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

                         王华庆 任长才 冯威健 林孟波 熊玉卿 黄平 赵文华 郝希山 陈声波 阎昭

                                       中华医学杂志

【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l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25 mg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2．5 mg，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。
【关键词】抗肿瘤药物； 乳腺癌； 多中心研究； 依西美坦
Treatm ent of advanced metastatic breast cancer with exem estane， a multicenter randomized controHed
study of 195 cases WANG Hua-qing ，REN Chang-cai，FENG Wei-jian，LIN Meng-bo，XIONG Yu-qing，
HUANGPing，Z O Wen-hua，HAOXi-shan，CHEN Sheng—bo，YAN Zhao． CancerHospital，TianjinMedical
Univers ，Tianjin 3DoD6D，China
【Abstract】 0bjective To observe the efficacy of exemestane for postmenopausal advanced metastatic
breast cancer ，and to assess its side efects．M ethods A randomized，double-blind，and parallel controlled
study was conducted among 195 patients witIl postmenopausal advanced metastatic breast cancer from December
2001 to JuBe 2002．Except for tIle 4 cases who were lost to folow—up．tIle remaining 191 patients were divided into
two groups：study group(n=96，treated wi山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
山e tulnor and 山e level of estrogen was tested 2 weeks before and 4 and 8 weeks after tlle be ginnlng oftreatment．
Results rI’he efective rate was 44．8％ in the study group and 45．3％ in the control group (P=0．971)．rI’he
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±1．98×1o4 pg／L in the study group and control group
respe ctively 8 weeks after tIle beginning of treatm ent，both decreased by 43．7％ in comparison witIl tIlose before
treatment(both P<0．001)，however，there was no significant diference between the study grouD and control
group(P=0．141)．The side efects of exemestane included thirst，giddiness，and nausea．Conclusion An
efective hormonal medicine， exemestane has good therapeutic eficacy in postm enopausal advaJlced metastatic
breast can cer with only mild side efects．
【Key words】 Antineoplasfic agents； Breast neoplasms； Multicenter studies： Exemestane