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

This study aimed to identify prognostic factors and develop a prognostic stratification system for progression-free survival (PFS) and overall survival (OS) in patients with locally advanced or metastatic urothelial carcinoma (la/m UC) treated with enfortumab vedotin (EV). We retrospectively analyzed 387 patients with la/m UC who received EV monotherapy and evaluated the prognostic factors using the Cox proportional hazards regression model. We then used the significant factors to derive a system for predicting prognosis. The median PFS and OS were 7.6 and 14.6 months, respectively. Multivariable analysis revealed six significant factors common to both PFS and OS: poor Eastern Cooperative Oncology Group performance status (≥ 1), presence of aberrant histology (histological subtypes or divergent differentiation), presence of bone metastasis, anemia (hemoglobin < 10 g/dL), high C-reactive protein levels (> 0.5 mg/dL), and hypercalcemia (corrected calcium > 10.2 mg/dL). Based on the number of positive factors, patients were categorized into three groups: 147 patients with none or one factor (low-risk group), 92 patients with two factors (intermediate-risk group), and 148 patients with three or more factors (high-risk group). The log-rank test indicated significant differences in both PFS and OS among the three groups, with C-indices of 0.634 and 0.700 for PFS and OS, respectively. Six factors were identified as common prognostic factors for both PFS and OS in la/m UC patients receiving EV monotherapy. The newly developed prognostic risk stratification system based on these factors is clinically useful, particularly for predicting OS.

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Publication Details

Journal
World Journal of Urology
Published
2026-09-11
DOI
https://doi.org/10.1007/s00345-026-06765-8
Primary Topic
Bladder and Urothelial Cancer Treatments
Type
article
Field-Weighted Citation Impact
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article

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

Shigenori Kakutani, Taketo Kawai, Yukari Uemura, Yukihiro YOSHIMI et al.
World Journal of Urology
Bladder and Urothelial Cancer Treatments
article

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

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

Abstract

This study aimed to identify prognostic factors and develop a prognostic stratification system for progression-free survival (PFS) and overall survival (OS) in patients with locally advanced or metastatic urothelial carcinoma (la/m UC) treated with enfortumab vedotin (EV). We retrospectively analyzed 387 patients with la/m UC who received EV monotherapy and evaluated the prognostic factors using the Cox proportional hazards regression model. We then used the significant factors to derive a system for predicting prognosis. The median PFS and OS were 7.6 and 14.6 months, respectively. Multivariable analysis revealed six significant factors common to both PFS and OS: poor Eastern Cooperative Oncology Group performance status (≥ 1), presence of aberrant histology (histological subtypes or divergent differentiation), presence of bone metastasis, anemia (hemoglobin < 10 g/dL), high C-reactive protein levels (> 0.5 mg/dL), and hypercalcemia (corrected calcium > 10.2 mg/dL). Based on the number of positive factors, patients were categorized into three groups: 147 patients with none or one factor (low-risk group), 92 patients with two factors (intermediate-risk group), and 148 patients with three or more factors (high-risk group). The log-rank test indicated significant differences in both PFS and OS among the three groups, with C-indices of 0.634 and 0.700 for PFS and OS, respectively. Six factors were identified as common prognostic factors for both PFS and OS in la/m UC patients receiving EV monotherapy. The newly developed prognostic risk stratification system based on these factors is clinically useful, particularly for predicting OS.

World Journal of UrologyVol. 44(1)
Nihon University (JP), Shinshu University (JP), Jichi Medical University (JP), Kyorin University (JP), Hamamatsu University School of Medicine (JP), Nagoya City University (JP), Konan Kosei Hospital (JP), Seirei Mikatabara General Hospital (JP), National Center for Global Health and Medicine (JP), Ome Municipal General Hospital (JP), Iwata City Hospital (JP), Tokyo Metropolitan Bokutoh Hospital (JP), University of Tokyo Hospital (JP), Mitsui Memorial Hospital (JP), Fujieda Municipal General Hospital (JP), Tokyo Teishin Hospital (JP), Anjo Kosei Hospital (JP), Musashino Red Cross Hospital (JP), Tokyo Metropolitan Tama Medical Center (JP), Kinan Hospital (JP), Hamamatsu Medical Center (JP), The University of Tokyo (JP), International University of Health and Welfare (JP), Teikyo University (JP)
University of Tokyo
Openalex Percentile: Top 8%
Bladder and Urothelial Cancer Treatments
DOIOpen Access PDFOpenAlex
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