Sheng Zhang, Fei Liang, and Xichun Hu, Shanghai Cancer Center and Shanghai Medical College, Fudan University, Shanghai; and Wenfeng Li, Affiliated Hospital of Qingdao University, Qingdao, People's Republic of China.
J Clin Oncol. 2015 May 20;33(15):1697-702. doi: 10.1200/JCO.2014.59.8862. Epub 2015 Apr 20.
Treatment decisions in clinical oncology are guided by results from phase III randomized clinical trials (RCTs). The results of subgroup analyses may be potentially important in individualizing patient care. We investigated the appropriateness of the use and interpretation of subgroup analyses in oncology RCTs on the basis of the CONSORT statement requirements.
Phase III RCTs published between January 1, 2011, and December 31, 2013, were reviewed to identify eligible studies of solid tumor treatments. Information related to the subgroup analyses included prespecification, number, subgroup factors, interaction test use, and claim of subgroup difference.
A total of 221 publications reporting data on 184,500 patients were analyzed. One hundred eighty-eight (85%) RCTs were reported with subgroup analyses. Of those, 146 (78%) trials were reported with at least six subgroups. For the majority of trials with subgroup analyses (173; 92%), the actual number of subgroup analyses conducted cannot be determined. Only 59 (31%) RCTs were reported with fully prespecified subgroups and only 64 (34%) trials were reported with interaction tests. In addition, 102 (54%) RCTs were reported with claims of subgroup differences. Of those, only 18 claims of RCTs (18%) were based on significant interaction test results.
The reporting of subgroup analyses in contemporary oncology RCTs is neither uniform nor complete; it requires improvement to ensure consistency and to provide critical information for guiding patient care. Major problems include testing of a large number of subgroups, subgroups without prespecifications, and inadequate use of interaction tests.
临床肿瘤学的治疗决策是基于 III 期随机临床试验（RCT）的结果。亚组分析的结果可能对患者个体化治疗具有重要意义。我们根据 CONSORT 声明的要求，研究了亚组分析在肿瘤 RCT 中的应用和解释的恰当性。
对 2011 年 1 月 1 日至 2013 年 12 月 31 日期间发表的 III 期 RCT 进行了回顾，以确定固体肿瘤治疗的合格研究。亚组分析相关信息包括预设、数量、亚组因素、交互检验使用和亚组差异的主张。
共分析了 221 篇报告了 184500 名患者数据的出版物。报告了 188 项（85%）RCT 进行了亚组分析。其中，146 项（78%）试验报告了至少 6 个亚组。对于大多数进行了亚组分析的试验（173 项；92%），无法确定实际进行的亚组分析数量。仅有 59 项（31%）RCT 报告了完全预设的亚组，仅有 64 项（34%）试验报告了交互检验。此外，102 项（54%）RCT 报告了亚组差异的主张。其中，仅有 18 项 RCT 主张（18%）是基于交互检验结果有统计学意义。
当代肿瘤学 RCT 中亚组分析的报告既不统一也不完整；需要改进报告，以确保一致性并为指导患者治疗提供关键信息。主要问题包括大量亚组的检验、无预设的亚组以及交互检验的使用不足。
