Immune-related adverse events in small-cell lung cancer patients treated with immune checkpoint inhibitors: a comprehensive analysis from the FDA adverse event reporting system

Yifeng Bai; Xiaomei Wang; Xiaoqin Dai; Qinghua Ma; Honglin Hu

doi:10.3389/fphar.2024.1398667

Immune-related adverse events in small-cell lung cancer patients treated with immune checkpoint inhibitors: a comprehensive analysis from the FDA adverse event reporting system

Front Pharmacol. 2024 Oct 30:15:1398667. doi: 10.3389/fphar.2024.1398667. eCollection 2024.

Authors

Yifeng Bai^#^{1

2}, Xiaomei Wang^#^{2

3}, Xiaoqin Dai^{2

4}, Qinghua Ma^{2

5}, Honglin Hu^{1

2}

Affiliations

¹ Department of Oncology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
² Chinese Academy of Sciences Sichuan Translational Medicine Research Hospital, Chengdu, China.
³ Department of Emergency, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
⁴ Department of Traditional Chinese Medicine, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
⁵ Department of Nursing, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.

^# Contributed equally.

Abstract

Background: The discovery and development of immune checkpoint inhibitors (ICIs) have resulted in their application as a novel therapeutic strategy for patients with small-cell lung cancer (SCLC). However, a comprehensive analysis of the potential adverse effects of ICIs in patients with SCLC remains to be conducted.

Methods: Adverse event (ADE) reports relating to SCLC patients, submitted to the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2013 to the second quarter of 2022, were extracted for analysis. The extracted data were subsequently screened and analyzed using the reporting odds ratio (ROR) method to assess the AE reports.

Results: A total of 4,522 ADE reports were obtained from patients with SCLC who had received either chemotherapy alone or a combination of ICIs with chemotherapy. The ROR analysis identified a total of 91 immune-related adverse events in SCLC patients associated with the ICIs (SCLC-irAEs).

Conclusion: This study revealed that the adverse effects resulting from irAEs in SCLC patients predominantly affected the hematologic and gastrointestinal systems, with the most severe cases potentially leading to fatality.

Keywords: FDA adverse event reporting system (FAERS); ICIs; SCLC; adverse (side) effects; immune check point inhibitors; irAEs (immune-related adverse events).

Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This work was supported by grants from the Key research and development project of science and technology department of Sichuan province (Number 2021YFS0128 and 2022YFS0156), Medical Science and Technology Project of Sichuan Provincial Health Commission (Number 21PJ153), Clinical Research Foundation of Wu Jiping Medical Foundation (Number 320.6750.2022-10-10), Research Project of Xinglin Scholars of Chengdu University of Traditional Chinese Medicine (Number YYZX2020021) and the Key Research and Development Program of Sichuan Provincial Department of Science and Technology (2023YFS0305).