Incidence of severe adverse events in cancer patients after treatment with immune-checkpoint inhibitors during the COVID- 19 pandemic

Abstract Immune-checkpoint inhibitors (ICIs) can cause inflammation and immune-related adverse events (irAEs). Although irAEs may be caused by dysregulation of cytokines, the impact of various COVID- 19-related factors on expression of ICI-related AEs remains unclear. Assessment of AEs following ICI...

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Main Authors: Sakiko Kimura, Hiroo Katsuya, Chiho Nakashima, Naoko Sueoka-Aragane, Koji Hayashida, Kazumi Sasaki, Rintaro Sogawa, Tatsuya Furuno, Moriyasu Yamauchi, Yoichiro Sugiyama, Hirokazu Noshiro, Motohiro Esaki, Mitsuru Noguchi, Hirokazu Takahashi, Keizo Anzai, Masatoshi Yokoyama, Kazunari Sugita, Yoshio Yamashita, Atsushi Kawaguchi, Shinya Kimura, Chisato Shimanoe
Format: Article
Language:English
Published: BMC 2025-04-01
Series:BMC Immunology
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Online Access:https://doi.org/10.1186/s12865-025-00711-w
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author Sakiko Kimura
Hiroo Katsuya
Chiho Nakashima
Naoko Sueoka-Aragane
Koji Hayashida
Kazumi Sasaki
Rintaro Sogawa
Tatsuya Furuno
Moriyasu Yamauchi
Yoichiro Sugiyama
Hirokazu Noshiro
Motohiro Esaki
Mitsuru Noguchi
Hirokazu Takahashi
Keizo Anzai
Masatoshi Yokoyama
Kazunari Sugita
Yoshio Yamashita
Atsushi Kawaguchi
Shinya Kimura
Chisato Shimanoe
author_facet Sakiko Kimura
Hiroo Katsuya
Chiho Nakashima
Naoko Sueoka-Aragane
Koji Hayashida
Kazumi Sasaki
Rintaro Sogawa
Tatsuya Furuno
Moriyasu Yamauchi
Yoichiro Sugiyama
Hirokazu Noshiro
Motohiro Esaki
Mitsuru Noguchi
Hirokazu Takahashi
Keizo Anzai
Masatoshi Yokoyama
Kazunari Sugita
Yoshio Yamashita
Atsushi Kawaguchi
Shinya Kimura
Chisato Shimanoe
author_sort Sakiko Kimura
collection DOAJ
description Abstract Immune-checkpoint inhibitors (ICIs) can cause inflammation and immune-related adverse events (irAEs). Although irAEs may be caused by dysregulation of cytokines, the impact of various COVID- 19-related factors on expression of ICI-related AEs remains unclear. Assessment of AEs following ICI administration during the COVID- 19 pandemic may provide valuable insights that enable optimization of patient selection, thereby maximizing the benefits of ICI therapy. The aim of this study was to investigate the actual occurrence of severe AEs after ICI administration during the COVID- 19 pandemic. The medical records of patients who received ICI at Saga University Hospital were examined retrospectively. The primary endpoint was the incidence of all AEs ≥ Grade 3 that occurred after ICI administration. The survey period, from Jan 2020 to Dec 2022, was divided into an earlier (Jan 2020–March 2021) and a later (April 2021–Dec 2022) period. AEs with a clear cause other than ICI were excluded from the analysis. A total of 527 patients were included in the analysis, with a median follow-up of 422 days. During the COVID- 19 pandemic, the incidence of AEs ≥ Grade 3 after ICI administration was 52.8%. The incidence of AEs ≥ Grade 3 AEs after ICI administration was significantly higher during the later period [23.4% (57/244) in the earlier period and 49.8% (236/474) in the later period; mixed effect model p < 0.0001, odds ratio, 3.37 (95% CI: 2.32–4.89)]. Overall survival was significantly worse in the group with AEs ≥ Grade 3 than in the group without AEs ≥ Grade 3 [HR (95% CI) = 0.48 (0.36–0.65), p = 0.0001]. During the COVID- 19 pandemic, it became clear that the incidence of severe AEs (including irAEs) increased after ICI administration, particularly during the later period of the disease. Various factors may be associated with occurrence of severe AEs after ICI administration, and long-term careful observation and prospective multicenter clinical studies are required.
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spelling doaj-art-a000b91ae6434ffb9c4e8cb0f25512462025-08-20T02:24:29ZengBMCBMC Immunology1471-21722025-04-0126111110.1186/s12865-025-00711-wIncidence of severe adverse events in cancer patients after treatment with immune-checkpoint inhibitors during the COVID- 19 pandemicSakiko Kimura0Hiroo Katsuya1Chiho Nakashima2Naoko Sueoka-Aragane3Koji Hayashida4Kazumi Sasaki5Rintaro Sogawa6Tatsuya Furuno7Moriyasu Yamauchi8Yoichiro Sugiyama9Hirokazu Noshiro10Motohiro Esaki11Mitsuru Noguchi12Hirokazu Takahashi13Keizo Anzai14Masatoshi Yokoyama15Kazunari Sugita16Yoshio Yamashita17Atsushi Kawaguchi18Shinya Kimura19Chisato Shimanoe20Department of Pharmacy, Saga University HospitalDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga UniversityDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga UniversityDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga UniversityDepartment of Medical Information, Saga University HospitalCancer Center, Saga University HospitalDepartment of Pharmacy, Saga University HospitalDepartment of Pharmacy, Saga University HospitalDepartment of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Saga UniversityDepartment of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Saga UniversityDepartment of Surgery, Faculty of Medicine, Saga UniversityDivision of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Saga UniversityDepartment of Urology, Faculty of Medicine, Saga UniversityLiver Center, Faculty of Medicine, Saga University Hospital, Saga UniversityDivision of Metabolism and Endocrinology, Department of Internal Medicine, Faculty of Medicine, Saga UniversityDepartment of Obstetrics and Gynecology, Faculty of Medicine, Saga UniversityDivision of Dermatology, Department Of Internal Medicine, Faculty of Medicine, Saga UniversityDepartment of Oral and Maxillofacial Surgery, Faculty of Medicine, Saga UniversityEducation and Research Center for Community Medicine, Faculty of Medicine, Saga UniversityDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga UniversityDepartment of Pharmacy, Saga University HospitalAbstract Immune-checkpoint inhibitors (ICIs) can cause inflammation and immune-related adverse events (irAEs). Although irAEs may be caused by dysregulation of cytokines, the impact of various COVID- 19-related factors on expression of ICI-related AEs remains unclear. Assessment of AEs following ICI administration during the COVID- 19 pandemic may provide valuable insights that enable optimization of patient selection, thereby maximizing the benefits of ICI therapy. The aim of this study was to investigate the actual occurrence of severe AEs after ICI administration during the COVID- 19 pandemic. The medical records of patients who received ICI at Saga University Hospital were examined retrospectively. The primary endpoint was the incidence of all AEs ≥ Grade 3 that occurred after ICI administration. The survey period, from Jan 2020 to Dec 2022, was divided into an earlier (Jan 2020–March 2021) and a later (April 2021–Dec 2022) period. AEs with a clear cause other than ICI were excluded from the analysis. A total of 527 patients were included in the analysis, with a median follow-up of 422 days. During the COVID- 19 pandemic, the incidence of AEs ≥ Grade 3 after ICI administration was 52.8%. The incidence of AEs ≥ Grade 3 AEs after ICI administration was significantly higher during the later period [23.4% (57/244) in the earlier period and 49.8% (236/474) in the later period; mixed effect model p < 0.0001, odds ratio, 3.37 (95% CI: 2.32–4.89)]. Overall survival was significantly worse in the group with AEs ≥ Grade 3 than in the group without AEs ≥ Grade 3 [HR (95% CI) = 0.48 (0.36–0.65), p = 0.0001]. During the COVID- 19 pandemic, it became clear that the incidence of severe AEs (including irAEs) increased after ICI administration, particularly during the later period of the disease. Various factors may be associated with occurrence of severe AEs after ICI administration, and long-term careful observation and prospective multicenter clinical studies are required.https://doi.org/10.1186/s12865-025-00711-wImmune-checkpoint inhibitorAdverse eventsCOVID- 19 pandemic
spellingShingle Sakiko Kimura
Hiroo Katsuya
Chiho Nakashima
Naoko Sueoka-Aragane
Koji Hayashida
Kazumi Sasaki
Rintaro Sogawa
Tatsuya Furuno
Moriyasu Yamauchi
Yoichiro Sugiyama
Hirokazu Noshiro
Motohiro Esaki
Mitsuru Noguchi
Hirokazu Takahashi
Keizo Anzai
Masatoshi Yokoyama
Kazunari Sugita
Yoshio Yamashita
Atsushi Kawaguchi
Shinya Kimura
Chisato Shimanoe
Incidence of severe adverse events in cancer patients after treatment with immune-checkpoint inhibitors during the COVID- 19 pandemic
BMC Immunology
Immune-checkpoint inhibitor
Adverse events
COVID- 19 pandemic
title Incidence of severe adverse events in cancer patients after treatment with immune-checkpoint inhibitors during the COVID- 19 pandemic
title_full Incidence of severe adverse events in cancer patients after treatment with immune-checkpoint inhibitors during the COVID- 19 pandemic
title_fullStr Incidence of severe adverse events in cancer patients after treatment with immune-checkpoint inhibitors during the COVID- 19 pandemic
title_full_unstemmed Incidence of severe adverse events in cancer patients after treatment with immune-checkpoint inhibitors during the COVID- 19 pandemic
title_short Incidence of severe adverse events in cancer patients after treatment with immune-checkpoint inhibitors during the COVID- 19 pandemic
title_sort incidence of severe adverse events in cancer patients after treatment with immune checkpoint inhibitors during the covid 19 pandemic
topic Immune-checkpoint inhibitor
Adverse events
COVID- 19 pandemic
url https://doi.org/10.1186/s12865-025-00711-w
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