摘要
目的:评估依西美坦用于他莫昔芬治疗失败的绝经后晚期乳腺癌的有效性和安全性。主要终点指标是客观 肿瘤缓解率(ORR),次要终点指标是肿瘤缓解持续时间(DTR)、肿瘤进展时间(TTP)、肿瘤治疗失败时间(TTF)、安全性评估 和毒副反应。方法:对入组的23例患者进行为期2年的开放、随机、平行对照研究,其中依西美坦组和甲地孕酮组的例数分别 是11例和12例;中位年龄为59岁和54岁,均为绝经后晚期乳腺癌,有可评价病灶。依西美坦25mg或甲地孕酮160mg,均为 每日1次口服。研究药物将至少应用8周(除非肿瘤迅速进展或出现难以接受的毒性),最长至26周。肿瘤评估在治疗的第 8、16和26周进行。患者在26周治疗后的继续治疗将按照另外一个随机方案进行。结果:依西美坦组与甲地孕酮组ORR分 别为18.2%和16.7%(P>0.05),但依西美坦组DTR、TTP和TTF比甲地孕酮组更长(P<0.05)。给予依西美坦的患者总体 生存率长于甲地孕酮组。与药物相关或不确定的不良事件包括:颜面潮红、乏力、出汗增多和食欲增加,体重增加患者(> 10%基础体重)甲地孕酮组为25.0%,依西美坦组为9.1%(P<0.05)。结论:对国人他莫昔芬治疗失败的绝经后晚期乳腺癌 患者,采用芳香化酶抑制剂依西美坦治疗安全有效,是一个新的选择。
Objective:To evaluate the efficacy and safety of exemenstane in post-menopausal advanced breast carcinoma failing to tamoxifen. The primary endpoint was objective response rate(ORR), and the second endpoints were the durative time of remission(DTR), time of tumor progression(TTP), time of treatment failure(TTF), safety assessment and adverse events. Methods:The open-label, randomized, parallel group and two years' comparative trial was performed on 23 cases, including 11 cases in exemenstane group and 12 cases in megace group. The mean age of two groups was 59 and 54 respectively. All the cases were postmenopausal advanced breast carcinoma patients with evaluable lesions. Exemenstane or megace were administrated orally on single daily dose schedule by 25mg or 160mg respectively. The clinical trial should continue no less than 8 weeks (but for quickly progression or intolerable toxicity), and no more than 26 weeks.The assessment was taken in week 8,16 and 26. The continuous treatment of these patients will be enrolled in another randomized clinical trial. Results:The ORR in exemenstane and megace group were 18.2% and 16.7% respectively (P>0.05).The median DTR, TTP and TTF in exemenstane group were much longer than that in megace group (P<0.05), so was the total survival rate. The drug-relevant or unconfirmed adverse events included as follows: hot brush, nausea, fatigue, sweating and appetite increasing. Weight gain patients in exemenstane group was 9.1% and 25.0%in megace group respectively (P<0.05). Conclusion:As an aromatase inhibitor, exemenstane maybe is an safe and effective drug in postmenopausal advanced breast carcinoma failing to tamoxifen.
出处
《临床肿瘤学杂志》
CAS
2005年第1期32-35,共4页
Chinese Clinical Oncology
