Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma

作者：Danny Rischin, Sandro Virgilio Porceddu, Fiona Lee Day, Daniel Brungs, Hayden Christie, James E. Jackson, Brian N. Stein, Yungpo Bernard Su, Rahul Ladwa, Gerard Adams, Samantha Elizabeth Bowyer, Zulfiquer Ali Otty, Naoya Yamazaki, Paolo Bossi, Amarnath Challapalli, Axel Hauschild, Annette May Ling Lim, Vishal Anil Patel, Joanna L. Walker, Maite De Liz Vassen Schurmann, Paola Queirolo, Javier Cañueto, Flávio Augusto Ferreira da Silva, Alexander J. Stratigos, Alexander David Guminski, Charles Y. Lin, Fernanda Damian, Lukas Flatz, Anne E. Taylor, David R. Carr, Samuel John Harris, Dmitry Kirtbaya, Gaelle Quereux, Piotr Lukasz Rutkowski, Nicole Basset‐Séguin, Nikhil I. Khushalani, Caroline Robert, Haisong Ju, Camryn Joseph, Shikha Bansal, Chieh-I Chen, Frank A. Seebach, Suk‐Young Yoo, Israel Lowy, Priscila Hermont Goncalves, Matthew G. Fury · 发表于：New England Journal of Medicine · 年份：2025 · DOI：10.1056/nejmoa2502449 · 被引用次数：82 · 研究领域：Nonmelanoma Skin Cancer Studies、Cutaneous Melanoma Detection and Management、Cancer and Skin Lesions

BACKGROUND: Patients who have cutaneous squamous-cell carcinoma with high-risk features are at risk for recurrence after definitive local therapy. The benefit of systemic adjuvant therapy options has not been well established in clinical trials. METHODS: In a phase 3, randomized trial, we enrolled patients with local or regional cutaneous squamous-cell carcinoma, after surgical resection and postoperative radiotherapy, at high risk for recurrence owing to nodal features (extracapsular extension with largest node ≥20 mm in diameter or at least three involved nodes) or nonnodal features (in-transit metastases, T4 lesion [with bone invasion], perineural invasion, or locally recurrent tumor with ≥1 additional risk feature). Patients were assigned in a 1:1 ratio to receive adjuvant cemiplimab (350 mg) or placebo, administered intravenously every 3 weeks for 12 weeks, followed by a dose increase to 700 mg administered every 6 weeks for up to 36 weeks (≤48 weeks total). The primary end point was disease-free survival. Secondary end points included freedom from locoregional recurrence, freedom from distant recurrence, and safety. RESULTS: A total of 415 patients were assigned to cemiplimab (209) or placebo (206). The median follow-up was 24 months. Cemiplimab was superior to placebo with respect to disease-free survival (24 vs. 65 events; hazard ratio for disease recurrence or death, 0.32; 95% confidence interval [CI], 0.20 to 0.51; P<0.001). The estimated 24-month disease-free survi...