title: Health-related quality of life in survivors of locally advanced breast cancer: an international randomised controlled phase III trial.
abstract: BACKGROUND
  Dose-intensive chemotherapy has generated much interest in the treatment of patients with locally advanced breast cancer because it might offer a survival benefit. We aimed to compare the effects of such an approach with those of standard chemotherapy on health-related quality of life (HRQOL).
  
  
  METHODS
  224 patients with locally advanced breast cancer were randomly assigned to 75 mg/m(2) cyclophosphamide given orally on days 1-14, and 60 mg/m(2) epirubicin and 500 mg/m(2) fluorouracil both given intravenously on days 1 and 8, for six cycles every 28 days (6 months' treatment; standard treatment) and 224 patients to 830 mg/m(2) cyclophosphamide and 120 mg/m(2) epirubicin both given intravenously on day 1, and 5 microg/kg filgrastim per day given subcutaneously on days 2-13, for six cycles every 14 days (3 months' treatment; dose-intensive treatment). HRQOL was assessed by use of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Baseline assessments were done before randomisation; then once a month for the first 3 months; and at months 6, 9, 12, 18, 26, 34, 42, 48, and 54. The primary endpoint was progression-free survival; secondary endpoints were HRQOL, response, safety, overall response, and health economics. Analyses were by intention to treat.
  
  
  RESULTS
  Previously reported data showed that groups did not differ in progression-free survival. Patients assigned shorter, intensified treatment had a significantly lower overall HRQOL score during the first 3 months than did those assigned standard treatment (mean score at 3 months 41.8 [SD 1.78] vs 49.6 [1.64], p=0.0015). However, scores returned to near baseline, with no difference between groups, at 12 months (62.6 [1.97] vs 65.6 [2.04], p=0.3007). Over the remaining 2 years, the groups showed few significant differences in HRQOL.
  
  
  CONCLUSIONS
  Dose-intensive treatment only has a temporary effect on HRQOL, thus enabling more research on intensive treatment for patients with locally advanced breast cancer.
authors.affiliation: European Organisation for Research and Treatment of Cancer, EORTC Data Center, Qualtiy of Life Unit, Brussels, Belgium. abo@eortc.be
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.forename: Patrick
authors.initials: P
authors.lastname: Therasse
authors.forename: Martine
authors.initials: M
authors.lastname: Piccart
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.forename: Carolyn
authors.initials: C
authors.lastname: Gotay
authors.forename: Marzena
authors.initials: M
authors.lastname: Welnicka-Jaskiewicz
authors.forename: Louis
authors.initials: L
authors.lastname: Mauriac
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Dyczka
authors.forename: Tanja
authors.initials: T
authors.lastname: Cufer
authors.forename: Michail R
authors.initials: MR
authors.lastname: Lichinitser
authors.forename: Jan H
authors.initials: JH
authors.lastname: Schornagel
authors.forename: Herve
authors.initials: H
authors.lastname: Bonnefoi
authors.forename: Lois
authors.initials: L
authors.lastname: Shepherd
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D000069585:Filgrastim; D005472:Fluorouracil / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins; D011795:Surveys and Questionnaires; D017741:Survivors; D013997:Time Factors
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D003520:Cyclophosphamide; D000069585:Filgrastim; D005472:Fluorouracil