Cell Reports Medicine (Oct 2021)
Neoadjuvant presurgical PD-1 inhibition in oral cavity squamous cell carcinoma
- Hannah M. Knochelmann,
- 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-Mayer,
- 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
Affiliations
- Hannah M. Knochelmann
- Department of Microbiology and Immunology, Medical University of South Carolina, Charleston, SC, USA; Department of Surgery – Oncology, Emory University, Atlanta, GA, USA; Department of Microbiology and Immunology, Emory University, Atlanta, GA, USA
- Joshua D. Horton
- Department of Otolaryngology – Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA
- Sixue Liu
- Division of Dermatology, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
- Kent Armeson
- Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA
- John M. Kaczmar
- Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA; Division of Medical Oncology, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA
- Megan M. Wyatt
- Department of Surgery – Oncology, Emory University, Atlanta, GA, USA; Department of Microbiology and Immunology, Emory University, Atlanta, GA, USA
- Mary S. Richardson
- Department of Pathology, Medical University of South Carolina, Charleston, SC, USA
- Shirley H. Lomeli
- Division of Dermatology, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
- Ying Xiong
- Department of Surgery, Medical University of South Carolina, Charleston, SC, USA
- Evan M. Graboyes
- Department of Otolaryngology – Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA
- Eric J. Lentsch
- Department of Otolaryngology – Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA
- Joshua D. Hornig
- Department of Otolaryngology – Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA
- Judith Skoner
- Department of Otolaryngology – Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA
- Seth Stalcup
- Department of Radiology, Medical University of South Carolina, Charleston, SC, USA
- Maria V. Spampinato
- Department of Radiology, Medical University of South Carolina, Charleston, SC, USA
- Elizabeth Garrett-Mayer
- American Society of Clinical Oncology, Alexandria, VA, USA
- Elizabeth C. O’Quinn
- Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA
- Cynthia D. Timmers
- Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA
- Martin J. Romeo
- Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA
- John M. Wrangle
- Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA; Division of Medical Oncology, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA
- M. Rita I. Young
- Department of Otolaryngology – Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA
- Mark P. Rubinstein
- Translational Therapeutics, The Ohio State University, The James Comprehensive Cancer Center, Columbus, OH, USA
- Terry A. Day
- Department of Otolaryngology – Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA
- Roger S. Lo
- Division of Dermatology, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Jonsson Comprehensive Cancer Center, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
- Chrystal M. Paulos
- Department of Microbiology and Immunology, Medical University of South Carolina, Charleston, SC, USA; Department of Surgery – Oncology, Emory University, Atlanta, GA, USA; Department of Microbiology and Immunology, Emory University, Atlanta, GA, USA
- David M. Neskey
- Department of Otolaryngology – Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA; Department of Cell and Molecular Pharmacology and Experimental Therapeutics, Medical University of South Carolina, Charleston, SC, USA; Corresponding author
- Journal volume & issue
-
Vol. 2,
no. 10
p. 100426
Abstract
Summary: Oral cavity squamous cell carcinoma (OCSCC) is a prevalent surgically treated subset of head and neck cancer with frequent recurrence and poor survival. Immunotherapy has demonstrated efficacy in recurrent/metastatic head and neck cancer. However, whether antitumor responses could be fostered by neoadjuvant presurgical immunotherapy remains unclear. Using a Simon’s two-stage design, we present results of a single-arm phase-II trial where 12 patients with stage II-IVA OCSCC received 3 to 4 biweekly doses of 3 mg/kg nivolumab followed by definitive surgical resection with curative intent. Presurgical nivolumab therapy in this cohort shows an overall response rate of 33% (n = 4 patients; 95% CI: 12%–53%). With a median follow up of 2.23 years, 10 out of 12 treated patients remain alive. Neoadjuvant nivolumab is safe, well-tolerated, and is not associated with delays in definitive surgical treatment in this study. This work demonstrates feasibility and safety for incorporation of nivolumab in the neoadjuvant setting for OCSCC (ClinicalTrials.gov: NCT03021993).