Guidelines for the Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response Criteria

By J. Wolchok, A. Hoos, S. O'Day, J. Weber, O. Hamid, C. Lebbé, M. Maio, Michael Binder, O. Bohnsack, G. Nichol and 2 more. Clinical Cancer Research, 2009

3,071 citations recorded by the source corpus.

Purpose: Immunotherapeutic agents produce antitumor effects by inducing cancer-specific immune responses or by modifying native immune processes. Resulting clinical response patterns extend beyond those of cytotoxic agents and can manifest after an initial increase in tumor burden or the appearance of new lesions (progressive disease). Response Evaluation Criteria in Solid Tumors or WHO criteria, designed to detect early effects of cytotoxic agents, may not provide a complete assessment of immunotherapeutic agents. Novel criteria for the evaluation of antitumor responses with immunotherapeutic agents are required. Experimental Design: The phase II clinical trial program with ipilimumab, an antibody that blocks CTL antigen-4, represents the most comprehensive data set available to date for an immunotherapeutic agent. Novel immune therapy response criteria proposed, based on the shared experience from community workshops and several investigators, were evaluated using data from ipilimumab phase II clinical trials in patients with advanced melanoma. Results: Ipilimumab monotherapy resulted in four distinct response patterns: (a) shrinkage in baseline lesions, without new lesions; (b) durable stable disease (in some patients followed by a slow, steady decline in total tumor burden); (c) response after an increase in total tumor burden; and (d) response in the presence of new lesions. All patterns were associated with favorable survival. Conclusion: Systematic criteria, designated immune-related response criteria, were defined in an attempt to capture additional response patterns observed with immune therapy in advanced melanoma beyond those described by Response Evaluation Criteria in Solid Tumors or WHO criteria. Further prospective evaluations of the immune-related response criteria, particularly their association with overall survival, are warranted. (Clin Cancer Res 2009;15(23):7412–20)

Subfields: Immunology, Oncology

View Paper: https://www.semanticscholar.org/paper/403afe818c9a66bc3ed8de2e058b9f0ab02f3d1c

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In Immunology

1. J. Wolchok
2. Antoni Ribas
3. D. Pardoll
4. S. Demaria
5. S. Formenti
6. E. Golden
7. Janis Taube
8. C. Robert

In Oncology

1. J. Wolchok
2. Antoni Ribas
3. D. Pardoll
4. M. Postow
5. C. Robert
6. F. Hodi
7. S. Demaria
8. S. Formenti

Citations in the corpus

• Immunotherapy Response Assessment in Neuro-Oncology (iRANO): A Report of the RANO Working Group (2015, methodology): “Finally, RANO does not require a repeat scan to confirm PD. Challenges Interpreting Worsened Radiographic Findings Following Immunotherapy [5] The interpretation of decreased size of an enhancing lesion is straightforward as such changes indicate a true anti-tumor effect because immunotherapeutics a”
• Tumor and Microenvironment Evolution during Immunotherapy with Nivolumab (2017, result): “Genes differentially expressed between groups could predict survival in other patients in this dataset and in other immunotherapy-treated cohorts, signifying their biologic relevance and suggesting that delays in clinical response may be secondary to immune infiltration (Wolchok et al., 2009).”
• Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study (2019, positive): “1,(16) (until April 2016 when independent central assessment ceased in order to ease the burden on study sites) and by investigators per irRC.(15) In this analysis, we report response per investigator-assessed irRC.”
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• Genomic and Transcriptomic Features of Response to Anti-PD-1 Therapy in Metastatic Melanoma (2016, positive): “These response patterns were based on irRECIST (Hoos et al., 2015; Wolchok et al., 2009).”
• PD-L1 Expression as a Predictive Biomarker in Cancer Immunotherapy (2015, background): “Alternatively, an enlarging lesion may represent a growing immune infiltrate invading a previously quiescent tumor, whichmay represent the biologic basis for immune-related radiographic criteria in assessment of treatment response (68).”
• Hyper-progressors after Immunotherapy: Analysis of Genomic Alterations Associated with Accelerated Growth Rate (2017, methodology): “Percent change was evaluated with immune-related response criteria (18).”
• Pseudoprogression and Immune-Related Response in Solid Tumors. (2015, background): “reached), and these patients had improved survival profiles compared with nonresponders.(7)”
• Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. (2016, methodology): “No confirmatory scan is required unless the protocol uses modified criteria for immunotherapy.(62) Visceral disease should be reported as being with or without other patterns of spread (node, bone).”
• A systematic review and network meta‐analysis of immunotherapy and targeted therapy for advanced melanoma (2017, methodology): “We adhered to the definition of progression and the criteria used by each trial [18].”
• Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors (2015, background): “Because immunotherapeutic agents may be associated with an initial increase in tumor burden followed by disease stabilization or response (22), revised response criteria that require confirmation of disease progressionmay better reflect the overall clinical benefit of these agents.”
• Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab (2023, methodology): “In clinically stable patients, treatment could be continued beyond initial disease progression pending subsequent confirmation of progression, consistent with proposed immune response criteria.(16) Patients with stable disease or an ongoing objective response (complete or partial) at the end of trea”
• Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. (2015, background): “In ipilimumab clinical trials, responses improved over time without further ipilimumab treatment; in others, stable disease improved to an objective response, and in some cases, patients with progressive disease achieved stable disease or an objective response over time.(6,23) Limitations to the pre”
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