EPIRUBICIN AT 2 DOSE LEVELS WITH PREDNISOLONE AS TREATMENT FOR ADVANCED BREAST-CANCER - THE RESULTS OF A RANDOMIZED TRIAL

被引:99
作者
HABESHAW, T
PAUL, J
JONES, R
STALLARD, S
STEWART, M
KAYE, SB
SOUKOP, M
SYMONDS, RP
REED, NS
RANKIN, EM
机构
[1] Beatson Oncology Centre, Western Infirmary, Glasgow
[2] Beatson Oncology Centre, Western Infirmary
关键词
D O I
10.1200/JCO.1991.9.2.295
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Two hundred eleven patients with advanced breast cancer were randomized to receive either epirubicin (E) 50 mg/m2 and prednisolone (LEP) or E 100 mg/m2 and prednisolone (HEP). The intended treatment consisted of 16 courses of LEP or eight courses of HEP given at 3-weekly intervals. Reasons for stopping treatment early included progressive disease, stable disease without symptomatic improvement, or severe toxicity deemed intolerable by either the patient or physician. Toxicity was recorded at 3-weekly and response at 9-weekly intervals using the World Health Organization (WHO) criteria of response and toxicity. Two hundred nine patients were eligible for analysis, 98% of whom have been followed for more than a year. One hundred four patients received LEP and 105 HEP. Significantly worse myelosuppresion, alopecia, nausea and vomiting, and mucositis were seen in the high-dose arm (P ≤ .001). More patients in the LEP arm stopped treatment before the fourth course than in the HEP arm, and the commonest reason for stopping was progressive disease. A similar median number of courses was given in each arm. There was a significantly higher response in the HEP arm (HEP - complete response [CR] + partial response [PR] = 41%, LEP - CR + PR = 23%). Despite this, no statistically significant difference was seen in overall survival or progression-free interval. The median survival for HEP and LEP was 44 and 46 weeks, respectively.
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页码:295 / 304
页数:10
相关论文
共 35 条
[1]   DOES CHEMOTHERAPY IMPROVE SURVIVAL IN ADVANCED BREAST-CANCER - A STATISTICAL OVERVIEW [J].
AHERN, RP ;
EBBS, SR ;
BAUM, MB .
BRITISH JOURNAL OF CANCER, 1988, 57 (06) :615-618
[2]   THE EFFECT ON SURVIVAL OF INITIAL CHEMOTHERAPY IN ADVANCED BREAST-CANCER - POLYCHEMOTHERAPY VERSUS SINGLE DRUG [J].
AHMANN, DL ;
SCHAID, DJ ;
BISEL, HF ;
HAHN, RG ;
EDMONSON, JH ;
INGLE, JN .
JOURNAL OF CLINICAL ONCOLOGY, 1987, 5 (12) :1928-1932
[3]  
ARMITAGE P, 1987, STATISTICAL METHODS, P382
[4]  
BARTOLUCCI AA, 1985, CANCER CLIN TRIALS, P337
[5]  
BAUM M, 1979, BREAST CANCER EXPERI, P223
[6]  
BONNADONNA G, 1983, RAD ONCOL BIOL PHYS, V9, P279
[7]  
BRAMBILLA C, 1986, CANCER TREAT REP, V70, P261
[8]  
BUMMA C, 1989, SEP EUR C CLIN ONC
[9]  
CANELLOS GP, 1976, CANCER, V38, P1882, DOI 10.1002/1097-0142(197611)38:5<1882::AID-CNCR2820380503>3.0.CO
[10]  
2-H