国产依西美坦治疗绝经后晚期乳腺癌的Ⅱ期临床试验研究

PhaseⅡclinical trial of domestic Exemestane in postmenopausal patients with advanced breast cancer

目的:评价国产依西美坦片治疗绝经后晚期乳腺癌的近期疗效和安全性。方法:采用多中心、双盲、随机临床试验,对118例晚期乳腺癌患者进行研究,其中国产依西美坦组(A组)58例,来曲唑组(B组)60例。结果:A组和B组客观有效率(CR+PR)分别为32.76%(19/58)和23.33%(14/60);A组和B组疗效指标(CR+PR+SD)率分别为86.21%(50/58)和71.67%(43/60)。治疗8周后,A组和B组血清雌二醇抑制率分别为(31.13±29.09)%和(32.03±21.56)%。A组和B组不良反应发生率分别为37.93%和28.33%,主要包括面部潮热、头晕、恶心和乏力。两组比较差异均无统计学意义(P>0.05)。结论:依西美坦作为一种新的芳香化酶抑制剂,临床疗效肯定,且耐受性良好,可作为绝经后晚期乳腺癌的内分泌治疗药物。

Objective:To evaluate the effect and toxicity of domestic Exemestane in postmenopausal patients with advanced breast cancer.Methods:A multi-center and double-blind clinical trial was conduct-ed in118patients with advanced breast cancer who were randomized to Exemestane group (group A,58patients)and Letrozole group(group B,60patients).Results:The objective response rates(CR+PR)were32.76%(19/58)in group A and23.33%(14/60)in group B,and the clinical benefit rates(CR+PR+SD)were86.21%(50/58)and71.67%(43/60)respectively.After8weeks of therapy,the suppressive rates of serum estradiol(E 2 )were(31.13±29.09)%in group A and(32.03±21.56)%in group B.The side-effect rates were37.93%and28.33%respectively,and the main drug-related adverse events were hot flushes,dizziness,nau-sea and fatigue in both groups.There was no significant difference in two groups(P>0.05).Conclusion:Ex-emestane is an endocrine therapy that is highly active and well tolerated as a new steroidal aromatase in-hibitor for postmenopausal patients with advanced breast cancer.