PMID- 35370654 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220405 IS - 1663-9812 (Print) IS - 1663-9812 (Electronic) IS - 1663-9812 (Linking) VI - 13 DP - 2022 TI - Efficacy and Adverse Events of PD-1 Inhibitors in Patients With Advanced Urothelial Carcinoma From a Real-World Experience. PG - 837499 LID - 10.3389/fphar.2022.837499 [doi] LID - 837499 AB - Background: Programmed death 1 (PD-1) inhibitors-tislelizumab, toripalimab, camrelizumab, and sintilimab-are used for advanced urothelial carcinoma (UC) in China. To date, the efficacy and adverse events (AEs) of these PD-1 inhibitors have been poorly reported for advanced UC. Methods: We reviewed 118 patients treated with PD-1 inhibitors for advanced UC from July 2019 to October 2021 at Yantai Yuhuangding Hospital. Patient data were obtained from hospital records and telephone follow-ups. The safety and efficacy of PD-1 inhibitors were assessed by RESIST and Common Terminology Criteria for Adverse Events (version 4.0), respectively. Results: During a median follow-up period of 6 months, 112 patients (95%) experienced AEs; of these, 104 (88%) were grade 1-2 AEs, and 60 (51%) were grade 3-4 AEs. The most common AE was anemia, and no patients died as a result of treatment. A subanalysis according to treatment method (PD-1 inhibitor vs. PD-1 inhibitor plus chemotherapy) was performed. The incidence of grade 1-2 AEs was not different between the groups (85% vs. 94%), but combination therapy significantly increased grade 3-4 AEs (32% vs. 89%). Monotherapy and combination therapy also did not differ with regard to immune-related AEs of grades 1-2 (13% vs. 22%) or grades 3-4 (1% vs. 6%). In efficacy, complete response was not observed, but 33 patients (28%) had partial response, 30 (25%) had stable disease, and 47 had progressive disease (40%). The overall response and disease control rates were 28% and 53%, respectively. The preliminary efficacy of disease control was better with combination therapy versus monotherapy (78 vs. 43%). Conclusion: PD-1 inhibitors show promising tolerance and efficacy in advanced UC. PD-1 inhibitors combined with chemotherapy offered better disease control but had more grade 3-4 AEs. The clinical use of combination therapy warrants caution. CI - Copyright (c) 2022 Sun, Wang, Liu, Wang, Zhang, Yao, Sun, Zhou, Lu and Wu. FAU - Sun, Fengze AU - Sun F AD - Department of Urology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China. FAU - Wang, Dawei AU - Wang D AD - Department of Urology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. FAU - Liu, Aina AU - Liu A AD - Department of Oncology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China. FAU - Wang, Tianqi AU - Wang T AD - Department of Urology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China. FAU - Zhang, Dongxu AU - Zhang D AD - Department of Urology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China. FAU - Yao, Huibao AU - Yao H AD - Department of Urology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China. FAU - Sun, Kai AU - Sun K AD - Department of Urology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China. FAU - Zhou, Zhongbao AU - Zhou Z AD - Department of Urology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. FAU - Lu, Guoliang AU - Lu G AD - Department of Urology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. FAU - Wu, Jitao AU - Wu J AD - Department of Urology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China. LA - eng PT - Journal Article DEP - 20220318 PL - Switzerland TA - Front Pharmacol JT - Frontiers in pharmacology JID - 101548923 PMC - PMC8971813 OTO - NOTNLM OT - adverse events OT - chemotherapy OT - efficacy OT - programmed death -1/programmed death ligand 1 (PD-1/PD-L1) OT - urothelial carcinoma COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/04/05 06:00 MHDA- 2022/04/05 06:01 PMCR- 2022/03/18 CRDT- 2022/04/04 05:27 PHST- 2021/12/16 00:00 [received] PHST- 2022/01/17 00:00 [accepted] PHST- 2022/04/04 05:27 [entrez] PHST- 2022/04/05 06:00 [pubmed] PHST- 2022/04/05 06:01 [medline] PHST- 2022/03/18 00:00 [pmc-release] AID - 837499 [pii] AID - 10.3389/fphar.2022.837499 [doi] PST - epublish SO - Front Pharmacol. 2022 Mar 18;13:837499. doi: 10.3389/fphar.2022.837499. eCollection 2022.