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. 2023 Jun 12;41(6):1003-1005.
doi: 10.1016/j.ccell.2023.04.012. Epub 2023 May 11.

RECISTv1.1 progression in oncology: Shades of gray

Brian Topp  1 , Alexandra Snyder  2 , Jedd Wolchok  3
Affiliations
Free article

RECISTv1.1 progression in oncology: Shades of gray

Brian Topp et al. Cancer Cell. .
Free article

Abstract

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.

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Conflict of interest statement

Declaration of interests B.T. is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, US. A.S. is an employee of Generate Biomedicine and owns stock in Merck. J.W. is a consultant for Apricity; Ascentage Pharma; AstraZeneca; BeiGene; Bicara Therapeutics; Bristol Myers Squibb; Chugai, Daiichi Sankyo; Dragonfly; Imvaq; Larkspur; Psioxus, Tizona; and Trishula Therapeutics. J.W. received grant/research support from Bristol Myers Squibb and Sephora. J.W. has equity in Apricity, Arsenal IO; Ascentage; CellCarta; Imvaq; Linneaus, Larkspur; Georgiamune; Maverick; Tizona Therapeutics; and Xenimmune.

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