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

被引:42
作者
Bottomley, A [1 ]
Therasse, P
Piccart, M
Efficace, F
Coens, C
Gotay, C
Welnicka-Jaskiewicz, M
Mauriac, L
Dyczka, J
Cufer, T
Lichinitser, MR
Schornagel, JH
Bonnefoi, H
Shepherd, L
机构
[1] European Org Res Treatment Canc, EORTC, Ctr Data, Qual Life Unit, Brussels, Belgium
[2] Inst Jules Bordet, B-1000 Brussels, Belgium
[3] Univ Hawaii, Canc Res Ctr, Honolulu, HI 96822 USA
[4] Med Univ Gdansk, Gdansk, Poland
[5] Inst Bergonie, Bordeaux, France
[6] Med Acad Lodz, Lodz, Poland
[7] Inst Oncol, Ljubljana, Slovenia
[8] Canc Res Ctr, Moscow, Russia
[9] Univ Hosp Geneva, Geneva, Switzerland
[10] Swiss Grp Clin Canc Res, SAKK, Bern, Switzerland
[11] NCIC, Clin Trials Grp, Kingston, ON, Canada
关键词
D O I
10.1016/S1470-2045(05)70100-5
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 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.
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收藏
页码:287 / 294
页数:8
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