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

par Bottomley, Andrew;Therasse, Patrick;Piccart-Gebhart, Martine ;Efficace, Fabio;Coens, Corneel;Gotay, Carolyn;Welnicka-Jaskiewicz, Marzena;Mauriac, Louis;Dyczka, Jaroslaw;Cufer, Tanja;Lichinitser, Michail;Schornagel, Jan;Bonnefoi, Herve;Shepherd, Lois
Référence Lancet oncology, 6, 5, page (287-294)
Publication Publié, 2005-05

Article révisé par les pairs

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Résumé :

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/m2 cyclophosphamide given orally on days 1-14, and 60 mg/m2 epirubicin and 500 mg/m2 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/m2 cyclophosphamide and 120 mg/m2 epirubicin both given intravenously on day 1, and 5 mu;g/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.