PMID- 35146460 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220501 IS - 2666-3643 (Electronic) IS - 2666-3643 (Linking) VI - 3 IP - 2 DP - 2022 Feb TI - A Real-World Study on the Effectiveness and Safety of Pembrolizumab Plus Chemotherapy for Nonsquamous NSCLC. PG - 100265 LID - 10.1016/j.jtocrr.2021.100265 [doi] LID - 100265 AB - INTRODUCTION: The real-world effectiveness of combination treatment with cytotoxic chemotherapy and programmed cell death protein-1 or programmed death-ligand 1 inhibitor for NSCLC, especially for the elderly (aged >/=75 y) or those with poor performance status (>/=2), has not been fully elucidated. We investigated the real-world effectiveness and safety of this combination therapy in these populations. METHODS: This multicenter retrospective study evaluated patients who are chemo-naive with advanced NSCLC who received a combination of platinum, pemetrexed, and pembrolizumab between December 2018 and June 2019. This was an updated prespecified secondary analysis with the primary objective of investigating the safety and effectiveness in this cohort. RESULTS: Overall, 299 patients were included. Multivariate analysis identified performance status (0-1) and programmed death-ligand 1 tumor proportion score (>/=50%) as significant independent predictors of progression-free survival (p = 0.007, and p = 0.003, respectively). The incidence of severe adverse events (AEs) was higher in the elderly and those with poor performance status than in their younger and good performance status counterparts. A total of 71 patients developed AEs that led to treatment discontinuation, and AE-related treatment discontinuation occurred at a significantly higher rate in older patients (median [range]) (70 [46-82] y) than in younger patients (68 [31-84] y) (p <0.001). CONCLUSIONS: Combination treatment with pembrolizumab plus chemotherapy had low real-world effectiveness for poor performance status patients. Severe AEs occurred at a higher rate in the elderly and poor performance status patients, and the AE-related treatment discontinuation rate increased with age. Physicians should be cautious about using this regimen, especially in the elderly and poor performance status patients. CI - (c) 2021 The Authors. FAU - Fujimoto, Daichi AU - Fujimoto D AD - Internal Medicine III, Wakayama Medical University, Wakayama, Japan. AD - Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. FAU - Miura, Satoru AU - Miura S AD - Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan. FAU - Yoshimura, Kenichi AU - Yoshimura K AD - Medical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan. FAU - Wakuda, Kazushige AU - Wakuda K AD - Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan. FAU - Oya, Yuko AU - Oya Y AD - Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. FAU - Haratani, Koji AU - Haratani K AD - Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan. FAU - Itoh, Shoichi AU - Itoh S AD - Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan. FAU - Uemura, Takehiro AU - Uemura T AD - Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University School of Medical Sciences, Nagoya, Japan. FAU - Morinaga, Ryotaro AU - Morinaga R AD - Department of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Japan. FAU - Takahama, Takayuki AU - Takahama T AD - Department of Medical Oncology, Kindai Nara Hospital, Ikoma, Japan. FAU - Nakashima, Kazuhisa AU - Nakashima K AD - Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine. FAU - Tachihara, Motoko AU - Tachihara M AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Saito, Go AU - Saito G AD - Department of Respirology, Chiba University Graduate School of Medicine, Chiba, Japan. FAU - Tanizaki, Junko AU - Tanizaki J AD - Department of Medical Oncology, Kishiwada City Hospital, Kishiwada, Japan. FAU - Otsubo, Kohei AU - Otsubo K AD - Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. FAU - Ikeda, Satoshi AU - Ikeda S AD - Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan. FAU - Matsumoto, Hirotaka AU - Matsumoto H AD - Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan. FAU - Hara, Satoshi AU - Hara S AD - Department of Respiratory Medicine, Itami City Hospital, Itami, Japan. FAU - Hata, Akito AU - Hata A AD - Department of Medical Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan. FAU - Masuda, Takeshi AU - Masuda T AD - Department of Respiratory Internal Medicine, Hiroshima University Hospital, Hiroshima, Japan. FAU - Yamamoto, Nobuyuki AU - Yamamoto N AD - Internal Medicine III, Wakayama Medical University, Wakayama, Japan. LA - eng PT - Journal Article DEP - 20211216 PL - United States TA - JTO Clin Res Rep JT - JTO clinical and research reports JID - 101769967 PMC - PMC8819387 OTO - NOTNLM OT - Immune checkpoint inhibitor OT - Pembrolizumab OT - Pneumonitis OT - Programmed Death-1 OT - Programmed Death-Ligand 1 EDAT- 2022/02/12 06:00 MHDA- 2022/02/12 06:01 PMCR- 2021/12/16 CRDT- 2022/02/11 05:44 PHST- 2021/07/27 00:00 [received] PHST- 2021/11/04 00:00 [revised] PHST- 2021/12/03 00:00 [accepted] PHST- 2022/02/11 05:44 [entrez] PHST- 2022/02/12 06:00 [pubmed] PHST- 2022/02/12 06:01 [medline] PHST- 2021/12/16 00:00 [pmc-release] AID - S2666-3643(21)00124-7 [pii] AID - 100265 [pii] AID - 10.1016/j.jtocrr.2021.100265 [doi] PST - epublish SO - JTO Clin Res Rep. 2021 Dec 16;3(2):100265. doi: 10.1016/j.jtocrr.2021.100265. eCollection 2022 Feb.