Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial

IF 58.7 1区医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY

Nature Medicine Pub Date : 2023-10-02 DOI:10.1038/s41591-023-02568-1

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

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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

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吉西他滨和顺铂联合尼沃单抗作为肌肉浸润性膀胱癌症的保留器官治疗：2期试验。

膀胱切除术是治疗肌肉浸润性癌症癌（MIBC）的标准方法，但它会改变生命。我们启动了一项2期研究，其中MIBC患者接受了四个周期的吉西他滨、顺铂和尼沃单抗治疗，然后进行临床再治疗。达到临床完全缓解（cCR）的患者可以不进行膀胱切除术。共同的主要目标是评估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或

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nature Medicine 医学-生化与分子生物学

CiteScore

100.90

自引率

0.70%

发文量

525

审稿时长

1 months

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