Developing a common language for tumor response to immunotherapy: immune-related response criteria using unidimensional measurements

Nishino, Mizuki; Giobbie-Hurder, Anita; Gargano, Maria; Suda, Margaret; Ramaiya, Nikhil H.; Hodi, F. Stephen

doi:10.1158/1078-0432.ccr-13-0895

Cited by 522Cancer Immunotherapy and BiomarkersMedical Imaging Techniques and ApplicationsCutaneous Melanoma Detection and Management

Developing a common language for tumor response to immunotherapy: immune-related response criteria using unidimensional measurements

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Nishino, Mizuki, Giobbie-Hurder, Anita, Gargano, Maria, Suda, Margaret, Ramaiya, Nikhil H., Hodi, F. Stephen·2013·Clinical Cancer Research

DOI 10.1158/1078-0432.ccr-13-0895PMC PMC3740724

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Abstract

PURPOSE: Immune-related response criteria (irRC) was developed to adequately assess tumor response to immunotherapy. The irRC are based on bidimensional measurements, as opposed to unidimensional measurements defined by Response Evaluation Criteria in Solid Tumors, which has been widely used in solid tumors. We aimed to compare response assessment by bidimensional versus unidimensional irRC in patients with advanced melanoma treated with ipilimumab. EXPERIMENTAL DESIGN: Fifty-seven patients with advanced melanoma treated with ipilimumab in a phase II, expanded access trial were studied. Bidimensional tumor measurement records prospectively conducted during the trial were reviewed to generate a second set of measurements using unidimensional, longest diameter measurements. The percent changes of measurements at follow-up, best overall response, and time-to-progression (TTP) were compared between bidimensional and unidimensional irRC. Interobserver variability for bidimensional and unidimensional measurements was assessed in 25 randomly selected patients. RESULTS: The percent changes at follow-up scans were highly concordant between the 2 criteria (Spearman r: 0.953-0.965, first to fourth follow-up). The best immune-related response was highly concordant between the 2 criteria (κw = 0.881). TTP was similar between the bidimensional and unidimensional assessments (progression-free at 6 months: 70% vs. 81%, respectively). The unidimensional measurements were more reproducible than bidimensional measurements, with the 95% limits of agreement of (-16.1%, 5.8%) versus (-31.3%, 19.7%), respectively. CONCLUSION: irRC using the unidimensional measurements provided highly concordant response assessment compared with the bidimensional irRC, with less measurement variability. The use of unidimensional irRC is proposed to assess response to immunotherapy in solid tumors, given its simplicity, higher reproducibility, and high concordance with the bidimensional irRC.

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Immune-related response criteria have been proposed and validated in malignant melanoma to better assess responses to immunostimulatory monoclonal antibodies.
“More recently, immune-related response criteria (irRC) have been proposed and validated in malignant melanoma to better assess the variety of responses that can be generated upon imAbs [176,177].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [176]

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Authors: Nishino, M., Giobbie-Hurder, A., Gargano, M., Suda, M., Ramaiya, N. H., & Hodi, F. S.
Affiliations: Brigham and Women's Hospital (US)
Authors' Affiliations: Departments of 1Radiology and 2Medical Oncology and Department of Medicine, Dana-Farber Cancer Institute and Brigham and Women's Hospital; and 3Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts
Corresponding author: Nishino, Mizuki
ORCID: Nishino, Mizuki
Ramaiya, Nikhil H.
Hodi, F. Stephen
Venue: Clinical Cancer Research
Publisher: American Association for Cancer Research (AACR)
Published: 2013-07-15
Volume: 19
Issue: 14
Pages: 3936-3943
ISSN: 1078-0432 (ISSN-L)
1557-3265
DOI: 10.1158/1078-0432.ccr-13-0895
PMC: PMC3740724
OpenAlex: W2153778867
Cited by: 522
References: 21
Citations by year: 2026: 19 · 2025: 21 · 2024: 27 · 2023: 53 · 2022: 51 · 2021: 56 · 2020: 76 · 2019: 57 · 2018: 49 · 2017: 39 · 2016: 36 · 2015: 23 · 2014: 13 · 2013: 2
FWCI: 13.12
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Clinical Cancer Research (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (5k23ca157631-02)
National Cancer Institute (K23-CA157631, 1K23CA157631)
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 › Oncology › Cutaneous Melanoma Detection and Management
Keywords: immune-related response criteria, tumor response assessment, immunotherapy, advanced melanoma, ipilimumab, interobserver variability, time to progression, best overall response, RECIST
MeSH terms: Ipilimumab, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Female, Humans, Immunotherapy, Male, Melanoma, Middle Aged, Models, Biological, Terminology as Topic, Models, Statistical, Treatment Outcome, Clinical Trials, Phase II as Topic, Disease-Free Survival, Statistics, Nonparametric, Kaplan-Meier Estimate

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Developing a common language for tumor response to immunotherapy: immune-related response criteria using unidimensional measurements

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