芳香化酶抑制剂治疗晚期乳腺癌的临床研究  

Clinical study of aromatase inhibitors in advanced breast cancer

作　　者：李惠平[1] 季加孚[2] 侯宽永[3] 贾廷珍[1] 赵红梅[3] 肖宇[1] 王墨培[1] 汪有蕃[1] 

机构地区：[1]北京大学第三医院肿瘤化疗科,北京100083 [2]北京大学临床肿瘤学院外科 [3]北京大学第三医院普外科,北京100083

出　　处：《北京大学学报（医学版）》2007年第2期193-196,共4页Journal of Peking University:Health Sciences

基　　金：国家自然科学基金(30672424)资助~~

摘　　要：目的：评价芳香化酶抑制剂治疗晚期乳腺癌的疗效和安全性。方法：观察2003年6月至2006年9月治疗的52例晚期乳腺癌患者,均为女性,年龄范围37-75岁,中位年龄58岁,其中8例绝经前患者中有6例行卵巢切除,2例应用戈舍瑞林抑制卵巢功能。患者均有可观察病灶,除11例因病情迅速进展外,均应用芳香化酶抑制剂治疗至少24周,所用芳香化酶抑制剂分别为依西美坦（36例）、阿那曲唑（13例）、来曲唑（3例）;主要观察指标为：客观反应率（ORR=CR＋PR,其中CR为完全缓解,PR为部分缓解）、临床获益率（CBR=CR＋PR＋SD≥24周,其中SD为疾病稳定）、肿瘤进展时间（TTP）,肿瘤治疗失败时间（TTF）、安全性和毒副反应。结果：CR6例（11.5%）,有1例维持CR152周,1例维持96周,另4例亦大于60周;PR19例（36.5%）,维持PR时间为32~96周;SD≥24周的患者有16例（30.8%）;PD（疾病进展）＋SD〈24周的有11例（21.2%）。患者的ORR为48%,CBR为78.8%,平均TTP时间78.87周（95%CI61.13%~96.61%）。Kaplan-Meier生存曲线表明,尽管未获客观反应的患者疾病进展后曾采用化疗、放疗或其他治疗（B组）,但与达到客观反应的患者（A组）相比生存时间差异仍有统计学意义,随访大于24周时两组的总生存率分别A组92%,B组81.5%[Log Rank（Mantel-Cox）检验,χ^2=3.85,P=0.047]。与药物相关的副反应包括潮红、出汗、小关节痛,其中有2例发生与治疗药物关系不确定的心力衰竭,经对症治疗后好转。结论：芳香化酶抑制剂治疗晚期乳腺癌单药有效率为48%,能明显延长达CR或PR患者的生存期,副反应易耐受。Objective： To assess the antitumor activity and safety of aromatase inhibitors in advanced breast cancer. Methods： Fifty-two advanced and female breast cancer patients with measurable and/or bone valuable tumor lesions were observed from June 2003 to September 2006. They were treated by aromatase inhibitors for at least 24 weeks, of whom 11 were treated less than 24 weeks because of disease progress; their age range was from 37 to 75 years（ median 58 ） ; 8 patients were pre-menopausal, 6 with ovarian ablation and 2 with Goserelin to suppress ovarian function. Thirty-six patients were treated with exemestane, 13 with anastrozole and 3 with letrozole. Major items were observed including objective response rate （ORR = CR ＋ PR）, clinical benefit rate （ CBR = CR ＋ PR ＋ SD I〉24 weeks）, time to progress（TrP）, time to failure（TrF）, safety and toxicity. Results： CR were 6 cases （ 11.5% ） , with 1 case going on for 152 weeks, 1 case for 96 weeks, and other 4 cases for longer than 60 weeks; PR were 19 cases （36.5%） , lasting 32 -96 weeks; 16 cases obtained SD≥24 weeks（30.8% ） ; and 11 cases PD（progress of disease） ＋ SD 〈 24 weeks （21.2%）. ORR were 48% , CBR 78.8% , and TrP 78.87 weeks （95% CI 61. 13% -96. 61% ）; although the patients who did not achieve objective response （ group B） were treated with chemotherapy, radiotherapy or another kind of aromatase inhibitor, but their survival time was significantly different from that of the patients who achieved objective response （group A） when defined by Kaplan-Meier survival estimate. The over survival was 92% in group A, and 81.5% in group B when patients follow up more thon 24 weeks [ Log Rank （Mantel-Cox） analysis, X^2 = 3.85, P = 0. 047 ] ;side effects were observed such as arthralgia, sweating, hot flash, and 2 patients developed heart failure with uncertain related drug before recovery. Conclusion： The single agent effective rate of aromatase inhibitor was 48%. The patients had long term surviv

关 键 词：芳香酶抑制剂 乳腺肿瘤 三唑类 雄二烯类 

分 类 号：R737.9[医药卫生—肿瘤]