{"title":"纳武单抗治疗复发胸膜间皮瘤的多效性分析：单中心回顾性研究。","authors":"Tomoki Higashiyama, Kozo Kuribayashi, Hiroshi Doi, Aki Kubota, Taiichiro Otsuki, Yasuhiro Nakajima, Koji Mikami, Ryo Takahashi, Akifumi Nakamura, Daichi Fujimoto, Kazuhiro Kitajima, Toshiyuki Minami, Takashi Kijima","doi":"10.1159/000543414","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>In August 2018, the Japanese PMDA approved nivolumab, an immune checkpoint inhibitor, for previously treated, unresectable, advanced, or recurrent pleural mesothelioma (PM) based on the MERIT trial, a phase II study of 34 cases. However, concerns regarding limited evidence persist.</p><p><strong>Methods: </strong>We retrospectively analyzed 83 patients with previously treated, unresectable, advanced, or recurrent malignant PM treated with nivolumab from August 2018 to May 2022. Efficacy was evaluated using overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) per modified RECIST criteria. Safety was assessed by treatment-related adverse events (TRAEs) according to CTCAE v5.0. PD-L1 expression was analyzed with the anti-PD-1 antibody (22C3).</p><p><strong>Results: </strong>The median age was 73 years. Histological subtypes included epithelioid (60), sarcomatoid (15), biphasic (6), and unknown (2). Lines of treatment were 2nd (62), 3rd (13), and 4th or later (8). Partial response was seen in 16 patients, stable disease in 30, progressive disease in 29, and not evaluable in 8, with an ORR of 19.3% and a disease control rate of 55.4%. Median PFS and OS were 5.1 and 12.4 months, respectively. TRAEs occurred in 45 patients (54.2%), with grade ≥3 in 6 (7.2%) and one treatment-related death. PFS correlated with male gender, TRAEs, and good performance status (PS: 0-1), while OS correlated with PS.</p><p><strong>Conclusion: </strong>Nivolumab demonstrated efficacy and safety in clinical practice, supporting its use in patients with good PS, even in later lines.</p>","PeriodicalId":19497,"journal":{"name":"Oncology","volume":" ","pages":"1-10"},"PeriodicalIF":2.5000,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Analysis of Pleiotropic Effects of Nivolumab in Patients with Relapsed Pleural Mesothelioma: A Single-Center Retrospective Study.\",\"authors\":\"Tomoki Higashiyama, Kozo Kuribayashi, Hiroshi Doi, Aki Kubota, Taiichiro Otsuki, Yasuhiro Nakajima, Koji Mikami, Ryo Takahashi, Akifumi Nakamura, Daichi Fujimoto, Kazuhiro Kitajima, Toshiyuki Minami, Takashi Kijima\",\"doi\":\"10.1159/000543414\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>In August 2018, the Japanese PMDA approved nivolumab, an immune checkpoint inhibitor, for previously treated, unresectable, advanced, or recurrent pleural mesothelioma (PM) based on the MERIT trial, a phase II study of 34 cases. However, concerns regarding limited evidence persist.</p><p><strong>Methods: </strong>We retrospectively analyzed 83 patients with previously treated, unresectable, advanced, or recurrent malignant PM treated with nivolumab from August 2018 to May 2022. Efficacy was evaluated using overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) per modified RECIST criteria. Safety was assessed by treatment-related adverse events (TRAEs) according to CTCAE v5.0. PD-L1 expression was analyzed with the anti-PD-1 antibody (22C3).</p><p><strong>Results: </strong>The median age was 73 years. Histological subtypes included epithelioid (60), sarcomatoid (15), biphasic (6), and unknown (2). Lines of treatment were 2nd (62), 3rd (13), and 4th or later (8). Partial response was seen in 16 patients, stable disease in 30, progressive disease in 29, and not evaluable in 8, with an ORR of 19.3% and a disease control rate of 55.4%. Median PFS and OS were 5.1 and 12.4 months, respectively. TRAEs occurred in 45 patients (54.2%), with grade ≥3 in 6 (7.2%) and one treatment-related death. PFS correlated with male gender, TRAEs, and good performance status (PS: 0-1), while OS correlated with PS.</p><p><strong>Conclusion: </strong>Nivolumab demonstrated efficacy and safety in clinical practice, supporting its use in patients with good PS, even in later lines.</p>\",\"PeriodicalId\":19497,\"journal\":{\"name\":\"Oncology\",\"volume\":\" \",\"pages\":\"1-10\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2025-01-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000543414\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000543414","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
Analysis of Pleiotropic Effects of Nivolumab in Patients with Relapsed Pleural Mesothelioma: A Single-Center Retrospective Study.
Introduction: In August 2018, the Japanese PMDA approved nivolumab, an immune checkpoint inhibitor, for previously treated, unresectable, advanced, or recurrent pleural mesothelioma (PM) based on the MERIT trial, a phase II study of 34 cases. However, concerns regarding limited evidence persist.
Methods: We retrospectively analyzed 83 patients with previously treated, unresectable, advanced, or recurrent malignant PM treated with nivolumab from August 2018 to May 2022. Efficacy was evaluated using overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) per modified RECIST criteria. Safety was assessed by treatment-related adverse events (TRAEs) according to CTCAE v5.0. PD-L1 expression was analyzed with the anti-PD-1 antibody (22C3).
Results: The median age was 73 years. Histological subtypes included epithelioid (60), sarcomatoid (15), biphasic (6), and unknown (2). Lines of treatment were 2nd (62), 3rd (13), and 4th or later (8). Partial response was seen in 16 patients, stable disease in 30, progressive disease in 29, and not evaluable in 8, with an ORR of 19.3% and a disease control rate of 55.4%. Median PFS and OS were 5.1 and 12.4 months, respectively. TRAEs occurred in 45 patients (54.2%), with grade ≥3 in 6 (7.2%) and one treatment-related death. PFS correlated with male gender, TRAEs, and good performance status (PS: 0-1), while OS correlated with PS.
Conclusion: Nivolumab demonstrated efficacy and safety in clinical practice, supporting its use in patients with good PS, even in later lines.
期刊介绍：
Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.
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