Cited by 366Cancer Immunotherapy and BiomarkersMedical Imaging Techniques and ApplicationsRadiomics and Machine Learning in Medical Imaging

Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST): Refining Guidelines to Assess the Clinical Benefit of Cancer Immunotherapy

Hodi, F. Stephen, Ballinger, Marcus, Lyons, Benjamin, Soria, Jean-Charles, Nishino, Mizuki, Tabernero, Josep, Powles, Thomas, Smith, David +8 more·2018·Journal of Clinical Oncology

Abstract

Purpose: Treating solid tumors with cancer immunotherapy (CIT) can result in unconventional responses and overall survival (OS) benefits that are not adequately captured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. We describe immune-modified RECIST (imRECIST) criteria, designed to better capture CIT responses. Patients and Methods: Atezolizumab data from clinical trials in non–small-cell lung cancer, metastatic urothelial carcinoma, renal cell carcinoma, and melanoma were evaluated. Modifications to imRECIST versus RECIST v1.1 included allowance for best overall response after progressive disease (PD) and changes in PD definitions per new lesions (NLs) and nontarget lesions. imRECIST progression-free survival (PFS) did not count initial PD as an event if the subsequent scan showed disease control. OS was evaluated using conditional landmarks in patients whose PFS differed by imRECIST versus RECIST v1.1. Results: The best overall response was 1% to 2% greater, the disease control rate was 8% to 13% greater, and the median PFS was 0.5 to 1.5 months longer per imRECIST versus RECIST v1.1. Extension of imRECIST PFS versus RECIST v1.1 PFS was associated with longer or similar OS. Patterns of progression analysis revealed that patients who developed NLs without target lesion (TL) progression had a similar or shorter OS compared with patients with RECIST v1.1 TL progression. Patients infrequently experienced a spike pattern (TLs increase, then decrease) but had longer OS than patients without TL reversion. Conclusion: Evaluation of PFS and patterns of response and progression revealed that allowance for TL reversion from PD per imRECIST may better identify patients with OS benefit. Progression defined by the isolated appearance of NLs, however, is not associated with longer OS. These results may inform additional modifications to radiographic criteria (including imRECIST) to better reflect efficacy with CIT agents.

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Crossref · 10.1200/jco.2017.75.1644

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  • Therapeutic effects of anti-TGF-β monotherapy or combination therapies on immune or other cells in the TME do not depend on TGF-β responsiveness of the cancer cells.

    “Notably, therapeutic effects of anti-TGF-β monotherapy or combination therapies on immune or other cells in the TME do not depend on TGF-β responsiveness of the cancer cells23,324.”

    From TGFβ biology in cancer progression and immunotherapy (2021) · cites this paper as [324]

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Authors
Hodi, F. S., Ballinger, M., Lyons, B., Soria, J.-C., Nishino, M., Tabernero, J., Powles, T., Smith, D., Hoos, A., McKenna, C., Beyer, U., Rhee, I., Fine, G., Winslow, N., Chen, D. S., & Wolchok, J. D.
Affiliations
Universitat Autònoma de Barcelona (ES)
Venue
Journal of Clinical Oncology
Published
2018-03-20
Volume
36
Issue
9
Pages
850-858
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2783708539
Cited by
366
References
34
Citations by year
2026: 21 · 2025: 34 · 2024: 29 · 2023: 45 · 2022: 47 · 2021: 50 · 2020: 65 · 2019: 43 · 2018: 30 · 2012: 1
FWCI
17.67
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Clinical Oncology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Pfizer
  • American Society of Clinical Oncology
Topics
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Medical Imaging Techniques and Applications
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiomics and Machine Learning in Medical Imaging
Keywords
RECIST 1.1, cancer immunotherapy, response evaluation criteria, solid tumors, atezolizumab, non-small cell lung cancer, metastatic urothelial carcinoma, renal cell carcinoma, melanoma, best overall response, disease control rate, progression-free survival, overall survival
MeSH terms
Progression-Free Survival, Antibodies, Monoclonal, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Humans, Immunotherapy, Kidney Neoplasms, Lung Neoplasms, Melanoma, Neoplasms, Urologic Neoplasms, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Antibodies, Monoclonal, Humanized

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