依立替康/顺铂与吉西他滨/顺铂方案一线治疗晚期非小细胞肺癌随机对照临床研究

背景与目的:晚期非小细胞肺癌仍以全身化疗为主,吉西他滨为第三代化疗药物,其与铂类联合治疗晚期非小细胞肺癌已广泛应用,依立替康加铂类一线治疗晚期非小细胞肺癌疗效问题国内尚未见随机研究报道。本研究采用前瞻性开放性随机对照研究方法,评价依立替康(irinotecan,CPT-11)联合顺铂(IP方案)与吉西他滨(gemcitabine,GEM)联合顺铂(GP方案)一线治疗晚期非小细胞肺癌的近期疗效和毒副反应。方法:63例患者随机采用IP或GP方案化疗。IP组:CPT-11 100 mg/m2,第1、8天;DDP 25 mg/m2,第1~3天。GP组:GEM1 000mg/m2,第1、8天;DDP 25 mg/m2,第1~3天。化疗至少2周期后评价疗效及不良反应。结果:IP组31例,PR 11例,SD 12例,PD 5例,在全样本疗效分析(ITT分析)时有效率35.5%,在有效样本疗效分析(PP分析)时有效率39.3%。GP组32例,PR 11例,SD 14例,PD 6例,在ITT分析时有效率34.4%,在PP分析时有效率35.5%;PFS时间IP组为4个月,GP组为4.2个月;两组比较差异均无显著性(P>0.05)。不良反应有所不同,IP组腹泻发生率为48.4%,与GP组差异有显著性(P<0.001)。GP组WBC减少发生率略低于IP组,但血小板下降发生率高于IP组,与IP组相比,差异有显著性(P<0.05).结论:依立替康或吉西他滨联合DDP一线治疗晚期NSCLC具有较好的耐受性和临床疗效,两者近期疗效比较差异无显著性,IP组不良反应以WBC下降和腹泻为主,GP组不良反应以WBC下降和血小板下降为主,但都可以耐受。

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

Background and purpose:Chemotherapy is one of the major strategies for the treatment in advanced non-small cell lung cancer(NSCLC).Gemcitabine(GEM) is a novel antineoplastic drug.The combination of GEM and platinum drug has been widely used for the treatment in advanced NSCLC,but the randomized trial of irinotecan(CPT-11) plus platinum drug as the first-line treatment in advanced NSCLC has not been investigated in our country.The purpose of this study was to prospectively evaluate the efficacy and toxicity of irinotecan plus cisplatin(DDP)(IP regimen) compared with GEM plus DDP(GP regimen) as the first-line treatment in advanced NSCLC.Methods:63 cases were randomly enrolled into two groups.Group IP was treated with CPT-11 100mg/m2 on day 1,8 and DDP 25 mg/m2 on day 1-3;group GP was treated with GEM 1 000mg/m2 on day 1,8 and DDP 25 mg/m2 on day 1-3.The efficacy and toxicity was evaluated after at least 2 cycles of chemotherapy given.Results:Among 31 cases in group IP,11 patients had PR,12 patients with SD and 5 with PD.The response rate in ITT and PP analysis was 35.5%,39.5% respectively.Among 32 cases in group GP,11 cases had PR,14 with SD and 6 with PD.The response rate in ITT and PP analysis was 34.4% and 35.5%,respectively.The PFS duration was 4 months in IP group and 4.2 months in GP group.The differences in terms of the response rate and the PFS time in two groups were nonsignificant(P>0.05).The incidence rate of diarrhea in IP group was 48.4% it was significantly higher than GP group(P<0.001).The incidence rate of leukopenia in GP group was lower than that in IP group;but the incidence rate of thrombocytopenia was higher than that in IP group,the difference was significant(P<0.05).Conclusions:The efficacy of IP regimen was similar to GP regimen as the first-line treatment of advanced non-small cell lung cancer,and the two regimens could be well tolerated.The major toxicities were leukopenia and diarrhea in IP group,thrombocytopenia and leukopenia in GP group.