来曲唑与氨鲁米特对照治疗绝经后晚期乳腺癌113例  

Comparison of letrezole and aminoglutethimide in treatment of 113 cases of postmenopausal women with advanced breast cancer

作　　者：刘冬耕[1] 管忠震[1] 沈镇宙[2] 韩企夏[2] 宋三泰[3] 刘晓晴[3] 

机构地区：[1]中山医科大学附属肿瘤医院,广州510060 [2]复旦大学附属肿瘤医院,上海200032 [3]军事医学科学院307医院,北京100039

出　　处：《中国新药杂志》2002年第11期870-872,共3页Chinese Journal of New Drugs

摘　　要：目的 :对比来曲唑和氨鲁米特治疗妇女绝经后晚期乳腺癌患者的有效性和耐受性。方法 :采用开放、随机、多中心对照研究 ,患者随机分组接受口服来曲唑 2 .5mg·d-1或氨鲁米特 1g·d-1的对照治疗。结果 :来曲唑组(n =5 9)有效率 2 3.73% (CR 2例 ,PR 12例 ,ITT有效率 2 1.88% ) ,SD 2 0 .31% (13例 )。氨鲁米特组 (n =5 4 )有效率 11.11% (CR 1例 ,PR 5例 ,ITT有效率 10 .17% ) ,SD 2 0 .34% (12例 ) ,2组疗效无统计学差异 (P >0 .0 5 )。来曲唑组和氨鲁米特组不良反应发生率分别为 18.6 4 %和 4 2 .11% ,与治疗相关的不良反应发生率分别为 13.5 6 %和33.33%。比较 2组总的和与治疗相关的不良反应发生率均以来曲唑组明显较低 ,P值均为 0 .0 0 2。结论 :来曲唑对绝经后、ER/PR阳性或不明的晚期乳腺癌患者有效率为 2 3.73% ,与氨鲁米特疗效比较无统计学差异。但来曲唑不良反应较氨鲁米特明显低 ,可以代替氨鲁米特用于晚期绝经后受体阳性或不明乳癌患者的治疗。Objective:To compare the efficacy and tolerability of letrozole with aminoglutethimide(AG) in postmenopousal women with advanced breast cancer.Methods:The multicenter,randomize controlled clinical trial was conducted in 113 patients.They were randomly received letrozole 2.5mg once daily or aminoglutethimide 250mg four times daily with hydrocortisone.Results:The OR in letrozole is 23.73%( 2CR and 12PR, ITT OR is 21.88%), which is higher than in aminoglutethimide (the OR 11.11%,1CR and 5PR, ITT 10.17%),however the difference has no statistical significance ( P > 0.05).Adverse events(AE) of letrozole ( n =59) is 18.64%, the treatment related AE(RAE) is 13.56%, which are significantly lower than the AE of AG ( n =57),42.11% and 33.33% respectively( P =0.002).Conclusion:Letrozole is effective in postmenopousal, hormonal receptor positive or unknown, advanced breast cancer. The OR is 23.73%, which is comparative to results reported abroad, but no statistical significant diffrence compared to the OR of AG. The AE in letrozole is lower than AG with a statistical difference.

关 键 词：来曲唑 氨鲁米特 治疗 绝经 晚期乳腺癌 

分 类 号：R737.9[医药卫生—肿瘤] R969[医药卫生—临床医学]