Neoadjuvant presurgical PD-1 inhibition in oral cavity squamous cell carcinoma

• DOI: 10.1016/j.xcrm.2021.100426
• Publication Date: 2021-10-22T09:38:09Z
• Authors: Hannah M. Knochel...; Joshua D. Horton; Sixue Liu; Kent Armeson; John M. Kaczmar; Megan M. Wyatt; Mary S. Richardson; Shirley H. Lomeli; Ying Xiong; Evan M. Graboyes; Eric J. Lentsch; Joshua D. Hornig; Judith Skoner; Seth Stalcup; Maria V. Spampinato; Elizabeth Garrett...; Elizabeth C. O’Quinn; Cynthia D. Timmers; Martin J. Romeo; John M. Wrangle; M. Rita I. Young; Mark P. Rubinstein; Terry A. Day; Roger S. Lo; Chrystal M. Paulos; David M. Neskey
• Keywords: Neoadjuvant Therapy

Oral cavity squamous cell carcinoma (OCSCC) is a prevalent surgically treated subset of head and neck cancer with frequent recurrence poor survival. Immunotherapy has demonstrated efficacy in recurrent/metastatic cancer. However, whether antitumor responses could be fostered by neoadjuvant presurgical immunotherapy remains unclear. Using Simon's two-stage design, we present results single-arm phase-II trial where 12 patients stage II-IVA OCSCC received 3 to 4 biweekly doses mg/kg nivolumab followed definitive surgical resection curative intent. Presurgical therapy this cohort shows an overall response rate 33% (n = patients; 95% CI: 12%–53%). With median follow up 2.23 years, 10 out remain alive. Neoadjuvant safe, well-tolerated, not associated delays treatment study. This work demonstrates feasibility safety for incorporation the setting (ClinicalTrials.gov: NCT03021993).