Piedbois Pascal, Buyse Marc
Department of Medical Oncology, Henri Mondor Hospital, Créteil, France.
Curr Opin Oncol. 2008 Jul;20(4):466-71. doi: 10.1097/CCO.0b013e32830218fe.
The purpose of this review is to discuss recently published work on endpoints for early and advanced colorectal cancer, as well as the statistical approaches used to validate surrogate endpoints.
Most attempts to validate surrogate endpoints have estimated the correlation between the surrogate and the true endpoint, and between the treatment effects on these endpoints. The correlation approach has made it possible to validate disease-free survival and progression-free survival as acceptable surrogates for overall survival in early and advanced disease, respectively.
The search for surrogate endpoints will intensify over the coming years. In parallel, efforts to either standardize or extend the endpoints or both will improve the reliability and relevance of clinical trial results.
本综述旨在讨论近期发表的关于早期和晚期结直肠癌终点指标的研究工作，以及用于验证替代终点指标的统计方法。
大多数验证替代终点指标的尝试都估计了替代指标与真实终点指标之间的相关性，以及治疗对这些终点指标的影响之间的相关性。相关性方法使得分别验证无病生存期和无进展生存期作为早期和晚期疾病总生存期的可接受替代指标成为可能。
在未来几年中，寻找替代终点指标的工作将更加深入。与此同时，标准化或扩展终点指标或两者兼而有之的努力将提高临床试验结果的可靠性和相关性。
