Kawahara Takashi, Hasizume Akihito, Uemura Koichi, Yamaguchi Katsuya, Ito Hiroki, Takeshima Teppei, Hasumi Hisashi, Teranishi Jun-Ichi, Ousaka Kimito, Makiyama Kazuhide, Uemura Hiroji
Departments of Urology and Renal Transplantation, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan.
Department of Urology, Graduate School of Medicine, Yokohama City University, Yokohama 236-0027, Japan.
Cancers (Basel). 2023 Aug 23;15(17):4227. doi: 10.3390/cancers15174227.
Enfortumab vedotin shows promise as a targeted therapy for advanced urothelial carcinoma, particularly in patients who have previously received platinum-based chemotherapy and an immune-checkpoint inhibitor. The EV-301 phase III trial demonstrated significantly improved overall survival and response rates compared to standard chemotherapy. However, more data, especially from larger real-world studies, are needed to further assess its effectiveness in Japanese patients.
A total of 6007 urothelial cancer patients inducted with pembrolizumab as a second-line treatment were analyzed. Among them, 563 patients received enfortumab vedotin after pembrolizumab, while 443 patients received docetaxel or paclitaxel after pembrolizumab, and all were included in the study for efficacy as a life prolonging agent.
The enfortumab vedotin group showed a longer overall survival than the paclitaxel/docetaxel group ( = 0.013, HR: 0.71). In multivariate analysis, enfortumab vedotin induction was the independent risk factor for overall survival ( = 0.013, HR: 0.70). There were no significant differences in cancer-specific survival.
Enfortumab vedotin prolonged the overall survival for Japanese advanced or metastatic urothelial carcinoma patients compared to paclitaxel or docetaxel after pembrolizumab treatment.
恩杂鲁胺维莫非尼作为晚期尿路上皮癌的靶向治疗药物显示出前景，尤其是在先前接受过铂类化疗和免疫检查点抑制剂治疗的患者中。EV-301 III期试验表明，与标准化疗相比，总体生存率和缓解率有显著提高。然而，需要更多的数据，特别是来自更大规模真实世界研究的数据，以进一步评估其在日本患者中的有效性。
共分析了6007例接受派姆单抗作为二线治疗的尿路上皮癌患者。其中，563例患者在接受派姆单抗治疗后接受了恩杂鲁胺维莫非尼治疗，而443例患者在接受派姆单抗治疗后接受了多西他赛或紫杉醇治疗，所有患者均被纳入作为延长生命药物的疗效研究。
恩杂鲁胺维莫非尼组的总生存期比紫杉醇/多西他赛组更长（P = 0.013，HR：0.71）。在多变量分析中，恩杂鲁胺维莫非尼诱导是总生存期的独立危险因素（P = 0.013，HR：0.70）。癌症特异性生存期无显著差异。
与派姆单抗治疗后使用紫杉醇或多西他赛相比，恩杂鲁胺维莫非尼延长了日本晚期或转移性尿路上皮癌患者的总生存期。
