Health-related quality of life in survivors of locally advanced breast cancer: an international randomised controlled phase III trial

Lancet Oncol. 2005 May;6(5):287-94. doi: 10.1016/S1470-2045(05)70100-5.


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.

Findings: 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.

Interpretation: Dose-intensive treatment only has a temporary effect on HRQOL, thus enabling more research on intensive treatment for patients with locally advanced breast cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Breast Neoplasms / drug therapy*
  • Chemotherapy, Adjuvant
  • Cyclophosphamide / administration & dosage
  • Disease-Free Survival
  • Drug Administration Schedule*
  • Epirubicin / administration & dosage
  • Female
  • Filgrastim
  • Fluorouracil / administration & dosage
  • Granulocyte Colony-Stimulating Factor / administration & dosage
  • Humans
  • Middle Aged
  • Quality of Life*
  • Recombinant Proteins
  • Surveys and Questionnaires
  • Survivors
  • Time Factors


  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Epirubicin
  • Cyclophosphamide
  • Filgrastim
  • Fluorouracil