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      Immune checkpoint inhibitors for metastatic uveal melanoma: a meta-analysis

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          Abstract

          Several studies have evaluated immune checkpoint inhibitors (ICIs) for metastatic uveal melanoma; however, the efficacy of ICIs in the previous studies varied greatly. In this systematic review, we searched for prospective or retrospective studies on single or dual-ICIs for metastatic uveal melanoma treatment. A random-effect model meta-analysis with generic inverse-variance was conducted, and 36 articles representing 41 cohorts of 1414 patients with metastatic uveal melanoma were included. The pooled outcomes were as follows: objective response rate (ORR) was 5.6% (95% confidence interval [95%CI] 3.7–7.5%; I 2, 36%), disease control rate (DCR) was 32.5% (95% CI 27.2–37.7%; I 2, 73%), median progression-free survival was 2.8 months (95% CI 2.7–2.9 months; I 2, 26%), and median overall survival (OS) was 11.2 months (95% CI 9.6–13.2 months; I 2, 74%). Compared to single-agent ICI, dual ICI led to better ORR (single-agent: 3.4% [95% CI 1.8–5.1]; dual-agent: 12.4% [95% CI 8.0–16.9]; P < 0.001), DCR (single-agent: 29.3%, [95% CI 23.4–35.2]; dual-agent: 44.3% [95% CI 31.7–56.8]; P = 0.03), and OS (single-agent: 9.8 months [95% CI 8.0–12.2]; dual-agent: 16.3 months [95% CI 13.5–19.7]; P < 0.001). Our analysis provided treatment outcomes as described above. Dual-ICIs appear better than single-agent ICIs for the treatment of metastatic uveal melanoma.

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          Measuring inconsistency in meta-analyses.

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            New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

            Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.
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                Author and article information

                Contributors
                takeuchi@yokohama-cu.ac.jp
                horitano@yokohama-cu.ac.jp
                Journal
                Sci Rep
                Sci Rep
                Scientific Reports
                Nature Publishing Group UK (London )
                2045-2322
                3 April 2024
                3 April 2024
                2024
                : 14
                : 7887
                Affiliations
                [1 ]Department of Ophthalmology and Visual Science, Yokohama City University Graduate School of Medicine, ( https://ror.org/0135d1r83) 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan
                [2 ]Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, ( https://ror.org/03tgsfw79) Kobe, Japan
                [3 ]Department of Pulmonology, Yokohama City University Graduate School of Medicine, ( https://ror.org/0135d1r83) Yokohama, Japan
                [4 ]Chemotherapy Center, Yokohama City University Hospital, ( https://ror.org/010hfy465) 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan
                Article
                55675
                10.1038/s41598-024-55675-5
                10991441
                38570507
                efb2447b-a1cf-4ee2-a514-3b4513b17803
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 23 July 2023
                : 26 February 2024
                Categories
                Article
                Custom metadata
                © Springer Nature Limited 2024

                Uncategorized
                cancer immunotherapy,eye cancer
                Uncategorized
                cancer immunotherapy, eye cancer

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