培美曲塞联合顺铂对比吉西他滨联合顺铂一线治疗晚期非鳞非小细胞肺癌的随机、对照、多中心临床研究  

A Randomized, Controlled, Multicenter Clinical Trial Comparing Pemetrexed/Cisplatin and Gemcitabine/Cisplatin as First-line Treatment for Advanced Nonsquamous Non-small Cell Lung Cancer

作　　者：黄岩[1] 刘云鹏[2] 周建英[3] 徐农[3] 李宝兰[4] 伍钢[5] 方健 李凯[7] 刘晓睛[8] 刘巍[9] 卢铀[10] 王孟昭[11] 刘文超[12] 梁后杰[13] 张沂平[14] 黄诚[15] 王顺金[16] 王雅杰[17] 于世英[18] 常建华[19] 王哲海[20] 胡志皇[1] 张力[1] 

机构地区：[1]中山大学肿瘤防治中心,华南肿瘤学国家重点实验室,广州510060 [2]中国医科大学附属第一医院,沈阳110001 [3]浙江大学医学院附属第一医院,杭州310003 [4]北京市胸科医院,北京101149 [5]华中科技大学同济医学院附属协和医院,武汉430022 [6]北京大学肿瘤医院,北京100142 [7]天津市肿瘤医院,天津300060 [8]中国人民解放军307医院,北京100071 [9]河北医科大学第四医院,石家庄050011 [10]四川大学华西医院,成都610041 [11]中国医学科学院协和医院,北京100730 [12]第四军医大学西京医院,西安710032 [13]第三军医大学第一附属医院,重庆400038 [14]浙江省肿瘤医院,杭州310022 [15]福建省肿瘤医院,福州350014 [16]南昌大学附属第二医院,南昌330006 [17]上海市长海医院,上海200433 [18]华中科技大学同济医学院附属同济医院,武汉430030 [19]复旦大学附属肿瘤医院,上海200032 [20]山东省肿瘤医院,济南250117

出　　处：《中国肺癌杂志》2012年第10期576-582,共7页Chinese Journal of Lung Cancer

基　　金：江苏豪森药业集团股份有限公司项目(ClinicalTrials.gov注册号:NCT01194453)资助~~

摘　　要：背景与目的目前晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的标准治疗仍是含铂两药方案,国内外多项临床研究显示培美曲塞联合顺铂在晚期非鳞NSCLC具有较好的疗效及安全性,本研究拟评估国产培美曲塞二钠联合顺铂一线治疗晚期NSCLC的疗效与安全性。方法本研究是一项多中心、随机、阳性药物平行对照的临床试验。入组患者按1:1随机分为两组,分别接受培美曲塞二钠联合顺铂(PC组)或吉西他滨联合顺铂(GC组)治疗,21天为一个周期。主要研究终点为无进展生存期,次要研究终点主要包括1年生存率、客观缓解率、无3度或4度毒性生存期及其安全性。结果全国20家研究中心共纳入288例患者(各组144例),基于全分析集进行分析,PC组与GC组患者的中位无进展生存期分别为168天(5.6个月)和140天(4.7个月)(P=0.16);1年生存率分别为50.0%和54.9%(P=0.47);客观缓解率分别为24.4%和14.2%(P=0.06);无3度/4度毒性生存期分别为11.3个月和8.1个月(P=0.23)。总体不良反应发生率PC组明显低于GC组(81.95%vs93.75%,P=0.003)。结论两种含铂方案治疗晚期非鳞NSCLC具有相似的疗效,但PC方案不良反应更轻,有望成为晚期非鳞NSCLC一线治疗的新选择。Background and objective Platinum-based doublet chemotherapy is still the standard first-line treat- ment for non-small cell lung cancer （NSCLC）. Previous studies have demonstrated that pemetrexed combined with platinum had promising efficacy and safety profile in NSCLC, especially in patients with nonsquamous NSCLC. This trial was conducted to evaluate the efficacy and safety ofpemetrexed made in China as first-line treatment. Methods The present study was a randomized, controlled, multicenter clinical trial. Patients were randomly assigned （1：1） to receive cisplatin plus pemetrexed chemotherapy （PC group） or gemcitabine plus cisplatin （GC group） every 3 weeks. The primary end point was progression free survival （PFS） and the secondary end points included 1 year survival rate, objective response rate （Oil）, survival with- out grade 3/4 toxicity （SWT3/4） and safety profile. Results A total of 288 patients from 20 institutions across China were enrolled into the study. Based on the Full Analyses Set （FAS）, the PFS was 168 days （5.6 months） us 140 days （4.7 months） （P=0.16）, one year survival rate was 50.0% us 54.9% （P=0.47）, ORR was 24.4% vs 14.2% （P=0.06） in the PC group and the GC group, respectively; Survival without grade 3/4 toxicity was 11.3 months in GC group vs 8.1 months in PC group （P=0.23）. In terms of the safety, side effects were less observed on the PC group （81.95% vs 93.75%, P=0.003）. The main side effects included leukopenia, neutropenia, emesis, anemia, thrombopenia. Conclusion The both regimens have similar efficacy as the treatment for advanced nonsquamous NSCLC, but pemetrexed plus cisplatin regimen has better safety profile and seems to have longer PFS, which makes it a new option as the first line setting.

关 键 词：肺肿瘤 培美曲塞 吉西他滨 顺铂 化学疗法 

分 类 号：R734.2[医药卫生—肿瘤]