【摘要】 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;DDP 25mg/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PR 27例,SD 16例,PD 12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,SD 9例,PD 7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。更多还原

【Abstract】 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.更多还原