학술논문
Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial
Document Type
Article
Author
Galsky, Matthew D.; Daneshmand, Siamak; Izadmehr, Sudeh; Gonzalez-Kozlova, Edgar; Chan, Kevin G.; Lewis, Sara; Achkar, Bassam El; Dorff, Tanya B.; Cetnar, Jeremy Paul; Neil, Brock O.; D’Souza, Anishka; Mamtani, Ronac; Kyriakopoulos, Christos; Jun, Tomi; Gogerly-Moragoda, Mahalya; Brody, Rachel; Xie, Hui; Nie, Kai; Kelly, Geoffrey; Horowitz, Amir; Kinoshita, Yayoi; Ellis, Ethan; Nose, Yohei; Ioannou, Giorgio; Cabal, Rafael; Del Valle, Diane M.; Haines, G. Kenneth; Wang, Li; Mouw, Kent W.; Samstein, Robert M.; Mehrazin, Reza; Bhardwaj, Nina; Yu, Menggang; Zhao, Qianqian; Kim-Schulze, Seunghee; Sebra, Robert; Zhu, Jun; Gnjatic, Sacha; Sfakianos, John; Pal, Sumanta K.
Source
Nature Medicine; November 2023, Vol. 29 Issue: 11 p2825-2834, 10p
Subject
Language
ISSN
10788956; 1546170X
Abstract
Cystectomy is a standard treatment for muscle-invasive bladder cancer (MIBC), but it is life-altering. We initiated a phase 2 study in which patients with MIBC received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging. Patients achieving a clinical complete response (cCR) could proceed without cystectomy. The co-primary objectives were to assess the cCR rate and the positive predictive value of cCR for a composite outcome: 2-year metastasis-free survival in patients forgoing immediate cystectomy or