伊立替康联合顺铂治疗复发或进展小细胞肺癌60例临床研究

Irinotecan plus cisplatin for relapsed or progressive small cell lung cancer in 60 cases

目的比较伊立替康联合顺铂的时辰化疗与常规化疗二线治疗复发或进展小细胞肺癌(SCLC)的疗效和不良反应。方法60例晚期非小细胞肺癌患者随机分成两组,实验组32例予时辰化疗,伊立替康60mg/m2静脉滴注第1、8、15天,2∶00开始,至08∶00结束,顺铂60mg/m2静脉滴注第1天,10∶00开始,至22∶00结束;对照组28例予常规化疗,每天10∶00先伊立替康,后顺铂静脉滴注(两药剂量同时辰化疗组),化疗至少2个周期后评价近期疗效。结果时辰化疗组有效率(CR+PR)为34.4%(15/32),常规化疗组有效率为(CR+PR)为25%(6/28),两组有效率比较,差异有统计学意义(P<0.05);主要不良反应为血液学毒性、恶心、呕吐及延迟性腹泻,时辰化疗组较常规化疗组低(P<0.05);两组疾病进展时间(TTP)及中位生存期比较,差异均无统计学意义(P>0.05)。结论伊立替康联合顺铂时辰化疗二线治疗复发或进展小细胞肺癌疗效优于常规化疗,不良反应轻,值得进一步深入研究。

Objective To compare the efficacy and toxicity of second-line chrono-chemotherapy（irinotecan and cisplatin） with routine chemotherapy for advanced small cell lung cancer（SCLC）. Methods Sixty cases of SCLC were randomly grouped,32 cases for chrono-chemotherapy were treated with irinoteean 60mg/m^2 , from 2 ： 00 to 8 ： 00, cisplatin 60mg/m^2 , from 10 ： 00 to 22 ： 00 ; and 28 cases were treated with conventional chemotherapy proceeded on 10： 00. For needs of evaluation, all patients must complete at least two cycles. Results The total response rate（CR＋PR） in chrono-chemotherapy and conventional chemotherapy were 34.4% and 25% respectively. The difference between two groups had statistical significance. The main adverse events of chemotherapy were leucopenia,gastrointestinal discomfort and delayed diarrhea, the toxicity of ehrono-chemotherapy groups were lowed compared with to routine-chemotherapy group. The difference between two groups had statistical significance. No difference were found between two groups in time to progress（TTP） and median survival time. Conclusion The second-line chrono-chemotherapy（irinotecan and cisplatin） is more effective than routine-chemotherapy for relapsed or progressive small cell lung cancer, and has wild adverse reactions as well. More clinical research should be taken.