Health-related quality of life in survivors of locally advanced breast cancer: an international randomised controlled phase III trial - 21/08/11
, Patrick Therasse, MD a, Martine Piccart, MD b, Fabio Efficace, PhD a, Corneel Coens, MSc a, Carolyn Gotay, PhD c, Marzena Welnicka-Jaskiewicz, MD d, Louis Mauriac, MD e, Jaroslaw Dyczka, MD f, Tanja Cufer, MD g, Michail R Lichinitser, MD h, Jan H Schornagel, MD i, Herve Bonnefoi, MD j, Lois Shepherd, MD kfor the European Organisation for Research and Treatment of Cancer Breast Cancer Group, the National Cancer Institute of Canada, and Swiss Group for Clinical Cancer Research
Summary |
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.
Published online April 7, 2005 DOI 10.1016/S1470-2045(05)70101-7
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Vol 6 - N° 5
P. 287-294 - mai 2005 Retour au numéro
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