PMID- 33330066 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231110 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 10 DP - 2020 TI - Safety and Efficacy of Immune Checkpoint Inhibitors for Patients With Metastatic Urothelial Carcinoma and End-Stage Renal Disease: Experiences From Real-World Practice. PG - 584834 LID - 10.3389/fonc.2020.584834 [doi] LID - 584834 AB - BACKGROUND: Immune checkpoint inhibitors (ICIs) are used widely for treating metastatic urothelial carcinoma (mUC). In practical settings, evidence is lacking on the efficacy of ICIs in some difficult-to-treat patients, such as those with end-stage renal disease (ESRD). Herein, we evaluate the safety and efficacy of ICIs for patients with mUC and ESRD. METHODS: For this retrospective study, patients with mUC who were given ICIs at Kaohsiung Chang Gang Memorial Hospital and Linkou Chang Gung Memorial Hospital between April 2016 and November 2019 were consecutively enrolled. All clinicopathologic data, treatment responses, and adverse events were recorded. The immune-related adverse events (AEs), objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were compared between ESRD and non-ESRD groups. RESULTS: In total, 129 patients with mUC were enrolled, with 11 patients categorized as the ESRD group. Among these patients with ESRD receiving ICIs, 7 of 11 (63.6%) had high-grade (grade >/=3) AEs, chiefly hematologic toxicity. Some rarely encountered AEs were noted, including toxic epidermal necrolysis, tuberculosis reactivation, ascites, and cytokine release syndrome. Patients in the ESRD group had numerically higher ORR (54.5% vs. 28.8%, p = 0.09), PFS (7.1 vs. 3.5 months, p = 0.42), and OS (not reached vs. 15.4 months) than the non-ESRD group. A multivariate Cox regression model demonstrated that leukocytosis (hazard ratio [HR]: 2.63; 95% confidence interval [CI]: 1.23-5.63; p = 0.01) and neutrophil-to-lymphocyte ratio (HR 2.91; 95% CI: 1.30-6.53; p = 0.01) were independent prognostic factors. CONCLUSION: Administration of ICIs in patients with mUC and ESRD demonstrated a modest antitumor activity, and should be used with caution for increasing risk of hematologic toxicity. CI - Copyright (c) 2020 Kuo, Su, Huang, Luo, Chiu, Li, Wu, Liu, Cheng, Kang and Su. FAU - Kuo, Ming-Chun AU - Kuo MC AD - Division of Hematology Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Su, Po-Jung AU - Su PJ AD - Division of Hematology Oncology, Chang Gung Memorial Hospital at Linkou and College of Medicine, Chang Gung University, Tao-Yuan, Taiwan. FAU - Huang, Chun-Chieh AU - Huang CC AD - Department of Radiation Oncology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Luo, Hao-Lun AU - Luo HL AD - Department of Urology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Chiu, Tai-Jan AU - Chiu TJ AD - Division of Hematology Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Li, Shau-Hsuan AU - Li SH AD - Division of Hematology Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Wu, Chia-Che AU - Wu CC AD - Division of Hematology Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Liu, Ting-Ting AU - Liu TT AD - Department of Pathology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Cheng, Yuan-Tso AU - Cheng YT AD - Department of Urology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Kang, Chih-Hsiung AU - Kang CH AD - Department of Urology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. FAU - Su, Yu-Li AU - Su YL AD - Division of Hematology Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan. AD - Clinical Trial Center, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. LA - eng PT - Journal Article DEP - 20201127 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 PMC - PMC7729012 OTO - NOTNLM OT - end-stage renal disease OT - immune checkpoint inhibitor OT - metastatic urothelial carcinoma OT - safety OT - survival 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- 2020/12/18 06:00 MHDA- 2020/12/18 06:01 PMCR- 2020/01/01 CRDT- 2020/12/17 05:52 PHST- 2020/07/18 00:00 [received] PHST- 2020/10/29 00:00 [accepted] PHST- 2020/12/17 05:52 [entrez] PHST- 2020/12/18 06:00 [pubmed] PHST- 2020/12/18 06:01 [medline] PHST- 2020/01/01 00:00 [pmc-release] AID - 10.3389/fonc.2020.584834 [doi] PST - epublish SO - Front Oncol. 2020 Nov 27;10:584834. doi: 10.3389/fonc.2020.584834. eCollection 2020.