吉西他滨联合5-FU或卡培他滨与吉西他滨单药治疗晚期胰腺癌对比的Meta分析

目的 通过Meta分析，探讨吉西他滨联合5-FU/卡培他滨化疗在治疗晚期胰腺癌病人中的意义。方法 通过检索MEDLINE、EMBASE、ASCO论文集等数据库中国内外已发表和未发表的相关文献。收集治疗组为吉西他滨联合5-FU/卡培他滨化疗，对照组为吉西他滨单药化疗的晚期胰腺癌的随机对照试验，由2位评价者分别按上述检索策略收集资料。按纳入标准入选，主要分析指标为半年和1年生存率，次要分析指标为客观缓解率、疾病无进展生存率、临床获益反应率和毒副作用等。结果共纳入了4个临床试验，在治疗晚期胰腺癌上，吉西他滨联合5-FU或卡培他滨与吉西他滨单药相比，可以提高半年生存率10％（95％CI0．01-0．19，P=0．03），差异有统计学意义，但是在1年生存率、半年疾病无进展生存率、客观缓解率和临床获益反应率上并没有提高，同时还增加了3/4级的血液学毒性及胃肠道的毒副作用。结论 吉西他滨联合5-FU/卡培他滨并不能提高晚期胰腺癌病人疗效，吉西他滨单药化疗仍是晚期胰腺癌的标准治疗方案。

A Meta-analyses about Advanced Pancreatic Cancer: Gemcitabine Combined with 5-FU or Capecitabine vs Gemcitabine Alone

Objectives Using meta-analysis to explore GEM combined with 5-FU chemotherapy effects on survival and life quality in patients with inoperable pancreatic cancer. Method Search strategy: Trials from both published and unpublished sources were identified by searching MEDLINE, EMBASE, ASCO Abstracts. Selection criteria: RCT for GEM combined with 5-FU/Capecitabine and GEM alone in inoperable pancreatic cancer. Data collection and analysis:A quantitative meta-analysis using updated information basing on inclusion and exclusion criteria from all available RCT was carried out by two reviewers. The meta-analysis was based on 6 months' survival, 1 year's survival,6-month PFS,CBR,and toxicity. Results Four trials are eligible, 10% relative increase was obtained in patients with inoperable pancreatic cancer treated by GEM combined with 5-FU/Capecitabine chemotherapy compared with GEM alone on 6 months' survival, and the results are of statistically significant difference. But on 1-year survival, 6-month PFS, CBR, ORR, the results are of no statistical significant difference. Moreover, GEM combined with 5-FU/Capecitabine has the tendency to increase toxicity. Conclusion There is no convincing evidence that GEM combined with 5-FU/Capecitabine can improve the chemotherapy effect compared with GEM alone. GEM alone is still the standard treatment for APCa.