Analysis of Pleiotropic Effects of Nivolumab in Patients with Relapsed Pleural Mesothelioma: A Single-Center Retrospective Study.

IF 2.5 3区医学 Q3 ONCOLOGY Oncology Pub Date : 2025-01-24 DOI:10.1159/000543414

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

{"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":"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.","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}

引用次数: 0

Abstract

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.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

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。

2018年8月，日本PMDA批准了nivolumab，一种免疫检查点抑制剂（ICI），用于先前治疗过的，不可切除的，晚期或复发性胸膜间皮瘤（PM），基于MERIT试验，一项34例的II期研究。然而，对有限证据的担忧仍然存在。方法：回顾性分析2018年8月至2022年5月期间接受纳武单抗治疗的83例既往治疗、不可切除、晚期或复发的恶性胸膜间皮瘤（MPM）患者。根据修改后的RECIST标准，使用总缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）来评估疗效。根据CTCAE v5.0通过治疗相关不良事件（TRAEs）评估安全性。用抗pd -1抗体（22C3）分析PD-L1的表达。结果：中位年龄为73岁。组织学亚型包括上皮样（60）、肉瘤样（15）、双相(6)和未知(2)。治疗方案为第2（62）、第3（13）、第4或更晚(8)。部分缓解（PR） 16例，病情稳定（SD） 30例，病情进展（PD） 29例，不可评估（NE） 8例，ORR为19.3%，疾病控制率为55.4%。中位PFS和OS分别为5.1和12.4个月。45例（54.2%）患者发生trae， 6例（7.2%）患者发生≥3级trae， 1例治疗相关死亡。PFS与男性性别、TRAEs和良好的表现状态（PS: 0-1）相关，而OS与PS相关。结论：Nivolumab在临床实践中证明了其有效性和安全性，支持其用于良好PS患者，甚至在后期线。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Oncology 医学-肿瘤学

CiteScore

6.00

自引率

2.90%

发文量

审稿时长

6-12 weeks

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.