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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
【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、EM-BASE、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 controlledtrial,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0.00~0.12,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。
【Abstract】 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 METHODS: All previously published or unpublished studies were comprehensively searched by two reviewers in the database such as MEDLINE, EMBASE and so on.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 front-line therapy for patients with APCa, but should be further evaluated in the well designed RCTs.
【Key words】 pancreatic neoplasms; gemcitabine; fixed dose rate; Meta-analysis;
- 【文献出处】 中华肿瘤防治杂志 ,Chinese Journal of Cancer Prevention and Treatment , 编辑部邮箱 ,2008年01期
- 【分类号】R735.9
- 【被引频次】11
- 【下载频次】259