Mari E, Floriani I, Tinazzi A, Buda A, Belfiglio M, Valentini M, Cascinu S, Barni S, Labianca R, Torri V
Consorzio Mario Negri Sud, Centro di Ricerche Farmacologiche e Biomediche, Dipartimento di Farmacologia ed Epidemiologia Clinica, S. Maria Imbaro, Italy.
Ann Oncol. 2000 Jul;11(7):837-43. doi: 10.1023/a:1008377101672.
Several studies have investigated the possible role of the adjuvant chemotherapy after curative resection for gastric cancer failing to show a clear indication; previous meta-analyses suggested small survival benefit of adjuvant chemotherapy, but the statistical methods used were open to criticisms.
Randomised trials were identified by means of Medline and CancerLit and by selecting references from relevant articles. Systematic review of all randomised clinical trials of adjuvant chemotherapy for gastric cancer compared with surgery alone, published before January 2000, were considered. Pooling of data was performed using the fixed effect model. Death for any cause was the study endpoint. The hazard ratio and its 95% confidence intervals (95% CI), derived according to the method of Parmar, were the statistics chosen for summarising the relative benefit of chemotherapy versus control.
Overall 20 articles (21 comparisons) were considered for analysis. Three studies used single agent chemotherapy, seven combination of 5-fluorouracil (5-FU) with anthracyclin, ten combination of 5-FU without anthracyclines. Information on 3658 patients, 2180 deaths, was collected. Chemotherapy reduced the risk of death by 18% (hazard ratio 0.82, 95% CI: 0.75-0.89, P < 0.001). Association of Anthracyclines to 5-FU did not show a statistically significant improvement when compared with the effect of the other regimens.
Chemotherapy produces a small survival benefit in patients with curatively resected gastric cancer. However, taking into account the limitations of literature based meta-analyses, adjuvant chemotherapy is still to be considered as an investigational approach.
多项研究探讨了胃癌根治性切除术后辅助化疗的潜在作用,但结果并不明确;此前的荟萃分析显示辅助化疗有微小的生存获益,但所采用的统计方法存在争议。
通过检索医学文献数据库(Medline)和癌症文献数据库(CancerLit)以及筛选相关文章的参考文献来识别随机试验。对2000年1月前发表的所有比较胃癌辅助化疗与单纯手术的随机临床试验进行系统评价。采用固定效应模型进行数据合并。任何原因导致的死亡作为研究终点。根据帕尔马方法得出的风险比及其95%置信区间(95%CI)作为总结化疗与对照组相对获益的统计量。
共纳入20篇文章(21项比较)进行分析。3项研究采用单药化疗,7项研究采用5-氟尿嘧啶(5-FU)与蒽环类药物联合化疗,10项研究采用不含蒽环类药物的5-FU联合化疗。收集了3658例患者的信息,其中2180例死亡。化疗使死亡风险降低了18%(风险比0.82,95%CI:0.75 - 0.89,P < 0.001)。与其他方案相比,蒽环类药物与5-FU联合使用未显示出统计学上的显著改善。
化疗对胃癌根治性切除患者有微小的生存获益。然而,考虑到基于文献的荟萃分析的局限性,辅助化疗仍应被视为一种试验性方法。