iRECIST and atypical patterns of response to immuno-oncology drugs

Abstract

With the advent of immunotherapy as one of the keystones of the treatment of our patients with cancer, a number of atypical patterns of response to these agents has been identified. These include pseudoprogression, where the tumor initially shows objective growth before decreasing in size, and hyperprogression, hypothesized to be a drug-induced acceleration of the tumor burden. Despite it being >10 years since the first immune-oncology drug was approved, neither the biology behind these paradoxical responses has been well understood, nor their incidence, identification criteria, predictive biomarkers, or clinical impact have been fully described. Immune-based Response Evaluation Criteria in Solid Tumors (iRECIST) guidelines have been published as a revision to the RECIST V.1.1 criteria for use in trials of immunotherapeutics, and the iRECIST subcommittee (of the RECIST Working Group) is working on elucidating these aspects, with data sharing a current major challenge to move forward with this unmet need in immuno-oncology.

Low Risk of Hyperprogression with First-Line Chemoimmunotherapy for Advanced Non-Small Cell Lung Cancer: Pooled Analysis of 7 Clinical Trials

“…Lastly, the RECIST-based hyperprogression criteria were selected for this study as it is simple to use, applicable to the first-line treatment setting, shown to have good concordance with tumor growth rate-based definition, and it captures data on emerging new lesions. 27 , 33 , 34 While many prior studies utilized tumor growth kinetics/rate-based definition of hyperprogression, such an approach is often not clinically applicable to contemporary first-line treatment of patients, and the hyperprogression risks reported here are comparable to prior studies. 5 , 13 , 27 , 32 , 35 …”

A landscape of checkpoint blockade resistance in cancer: underlying mechanisms and current strategies to overcome resistance

“…Uncommon response patterns represent an additional challenge in defining clinical resistance to ICIs. 23 , 69 One of these patterns is known as pseudoprogression and describes patients who appear to have PD after radiographic confirmation, but experienced tumor shrinkage months after treatment cessation. 23 , 69 , 70 This type of response was first observed in a phase II clinical trial that evaluated the efficacy of ipilimumab in metastatic melanoma patients.…”

Translating Data Science Results into Precision Oncology Decisions: A Mini Review

“…As ML methods can identify different features based on performance optimized over selected but limited validation sets, it is expected that an even more challenging validation can be shown with integrative radiomic models analyzing the relationship between radiomic features, immune correlates, tumor mutations, and prognostic scores into radiomics models [ 56 ]. However, an interesting direction was recently explored by an imaging biomarker indicating intra-tumoral immune status in NSCLC [ 57 ], named the immune ecosystem diversity index.…”