完全性切除非小细胞肺癌围术期化疗的随机研究  

A randomized study of peri-operative chemotherapy in patients with completed resected non-small-cell lung cancer

作　　者：廖美琳[1] 周允中[1] 丁嘉安[2] 倪国兴[3] 张心敏[1] 沈洁[1] 陈智伟[1] 陆舜[1] 

机构地区：[1]上海市胸科医院,上海200030 [2]上海市肺科医院,上海200433 [3]上海市华东医院,上海200040

出　　处：《中国癌症杂志》2005年第3期228-233,共6页China Oncology

基　　金：常见恶性实体瘤共性关键技术的研究课题;上海市医学发展基金重点研究(99ZDⅡ004).

摘　　要：目的:探讨围术期化疗对NSCLC生存率预后因素的影响。方法:1995年2月至2003年12月Ⅰ-ⅢA期根治性手术NSCLC的随机多中心研究分为术前先行化疗和先行手术两组,术后除部分I期外均作术后辅助化疗,以Kaplan-Meier曲线统计累积生存率及LogRank检验,Cox单因素和多因素分析生存率影响因素并计算风险比(HR)。结果:全组337例,术前先行化疗组169例,先行手术组168例。先手术组的累积年生存率优于先化疗组,如5年生存率为47.85%∶36.52%,MST为56.63月∶39.14月(P=0.03);Cox多因素分析显示术前化疗、年龄、性别、病理类型与年生存率不相关(P>0.05),期别及术后化疗和生存率显著相关(P<0.01);Ⅱ期术前先化疗组累积年生存率、MST在Cox单因素分析中明显差于先手术组,如5年生存率为28.50%∶58.91%,MST为35.38月∶60+月(P=0.02);Ⅰ、Ⅲ期中未见两组生存率有统计学差别。两组NSCLC的疾病无进展生存期(PFS)无统计学差异(P=0.10);Cox多因素分析提示期别及术后化疗次数和PFS显著相关(P<0.01),HR分别为2.08和0.86;Ⅱ期先化疗组的年PFS明显低于先手术组(P=0.03),而Ⅰ期、ⅢA期的两组的PFS无明显差别(P>0.05)。术后化疗<3周期的有121例,≥3周期的有216例,年生存率、MST以≥3周期优于<3周期者(P=0.04)。Ⅰ期行术后化疗未见生存收益(P>Purpose:To evaluate the effect of cisplatin-based peri-operation chemotherapy (CT) on survival after completed resection of non small cell lung cancer (NSCLC)Methods:A prospective, randomized, multicenter study was conducted by Shanghai Lung Cancer Team since Feb 1995 to Dec 2003 for stage Ⅰ~ⅢA NSCLC with completed resection. Patients were randomly assigned to receive pre-operative CT or no pre-operative CT (pre-op CT). Post-operative CT (post-op CT) were used for majority of the patients, except for partial stage I patients. Accumulated survival, log rank, MST, Cox uni-variance and multi-variance analyses, HR were used as statistics for evaluation Results:A total of 337 patients underwent randomization, 169 cases received pre-operative CT, and 168 cases didn't receive pre-operative CT. There was statistical survival difference between the group with no pre-op CT and with pre-op CT, 5-yr survival rate were of 47.85%∶ 36.52%, MST were 56.63∶39.14(P=0.03), respectively. Stage and post-op CT were the only two meaningful parameters with statistical survival difference calculated by multi-variance analyses (P<0.01), but no difference was found in others 4 parameters (age, sex, type and pre-op CT). In various stage, a statistical survival difference was only shown in stage Ⅱ NSCLC,(P=0.02), 5-yr survival rate and MST were worse in the group with pre-op CT, 28.50%∶58.91% and 35.38 months∶60 months, respectively, but no difference was seen in stage I and stage ⅢA NSCLC. There was no statistical progression-free survival (PFS) difference between the group with no pre-op CT and with pre-op CT (P=0.10), Stage and post-op CT were two meaningful parameters with statistical PFS difference calculated by multi-variance analyses,HR=2.08 and 0.86, respectively. Stage Ⅱ patients assigned to no pre-op CT had a significantly higher PFS rate than those assigned to pre-op CT (P=0.03), but no difference was seen in stage I and ⅢA NSCLC(P>0.05). There were 121 cases received more than 3 cycles post-op CT, 216 cases re

关 键 词：非小细胞肺癌 围术期化疗 生存率 手术 外科 

分 类 号：R734.2[医药卫生—肿瘤] R730.53[医药卫生—临床医学]