{"title":"恩福单抗维多汀治疗晚期尿路上皮癌的良好疗效与身体(而非实验室)治疗相关不良事件有关:一项具有里程碑意义的分析。","authors":"Satoru Taguchi, Taketo Kawai, Yoshiki Ambe, Kenjiro Kishitani, Michio Noda, Tomoyuki Kaneko, Jimpei Miyakawa, Yu Nakamura, Hayato Hoshina, Daisuke Obinata, Kenya Yamaguchi, Shigenori Kakutani, Yoshitsune Furuya, Yujiro Sato, Yume Adachi, Kazuma Sugimoto, Keigo Sato, Mariko Tabata, Takehiro Tanaka, Katsuhiko Nara, Yukari Uemura, Jun Kamei, Yoshiyuki Akiyama, Yusuke Sato, Yuta Yamada, Aya Niimi, Daisuke Yamada, Tappei Takada, Sayuri Takahashi, Yukio Yamada, Hideyo Miyazaki, Yutaka Enomoto, Hiroaki Nishimatsu, Tetsuya Fujimura, Hiroshi Fukuhara, Tohru Nakagawa, Satoru Takahashi, Haruki Kume","doi":"10.1111/iju.15640","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>While the occurrence of immune-related adverse events has been recognized as a prognostic marker in patients receiving immune checkpoint inhibitors, the prognostic significance of treatment-related adverse events (trAEs) in patients undergoing antibody-drug conjugates such as enfortumab vedotin (EV) is controversial.</p><p><strong>Methods: </strong>We reviewed 106 patients with advanced urothelial carcinoma who were treated with EV therapy at 10 institutions between 2021 and 2023. Associations of clinical parameters with overall survival and progression-free survival were assessed using the Cox proportional hazards model. For the assessment of trAEs, landmark analysis was conducted to minimize immortal time bias.</p><p><strong>Results: </strong>Of 106 patients, 55 (51.9%) experienced disease progression and 44 (41.5%) died during the follow-up period. Any grade and grade ≥3 trAEs occurred in 94 (88.7%) and 44 (41.5%) patients, respectively. Common trAEs included skin disorders (74.5%), gastrointestinal disorders (62.3%), fatigue (50.0%), peripheral neuropathy (36.8%), and hematological disorders (37.7%). One patient died of interstitial pneumonia (grade 5). According to landmark analysis using 88 patients who survived for 2 months or more, trAEs were significantly associated with longer survival. Furthermore, when trAEs were classified into \"physical trAEs\" such as skin disorders and \"laboratory trAEs\" such as hematological disorders, the former were associated with longer survival while the latter were associated with shorter survival.</p><p><strong>Conclusions: </strong>Physical, but not laboratory, trAEs are associated with favorable outcomes of EV therapy for advanced urothelial carcinoma. Both managing trAEs and utilizing them as prognostic markers are key points in the use of antibody-drug conjugates such as EV.</p>","PeriodicalId":14323,"journal":{"name":"International Journal of Urology","volume":" ","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Physical, but not laboratory, treatment-related adverse events are associated with favorable outcomes of enfortumab vedotin for advanced urothelial carcinoma: A landmark analysis.\",\"authors\":\"Satoru Taguchi, Taketo Kawai, Yoshiki Ambe, Kenjiro Kishitani, Michio Noda, Tomoyuki Kaneko, Jimpei Miyakawa, Yu Nakamura, Hayato Hoshina, Daisuke Obinata, Kenya Yamaguchi, Shigenori Kakutani, Yoshitsune Furuya, Yujiro Sato, Yume Adachi, Kazuma Sugimoto, Keigo Sato, Mariko Tabata, Takehiro Tanaka, Katsuhiko Nara, Yukari Uemura, Jun Kamei, Yoshiyuki Akiyama, Yusuke Sato, Yuta Yamada, Aya Niimi, Daisuke Yamada, Tappei Takada, Sayuri Takahashi, Yukio Yamada, Hideyo Miyazaki, Yutaka Enomoto, Hiroaki Nishimatsu, Tetsuya Fujimura, Hiroshi Fukuhara, Tohru Nakagawa, Satoru Takahashi, Haruki Kume\",\"doi\":\"10.1111/iju.15640\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>While the occurrence of immune-related adverse events has been recognized as a prognostic marker in patients receiving immune checkpoint inhibitors, the prognostic significance of treatment-related adverse events (trAEs) in patients undergoing antibody-drug conjugates such as enfortumab vedotin (EV) is controversial.</p><p><strong>Methods: </strong>We reviewed 106 patients with advanced urothelial carcinoma who were treated with EV therapy at 10 institutions between 2021 and 2023. Associations of clinical parameters with overall survival and progression-free survival were assessed using the Cox proportional hazards model. For the assessment of trAEs, landmark analysis was conducted to minimize immortal time bias.</p><p><strong>Results: </strong>Of 106 patients, 55 (51.9%) experienced disease progression and 44 (41.5%) died during the follow-up period. Any grade and grade ≥3 trAEs occurred in 94 (88.7%) and 44 (41.5%) patients, respectively. Common trAEs included skin disorders (74.5%), gastrointestinal disorders (62.3%), fatigue (50.0%), peripheral neuropathy (36.8%), and hematological disorders (37.7%). One patient died of interstitial pneumonia (grade 5). According to landmark analysis using 88 patients who survived for 2 months or more, trAEs were significantly associated with longer survival. Furthermore, when trAEs were classified into \\\"physical trAEs\\\" such as skin disorders and \\\"laboratory trAEs\\\" such as hematological disorders, the former were associated with longer survival while the latter were associated with shorter survival.</p><p><strong>Conclusions: </strong>Physical, but not laboratory, trAEs are associated with favorable outcomes of EV therapy for advanced urothelial carcinoma. Both managing trAEs and utilizing them as prognostic markers are key points in the use of antibody-drug conjugates such as EV.</p>\",\"PeriodicalId\":14323,\"journal\":{\"name\":\"International Journal of Urology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2024-11-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Urology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/iju.15640\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/iju.15640","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Physical, but not laboratory, treatment-related adverse events are associated with favorable outcomes of enfortumab vedotin for advanced urothelial carcinoma: A landmark analysis.
Background: While the occurrence of immune-related adverse events has been recognized as a prognostic marker in patients receiving immune checkpoint inhibitors, the prognostic significance of treatment-related adverse events (trAEs) in patients undergoing antibody-drug conjugates such as enfortumab vedotin (EV) is controversial.
Methods: We reviewed 106 patients with advanced urothelial carcinoma who were treated with EV therapy at 10 institutions between 2021 and 2023. Associations of clinical parameters with overall survival and progression-free survival were assessed using the Cox proportional hazards model. For the assessment of trAEs, landmark analysis was conducted to minimize immortal time bias.
Results: Of 106 patients, 55 (51.9%) experienced disease progression and 44 (41.5%) died during the follow-up period. Any grade and grade ≥3 trAEs occurred in 94 (88.7%) and 44 (41.5%) patients, respectively. Common trAEs included skin disorders (74.5%), gastrointestinal disorders (62.3%), fatigue (50.0%), peripheral neuropathy (36.8%), and hematological disorders (37.7%). One patient died of interstitial pneumonia (grade 5). According to landmark analysis using 88 patients who survived for 2 months or more, trAEs were significantly associated with longer survival. Furthermore, when trAEs were classified into "physical trAEs" such as skin disorders and "laboratory trAEs" such as hematological disorders, the former were associated with longer survival while the latter were associated with shorter survival.
Conclusions: Physical, but not laboratory, trAEs are associated with favorable outcomes of EV therapy for advanced urothelial carcinoma. Both managing trAEs and utilizing them as prognostic markers are key points in the use of antibody-drug conjugates such as EV.
期刊介绍:
International Journal of Urology is the official English language journal of the Japanese Urological Association, publishing articles of scientific excellence in urology. Submissions of papers from all countries are considered for publication. All manuscripts are subject to peer review and are judged on the basis of their contribution of original data and ideas or interpretation.