伊立替康或足叶乙甙联合顺铂方案一线治疗小细胞肺癌的临床随机对照研究

Randomized Trial Comparing Irinotecan plus Cisplatin with Etoposide plus Cisplatin as First-line Therapy for Small Cell Lung Cancer

目的:本研究为比较伊立替康联合顺铂(irinotecan plus cisplatin,IP)方案与足叶乙甙联合顺铂(etoposide plus cisplatin,EP)方案一线治疗小细胞肺癌(SCLC)的近期疗效、远期生存及不良反应。方法:首都医科大学附属北京胸科医院肿瘤内科从2008年3月至2010年3月收治的60例SCLC患者,随机分为两组,分别接受IP和EP方案的治疗。主要研究终点为无进展生存期(progression-freesurvival,PFS),次要研究终点为总生存(overall survival,OS),客观反应率(response rate,RR)和不良反应。结果:60例患者中,59例可评价疗效,其中IP组RR 65.4%(19/29),中位PFS为9.6个月,中位OS为17.3个月;EP组RR 73.3%(22/30),中位PFS为9.7个月,中位OS为17.4个月,两组比较均无统计学差异(P=0.864;P=0.982;P=0.997)。两组主要不良反应均为骨髓抑制和胃肠道反应,但Ⅲ+Ⅳ度不良反应均无统计学差异(P>0.05),IP组腹泻发生率高于EP组(26.6%vs.0),两组比较差异具有统计学意义(P=0.003)。结论:IP方案一线治疗SCLC近期疗效及远期生存均与EP方案相当,且不良反应可耐受。

To compare the efficacy and toxicity of irinotecan plus etoposide （ IP ） with those of etoposide plus cisplatin （ EP ） as first-line treatments for small cell lung cancer （ SCLC ）. Methods： A total of 60 patients were randomly assigned into the IP arm and the EP arm. The primary endpoint was progression-free survival （ PFS ）. The secondary endpoints were overall survival （ OS ）, response rate, and toxicity. Results： Of the 60 patients, 59 were eligible. The median PFS was 9.6 months in the IP arm and 9.7 months in the EP arm （ P = 0.982 ）. The median OS was 17.3 months for the IP arm and 17.4 months for the EP arm（ P = 0.997 ）. No significant difference was observed. The response rate was 65.4 % in the IP arm and 73.3 % in the EP arm. No significant difference in response rate was observed between the two arms （ P 〉 0.05 ）. The main common adverse reactions were myelosuppression and gastrointestinal response in both treatment arms. No significant difference in grade 3 and grade 4 toxicity was observed between the arms （ P 〉 0.05 ）. Diarrhea was significantly more frequent in the IP arm than in the EP arm （ P = 0.003 ）. Conclusion： The effects oflP and EP as first-line therapy for SCLC are comparable and equivalent and their adverse reactions can be tolerated.