Tierney J F, Mosseri V, Stewart L A, Souhami R L, Parmar M K
MRC Cancer Trials Office, Cambridge, UK.
Br J Cancer. 1995 Aug;72(2):469-75. doi: 10.1038/bjc.1995.357.
Fifteen published randomised trials comparing adjuvant chemotherapy with no chemotherapy in soft-tissue sarcoma (STS) were identified (1546 patients). A qualitative review and a meta-analysis of this published literature were performed. With the qualitative review it was not possible to synthesise the apparently conflicting results of individual trials. The meta-analysis of the published data suggests an improvement in survival at 2 years (OR = 0.73, 95% CI = 0.53-0.99, P = 0.044) and at 5 years (OR = 0.59, 95% CI = 0.45-0.78, P = 0.0002) in favour of chemotherapy. However, the assumptions and approximations required to conduct this quantitative summary demand that the results are interpreted with caution. The only reliable means of assessing the current evidence on whether adjuvant chemotherapy has a role in the treatment of patients with STS, is to collect, check and reanalyse individual patients data (IPD) from each trial centrally, and formally combine the results in a stratified time-to-event analysis. Such an IPD analysis is currently being undertaken by an international collaborative group.
共纳入15项已发表的随机试验（1546例患者），这些试验比较了软组织肉瘤（STS）辅助化疗与不进行化疗的疗效。对这些已发表的文献进行了定性综述和荟萃分析。通过定性综述，无法综合各个试验中明显相互矛盾的结果。对已发表数据的荟萃分析表明，化疗组在2年生存率（OR = 0.73，95%CI = 0.53 - 0.99，P = 0.044）和5年生存率（OR = 0.59，95%CI = 0.45 - 0.78，P = 0.0002）方面有所改善。然而，进行这种定量总结所需的假设和近似值要求对结果进行谨慎解读。评估辅助化疗在STS患者治疗中是否起作用的当前证据的唯一可靠方法，是集中收集、检查和重新分析每个试验的个体患者数据（IPD），并在分层的事件发生时间分析中正式合并结果。目前，一个国际协作组正在进行这样的IPD分析。
