Ward L C, Fielding J W, Dunn J A, Kelly K A
Cancer Research Campaign Trials Unit, University of Birmingham, UK.
Br J Cancer. 1992 Nov;66(5):943-50. doi: 10.1038/bjc.1992.390.
A randomised trial of adjuvant chemotherapy vs placebo in operable stomach cancer recruited 249 patients from the West Midlands Region between 1976-1980. A Cancer Registry survey identified a further 1261 suitable concurrent cases. Trial patients were compared with the 960 non-trial cases from participating Districts. Only 493 (51%) non-trial cases passed all of the prospective trial selection criteria for entry. Stage and fitness caused the majority of exclusions and were also highly prognostic. A univariate analysis comparing eligible patients with the trial showed the two groups to be balanced for the significant independent prognostic factors of the trial. However, differences in patient age and the surgery performed indicate that recruitment may have been influenced by unknown selection factors. This survey highlights the difficulty of retrospective selection and confirms the need for randomised controls. Data available from specialist Registries may be used to help develop new protocols and to verify and extend trial results.
1976年至1980年间，一项关于可手术胃癌辅助化疗与安慰剂对比的随机试验从西米德兰兹地区招募了249名患者。癌症登记调查又确定了另外1261例合适的同期病例。将试验患者与来自参与地区的960例非试验病例进行比较。只有493例（51%）非试验病例通过了所有前瞻性试验入选标准。分期和身体状况导致了大多数排除情况，并且也是高度预后因素。一项将符合条件的患者与试验组进行比较的单因素分析表明，两组在该试验的重要独立预后因素方面是平衡的。然而，患者年龄和所进行的手术存在差异，这表明招募可能受到了未知选择因素的影响。这项调查突出了回顾性选择的困难，并证实了随机对照的必要性。来自专科登记处的可用数据可用于帮助制定新方案，并验证和扩展试验结果。
