PMID- 37648337 OWN - NLM STAT- MEDLINE DCOM- 20230901 LR - 20230901 IS - 1791-7530 (Electronic) IS - 0250-7005 (Linking) VI - 43 IP - 9 DP - 2023 Sep TI - Efficacy and Tolerability of Enfortumab Vedotin for Metastatic Urothelial Carcinoma: Early Experience in the Real World. PG - 4055-4060 LID - 10.21873/anticanres.16594 [doi] AB - BACKGROUND/AIM: This study retrospectively investigated the impact of enfortumab vedotin (EV) monotherapy on the oncological outcome, safety profile, and health-related quality of life (HRQoL) in patients with metastatic urothelial carcinoma. PATIENTS AND METHODS: We assessed 26 consecutive patients who had received EV monotherapy after failure of platinum-based chemotherapy and immune checkpoint blockade therapy at our single institution from December 2021 to January 2023. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), incidence of adverse events (AEs), and EORTC QLQ-C30 as an HRQoL instrument were evaluated. RESULTS: The ORR and DCR were 57.7% and 80.8%, respectively. EV was effective regardless of the patient and tumor characteristics, including the efficacy of previous systemic therapy, performance status, number of Bellmunt risk factors, and presence of variant histology. With a median follow-up time of 7.5 months, the median durations of PFS and OS were 5.4 months and 10.3 months, respectively. Grade >/=3 AEs included neutropenia (15.4%), fatigue (7.7%), appetite loss (7.7%), rash (3.8%), febrile neutropenia (3.8%), hyperglycemia (3.8%), and interstitial pneumonia (3.8%). AEs resulting in withdrawal of EV, interruption of EV, and dose reduction occurred in two (7.7%), nine (34.6%), and 13 patients (50.0%), respectively. The EORTC QLQ-C30 scores from baseline to post-EV introduction remained stable. CONCLUSION: EV monotherapy demonstrated promising anti-tumor activity and tolerability in patients with metastatic urothelial carcinoma. CI - Copyright (c) 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved. FAU - Minato, Akinori AU - Minato A AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; a-minato@med.uoeh-u.ac.jp. FAU - Kimuro, Rieko AU - Kimuro R AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Ohno, Daichi AU - Ohno D AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Tanigawa, Kentarou AU - Tanigawa K AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Kuretake, Keisuke AU - Kuretake K AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Matsukawa, Takuo AU - Matsukawa T AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Takaba, Tomohisa AU - Takaba T AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Jojima, Kazumasa AU - Jojima K AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Harada, Mirii AU - Harada M AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Higashijima, Katsuyoshi AU - Higashijima K AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Nagata, Yujiro AU - Nagata Y AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Tomisaki, Ikko AU - Tomisaki I AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Harada, Kenichi AU - Harada K AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Fujimoto, Naohiro AU - Fujimoto N AD - Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. FAU - Miyamoto, Hiroshi AU - Miyamoto H AD - Department of Pathology & Laboratory Medicine, University of Rochester Medical Center, Rochester, NY, U.S.A. LA - eng PT - Journal Article PL - Greece TA - Anticancer Res JT - Anticancer research JID - 8102988 RN - DLE8519RWM (enfortumab vedotin) SB - IM MH - Humans MH - *Carcinoma, Transitional Cell MH - Quality of Life MH - Retrospective Studies MH - *Urinary Bladder Neoplasms MH - *Neutropenia OTO - NOTNLM OT - Enfortumab vedotin OT - antibody-drug conjugate OT - bladder cancer OT - upper urinary tract cancer OT - urothelial carcinoma EDAT- 2023/08/31 00:41 MHDA- 2023/09/01 06:43 CRDT- 2023/08/30 20:54 PHST- 2023/05/31 00:00 [received] PHST- 2023/06/28 00:00 [revised] PHST- 2023/06/29 00:00 [accepted] PHST- 2023/09/01 06:43 [medline] PHST- 2023/08/31 00:41 [pubmed] PHST- 2023/08/30 20:54 [entrez] AID - 43/9/4055 [pii] AID - 10.21873/anticanres.16594 [doi] PST - ppublish SO - Anticancer Res. 2023 Sep;43(9):4055-4060. doi: 10.21873/anticanres.16594.