{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T10:16:00Z","timestamp":1768904160978,"version":"3.49.0"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2024,9,3]],"date-time":"2024-09-03T00:00:00Z","timestamp":1725321600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical Co., Ltd","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Bristol Myers Squibb"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>This post-marketing surveillance (PMS) was conducted to evaluate the incidence of adverse events with nivolumab in patients with unresectable, advanced or recurrent malignant pleural mesothelioma (MPM) that had progressed after first-line chemotherapy and to identify factors that potentially affected its safety in real-world clinical practice.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients who had not received nivolumab previously were registered between November 2018 and February 2021. Nivolumab was given intravenously 240\u00a0mg every 2\u00a0weeks or 480\u00a0mg every 4\u00a0weeks. Patients were followed up for 6\u00a0months after treatment initiation. Information on patient characteristics, treatment status, and adverse events was collected.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>This PMS enrolled 124 patients, involving 48 sites across Japan. At 6\u00a0months, nivolumab therapy was ongoing in 35.5% of patients (44\/124) and had been discontinued in 64.5% (80\/124). The overall incidence of treatment-related adverse events (TRAEs) was 40.3%; the incidence of Grade 3 or higher TRAEs was 12.9%. The pattern of TRAEs based on System Organ Class categories was generally consistent with those seen in the Japanese phase II MERIT study. The most common Grade 3 or higher TRAEs were interstitial lung disease (2.4%), lung disorder, and diarrhea (each 1.6%). The incidence of TRAEs was significantly higher in inpatients or patients who had good PS, high bodyweight, high body mass index, or autoimmune diseases than in those without these characteristics.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The post-marketing incidence of TRAEs with nivolumab in patients with MPM has been evaluated, and no new safety signals were identified compared to the phase II clinical trial in Japan.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyae119","type":"journal-article","created":{"date-parts":[[2024,9,3]],"date-time":"2024-09-03T13:50:37Z","timestamp":1725371437000},"page":"1321-1328","source":"Crossref","is-referenced-by-count":1,"title":["Real-world safety of nivolumab in patients with malignant pleural mesothelioma in Japan: post-marketing surveillance study"],"prefix":"10.1093","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4516-0433","authenticated-orcid":false,"given":"Nobukazu","family":"Fujimoto","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Okayama Rosai Hospital , Okayama,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ayumi","family":"Akamatsu","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division, Ono Pharmaceutical , Osaka,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chikara","family":"Honda","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division, Ono Pharmaceutical , Osaka,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miki","family":"Aoki","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division, Ono Pharmaceutical , Osaka,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6137-073X","authenticated-orcid":false,"given":"Yuichiro","family":"Ohe","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, National Cancer Center Hospital , Tokyo,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,9,3]]},"reference":[{"key":"2024121023185297800_ref1","first-page":"491","article-title":"Malignant pleural mesothelioma: an epidemiological perspective","volume":"1","author":"Robinson","year":"2012","journal-title":"Ann Cardiothorac Surg"},{"key":"2024121023185297800_ref2","author":"Ministry of Health, Labour and Welfare (MHLW)"},{"key":"2024121023185297800_ref3","author":"Japan Lung Cancer Society"},{"key":"2024121023185297800_ref4","author":"NCCN"},{"key":"2024121023185297800_ref5","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1016\/j.annonc.2021.11.005","article-title":"Malignant pleural mesothelioma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up","volume":"33","author":"Popat","year":"2022","journal-title":"Ann Oncol"},{"key":"2024121023185297800_ref6","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1016\/S1470-2045(18)30765-4","article-title":"Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial","volume":"20","author":"Scherpereel","year":"2019","journal-title":"Lancet Oncol"},{"key":"2024121023185297800_ref7","doi-asserted-by":"crossref","first-page":"260","DOI":"10.1016\/S2213-2600(18)30420-X","article-title":"Ipilimumab and nivolumab in the treatment of recurrent malignant pleural mesothelioma (INITIATE): results of a prospective, single-arm, phase 2 trial","volume":"7","author":"Disselhorst","year":"2019","journal-title":"Lancet Respir Med"},{"key":"2024121023185297800_ref8","doi-asserted-by":"crossref","first-page":"1569","DOI":"10.1016\/j.jtho.2018.05.038","article-title":"Programmed death 1 blockade with nivolumab in patients with recurrent malignant pleural mesothelioma","volume":"13","author":"Quispel-Janssen","year":"2018","journal-title":"J Thorac Oncol"},{"key":"2024121023185297800_ref9","doi-asserted-by":"crossref","first-page":"1530","DOI":"10.1016\/S1470-2045(21)00471-X","article-title":"Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial","volume":"22","author":"Fennell","year":"2021","journal-title":"Lancet Oncol"},{"key":"2024121023185297800_ref10","doi-asserted-by":"crossref","first-page":"5485","DOI":"10.1158\/1078-0432.CCR-19-0103","article-title":"Clinical efficacy and safety of Nivolumab: results of a multicenter, open-label, single-arm, Japanese phase II study in malignant pleural mesothelioma (MERIT)","volume":"25","author":"Okada","year":"2019","journal-title":"Clin Cancer Res"},{"key":"2024121023185297800_ref11","doi-asserted-by":"crossref","first-page":"1169","DOI":"10.21037\/tlcr-19-686","article-title":"Nivolumab in pre-treated malignant pleural mesothelioma: real-world data from the Dutch expanded access program","volume":"9","author":"Cantini","year":"2020","journal-title":"Transl Lung Cancer Res"},{"key":"2024121023185297800_ref17","article-title":"Clinical efficacy and safety of nivolumab in Japanese patients with malignant pleural mesothelioma: 3-year results of the MERIT study","volume":"2","author":"Fujimoto","year":"2021","journal-title":"JTO Clin Res Rep"},{"key":"2024121023185297800_ref12","doi-asserted-by":"crossref","first-page":"1061","DOI":"10.1007\/s10147-022-02155-3","article-title":"Real- world safety and effectiveness of nivolumab for advanced renal cell carcinoma in Japan: a post-marketing surveillance","volume":"27","author":"Uemura","year":"2022","journal-title":"Int J Clin Oncol"},{"key":"2024121023185297800_ref13","doi-asserted-by":"crossref","first-page":"730","DOI":"10.1093\/jjco\/hyad034","article-title":"The safety profile of nivolumab plus ipilimumab combination therapy in Japanese patients with renal cell carcinoma: results from post-marketing surveillance","volume":"53","author":"Uemura","year":"2023","journal-title":"Jpn J Clin Oncol"},{"key":"2024121023185297800_ref14","doi-asserted-by":"crossref","first-page":"862","DOI":"10.1111\/1346-8138.16432","article-title":"Safety and effectiveness of nivolumab in Japanese patients with malignant melanoma: final analysis of a post-marketing surveillance","volume":"49","author":"Uhara","year":"2022","journal-title":"J Dermatol"},{"key":"2024121023185297800_ref15","doi-asserted-by":"crossref","first-page":"1619","DOI":"10.1007\/s10147-021-01949-1","article-title":"Real-world safety and effectiveness of nivolumab for recurrent or metastatic head and neck cancer in Japan: a post-marketing surveillance","volume":"26","author":"Tahara","year":"2021","journal-title":"Int J Clin Oncol"},{"key":"2024121023185297800_ref16","doi-asserted-by":"crossref","first-page":"4692","DOI":"10.1111\/cas.15117","article-title":"Real-world safety of nivolumab in patients with non-small-cell lung cancer in Japan: Postmarketing surveillance","volume":"112","author":"Yamamoto","year":"2021","journal-title":"Cancer Sci"}],"container-title":["Japanese Journal of Clinical 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