依西美坦治疗晚期转移性乳腺癌195例多中心随机对照研究  

Treatment of advanced metastatic breast cancer with exemestane, a multicenter randomized controlled study of 195 cases

作　　者：王华庆[1] 任长才[2] 冯威健[3] 林孟波[4] 熊玉卿[5] 黄平[6] 赵文华[1] 郝希山[1] 陈声波[5] 阎昭[1] 

机构地区：[1]天津医科大学肿瘤医院内一科,300060 [2]复旦大学附属华山医院内科 [3]河北医科大学第四附属医院化疗科 [4]福建省立医院肿瘤内科 [5]江西医学院第一附属医院内科 [6]江西医学院第二附属医院内科

出　　处：《中华医学杂志》2003年第3期188-190,共3页National Medical Journal of China

摘　　要：目的　探讨芳香化酶抑制剂依西美坦对绝经后晚期转移性乳腺癌的治疗效果及毒副作用。方法　采用随机、双盲、平行对照方法 ,对来自 6家肿瘤中心的 195例绝经后晚期转移性乳腺癌患者进行了多中心临床对照研究。其中治疗组 (依西美坦 ) 96例 ,对照组 (来曲唑 ) 95例 ,4例失访。治疗组应用依西美坦胶囊 ,每日 1次 ,每次 2 5mg口服 ,同时给予与来曲唑外观相同的空白片剂 1片 ,疗程 8周 ;对照组应用来曲唑片每日服药 1次 ,每次 2 5mg,同时给予与依西美坦外观相同的空白胶囊 1粒 ,疗程 8周。治疗前 2周 ,治疗后 4周、8周分别通过影像学拍片或体表直接测量记录肿瘤转归 ,同时检测雌激素抑制率。结果　依西美坦组服药 8周后肿瘤缓解率为 44 8% ;来曲唑组服药 8周后肿瘤缓解率 45 3% ;两组比较差异无显著意义。依西美坦组主要不良反应有口干、恶心、眩晕等 ,无外周血象、肝肾功能、心电图、血压异常。结论　依西美坦对绝经后晚期转移性乳腺癌有较好的治疗效果 ,毒副反应轻微 ,是较好的肿瘤内分泌治疗剂。Objective To observe the efficacy of exemestane for postmenopausal advanced metastatic breast cancer , and to assess its side effects. Methods A randomized, double-blind, and parallel controlled study was conducted among 195 patients with postmenopausal advanced metastatic breast cancer from December 2001 to June 2002. Except for the 4 cases who were lost to follow-up, the remaining 191 patients were divided into two groups: study group (n=96, treated with exemestane capsule 25 mg and one model tablet of letrozole orally q.d. for 8 weeks), and control group (n=95, treated with letrozole 2.5mg and one model capsule of exemestane orally q.d. for 8 weeks). Physical examination, roentgenography and CT were conducted to observe the outcome of the tumor and the level of estrogen was tested 2 weeks before and 4 and 8 weeks after the beginning of treatment. Results The effective rate was 44.8% in the study group and 45.3% in the control group (P=0.971). The level of estradiol was 5.17±6.68×104 pg/L and 4.19±3.06×104 pg/L in the study group and control group respectively; and was 3.08±2.80×104 pg/L and 2.76±1.98×104 pg/L in the study group and control group respectively 8 weeks after the beginning of treatment, both decreased by 43.7% in comparison with those before treatment (both P<0.001), however, there was no significant difference between the study group and control group (P=0.141). The side effects of exemestane included thirst, giddiness, and nausea. Conclusion An effective hormonal medicine, exemestane has good therapeutic efficacy in postmenopausal advanced metastatic breast cancer with only mild side effects.

关 键 词：依西美坦 治疗 晚期 转移性乳腺癌 多中心研究 

分 类 号：R737.9[医药卫生—肿瘤] R730.53[医药卫生—临床医学]