RECISTv1.1 progression in oncology: Shades of gray

Brian Topp; Alexandra Snyder; Jedd Wolchok

doi:10.1016/j.ccell.2023.04.012

RECISTv1.1 progression in oncology: Shades of gray

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

Authors

Brian Topp¹, Alexandra Snyder², Jedd Wolchok³

Affiliations

¹ Merck & Co., Inc., Rahway, NJ, USA. Electronic address: [email protected].
² Generate Biomedicines, Boston, MA, USA.
³ Weill Cornell Medical Center, Department of Medicine, New York, NY, USA.

PMID: 37172579
DOI: 10.1016/j.ccell.2023.04.012

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.

MeSH terms

Humans
Medical Oncology
Neoplasms* / drug therapy
Progression-Free Survival
Response Evaluation Criteria in Solid Tumors
Treatment Outcome