Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Administration of Enfortumab Vedotin after an Immune Checkpoint Inhibitor and the Prognosis in Japanese Metastatic Urothelial Carcinoma: A Large Database Study

Takashi Kawahara
* ORCID logo ,
Akihito Hasizume
,
Koichi Uemura
,
Katsuya Yamaguchi
,
Hiroki Ito
,
Teppei Takeshima
,
Hisashi Hasumi
,
Jun-ichi Teranishi
,
Kimito Ousaka
,
Kazuhide Makiyama
,
Hiroji Uemura
Version 1 : Received: 27 July 2023 / Approved: 28 July 2023 / Online: 28 July 2023 (11:46:48 CEST)

A peer-reviewed article of this Preprint also exists.

Kawahara, T.; Hasizume, A.; Uemura, K.; Yamaguchi, K.; Ito, H.; Takeshima, T.; Hasumi, H.; Teranishi, J.-I.; Ousaka, K.; Makiyama, K.; Uemura, H. Administration of Enfortumab Vedotin after Immune-Checkpoint Inhibitor and the Prognosis in Japanese Metastatic Urothelial Carcinoma: A Large Database Study on Enfortumab Vedotin in Metastatic Urothelial Carcinoma. Cancers 2023, 15, 4227. Kawahara, T.; Hasizume, A.; Uemura, K.; Yamaguchi, K.; Ito, H.; Takeshima, T.; Hasumi, H.; Teranishi, J.-I.; Ousaka, K.; Makiyama, K.; Uemura, H. Administration of Enfortumab Vedotin after Immune-Checkpoint Inhibitor and the Prognosis in Japanese Metastatic Urothelial Carcinoma: A Large Database Study on Enfortumab Vedotin in Metastatic Urothelial Carcinoma. Cancers 2023, 15, 4227.

Abstract

Background Enfortumab vedotin shows promise as a targeted therapy for advanced urothelial carcinoma, particularly in patients who previously received platinum-based chemotherapy and immune checkpoint inhibitors. The EV-301 phase III trial demonstrated a significantly improved overall survival and response rates compared with standard chemotherapy. However, more data, especially from larger real-world studies, are needed to assess its effectiveness in Japanese patients. Methods A total of 6,007 urothelial cancer patients treated with pembrolizumab as second-line treatment were analyzed. Among them, 619 patients received enfortumab vedotin after pembrolizumab, while 394 received docetaxel or paclitaxel after pembrolizumab. Results The enfortumab vedotin group showed a longer overall survival than the paclitaxel/docetaxel group (p=0.013, hazard ratio: 0.71). In the multivariate analysis, enfortumab vedotin induction was an independent risk factor for the overall survival (p=0.013, hazard ratio: 0.70). There were no significant differences in the cancer-specific survival. Conclusions Enfortumab vedotin prolonged the overall survival in Japanese patients with advanced or metastatic urothelial carcinoma compared with paclitaxel or docetaxel after pembrolizumab treatment.

Keywords

enfortumab vedotin; urothelial carcinoma; database; real‐world; immune checkpoint

Subject

Medicine and Pharmacology, Urology and Nephrology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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