RECISTv1.1 progression in oncology: Shades of gray

• Published in: Cancer cell 2023-06, Vol.41 (6), p.1003-1005
• Main Authors: Topp, Brian, Snyder, Alexandra, Wolchok, Jedd
• Format: Article
• Language: English
• ISSN: 1535-6108; 1878-3686
• DOI: 10.1016/j.ccell.2023.04.012

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. 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.