伊立替康联合顺铂与吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的随机对照研究

目的　探讨伊立替康（ＣＰＴ １１）联合顺铂（ＤＤＰ）方案（ＩＰ方案）与吉西他滨（ＧＥＭ）联合ＤＤＰ方案（ＧＰ方案）一线治疗非小细胞肺癌（ＮＳＣＬＣ）的近期疗效和毒副反应。方法　采用前瞻性、开放性、随机对照的临床研究设计，纳入经组织学或细胞学确诊的初治晚期ＮＳＣＬＣ患者８８例，按２∶１比例随机分入ＩＰ方案组和ＧＰ方案组，ＩＰ方案组６０例，ＧＰ方案组２８例。ＩＰ方案组：ＣＰＴ-11 １００ｍｇ／ｍ２，ｄ１、ｄ８；ＤＤＰ２５ｍｇ／ｍ２，ｄ１ ～ｄ３；２１天为１周期。ＧＰ方案组：ＧＥＭ １０００ｍｇ／ｍ２，ｄ１、ｄ８；ＤＤＰ２５ｍｇ／ｍ２，ｄ１～ｄ３；２１天为１周期。２个周期评价疗效和不良反应。结果　ＩＰ方案组获ＰＲ２７例，ＳＤ１６例，ＰＤ１２例，死亡１例，有效率按意向性治疗分析（ＩＴＴ）为４５.０％，按符合方案分析（ＰＰ）为４８.２％，中位生存时间为１１.２个月，１年生存率为４６.４％；ＧＰ方案组获ＰＲ１０例，ＳＤ９例，ＰＤ７例，有效率按ＩＴＴ为３５.７１％，按ＰＰ为３８.５％，中位生存时间为１１.８个月，１年生存率为４６.２％。两组主要不良反应为血液学毒性、消化道反应、疲乏和脱发，ＩＰ方案组腹泻、疲乏、脱发的发生率高于ＧＰ方案组，血小板减少发生率低于ＧＰ方案组（Ｐ＜０.０５）。结论　ＩＰ方案和ＧＰ方案治疗晚期ＮＳＣＬＣ的疗效确切且无显著差异，毒副反应均可耐受。

A randomized controlled clinical trial on irinotecan plus cisplatin versus gemcitabine plus cisplatin as the first-line treatment for advanced non-small cell lung cancer

Objective To prospectively evaluate the efficacy and toxicity of irinotecan plus cisplatin（IP regimen）compared with gemcitabine plus cisplatin（GP regimen）as the first-line treatment for advanced non-small cell lung cancer（NSCLC）.Methods A total of 88 patients were randomly assigned to two regimens in 2∶1 proportions.IP Group： cisplatin 25mg/m2,iv,d1-d3;irinotecan 100mg/m2,iv,d1,d8;3 weeks was a cycle.GP Group： cisplatin 25mg/m2,iv,d1-d3;gemcitabine 1000mg/m2,d1,d8;3 weeks was a cycle.The efficacy and toxicity were evaluated after 2 cycles of chemotherapy.Results Among the 60 cases in IP group,27 patients had PR,16 patients with SD and 12 patients with PD.The response rate in intention to treat（ITT） and per protocol（PP） analysis was 45.0% and 48.2% respectively.Median survival time was 11.2 months and the 1-year survival rate was 46.5%.Among 28 cases in GP group,10 patients had PR,9 patients had SD and 7 patients had PD.The response rate in ITT and PP analysis was 35.7% and 38.5% respectively.Median survival time was 11.8 months and the 1-year survival rate was 46.2%.The main side effects of the two groups included hematologic toxicites,digestive tract reaction,fatigue and hairloss.The incidence of diarrhea,fatigue and hairloss in IP group was lower than that in GP group,but thrombocytopeania on the contrary.Conclusion The two regimens have similar efficacy as the first-line treatment for advanced NSCLC.The major toxicities of the two regimens are well tolerable.