吉西他滨单药与以其为基础的联合化疗治疗进展期胰腺癌疗效的meta分析

目的 研究吉西他滨(GEM)单药与以吉西他滨为基础的两种药物联合用药(GEMCOM)对于进展期胰腺癌的治疗效果.方法 以PhaseⅢ、gemcitabine、pancreatic cancer为检索词,在Pubmed中检索2002至2010年GEM和GEMCOM治疗进展期胰腺癌三期临床试验文献,以文献为基础采用固定效应模型或随机效应模型对客观缓解率、1年生存率进行meta分析.结果 Meta分析的结果显示,14个临床随机对照试验(RCT)入选客观缓解率分析,结果为GEMCOM组客观缓解率优于GEM单用组(z=4.400,P=0.000);10个RCT入选两组1年生存率分析,GEMCOM组1年生存率高于GEM单用组(z=2.190,P=0.028).14个RCT获益率分析发现,GEMCOM组获益率高于GEM单用组(z=4.400,P=0.000).通过Egger直线回归法检测,入选客观缓解率分析的14个RCT中,尚不能说明存在发表偏倚(t=0.070,P=0.946);入选1年生存率分析的10个RCT中,尚不能说明存在发表偏倚(t=-0.740,P=0.483).结论 吉西他滨联合用药的客观缓解率、1年生存率、获益率高于吉西他滨单独用药组.吉西他滨联合用药有优于吉西他滨单用的可能.

Abstract：

Objective To compare the efficacy of gemcitabine (GEM)alone and gemcitabine based combination chemotherapy (GEMCOM) on advanced pancreatic cancer. Methods Keywords Phase Ⅲ,gemcitabine and pancreatic cancer were used to search and collect Phase Ⅲ-randomized references about gemcitabine and gemcitabine-based combination chemotherapy applied on advanced pancreatic cancer. A references-based meta-analysis was made to compare the efficacy between GEM and GEMCOM.Beefore that,test for heterogeneity was committed. Fixed effect model was used if the I2 ≤50% ,and random effect model was used if not. The evaluating indicators were overall response rate and 1-year survival rate. Results There were 14 randomized controlled trial(RCT) and 10 RCT enrolled in overall response rate analysis and 1-year survival rate analysis, respectively. Results of meta-analysis showed that, arm GEMCOM's overall response rate and 1-year survival rate were higher than arm GEM's(z =2. 190,P =0. 028 vs. z =4. 400,P =0. 000).The differences were significant. The biases of the results were tested by Egger-test. The tests showed that no bias exists in both of two meta-analysis (t = 0. 070, P = 0. 946 and t = - 0. 740, P = 0. 483) respectively.Conclusion There is a possibility that the gemcitabine-combination is more effective than the gemcitabine on overall response rate and 1-year survival rate.

Meta-analysis of the efficacy between gemcitabine-alone and gemcitabine-based chemotherapy applied in advanced pancreatic cancer

Objective To compare the efficacy of gemcitabine (GEM)alone and gemcitabine based combination chemotherapy (GEMCOM) on advanced pancreatic cancer. Methods Keywords Phase Ⅲ,gemcitabine and pancreatic cancer were used to search and collect Phase Ⅲ-randomized references about gemcitabine and gemcitabine-based combination chemotherapy applied on advanced pancreatic cancer. A references-based meta-analysis was made to compare the efficacy between GEM and GEMCOM.Beefore that,test for heterogeneity was committed. Fixed effect model was used if the I2 ≤50% ,and random effect model was used if not. The evaluating indicators were overall response rate and 1-year survival rate. Results There were 14 randomized controlled trial(RCT) and 10 RCT enrolled in overall response rate analysis and 1-year survival rate analysis, respectively. Results of meta-analysis showed that, arm GEMCOM's overall response rate and 1-year survival rate were higher than arm GEM's(z =2. 190,P =0. 028 vs. z =4. 400,P =0. 000).The differences were significant. The biases of the results were tested by Egger-test. The tests showed that no bias exists in both of two meta-analysis (t = 0. 070, P = 0. 946 and t = - 0. 740, P = 0. 483) respectively.Conclusion There is a possibility that the gemcitabine-combination is more effective than the gemcitabine on overall response rate and 1-year survival rate.