Volume 31, Issue 4 pp. 342-347
Original Article

Real world evidence of enfortumab vedotin in patients with advanced urothelial cancer: A multicenter observational study

Wataru Fukuokaya

Corresponding Author

Wataru Fukuokaya

Department of Urology, The Jikei University School of Medicine, Tokyo, Japan

Correspondence

Wataru Fukuokaya M.D., Department of Urology, The Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan.

Email: [email protected]

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Yuhei Koike

Yuhei Koike

Department of Urology, The Jikei University School of Medicine, Tokyo, Japan

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Yuji Yata

Yuji Yata

Department of Urology, The Jikei University School of Medicine, Tokyo, Japan

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Kazumasa Komura

Kazumasa Komura

Department of Urology, Osaka Medical and Pharmaceutical University, Osaka, Japan

Translational Research Program, Osaka Medical and Pharmaceutical University, Osaka, Japan

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Taizo Uchimoto

Taizo Uchimoto

Department of Urology, Osaka Medical and Pharmaceutical University, Osaka, Japan

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Takuya Tsujino

Takuya Tsujino

Department of Urology, Osaka Medical and Pharmaceutical University, Osaka, Japan

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Masanobu Saruta

Masanobu Saruta

Department of Urology, Fujita-Health University School of Medicine, Toyoake, Japan

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Kiyoshi Takahara

Kiyoshi Takahara

Department of Urology, Fujita-Health University School of Medicine, Toyoake, Japan

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Kazutoshi Fujita

Kazutoshi Fujita

Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan

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Takafumi Minami

Takafumi Minami

Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan

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Takahiro Adachi

Takahiro Adachi

Department of Urology, Tokyo Medical University, Tokyo, Japan

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Yosuke Hirasawa

Yosuke Hirasawa

Department of Urology, Tokyo Medical University, Tokyo, Japan

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Takeshi Hashimoto

Takeshi Hashimoto

Department of Urology, Tokyo Medical University, Tokyo, Japan

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Yoshio Ohno

Yoshio Ohno

Department of Urology, Tokyo Medical University, Tokyo, Japan

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Hirotsugu Uemura

Hirotsugu Uemura

Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan

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Ryoichi Shiroki

Ryoichi Shiroki

Department of Urology, Fujita-Health University School of Medicine, Toyoake, Japan

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Haruhito Azuma

Haruhito Azuma

Department of Urology, Osaka Medical and Pharmaceutical University, Osaka, Japan

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Takahiro Kimura

Takahiro Kimura

Department of Urology, The Jikei University School of Medicine, Tokyo, Japan

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First published: 19 December 2023
Citations: 14

Abstract

Objectives

To explore the characteristics of patients and assess the effectiveness of enfortumab vedotin (EV) in those with treatment-resistant advanced urothelial cancer in a real-world setting.

Patients and Methods

A multicenter observational study was conducted on 103 evaluable patients with advanced urothelial cancer who received EV. Outcomes were assessed by radiographic response, progression-free survival (PFS), and overall survival (OS), with treatment-related adverse events (trAEs). Radiographic response was assessed using Response Evaluation Criteria in Solid Tumors version 1.1, while trAEs were studied in line with Common Terminology Criteria for Adverse Events version 5.0.

Results

The median follow-up was 8.9 months (range, 0.1–16.4). The observed objective response rate was 50.5%. The median PFS was 6.0 months (95% CI: 4.7–9.8), and the median OS was 14.5 months (95% CI: 12.4–not reached). Out of the 103 patients, 19 (18.4%) had an Eastern Cooperative Oncology Group performance status of 2 or more, 14 (14.7%) had an non-urothelial carcinoma histology, and 40 (38.3%) had at least one pre-existing comorbidity. There were 26 (25.2%) patients who reported 49 trAEs, with 9 (18.3%) being grade 3 or higher. The most common trAEs included rash, occurring in 18.4%.

Conclusions

This study describes the characteristics and outcomes of patients with previously treated advanced urothelial cancer receiving EV. The findings demonstrate that EV showed robust anti-tumor activity and had manageable safety profiles outside the clinical trial setting.

CONFLICT OF INTEREST STATEMENT

Wataru Fukuokaya certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (e.g., employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Takahiro Kimura, Hirotsugu Uemura, and Kazutoshi Fujita have received speaker honoraria from Astellas. Takahiro Kimura has received speaker honoraria from Janssen, AstraZeneca, Bayer, and Sanofi. The remaining authors have nothing to disclose.

DATA AVAILABILITY STATEMENT

Our research data are available upon reasonable request.

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