PMID- 36923080 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230316 IS - 2305-5839 (Print) IS - 2305-5847 (Electronic) IS - 2305-5839 (Linking) VI - 11 IP - 4 DP - 2023 Feb 28 TI - A real-world retrospective study of incidence and associated factors of endocrine adverse events related to PD-1/PD-L1 inhibitors. PG - 164 LID - 10.21037/atm-22-5459 [doi] LID - 164 AB - BACKGROUND: The adverse events (AEs) related to immune checkpoint inhibitors (ICIs) have been mostly described in clinical trials, however, such trials are restricted to selection criteria and the results cannot wholly represent the real-world setting. We aimed to evaluate the real-world endocrine AEs associated with programmed death receptor-1/programmed death ligand-1 (PD-1/PD-L1) inhibitors in Chinese population. METHODS: This retrospective study included cancer patients who were treated with PD-1/PD-L1 inhibitors between January 2018 and December 2020 at Xinqiao Hospital, the Third Military Medical University. The information of 581 patients was reviewed, and data on clinical characteristics, PD-1/PD-L1 use, occurrence of endocrine AEs, and response to PD-1 blockade treatment were collated. The definition of endocrine AEs relied on diagnostic tests. Fisher's exact test or Pearson's chi-squared test was used to analyze the associations between endocrine variables and several categorical variables. Multivariate analyses were performed using a logistic regression model. RESULTS: Endocrine AEs were observed in 116 of the 581 patients (20.0%). The median time to onset of endocrine AEs was approximately 12 weeks. Pembrolizumab was associated with a significantly higher incidence of endocrine AEs compared to other anti-PD-1 agents (38.5%; P=0.0002); PD-1/PD-L1 inhibitor treatment combined with antiangiogenic therapy or with two other therapies (chemotherapy and antiangiogenic therapy) was associated with a significantly increased occurrence of endocrine AEs, compared to PD-1 blockade treatment alone (41.2%; P=0.015), both based on multivariate analysis. Patients who developed endocrine AEs had significantly higher overall response rates (ORRs; 33.3% vs. 23.1%, P=0.045) and disease control rates (DCRs; 91.1% vs. 79.1%, P=0.008) compared to patients without endocrine AEs. In multivariate analysis, endocrine AEs remained an independent factor for both ORR (OR: 1.764, 95% CI: 1.052-2.957, P=0.031) and DCR (OR: 2.896, 95% CI: 1.324-6.332, P=0.008) after adjusting for the confounding factors. CONCLUSIONS: A real-world Chinese population receiving PD-1/PD-L1 treatment, pembrolizumab administrated and triple therapy treatment modalities had a higher incidence of endocrine AEs. Patients who developed endocrine AEs demonstrated a favorable response to PD-l blockade treatment. CI - 2023 Annals of Translational Medicine. All rights reserved. FAU - Wang, Zhiyi AU - Wang Z AD - Institute of Cancer, Xinqiao Hospital, the Third Military Medical University, Chongqing, China. AD - Chongqing Key Laboratory of Immunotherapy, Chongqing, China. FAU - Hu, Chunyan AU - Hu C AD - Institute of Cancer, Xinqiao Hospital, the Third Military Medical University, Chongqing, China. AD - Chongqing Key Laboratory of Immunotherapy, Chongqing, China. FAU - Zhang, Anmei AU - Zhang A AD - Institute of Cancer, Xinqiao Hospital, the Third Military Medical University, Chongqing, China. AD - Chongqing Key Laboratory of Immunotherapy, Chongqing, China. FAU - Wang, Xinxin AU - Wang X AD - Institute of Cancer, Xinqiao Hospital, the Third Military Medical University, Chongqing, China. AD - Chongqing Key Laboratory of Immunotherapy, Chongqing, China. FAU - Zeng, Dong AU - Zeng D AD - Institute of Cancer, Xinqiao Hospital, the Third Military Medical University, Chongqing, China. AD - Chongqing Key Laboratory of Immunotherapy, Chongqing, China. FAU - Long, Tao AU - Long T AD - Institute of Cancer, Xinqiao Hospital, the Third Military Medical University, Chongqing, China. AD - Chongqing Key Laboratory of Immunotherapy, Chongqing, China. FAU - Zhu, Bo AU - Zhu B AD - Institute of Cancer, Xinqiao Hospital, the Third Military Medical University, Chongqing, China. AD - Chongqing Key Laboratory of Immunotherapy, Chongqing, China. FAU - Wang, Zhongyu AU - Wang Z AD - Institute of Cancer, Xinqiao Hospital, the Third Military Medical University, Chongqing, China. AD - Chongqing Key Laboratory of Immunotherapy, Chongqing, China. LA - eng PT - Journal Article PL - China TA - Ann Transl Med JT - Annals of translational medicine JID - 101617978 PMC - PMC10009552 OTO - NOTNLM OT - Programmed death receptor-1/programmed death ligand-1 (PD-1/PD-L1) inhibitors OT - cancer OT - endocrine adverse events (AEs) OT - real-world evidence COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://atm.amegroups.com/article/view/10.21037/atm-22-5459/coif). Zhongyu Wang reports funding support from the National Natural Science Foundation of China (No. 82173097). The other authors have no conflicts of interest to declare. EDAT- 2023/03/17 06:00 MHDA- 2023/03/17 06:01 PMCR- 2023/02/28 CRDT- 2023/03/16 02:16 PHST- 2022/10/09 00:00 [received] PHST- 2023/02/10 00:00 [accepted] PHST- 2023/03/16 02:16 [entrez] PHST- 2023/03/17 06:00 [pubmed] PHST- 2023/03/17 06:01 [medline] PHST- 2023/02/28 00:00 [pmc-release] AID - atm-11-04-164 [pii] AID - 10.21037/atm-22-5459 [doi] PST - ppublish SO - Ann Transl Med. 2023 Feb 28;11(4):164. doi: 10.21037/atm-22-5459.