Six-factor-based stratification system for enfortumab vedotin monotherapy in pre-treated patients with metastatic or locally advanced urothelial carcinoma - Report - MDSpire
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A Six-Factor Stratification Approach for Enfortumab Vedotin Treatment in Previously Treated Patients with Advanced Urothelial Carcinoma

  • By

  • Yuto Matsushita

  • Satoru Taguchi

  • Taku Naiki

  • Gaku Ishikawa

  • Yu Nakamura

  • Jimpei Miyakawa

  • Takashi Nagai

  • Tomoyuki Kaneko

  • Hiroki Kubota

  • Hayato Hoshina

  • Jun Kamei

  • Aya Niimi

  • Yuta Yamada

  • Daisuke Obinata

  • Shigenori Kakutani

  • Masashi Shiozaki

  • Kento Ozawa

  • Michio Noda

  • Daichi Hirata

  • Yuichi Kitagawa

  • Yukihiro Yoshimi

  • Nozomi Sugiyama

  • Nobuhiko Shimizu

  • Yohei Tsubouchi

  • Keigo Sato

  • Kosuke Uchida

  • Shinya Watanabe

  • Jun Takahashi

  • Toshiharu Morikawa

  • Yoichi Mori

  • Takashi Murata

  • Taro Murata

  • Taketo Kawai

  • Takehiro Tanaka

  • Yukari Uemura

  • Tappei Takada

  • Sayuri Takahashi

  • Toshiki Ito

  • Masao Nagata

  • Hideyo Miyazaki

  • Satoshi Kurokawa

  • Yukio Yamada

  • Ryo Sato

  • Atsushi Otsuka

  • Yusuke Sato

  • Hiroaki Nishimatsu

  • Yukihiro Umemoto

  • Hiroshi Furuse

  • Yoshiyuki Akiyama

  • Yutaka Enomoto

  • Satoru Takahashi

  • Tetsuya Fujimura

  • Tohru Nakagawa

  • Hiroshi Fukuhara

  • Takahiro Yasui

  • Haruki Kume

  • Teruo Inamoto

  • September 11, 2026

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Clinical Report: A Six-Factor Stratification Approach for Enfortumab Vedotin Treatment

Overview

This study investigates prognostic factors in patients with advanced urothelial carcinoma treated with enfortumab vedotin (EV) monotherapy. A six-factor stratification system was developed to predict clinical outcomes.

Background

Enfortumab vedotin has shown significant benefits over standard chemotherapy in advanced urothelial carcinoma, as evidenced by the EV-301 trial, which demonstrated improved progression-free survival and overall survival. Understanding prognostic factors is essential for optimizing treatment strategies in this challenging disease.

Data Highlights

CharacteristicValue
Median Age74 years
Male Percentage72.6%
Upper Urinary Tract Urothelial Carcinoma53.8%
ECOG PS ≥ 216.5%
eGFR ≤ 60 mL/min/1.73m280.6%

Key Findings

  • The study included 387 patients with advanced urothelial carcinoma who received EV monotherapy.
  • Patients had a median of two prior systemic therapies, with a range of 1-5.
  • 80.6% of patients had an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73m2 or lower at the start of treatment.
  • 14.2% of patients exhibited aberrant histology.
  • Statistical analysis utilized univariable and multivariable Cox proportional hazards regression to assess prognostic factors.

Clinical Implications

The identification of prognostic factors can guide clinicians in stratifying patients for enfortumab vedotin treatment.

Conclusion

The development of a six-factor stratification system provides a valuable tool for predicting outcomes in patients receiving enfortumab vedotin.

Related Resources & Content

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  7. ESMO Clinical Practice Guideline interim update on first-line therapy in advanced urothelial carcinoma - ScienceDirect
  8. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma - PubMed

Original Source(s)

Six-factor-based stratification system for enfortumab vedotin monotherapy in pre-treated patients with metastatic or locally advanced urothelial carcinoma

  • by Yuto Matsushita, Satoru Taguchi, Taku Naiki, Gaku Ishikawa, Yu Nakamura, Jimpei Miyakawa, Takashi Nagai, Tomoyuki Kaneko, Hiroki Kubota, Hayato Hoshina, Jun Kamei, Aya Niimi, Yuta Yamada, Daisuke Obinata, Shigenori Kakutani, Masashi Shiozaki, Kento Ozawa, Michio Noda, Daichi Hirata, Yuichi Kitagawa, Yukihiro Yoshimi, Nozomi Sugiyama, Nobuhiko Shimizu, Yohei Tsubouchi, Keigo Sato, Kosuke Uchida, Shinya Watanabe, Jun Takahashi, Toshiharu Morikawa, Yoichi Mori, Takashi Murata, Taro Murata, Taketo Kawai, Takehiro Tanaka, Yukari Uemura, Tappei Takada, Sayuri Takahashi, Toshiki Ito, Masao Nagata, Hideyo Miyazaki, Satoshi Kurokawa, Yukio Yamada, Ryo Sato, Atsushi Otsuka, Yusuke Sato, Hiroaki Nishimatsu, Yukihiro Umemoto, Hiroshi Furuse, Yoshiyuki Akiyama, Yutaka Enomoto, Satoru Takahashi, Tetsuya Fujimura, Tohru Nakagawa, Hiroshi Fukuhara, Takahiro Yasui, Haruki Kume, Teruo Inamoto

  • September 11, 2026

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