Stocken D D, Büchler M W, Dervenis C, Bassi C, Jeekel H, Klinkenbijl J H G, Bakkevold K E, Takada T, Amano H, Neoptolemos J P
Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Br J Cancer. 2005 Apr 25;92(8):1372-81. doi: 10.1038/sj.bjc.6602513.
The aim of this study was to investigate the worldwide evidence of the roles of adjuvant chemoradiation and adjuvant chemotherapy on survival in potentially curative resected pancreatic cancer. Five randomised controlled trials of adjuvant treatment in patients with histologically proven pancreatic ductal adenocarcinoma were identified, of which the four most recent trials provided individual patient data (875 patients). This meta-analysis includes previously unpublished follow-up data on 261 patients. The pooled estimate of the hazard ratio (HR) indicated a 25% significant reduction in the risk of death with chemotherapy (H = 0.75, 95% confidence interval (CI): 0.64, 0.90, P-values(stratified) (Pstrat) = 0.001) with median survival estimated at 19.0 (95% CI: 16.4, 21.1) months with chemotherapy and 13.5 (95% CI: 12.2, 15.8) without. The 2- and 5-year survival rates were estimated at 38 and 19%, respectively, with chemotherapy and 28 and 12% without. The pooled estimate of the HR indicated no significant difference in the risk of death with chemoradiation (HR = 1.09, 95% CI: 0.89, 1.32, Pstrat = 0.43) with median survivals estimated at 15.8 (95% CI: 13.9, 18.1) months with chemoradiation and 15.2 (95% CI: 13.1, 18.2) without. The 2- and 5-year survival rates were estimated at 30 and 12%, respectively, with chemoradiation and 34 and 17% without. Subgroup analyses estimated that chemoradiation was more effective and chemotherapy less effective in patients with positive resection margins. These results show that chemotherapy is effective adjuvant treatment in pancreatic cancer but not chemoradiation. Further studies with chemoradiation are warranted in patients with positive resection margins, as chemotherapy appeared relatively ineffective in this patient subgroup.
本研究旨在调查辅助放化疗和辅助化疗对可切除胰腺癌患者生存影响的全球证据。我们检索到五项关于组织学确诊的胰腺导管腺癌患者辅助治疗的随机对照试验，其中四项最新试验提供了个体患者数据（875例患者）。这项荟萃分析纳入了261例患者此前未发表的随访数据。风险比（HR）的合并估计值表明，化疗可使死亡风险显著降低25%（HR = 0.75，95%置信区间（CI）：0.64，0.90，分层P值（Pstrat）= 0.001），化疗组的中位生存期估计为19.0（95%CI：16.4，21.1）个月，未化疗组为13.5（95%CI：12.2，15.8）个月。化疗组的2年和5年生存率分别估计为38%和19%，未化疗组为28%和12%。HR的合并估计值表明，放化疗在死亡风险方面无显著差异（HR = 1.09，95%CI：0.89，1.32，Pstrat = 0.43），放化疗组的中位生存期估计为15.8（95%CI：13.9，18.1）个月，未放化疗组为15.2（95%CI：13.1，18.2）个月。放化疗组的2年和5年生存率分别估计为30%和12%，未放化疗组为34%和17%。亚组分析估计，切缘阳性患者接受放化疗更有效，而化疗效果较差。这些结果表明，化疗是胰腺癌有效的辅助治疗方法，但放化疗并非如此。鉴于化疗在该患者亚组中相对无效，对于切缘阳性患者，有必要进一步开展放化疗研究。
