Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study

被引:18
作者
Fujimoto, Nobukazu [1 ]
Okada, Morihito [2 ]
Kijima, Takashi [3 ]
Aoe, Keisuke [4 ]
Kato, Terufumi [5 ]
Nakagawa, Kazuhiko [6 ]
Takeda, Yuichiro [7 ]
Hida, Toyoaki [8 ]
Kanai, Kuninobu [9 ]
Hirano, Jun [10 ]
Ohe, Yuichiro [11 ,12 ]
机构
[1] Okayama Rosai Hosp, Dept Med Oncol, Okayama, Japan
[2] Hiroshima Univ, Res Inst Radiat Biol & Med, Grad Sch Biomed & Hlth Sci, Dept Surg Oncol, Hiroshima, Japan
[3] Hyogo Coll Med, Div Resp Med, Nishinomiya, Japan
[4] Yamaguchi Ube Med Ctr, Dept Med Oncol & Clin Res, Ube, Japan
[5] Kanagawa Canc Ctr, Dept Thorac Oncol, Yokohama, Japan
[6] Kindai Univ, Fac Med, Dept Med Oncol, Osakasayama, Japan
[7] Natl Ctr Global Hlth & Med, Dept Resp Med, Tokyo, Japan
[8] Aichi Canc Ctr Hosp, Dept Thorac Oncol, Nagoya, Japan
[9] Wakayama Med Univ, Dept Pulm Med & Oncol, Wakayama, Japan
[10] Ono Pharmaceut Co Ltd, Oncol Clin Dev Planning 1, Oncol Clin Dev Unit, Osaka, Japan
[11] Natl Canc Ctr, Dept Thorac Oncol, Tokyo, Japan
[12] Natl Canc Ctr, Dept Thorac Oncol, 5-1-1 Tsukiji,Chuo Ku, Tokyo 1040045, Japan
来源
JTO CLINICAL AND RESEARCH REPORTS | 2021年 / 2卷 / 03期
关键词
Malignant pleural mesothelioma; Nivolumab; Programmed death-1; Japan; PLUS; SURVIVAL;
D O I
10.1016/j.jtocrr.2020.100135
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Introduction: We examined the long-term efficacy and safety of nivolumab, a human monoclonal antibody that inhibits interactions between the programmed cell death protein-1 receptor and its ligands (programmed death-ligand 1 and programmed death-ligand 2), in Japanese patients with malignant pleural mesothelioma (MPM).Methods: Japanese patients with previously treated MPM (one or two regimens) were enrolled in a single-arm, phase 2 study and received nivolumab intravenously 240 mg every 2 weeks until progressive disease or unacceptable toxicity. The primary end point was the centrally assessed objective response rate. Other end points included overall survival (OS), progression-free survival (PFS), treatment -related adverse events, and patient-reported outcomes (Lung Cancer Symptom Scale for mesothelioma and Euro-QOL visual analog scale). Patient enrollment started on June 16, 2016. Here, we report 3-year follow-up data (cutoff date: November 12, 2019). Results: Thirty-four patients were enrolled. The centrally assessed objective response rate was previously reported (29.4%). The 2-and 3-year OS rates were 35.3% and 23.5%, respectively, and the corresponding PFS rates were 17.0% and 12.7%. Median OS and PFS were 17.3 and 5.9 months, respectively. Eight patients were alive at 3 years of follow-up. Nivolumab was well tolerated and no new safety signals were found. The patient-reported outcomes were maintained without marked deteriorations during the study.Conclusions: Our results reveal clinically relevant long-term efficacy and safety of nivolumab for the treatment of MPM.(c) 2021 The Authors. Published by Elsevier Inc. on behalf of the International Association for the Study of Lung Cancer. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
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页数:9
相关论文
共 13 条
[1]  
[Anonymous], 2022, NCCN Guidelines Version 1.2022 Breast Cancer Risk Reduction
[2]  
Baas P, 2020, J THORAC ONCOL, V15, pE42
[3]   Modified RECIST criteria for assessment of response in malignant pleural mesothelioma [J].
Byrne, MJ ;
Nowak, AK .
ANNALS OF ONCOLOGY, 2004, 15 (02) :257-260
[4]   Treatment and survival analyses of malignant mesothelioma in Japan [J].
Gemba, Kenichi ;
Fujimoto, Nobukazu ;
Aoe, Keisuke ;
Kato, Katsuya ;
Takeshima, Yukio ;
Inai, Kouki ;
Kishimoto, Takumi .
ACTA ONCOLOGICA, 2013, 52 (04) :803-808
[5]   National survey of malignant mesothelioma and asbestos exposure in Japan [J].
Gemba, Kenichi ;
Fujimoto, Nobukazu ;
Kato, Katsuya ;
Aoe, Keisuke ;
Takeshima, Yukio ;
Inai, Kouki ;
Kishimoto, Takumi .
CANCER SCIENCE, 2012, 103 (03) :483-490
[6]   Adapting the Lung Cancer Symptom Scale (LCSS) to mesothelioma [J].
Hollen, PJ ;
Gralla, RJ ;
Liepa, AM ;
Symanowski, JT ;
Rusthoven, JJ .
CANCER, 2004, 101 (03) :587-595
[7]   Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma [J].
Jassem, Jacek ;
Ramlau, Rodryg ;
Santoro, Armando ;
Schuette, Wolfgang ;
Chemaissani, Assad ;
Hong, Shengyan ;
Blatter, Johannes ;
Adachi, Susumu ;
Hanauske, Axel ;
Manegold, Christian .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (10) :1698-1704
[8]   Carboplatin Plus Pemetrexed as First-line Treatment of Patients With Malignant Pleural Mesothelioma: A Phase II Study [J].
Katirtzoglou, Nikolaos ;
Gkiozos, Ioannis ;
Makrilia, Nektaria ;
Tsaroucha, Emilia ;
Rapti, Aggeliki ;
Stratakos, Grigorios ;
Fountzilas, Georgios ;
Syrigos, Konstantinos N. .
CLINICAL LUNG CANCER, 2010, 11 (01) :30-35
[9]   Long-Term Efficacy and Safety of Nivolumab in Second- or Third-Line Japanese Malignant Pleural Mesothelioma Patients (Phase II: MERIT Study) [J].
Nakano, T. ;
Okada, M. ;
Kijima, T. ;
Aoe, K. ;
Kato, T. ;
Fujimoto, N. ;
Nakagawa, K. ;
Takeda, Y. ;
Hida, T. ;
Kanai, K. ;
Imamura, F. ;
Oizumi, S. ;
Takahashi, T. ;
Takenoyama, M. ;
Tanaka, H. ;
Ohe, Y. .
JOURNAL OF THORACIC ONCOLOGY, 2018, 13 (10) :S338-S338
[10]   Survival and Prognostic Factors in Malignant Pleural Mesothelioma: A Retrospective Study of 314 patients in the West Part of Japan [J].
Nojiri, Shuko ;
Gemba, Kenichi ;
Aoe, Keisuke ;
Kato, Katsuya ;
Yamaguchi, Takuhiro ;
Sato, Tsugumichi ;
Kubota, Kiyoshi ;
Kishimoto, Takumi .
JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2011, 41 (01) :32-39