依西美坦治疗绝经后晚期乳腺癌Ⅱ期临床试验

PhaseⅡtrial of Exemestane in the treatment of postmenopausal women with advance breast cancer

目的 探讨依西美坦治疗绝经后妇女晚期乳腺癌的临床疗效和不良反应。方法 应用双盲双模拟随机对照方法 ,将 40例绝经晚期乳腺癌患者分为 A组 (治疗组 )和 B组 (对照组 )各 2 0例 ,采用双模拟阳性对照。A组 :依西美坦 2 5 mg,加来曲唑模拟片 ,早餐后口服 ,每日 1次 ;B组 :来曲唑 2 .5 mg,加依西美坦模拟片 ,早餐后口服 ,每日 1次。两组疗前 2周内及治疗每 4周后检测血中雌二醇 ( E2 )水平 ,治疗 4～ 1 2周后评价疗效和不良反应。结果 两组所有患者均可进行疗效评价和不良反应分析。A,B组均无 CR者 ;A组和B组部分缓解 ( PR)分别为 4例 (缓解率为 2 0 % )和 2例 (缓解率为 1 0 % ) ;稳定 ( SD)分别为 8例和 1 0例 ;软组织疗效稍高于内脏转移 ,治疗第 8周 E2 抑制率分别为 2 1 .4%和 1 1 .8% ;不良反应包括恶心、呕吐、潮热、头晕、浮肿 ,一般较轻 ,可以耐受。结论 依西美坦作为一种新的甾体类芳香化酶抑制剂 ,对血清 E2有一定的抑制作用 ,对绝经后晚期乳腺癌疗效肯定 ,不良反应均较轻微 。

Objective To evaluate the antitumor activity and toxicity of a new steroidal aromatase inactivator Exemestane in postmenopausal women with advancec breast cancer Methods A double blind, open label, randomized clinical trial on the effect of exemestane was conducted. 40 patients were randomized divided into A group and B group.Each patient of A group was treated by oral Exemestane,25mg/d and analogue tablet Letrozole. Each patient of B group was treated by oral Letrozole,2 5mg/d and analogue tablet Exemestane.Each patient received 4~12 weeks.Plasma estradiol concentrations was detected 2 weeks before treatment and after per 4 weeks. The effect and adverse reactions were evaluated Results All cases were evaluable.The response rate in A and B group were 20% and 10%, respectively;the effect of soft tissue metastasis is superior to visceral metastasis in some sort.Plasma level of estradiol in A and B group after 8 weeks were suppressed by 21 4% and 11 8%,respectively.The main adverse reactions,including nausea,hot flushes,dizziness,peripheral oedema,were generally tolerable Conclusions As a new steroidal aromatase inactivator capable of decreasing plasma estradiol level,Exemestane is a unique therapy that is highly active and well tolerated as a new treatment for women with advance breast cancer.Side effects are mild and tolerable