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      Prediction of response to immune checkpoint inhibitor therapy using 18F-FDG PET/CT in patients with melanoma

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          Abstract

          We aimed to assess serial 18F-FDG PET/CT imaging according to morphological (RECIST1.1, iRECIST) and functional (PERCIST, PECRIT) criteria to predict clinical response to therapy in patients with advanced melanoma receiving immune checkpoint blocking agents.

          Retrospective data collection and analysis was done for 37 patients with unresectable metastatic cutaneous melanoma eligible for immunotherapy (cycles: 4 for ipilimumab and pembrolizumab/ 6 for nivolumab). 18F-FDG PET/CT imaging was performed prior to ( 18F-FDG PET/CT 0) and 14 weeks after ICI onset ( 18F-FDG PET/CT 1). Some cases during the follow-up required imaging ( 18F-FDG PET/CT 2). Assessment of patient response to treatment was done according to RECIST1.1, iRECIST, PERCIST and PECRIT criteria.

          Among 37 assessed patients, 27 had 1 line of ICI, 8 had 2 lines of ICI and 2 patients had 3 lines of ICI: total of 49 PET/CTs. Mean time between initiation of ICI and 18F-FDG PET/CT (1 or 2) were respectively 13.82 ± 4.32 and 24.73 ± 9.53 weeks. Time between 18F-FDG PET/CT 1 and 18F-FDG PET/CT 2 was at mean +/− SD: 11.19w ± 5.59. Median PFS was 29.62 months (range 22.52–36.71) ( P = .001: RECIST 1.1), ( P < .0001: iRECIST), ( P = .000: PERCIST), ( P = .072: PECRIT). Median OS was 36.62 months (30.46–42.78) ( P = .005: RECIST 1.1), ( P < .0001: iRECIST), ( P = .001: PERCIST), ( P = .082 PECRIT).

          18F-FDG PET/CT could detect eventual ICI-response in patients with metastatic melanoma undergoing ICI using iRECIST and PERCIST criteria

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          From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors.

          Richard L. Wahl, Heather Jacene, Yvette Kasamon … (2009)
          The purpose of this article is to review the status and limitations of anatomic tumor response metrics including the World Health Organization (WHO) criteria, the Response Evaluation Criteria in Solid Tumors (RECIST), and RECIST 1.1. This article also reviews qualitative and quantitative approaches to metabolic tumor response assessment with (18)F-FDG PET and proposes a draft framework for PET Response Criteria in Solid Tumors (PERCIST), version 1.0. PubMed searches, including searches for the terms RECIST, positron, WHO, FDG, cancer (including specific types), treatment response, region of interest, and derivative references, were performed. Abstracts and articles judged most relevant to the goals of this report were reviewed with emphasis on limitations and strengths of the anatomic and PET approaches to treatment response assessment. On the basis of these data and the authors' experience, draft criteria were formulated for PET tumor response to treatment. Approximately 3,000 potentially relevant references were screened. Anatomic imaging alone using standard WHO, RECIST, and RECIST 1.1 criteria is widely applied but still has limitations in response assessments. For example, despite effective treatment, changes in tumor size can be minimal in tumors such as lymphomas, sarcoma, hepatomas, mesothelioma, and gastrointestinal stromal tumor. CT tumor density, contrast enhancement, or MRI characteristics appear more informative than size but are not yet routinely applied. RECIST criteria may show progression of tumor more slowly than WHO criteria. RECIST 1.1 criteria (assessing a maximum of 5 tumor foci, vs. 10 in RECIST) result in a higher complete response rate than the original RECIST criteria, at least in lymph nodes. Variability appears greater in assessing progression than in assessing response. Qualitative and quantitative approaches to (18)F-FDG PET response assessment have been applied and require a consistent PET methodology to allow quantitative assessments. Statistically significant changes in tumor standardized uptake value (SUV) occur in careful test-retest studies of high-SUV tumors, with a change of 20% in SUV of a region 1 cm or larger in diameter; however, medically relevant beneficial changes are often associated with a 30% or greater decline. The more extensive the therapy, the greater the decline in SUV with most effective treatments. Important components of the proposed PERCIST criteria include assessing normal reference tissue values in a 3-cm-diameter region of interest in the liver, using a consistent PET protocol, using a fixed small region of interest about 1 cm(3) in volume (1.2-cm diameter) in the most active region of metabolically active tumors to minimize statistical variability, assessing tumor size, treating SUV lean measurements in the 1 (up to 5 optional) most metabolically active tumor focus as a continuous variable, requiring a 30% decline in SUV for "response," and deferring to RECIST 1.1 in cases that do not have (18)F-FDG avidity or are technically unsuitable. Criteria to define progression of tumor-absent new lesions are uncertain but are proposed. Anatomic imaging alone using standard WHO, RECIST, and RECIST 1.1 criteria have limitations, particularly in assessing the activity of newer cancer therapies that stabilize disease, whereas (18)F-FDG PET appears particularly valuable in such cases. The proposed PERCIST 1.0 criteria should serve as a starting point for use in clinical trials and in structured quantitative clinical reporting. Undoubtedly, subsequent revisions and enhancements will be required as validation studies are undertaken in varying diseases and treatments.
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            Intratumoral immune cell infiltrates, FoxP3, and indoleamine 2,3-dioxygenase in patients with melanoma undergoing CTLA4 blockade.

            Pilar de la Peña, Vivian Dissette, Athanasios Economou … (2009)
            CTL-associated antigen 4 (CTLA4)-blocking monoclonal antibodies induce long-term regression of metastatic melanoma in some patients, but the exact mechanism is unknown. In this study, biopsies of selected accessible tumor lesions from patients treated with tremelimumab were examined to further elucidate the mechanism of its antitumor activity. Fifteen tumor biopsies from 7 patients who had been treated with tremelimumab (CP-675,206) were collected. Samples were analyzed for melanoma markers, immune cell subset markers, the presence of the T regulatory-specific transcription factor FoxP3 and the immunosuppressive enzyme indoleamine 2,3-dioxygenase (IDO). Clinically responding lesions had diffuse intratumoral infiltrates of CD8(+) T cells that were markedly increased in cases where comparison with a baseline biopsy was available. Nonregressing lesions had sparse, patchy CD8(+) intratumoral infiltrates. Patients with regressing lesions had an increased frequency of CD8(+) cells with or without a concomitant increase in CD4(+) cells. Two of 3 responding patients with paired samples showed a slight increase in the number of FoxP3(+) cells in the postdosing biopsies. In patients with regressing lesions who had paired samples, the intensity of IDO staining in macrophages and/or melanoma cells showed no clear pattern of change postdosing. Administration of tremelimumab was associated with massive intratumoral infiltrates of CD8(+) CTLs in patients with regressing tumors but had varying effects on intratumoral infiltrates of CD4(+) and FoxP3(+) cells or intratumoral expression of IDO.
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              The role of interim 18F-FDG PET/CT in prediction of response to ipilimumab treatment in metastatic melanoma

              Christos Sachpekidis, Hoda Anwar, Julia Winkler … (2018)
              Article 0 comments Cited 39 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicine (Baltimore)
                Journal ID (iso-abbrev): Medicine (Baltimore)
                Journal ID (publisher-id): MEDI
                Title: Medicine
                Publisher: Wolters Kluwer Health
                ISSN (Print): 0025-7974
                ISSN (Electronic): 1536-5964
                Publication date Collection: July 2019
                Publication date (Electronic): 19 July 2019
                Volume: 98
                Issue: 29
                Electronic Location Identifier: e16417
                Affiliations
                [a ]Oncology Department
                [b ]Nuclear Medicine Department
                [c ]Radiotherapy department, University Hospital Morvan, 29609 Brest Cedex
                [d ]EA 3878 GETBO IFR 148, Brest
                [e ]Université of Bretagne Occidentale
                [f ]Brest Medical University Hospital- Inserm CIC 1412, France.
                Author notes
                [∗ ]Correspondence: Solène Querellou, Nuclear medicine department, MORVAN hospital, 2 Avenue Foch, 29200 Brest, France (e-mail: solene.querellou@ 123456chu-brest.fr ).
                Article
                Publisher ID: MD-D-18-08217 Accession ID: 16417
                DOI: 10.1097/MD.0000000000016417
                PMC ID: 6708819
                PubMed ID: 31335691
                SO-VID: da040537-d762-4899-a4d0-fb3c2663e0d8
                Copyright © Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

                History
                Date received : 14 November 2018
                Date revision received : 23 April 2019
                Date accepted : 20 June 2019
                Categories
                Subject: 5700
                Subject: Research Article
                Subject: Quality Improvement Study
                Custom metadata
                OPEN-ACCESS TRUE

                Keywords: criteria,fdg pet/ct,immune checkpoint inhibitor,melanoma,response assessment
                Data availability:
                Keywords: criteria, fdg pet/ct, immune checkpoint inhibitor, melanoma, response assessment

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