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

Journal volume & issue
Vol. 2, no. 10
p. 100426

Abstract

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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).

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