RT Journal Article SR Electronic T1 Efficacy and Tolerability of Enfortumab Vedotin for Metastatic Urothelial Carcinoma: Early Experience in the Real World JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 4055 OP 4060 DO 10.21873/anticanres.16594 VO 43 IS 9 A1 AKINORI MINATO A1 RIEKO KIMURO A1 DAICHI OHNO A1 KENTAROU TANIGAWA A1 KEISUKE KURETAKE A1 TAKUO MATSUKAWA A1 TOMOHISA TAKABA A1 KAZUMASA JOJIMA A1 MIRII HARADA A1 KATSUYOSHI HIGASHIJIMA A1 YUJIRO NAGATA A1 IKKO TOMISAKI A1 KENICHI HARADA A1 NAOHIRO FUJIMOTO A1 HIROSHI MIYAMOTO YR 2023 UL http://ar.iiarjournals.org/content/43/9/4055.abstract 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.