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Validity of Surrogate End Points for Prostate Cancer
JAMA Oncology ( IF 28.4 ) Pub Date : 2018-01-01 , DOI: 10.1001/jamaoncol.2017.0334
Stuart G Baker 1
Affiliation  

To the Editor A valid surrogate end point is a substitute for a true end point that allows conclusions about the effect of treatment on the true end point to be drawn sooner than with a true end point. Royce et al1 argued that a prostate-specific antigen nadir value greater than 0.5 ng/mL is a good surrogate end point for all-cause mortality in men with prostate cancer. They base their claim on the proportion of treatment effect explained (PTE) of 103.86%. However, PTE is not a reliable measure of surrogacy. First, the confidence intervals, which were not reported, are typically too large to be useful,2 particularly if the effect of treatment on the true end point (not adjusted for the surrogate end point) is small.3 Second, PTE is based on an assumption, which may not hold, that treatment and surrogate end point have an additive effect, with no interaction, on the hazard function for all-cause mortality.3



中文翻译:

前列腺癌替代终点的有效性

致编辑一个有效的替代终点是真实终点的替代品,它可以比真实终点更快地得出关于治疗对真实终点的影响的结论。Royce 等人1认为,前列腺特异性抗原最低值大于 0.5 ng/mL 是前列腺癌男性全因死亡率的一个很好的替代终点。他们的主张基于 103.86% 的治疗效果解释比例 (PTE)。但是,PTE 并不是代孕的可靠衡量标准。首先,未报告的置信区间通常太大而无用,2特别是在治疗对真实终点(未针对替代终点进行调整)的影响很小的情况下。3其次,PTE 是基于一个可能不成立的假设,即治疗和替代终点对全因死亡率的风险函数具有累加效应,没有相互作用。3

更新日期:2018-01-11
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