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. 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.