Fadrozole versus megestrol acetate: A double-blind randomised trial in advanced breast cancer

被引:13
作者
Bezwoda, WR
Gudgeon, A
Falkson, G
Jordaan, JP
Goedhals, L
机构
[1] Univ Witwatersrand, Sch Med, Dept Med, Div Clin Haematol & Med Oncol, ZA-2193 Johannesburg, South Africa
[2] Univ Cape Town, ZA-7925 Cape Town, South Africa
[3] Univ Pretoria, ZA-0002 Pretoria, South Africa
[4] Univ Natal, ZA-4001 Durban, South Africa
[5] Univ Orange Free State, Bloemfontein, South Africa
关键词
metastatic breast cancer; aromatase inhibitor; fadrozole; second-line hormone treatment; megestrol acetate;
D O I
10.1159/000011888
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Ninety-six patients were entered into a randomised, double-blind, double-dummy, clinical trial to assess the efficacy and safety of fadrozole as compared to megestrol acetate as second-line hormonal treatment for patients with advanced breast cancer. Analysis of results was on an intention-to-treat basis and included response rate, time to progression (TTP), time to treatment failure (TTF) and survival. Forty-six patients received fadrozole and 50 were randomised to megestrol acetate. Patients and pretreatment prognostic variables were balanced in the two arms of the trial. The objective response rates [3/46 (7 %) for fadrozole and 3/50 (6 %) for megestrol acetate], TTP, TTF and survival were similar in the two arms of the trial. Toxicity was also similar in the two arms of the trial and consisted mainly of oedema, hypertension and minor gastrointestinal symptoms. Fadrozole appears to be as active as megestrol acetate in second-line hormonal treatment of advanced breast cancer.
引用
收藏
页码:416 / 420
页数:5
相关论文
共 15 条
[1]   New aromatase inhibitors: More selectivity, less toxicity, unfortunately, the same activity [J].
CastiglioneGertsch, M .
EUROPEAN JOURNAL OF CANCER, 1996, 32A (03) :393-395
[2]  
Cocconi G, 1996, ANN ONCOL, V7, P433
[3]   POTENCY AND SELECTIVITY OF THE NONSTEROIDAL AROMATASE INHIBITOR CGS 16949A IN POSTMENOPAUSAL BREAST-CANCER PATIENTS [J].
DOWSETT, M ;
STEIN, RC ;
MEHTA, A ;
COOMBES, RC .
CLINICAL ENDOCRINOLOGY, 1990, 32 (05) :623-634
[4]  
Falkson CI, 1996, ANN ONCOL, V7, P465
[5]  
HARVEY HA, 1991, AROMTASE INHIBITION, P89
[6]  
HAYWARD JL, 1977, CANCER, V39, P1289, DOI 10.1002/1097-0142(197703)39:3<1289::AID-CNCR2820390340>3.0.CO
[7]  
2-F
[8]   THE PHARMACODYNAMIC INHIBITION OF ESTROGEN SYNTHESIS BY FADROZOLE, AN AROMATASE INHIBITOR, AND ITS PHARMACOKINETIC DISPOSITION [J].
KOCHAK, GM ;
MANGAT, S ;
MULAGHA, MT ;
ENTWISTLE, EA ;
SANTEN, RJ ;
LIPTON, A ;
DEMERS, L .
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, 1990, 71 (05) :1349-1355
[9]  
LIPTON A, 1990, CANCER, V65, P1279, DOI 10.1002/1097-0142(19900315)65:6<1279::AID-CNCR2820650604>3.0.CO
[10]  
2-3