In the EV-301 trial, enfortumab vedotin prolonged survival in patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum-based therapy and programmed cell death 1/programmed death-ligand 1 inhibitor. However, real-world Asian data are limited, and potential prognostic markers are non-existent. We aimed to investigate potential prognostic markers for enfortumab vedotin therapy in Asian patients.
We retrospectively enrolled 61 Japanese patients treated with enfortumab vedotin therapy at our hospital and affiliated hospitals between January 2019 and September 2023.
Enrolled patients (38 men, 23 women; median age 74 [IQR: 68-79] years) had bladder cancer (26 patients) or upper-tract urothelial carcinoma (35 patients). Fifty-four patients reported adverse events (grade >3 in 12). Skin disorders, pruritus, and neuropathy were common adverse effects. The median overall survival was 17.1 months (95% confidence interval: 10.0-not applicable). In multivariate analysis, the C-reactive protein level was an independent marker predicting favorable overall survival with enfortumab vedotin. Patient characteristics did not differ between C-reactive protein-high and -low groups.
Our study provides real-world data showing that enfortumab vedotin prolonged survival in Asian patients similar to the EV-301 trial. Additionally, the C-reactive protein level might be considered a prognostic marker of enfortumab vedotin therapy in such patients.
Cancers. 2024 Apr 28*** epublish ***
Toshiharu Morikawa, Taku Naiki, Yosuke Sugiyama, Aya Naiki-Ito, Takashi Nagai, Toshiki Etani, Keitaro Iida, Teruki Isobe, Yusuke Noda, Nobuhiko Shimizu, Maria Aoki, Masakazu Gonda, Rika Banno, Hiroki Kubota, Ryosuke Ando, Yukihiro Umemoto, Noriyasu Kawai, Takahiro Yasui
Department of Nephro-Urology, Graduate School of Medical Sciences, Nagoya City University, Nagoya 467-8601, Japan., Department of Pharmacy, Nagoya City University Hospital, Nagoya 467-8601, Japan., Department of Experimental Pathology and Tumor Biology, Graduate School of Medical Sciences, Nagoya City University, Nagoya 467-8601, Japan., Department of Urology, Konan Hospital, Konan 483-8704, Japan., Department of Urology, Kainan Hospital, Yatomi 498-8502, Japan.