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
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.
PURPOSE: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.