Merck & Co., Inc., Rahway, NJ, USA.
Generate Biomedicines, Boston, MA, USA.
Cancer Cell. 2023 Jun 12;41(6):1003-1005. doi: 10.1016/j.ccell.2023.04.012. Epub 2023 May 11.
The Response Evaluation Criteria in Solid Tumors (RECIST)-based outcomes, such as objective response rate (ORR) or progression free survival (PFS), are standard outcomes for early oncology trials. These indices provide a black-and-white interpretation of response to therapy. We propose that lesion-level analysis and mechanism-based pharmacodynamic endpoints may provide a more informative index of response to therapy. Accounting for "shades of gray" in lesion-level response assessments may reduce bias in go/no-go decisions and biomarker analyses for novel oncology compounds and discontinuation decisions for individual patients.
基于实体瘤反应评价标准（RECIST）的结果，如客观缓解率（ORR）或无进展生存期（PFS），是早期肿瘤学试验的标准结果。这些指标提供了对治疗反应的黑白解释。我们提出，病变水平分析和基于机制的药效终点可能为治疗反应提供更具信息量的指标。考虑病变水平反应评估中的“灰度”可能会减少新型肿瘤化合物的去留决策和生物标志物分析中的偏差，以及个别患者的停药决策。
