胃癌新辅助化疗疗效的系统评价——Meta分析

Meta Analysis of Clinical Effectiveness of Neoadjuvant Chemotherapy for Gastric Cancer

背景与目的:自1989年首次报道新辅助化疗在胃癌治疗中的应用以来,新辅助化疗作为胃癌综合治疗的一种方法已得到越来越多的关注,但其在胃癌治疗的价值仍有争议。本研究拟对全世界中、英文相关随机对照试验研究的结果进行Meta分析,以对胃癌新辅助化疗的疗效进行评价。方法:采用Cochrane系统评价方法,检索Cochrane图书馆临床对照试验库、PubMed、Embase、中国生物医学文献数据库(Chinese Biomedical Literature Database,CBM)、中文科技期刊全文数据库(Chinese Scientific Journal Full-text Database,CSJD)、中国期刊全文数据库(Chinese Journal Full-text Database,CJFD)等数据库,并辅以手工检索和其它检索。由2名评价者独立评价并交叉核对纳入研究的质量,对同质研究采用RevMan4.2.10软件进行Meta分析。结果:共5个随机对照试验838例患者纳入研究,其中2个随机对照研究来自日本,另3个分别来自荷兰、英国和中国;包括新辅助化疗组373例患者,手术组465例患者。5个研究均报道采用了随机方法,David使用了盲法,Yutaka对分配隐藏方案进行了描述。Meta分析结果:新辅助化疗组与单纯手术组的手术切除率、治愈率、1年生存率和5年生存率差异均无统计学意义,其OR值和95%CI分别为1.09(0.67,1.77)、1.25(0.85,1.84)、1.61(0.90,2.90)、1.13(0.83,1.53)。结论:进展期胃癌新辅助化疗的疗效并不优于单纯手术,在没有取得新辅助化疗治疗胃癌有效的临床证据之前,不宜将此治疗方法作为胃癌的临床常规治疗。

BACKGROUND ＆ OBJECTIVE. Neoadjuvant chemotherapy has gained increasing attention as a treatment for gastric cancer since Wilke first reported its application to the treatment of gastric cancer in 1989. However, its value in treating gastric cancer remains controversial. This research was to assess the efficacy of neoadjuvant chemotherapy on gastric cancer through a Meta analysis of the randomized controlled trials published worldwide in both English and Chinese. METHODS： Cochrane systematic evaluation was used to search through Cochrane libraries of clinical comparative trials, PubMed, Embase, Chinese Biomedical Literature Database （CBM）, Chinese Scientific Journal Full-text Database （CSJD） and Chinese Journal Full-text Database （CJFD）, aided with manual retrieval and other retrievals. The quality of the assessment was independently evaluated and cross-checked by two evaluators, and the results of homogeneous studies were analyzed with RevMan4.2.10 software. RESULTS： Five randomized controlled trials involved a total of 838 patients were studied. Of the 5 trials, 2 were performed in Japan, 1 in the Netherlands, 1 in the United Kingdom, 1 in China. Of the 838 patients, 373 were treated with neoadjuvant chemotherapy and 465 were treated with surgery alone. Among the above 5 studies, one used blind method and one described random allocation concealment method. No statistical differences were found in the resection rate, cure rate, 1- and 5-year survival rates between neoadjuvant chemotherapy group and surgery group [odds ratio （OR）=1.09, 95% confidence interval （CI）=0.67-1.77 for resection rate; OR=1.25, 95% Cl=0.85-1.84 for cure rate; OR=1.61, 95% Cl=0.90-2.90 for 1-year survival rate; OR=1.13, 95% Cl=0.83-1.53 for 5-year survival rate]. CONCLUSIONS： The efficacy of neoadjuvant chemotherapy on gastric cancer is not better than that of surgery alone. Therefore, neoadjuvant chemotherapy should not be recommended as a regular treatment for gastric cancer before obtaining evidences of its certain efficacy on gastric cancer.