吉西他滨固定剂量率输注一线治疗晚期胰腺癌随机对照试验的Meta分析  

Fixed dose rate infusion of gemcitabine as first line therapy for advanced pancreatic cancer:a Meta-analysis of randomized controlled trials

作　　者：杨琼[1] 江志敏[1] 郭双双[2] 陈邓林[1] 毕卓菲[1] 谢德荣[1] 

机构地区：[1]中山大学附属第二医院肿瘤科,广东广州510120 [2]河南科技大学附属第二医院肿瘤科,河南洛阳471000

出　　处：《中华肿瘤防治杂志》2008年第1期57-60,共4页Chinese Journal of Cancer Prevention and Treatment

基　　金：广东省科技计划项目(2007B031516014)

摘　　要：目的：探讨吉西他滨固定剂量率（fixed dose rate，FDR）输注一线治疗晚期胰腺癌的价值。方法：通过MEDLINE、EMBASE、ASCO和ECCO等数据库及论文集检索相关文献，选择FDR组为吉西他滨FDR化疗，对照组为吉西他滨30min化疗的晚期胰腺癌随机对照试验（randomized controlled trial，RCT）。由2位评价者依据检索策略收集资料，按纳入标准筛选文献，主要对总生存率，其次是客观缓解率和毒副反应进行Meta分析。结果：从876篇文献中筛选出符合纳入标准的2个RCT，涉及648例患者。FDR组与对照组相比，FDR组1年生存率提高6％，95％CI为0．00～0．12，P=0．060；客观缓解率提高5％，95％CI为0．00～0．09，P=0．030；3～4度中性粒细胞减少症增加25％，95％CI为0．18～0．33，P〈0．000；血小板减少症增加19％，95％CI为0．13～0．26，P〈0．000；贫血增加8％，95％CI为0．02～0．13，P=0．007；恶心呕吐增加4％，RD=0．04，95％CI为0．00～O．12，P=0．160。结论：现有证据不推荐吉西他滨FDR输注常规临床应用，但值得进一步的临床试验。OBJECTIVE.. To explore the therapeutic value of fixed dose rate infusion of gemcitabine as standard front-line therapy for advanced pancreatic cancer （APCa）. METHODS： All previously published or unpublished studies were comprehensively searched by two reviewers in the database such as MEDLINE, EMBASE and so on. The Meta-analysis included all randomized clinical trials comparing fixed dose rate infusion with standard infusion of gemcitabine with respect to 1-year survival rate （1-y SR）, objective remission rate （ORR） and toxicities in patients with APCa. RESULTS.. From 876 reports, two RCTs involving 648 APCa patients were identified by two reviewers. There was improvement for FDR arm in ORR （RD=0. 05,95% CI 0.00-0.09, P= 0. 030） and 1-y SR （RD=0.06,95% CI 0. 00-0.12, P=0. 060）. WHO 3/4 grade hematological toxicities including neutropenia, thrombocytopenia and anemia were higher for FDR arm with increasing by 25% （95% CI 0.18-0.33, P〈0.000）, 19% （95% CI 0.13-0. 26, P〈0. 000） and 8% （95% CI 0. 02-0.13, P= 0. 007）, respectively. No significant difference in nausea/vomiting was observed between the two arms, 95% CI 0.00-0. 12, P=0. 160. CONCLUSION： Based on the available evidence, FDR infusion of gemcitabine is not recommend as the standard frontine- therapy for patients with APCa, but should be further evaluated in the well designed RCTs.

关 键 词：胰腺肿瘤 吉西他滨 固定剂量率 META分析 

分 类 号：R735.9[医药卫生—肿瘤]