联合奥沙利铂或顺铂二线治疗晚期非小细胞肺癌的临床研究  

Combined with oxaliplatin or cisplatin in second line treatment of advanced non-small cell lung cancer

作　　者：戴月娣[1] 张德祥[2] 郭伟剑[3] 江联萍[1] 吴海霞[1] 张宁[1] 肖迷 

机构地区：[1]复旦大学附属肿瘤医院闵行分院肿瘤内科,上海200240 [2]复旦大学附属中山医院普外科,上海200032 [3]复旦大学附属肿瘤医院肿瘤内科,复旦大学上海医学院肿瘤学系,上海200032

出　　处：《中国癌症杂志》2014年第2期139-145,共7页China Oncology

基　　金：上海市闵行区卫生局及闵行区科委课题资助(No:2011MW14;2011MHZ06;2011MHZ25)

摘　　要：背景与目的：晚期非小细胞肺癌（non-small cell lung cancer，NSCLC）二线化疗可选择单药多西他赛或培美曲塞，联合铂类能否提高疗效及延长生存尚不明确。本研究比较单药多西他赛或培美曲塞与联合奥沙利铂或顺铂方案二线治疗晚期NSCLC近期疗效、生存期和安全性。方法：经一线联合顺铂或卡铂治疗失败的12l例晚期NSCLC患者按3：2：1比例随机分组，对照组（n=56）：多西他赛75mg／m^2（所有肺癌）或培美曲塞500mg／m^2（非鳞癌），第1天；顺铂组（n=45）：顺铂25mg／m^2，第1～3天联合多西他赛或培美曲塞；奥沙利铂组（n=20）：奥沙利铂130mg／m^2，第1天联合多西他赛或培美曲塞。3周为1个周期，治疗每个周期评价不良反应，每2个周期评价疗效，回访生存期。结果：3组的治疗疾病反应率、无进展生存期（progression free survival，PFS）、总生存期（overall survival，OS）及不良反应差异均无统计学意义（Ｐ〉0．05）。≥60岁老年患者较〈60岁患者PFS更长（ＨＲ=O．56，95％CI：0．35～0．90，P=O．015）；PS评分0～1分患者PFS和OS更长（HR=1．52，95％C1：1．01～2．30，P=O．048；HR=1．90，95％CI：1．17～3．09，P=0．009）。治疗反应率与PFS和0S相关（HR：2．93，95％CI：2．01～4．26，P=O．000：HR=2．03，95％CI：1．37～3．01，P：O．000）。化疗后发生贫血患者PFS和OS呈缩短趋势（HR=1．59，95％CI：0．97～2．61，P=O．066；HR=I．60，95％CI：0．94-2．75，P=O．085），血小板减少患者0s更短（HR=2．97，95％CI：1．01-8．78，P=O．049）。有神经毒性患者PFS呈缩短趋势（HR=3．36，95％CI：0．92～12．25，P=O．066）。二线治疗失败后接受后续治疗者0S有获益（舰=0．36，95％CI：0．22～0．61，P=O．000）。结论：二线联合奥沙利铂或顺铂治疗NSCLC患者疗效和生存期无提高。疾病反应、PS评分与PFS及0S相关，�Background and purpose： Single drug of docetaxel and pemetrexed as second line treatment is standard treatment of advanced non-small cell lung cancer （NSCLC）. Whether combined with platinum can increase the response and survival is still not elucidated. This study was designed to investigate the treatment response, overall survival （OS） and the safety of combined with oxaliplatin or cisplatin regimens as second line in treating NSCLC patients. Methods： Advanced NSCLC inpatients, failure of cisplatin or carboplatin in initial treatment, were dividedinto three groups at random in 3 ： 2 ： 1 rate. Control group： who received docetaxel, 75 mg/m^2 （for all patients）, dl or pemetrexed 500 mg/m^2 （for non-squamous carcinoma）; Cisplatin group： who received cisplatin 25 mg/m^2, dl-3 and docetaxel/pemetrexed; Oxaliplatin group： who received oxaliplatin 130 mg/m^2 dl and docetaxel/pemetrexed. Every 3 weeks were repeated as one cycle. The side effect was assessed every cycle and treatment efficacy was investigated every two cycles. Follow-up examination was taken every 3 months after treatment. Results： There were no differences in treatment response, progress free survival （PFS）, OS and toxicity among the three groups （P〉0.05）. Old patients （≥60 years） had a better PFS than that of patients less than 60 years （HR=0.56, 95%CI： 0.35-0.90, P=0.015）. Patients with performance score 0-1 had a better PFS and OS （HR=l.52, 95%CI： 1.01-2.30, P=0.048; HR=I.90, 95%CI： 1.17-3.09, P=0.009）. Treatment response had relation to PFS and OS （HR=2.93, 95%CI： 2.01-4.26, P=0.000; HR=2.03, 95%CI： 1.37-3.01, P=0.000）. Patients with anemia after treatment tended to have a worse PFS and OS （HR=l.59, 95%CI： 0.97- 2.61, P=0.066; HR=I.60, 95%CI： 0.94-2.75, P=0.085）. Patients with thrombocytopenia after therapy had a worse OS （HR=2.97, 95%CI： 1.01-8.78, P=0.049）. Patients with neural toxicity after chemotherapy tended to have a worse PFS （HR=3.36, 95%CI： 0.92-12.25,

关 键 词：非小细胞肺癌 二线治疗 化学治疗 

分 类 号：R734.2[医药卫生—肿瘤]