authors.lastname: De Maio
authors.forename: Maria Carmela
authors.initials: MC
authors.lastname: Piccirillo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Aiuto
authors.forename: Renato
authors.initials: R
authors.lastname: Thomas
authors.forename: Massimo
authors.initials: M
authors.lastname: Rinaldo
authors.forename: Gerardo
authors.initials: G
authors.lastname: Botti
authors.forename: Maurizio
authors.initials: M
authors.lastname: Di Bonito
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Maio
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Andrea
authors.initials: A
authors.lastname: de Matteis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D000069287:Capecitabine; D005472:Fluorouracil