Real-world evidence regarding enfortumab vedotin for unresectable or metastatic urothelial carcinoma is scarce, particularly in Japan. We investigated real-world data focusing on patient background, previous treatments, response, survival and adverse events in patients receiving enfortumab vedotin.
A multicentre database was used to register 556 patients diagnosed with metastatic urothelial carcinoma from 2008 to 2023; 34 patients (6.1%) treated with enfortumab vedotin were included. Best radiographic objective responses were evaluated using the Response Evaluation Criteria in Solid Tumors (v1.1) during treatments. Overall survival and progression-free survival were estimated (Kaplan-Meier method). Toxicities were reported according to the Common Terminology Criteria for Adverse Events, version 5.0. The relative dose intensity, which could impact oncological outcomes, was calculated.
The median number of enfortumab vedotin therapy cycles was 5. The best objective response to enfortumab vedotin was partial response, stable disease and progressive disease in 19 (56%), 5 (15%) and 10 (29%) patients, respectively. The median overall survival and progression-free survival after the first enfortumab vedotin dose were 16 and 9 months, respectively. No significant relationship was observed between survival outcomes after enfortumab vedotin initiation and the enfortumab vedotin relative dose intensity. The median overall survival from first-line platinum-based chemotherapy initiation was 42 months. Twenty-six (76%) patients experienced any grade of enfortumab vedotin-related toxicities; eight (24%) experienced Grades 3-4 toxicities, the most common being skin toxicity (any grade, 47%; Grades 3-4, 12%).
Here, we report real-world evidence for enfortumab vedotin therapy in Japan. Tumour responses and safety profiles were comparable with those of clinical trials on this novel treatment.
Japanese journal of clinical oncology. 2023 Dec 07 [Epub ahead of print]
Makito Miyake, Nobutaka Nishimura, Yuki Oda, Tatsuki Miyamoto, Chihiro Ohmori, Norimi Takamatsu, Yoshitaka Itami, Akira Tachibana, Yoshihiro Matsumoto, Keisuke Kiba, Atsushi Tomioka, Hiroaki Yamamoto, Eijiro Okajima, Kuwata Masaomi, Keichi Sakamoto, Mitsuru Tomizawa, Takuto Shimizu, Kenta Ohnishi, Shunta Hori, Yosuke Morizawa, Daisuke Gotoh, Yasushi Nakai, Kazumasa Torimoto, Nobumichi Tanaka, Kiyohide Fujimoto, Nara Urological Research and Treatment Group
Department of Urology, Nara Medical University, Kashihara, Nara, Japan., Department of Urology, Takai Hospital, Tenri, Nara, Japan., Department of Urology, Nara Prefecture General Medical Center, Nara, Nara, Japan., Department of Urology, Yamatotakada Municipal Hospital, Yamatotakada, Nara, Japan., Department of Urology, Tane General Hospital, Osaka, Osaka, Japan., Department of Urology, Hoshigaoka Medical Center, Hirakata, Osaka, Japan., Department of Urology, Kindai University Nara Hospital, Ikoma, Nara, Japan., Department of Urology, Saiseikai Chuwa Hospital, Sakurai, Nara, Japan., Department of Urology, Minami Nara Medical Center, Yoshino, Nara, Japan., Department of Urology, Nara City Hospital, Nara, Nara, Japan., Department of Urology, Matsusaka Chuo General Hospital, Matsusaka, Mie, Japan., Department of Urology, Osaka Kaisei Hospital, Osaka, Osaka, Japan.