Optimizing immune-related tumor response assessment: does reducing the number of lesions impact response assessment in melanoma patients treated with ipilimumab?

Nishino, Mizuki; Gargano, Maria; Suda, Margaret; Ramaiya, Nikhil H; Hodi, F Stephen

doi:10.1186/2051-1426-2-17

Cited by 95Cancer Immunotherapy and BiomarkersCutaneous Melanoma Detection and ManagementMedical Imaging Techniques and Applications

Optimizing immune-related tumor response assessment: does reducing the number of lesions impact response assessment in melanoma patients treated with ipilimumab?

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Nishino, Mizuki, Gargano, Maria, Suda, Margaret, Ramaiya, Nikhil H, Hodi, F Stephen·2014·Journal for ImmunoTherapy of Cancer

DOI 10.1186/2051-1426-2-17PMC PMC4077549

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Abstract

BACKGROUND: Investigate the impact of the reduction of the number of target lesions on immune-related response assessment in advanced melanoma patients treated with ipilimumab. METHOD: Ninety patients (53 males, 37 females; age range: 25-87) with advanced melanoma treated with ipilimumab in two clinical trials were studied. Tumor measurements during trial allowing up to 5 lesions per organ and 10 lesions in total were retrospectively reviewed. A second set of tumor measurements allowing up to 2 lesions per organ and 5 lesions in total was generated. Immune-related response assessments by two measurements were compared. RESULTS: The number of target lesions was significantly reduced when up to 2 per organ and 5 in total lesions were allowed (Wilcoxon P < 0.0001). The immune-related response assessment using reduced number of lesions was highly concordant with assessment using the original number of lesions (Spearman r for the percent change on 1(st)-3(rd) follow-up: 0.860-0.970; κw for best immune-related response: 0.908). Median time-to-progression was 26.9 months (95%CI: 9.1-∞) by both assessments. Interobserver agreement of measurements was high for both assessments, with the concordance correlation coefficient above 0.98. CONCLUSION: Reduction of the number of target lesions did not significantly affect immune-related response assessment or the measurement variability in advanced melanoma patients treated with ipilimumab. Using up to 2 per organ and 5 in total target lesions is proposed to assess immune-related response, while it is important to keep other novel features of immune-related response criteria such as confirmation of progression and inclusion of new lesion measurements.

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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 [177]

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“iUPD is used as the event date,(5) whereas in Nishino’s study, the date on which the confirmation of PD occurred was defined as the time of PD according to the irRC and irRECIST scheme.(29,30) The insignificant difference of PFS between iRECIST and RECIST 1.”
Method
Prediction of response to immune checkpoint inhibitor therapy using 18F-FDG PET/CT in patients with melanoma
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Immunotherapy Monitoring with Immune Checkpoint Inhibitors Based on [18F]FDG PET/CT in Metastatic Melanomas and Lung Cancer
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Immune-Checkpoint Inhibitors in the Era of Precision Medicine: What Radiologists Should Know
Braschi‐Amirfarzan, M., Tirumani, S. H., Hodi, F. S., & Nishino, M. (2017) · Korean Journal of Radiology · doi:10.3348/kjr.2017.18.1.42 · Cited by 36 · see citing works
Which criteria should we use to evaluate the efficacy of immune-checkpoint inhibitors?
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“IrRC requires evaluation of the two-dimensional tumor burden, which requires more effort than one-dimensional evaluation (12).”
Imaging of Cancer Immunotherapy: Response Assessment Methods, Atypical Response Patterns, and Immune-Related Adverse Events, From the AJR Special Series on Imaging of Inflammation
Sheikhbahaei, S., Marcus, C. V., Sadaghiani, M. S., Rowe, S. P., Pomper, M. G., & Solnes, L. B. (2021) · American Journal of Roentgenology · doi:10.2214/ajr.21.26538 · Cited by 24 · see citing works
The Evaluation of Response to Immunotherapy in Metastatic Renal Cell Carcinoma: Open Challenges in the Clinical Practice
Raimondi, A., Randon, G., Sepe, P., Claps, M., Verzoni, E., de Braud, F., & Procopio, G. (2019) · International Journal of Molecular Sciences · doi:10.3390/ijms20174263 · Cited by 23 · see citing works
“These results are extremely promising, and in the ongoing and recently-presented clinical trials on immunotherapy and anti-vascular agents combinations in the first-line setting (Javelin Renal 101, Keynote 426 and IMmotion 151) [14–17] the irRECIST [46,48] are included in the secondary or exploratory endpoints.”
BackgroundResult
Anatomic versus Metabolic Tumor Response Assessment after Radioembolization Treatment
Jongen, J. M. J., Rosenbaum, C. E. N. M., Braat, M. N. G. J. A., van den Bosch, M. A. A. J., Sze, D. Y., Kranenburg, O., Rinkes, I. H. M. B., Lam, M. G. E. H., & van den Hoven, A. F. (2017) · Journal of Vascular and Interventional Radiology · doi:10.1016/j.jvir.2017.09.024 · Cited by 22 · see citing works
“Therefore, other response criteria systems have been developed, such as the European Association for the Study of the Liver criteria and modified RECIST for intra-arterial therapy in hepatocellular carcinoma (4,5), the Choi criteria for the treatment of gastrointestinal stromal tumors (6), and the immunerelated Respon…”
Method
Anti-CTLA-4 Therapy for Malignant Mesothelioma
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Role of medical imaging for immune checkpoint blockade therapy: From response assessment to prognosis prediction
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The European Organization for Research and Treatment of Cancer perspective on designing clinical trials with immune therapeutics
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RECIST 1.1, irRECIST 1.1, and mRECIST: How to Do
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Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy
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Cancer Imaging in Immunotherapy
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Imaging Assessment of Tumor Response in the Era of Immunotherapy
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“1, and proved that new criteria termed irRECIST were successful for predicting response to ipilimumab [81] (Table 2).”
Background
Pseudoprogression and Measurement Variability
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Overall survival benefit of continuing immune checkpoint inhibitors treatment post dissociated response in patients with advanced lung cancer
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Imaging spectrum of adverse events of immune checkpoint inhibitors
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Radiologische Responsebeurteilung moderner Immuntherapien mithilfe von iRECIST
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“1) (19), intolerance of study treatment, need for alternative anticancer therapy, or 24 months from the first dose of T-VEC, whichever occurred first.”
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Method
Correlation between the magnitude of best tumor response and patient survival in nivolumab therapy for metastatic renal cell carcinoma
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The RECIST criteria compared to conventional response evaluation after peptide receptor radionuclide therapy in patients with neuroendocrine neoplasms
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Achieving objective response in treatment of non-resectable neuroendocrine tumors does not predict longer time to progression compared to achieving stable disease
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Post-immunotherapy imaging in lung cancer
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Multiparametric Magnetic Resonance Imaging for Immediate Target Hit Assessment of CD13—Targeted Tissue Factor tTF-NGR in Advanced Malignant Disease
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Cancer Imaging in Immunotherapy
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A phase II study of pembrolizumab plus carboplatin in BRCA-related metastatic breast cancer (PEMBRACA)
Cortesi, L., Venturelli, M., Cortesi, G., Caggia, F., Toss, A., Barbieri, E., Giorgi, U. D., Guarneri, V., Musolino, A., Matteis, E. D., et al. (2023) · ESMO Open · doi:10.1016/j.esmoop.2023.101207 · Cited by 6 · see citing works
Intra- and inter-reader agreement of iRECIST and RECIST 1.1 criteria for the assessment of tumor response in patients receiving checkpoint inhibitor immunotherapy for lung cancer
Castellanos, S. H., Pagano, A., Plodkowski, A. J., Girshman, J., Hellmann, M. D., Rizvi, H. A., Flynn, J. R., Zheng, J., Capanu, M., Halpenny, D. F., et al. (2021) · Lung Cancer · doi:10.1016/j.lungcan.2021.08.020 · Cited by 5 · see citing works
Imaging evaluation of lung cancer treated with PD-1/PD-L1 inhibitors
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Imaging of Novel Oncologic Treatments in Lung Cancer Part 1
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Radiopharmaceuticals as Novel Immune System Tracers
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iRECIST: Response-Assessment von Immuntherapien
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“In den folgenden Jahren 2013 und 2014 wurden diese Kriterien in unidimensional irRECIST 1.0 und 1.1 adaptiert, wobei neue messbare Läsionen in die Gesamtsumme aufgenommen wurden und ab ≥20% Zunahme als Progress bewertet wurden [6].”
Influential
Response evaluations in non-small cell lung cancer patients undergoing immunotherapy: a comparative analysis of RECIST 1.1, iRECIST, and imRECIST criteria
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Genomic and transcriptomic analyses of melanoma in Japanese patients reveal candidate biomarkers for immune checkpoint inhibitor responders
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Thoracic Imaging of Solid Tumor Patients Treated with Immune Checkpoint Inhibitors
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Friedman, C. F., Hainsworth, J. D., Kurzrock, R., Spigel, D. R., Burris, H. A., Sweeney, C. J., Meric‐Bernstam, F., Wang, Y., Levy, J., Grindheim, J. M., et al. (2023) · doi:10.1158/2159-8290.22540966.v1 · Cited by 1 · see citing works
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“More recently, immunerelated response criteria (irRC) have been proposed and validated in malignant melanoma to better assess the variety of responses that can be generated upon imAbs [16-18].”
Background
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Radiographic Evaluation of Immunotherapy
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EVALUATION OF THE EFFECTIVENESS OF MODERN IMMUNOTHERAPY
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Supplementary Data from Atezolizumab Treatment of Tumors with High Tumor Mutational Burden from MyPathway, a Multicenter, Open-Label, Phase IIa Multiple Basket Study
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Authors: Nishino, M., Gargano, M., Suda, M., Ramaiya, N. H., & Hodi, F. S.
Affiliations: Brigham and Women's Hospital (US)
Corresponding author: Nishino, Mizuki
ORCID: Nishino, Mizuki
Ramaiya, Nikhil H
Hodi, F Stephen
Venue: Journal for ImmunoTherapy of Cancer
Publisher: BMJ
Published: 2014-06-18
Volume: 2
Issue: 1
Pages: 17-17
ISSN: 2051-1426 (ISSN-L)
DOI: 10.1186/2051-1426-2-17
PMC: PMC4077549
OpenAlex: W2117110700
Cited by: 95
References: 24
Citations by year: 2026: 4 · 2025: 3 · 2024: 2 · 2023: 8 · 2022: 5 · 2021: 8 · 2020: 13 · 2019: 13 · 2018: 11 · 2017: 15 · 2016: 9 · 2015: 3 · 2014: 1
FWCI: 4.48
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
Locations: Journal for ImmunoTherapy of Cancer (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Funders: National Cancer Institute (1K23CA157631)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Medical Imaging Techniques and Applications
Keywords: ipilimumab, advanced melanoma, tumor response assessment, immune checkpoint inhibitors, interobserver agreement, time to progression

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Optimizing immune-related tumor response assessment: does reducing the number of lesions impact response assessment in melanoma patients treated with ipilimumab?

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