@article{uoadl:3494914,
    volume = "43",
    number = "1",
    pages = "15 – 21",
    journal = "World Journal of Clinical Oncology",
    keywords = "Aged; Aged, 80 and over; Antineoplastic Agents, Immunological; B7-H1 Antigen; Carcinoma, Transitional Cell; Chemotherapy, Adjuvant; Disease-Free Survival; Double-Blind Method; Female; Humans; Male; Middle Aged; Neoplasm Invasiveness; Neoplasm Recurrence, Local; Nivolumab; Urinary Bladder Neoplasms; cisplatin; nivolumab; placebo; programmed death 1 ligand 1; immunological antineoplastic agent; nivolumab; programmed death 1 ligand 1; adjuvant therapy; aged; Article; cancer adjuvant therapy; cancer recurrence; cancer risk; cancer staging; controlled study; disease free survival; distant metastasis free survival; double blind procedure; female; follow up; health care quality; human; intention to treat analysis; major clinical study; male; muscle invasive bladder cancer; overall survival; phase 3 clinical trial; progression free survival; protein expression; radical resection; randomized controlled trial; recurrence free survival; adjuvant chemotherapy; bladder tumor; clinical trial; drug therapy; metabolism; middle aged; mortality; pathology; transitional cell carcinoma; tumor invasion; tumor recurrence; very elderly",
    BIBTEX_ENTRY = "article",
    year = "2025",
    author = "Galsky, Matthew D. and Witjes, Johannes Alfred and Gschwend, Jürgen E. and Milowsky, Matthew I. and Schenker, Michael and Valderrama, Begoña P. and Tomita, Yoshihiko and Bamias, Aristotelis and Lebret, Thierry and Shariat, Shahrokh F. and Park, Se Hoon and Agerbaek, Mads and Jha, Gautam and Stenner, Frank and Ye, Dingwei and Giudici, Fabio and Dutta, Santanu and Askelson, Margarita and Nasroulah, Federico and Zhang, Joshua and Brophy, Lynne and Bajorin, Dean F.",
    abstract = "Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. CheckMate 274 is a phase III, randomized, double-blind trial of adjuvant nivolumab versus placebo for muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence after radical resection. The primary end points of disease-free survival (DFS) in intent-to-treat (ITT) and tumor PD-L1 expression ≥1% populations were met. We report results at an extended median follow-up of 36.1 months in the ITT population. In addition, we report interim overall survival (OS) data for the first time and an exploratory analysis among patients with bladder primary tumors (muscle-invasive bladder cancer [MIBC]). Consistent DFS benefit with nivolumab versus placebo was observed in both the ITT (hazard ratio [HR], 0.71 [95% CI, 0.58 to 0.86]) and PD-L1 ≥1% (HR, 0.52 [95% CI, 0.37 to 0.72]) patients. The HR for OS with nivolumab versus placebo was 0.76 (95% CI, 0.61 to 0.96) in the ITT population and 0.56 (95% CI, 0.36 to 0.86) in the PD-L1 ≥1 population. Continuous benefit in nonurothelial tract recurrence-free survival and distant metastasis-free survival was also observed in both patient populations. The exploratory analysis of patients with MIBC also showed continued efficacy benefits, irrespective of PD-L1 status. No new safety signals were reported. Overall, these results further support adjuvant nivolumab as a standard of care for high-risk MIUC after radical resection. © 2024 by American Society of Clinical Oncology.",
    title = "Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274",
    doi = "10.1200/JCO.24.00340"
}