吉西他滨和顺铂加纳武单抗作为肌肉浸润性膀胱癌的器官保留治疗：一项 2 期试验。
Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.
发表日期：2023 Oct 02
作者：
Matthew D Galsky, Siamak Daneshmand, Sudeh Izadmehr, Edgar Gonzalez-Kozlova, Kevin G Chan, Sara Lewis, Bassam El Achkar, Tanya B Dorff, Jeremy Paul Cetnar, Brock O Neil, Anishka D'Souza, Ronac Mamtani, Christos Kyriakopoulos, Tomi Jun, Mahalya Gogerly-Moragoda, Rachel Brody, Hui Xie, Kai Nie, Geoffrey Kelly, Amir Horwitz, Yayoi Kinoshita, Ethan Ellis, Yohei Nose, Giorgio Ioannou, Rafael Cabal, G Kenneth Haines, Li Wang, Kent W Mouw, Robert M Samstein, Reza Mehrazin, Nina Bhardwaj, Menggang Yu, Qianqian Zhao, Seunghee Kim-Schulze, Robert Sebra, Jun Zhu, Sacha Gnjatic, John Sfakianos, Sumanta K Pal
来源：
NATURE MEDICINE
摘要：
膀胱切除术是肌层浸润性膀胱癌 (MIBC) 的标准治疗方法，但它会改变生活。我们启动了一项 2 期研究，其中 MIBC 患者接受四个周期的吉西他滨、顺铂加纳武单抗治疗，然后进行临床再分期。达到临床完全缓解（cCR）的患者无需进行膀胱切除术即可继续治疗。共同主要目标是评估 cCR 率和 cCR 对复合结果的阳性预测价值：放弃立即膀胱切除术的患者的 2 年无转移生存率或选择立即膀胱切除术的患者的
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