PT  - JOURNAL ARTICLE
AU  - AKINORI MINATO
AU  - RIEKO KIMURO
AU  - DAICHI OHNO
AU  - KENTAROU TANIGAWA
AU  - KEISUKE KURETAKE
AU  - TAKUO MATSUKAWA
AU  - TOMOHISA TAKABA
AU  - KAZUMASA JOJIMA
AU  - MIRII HARADA
AU  - KATSUYOSHI HIGASHIJIMA
AU  - YUJIRO NAGATA
AU  - IKKO TOMISAKI
AU  - KENICHI HARADA
AU  - NAOHIRO FUJIMOTO
AU  - HIROSHI MIYAMOTO
TI  - Efficacy and Tolerability of Enfortumab Vedotin for Metastatic Urothelial Carcinoma: Early Experience in the Real World
AID  - 10.21873/anticanres.16594
DP  - 2023 Sep 01
TA  - Anticancer Research
PG  - 4055--4060
VI  - 43
IP  - 9
4099  - http://ar.iiarjournals.org/content/43/9/4055.short
4100  - http://ar.iiarjournals.org/content/43/9/4055.full
SO  - Anticancer Res2023 Sep 01; 43
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.