Supplementary Figure from Pilot Phase II Trial of Neoadjuvant Immunotherapy in Locoregionally Advanced, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck
posted on 2023-03-31, 22:49authored byRenata Ferrarotto, Moran Amit, Priyadharsini Nagarajan, M. Laura Rubin, Ying Yuan, Diana Bell, Adel K. El-Naggar, Jason M. Johnson, William H. Morrison, David I. Rosenthal, Bonnie S. Glisson, Faye M. Johnson, Charles Lu, Frank E. Mott, Bita Esmaeli, Eduardo M. Diaz, Paul W. Gidley, Ryan P. Goepfert, Carol M. Lewis, Randal S. Weber, Jennifer A. Wargo, Sreyashi Basu, Fei Duan, Shalini S. Yadav, Padmanee Sharma, James P. Allison, Jeffrey N. Myers, Neil D. Gross
Supplementary Figure from Pilot Phase II Trial of Neoadjuvant Immunotherapy in Locoregionally Advanced, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck
Funding
Regeneron
American Head and Neck Society
American Academy of Otolaryngology Head
Neck Surgery Foundation Surgeon Scientist Combined award
National Cancer Institute
History
ARTICLE ABSTRACT
In locoregionally advanced, resectable cutaneous squamous cell carcinoma of the head and neck (CSCC-HN), surgery followed by radiotherapy is standard but can be cosmetically and functionally devastating, and many patients will have recurrence.
Newly diagnosed or recurrent stage III–IVA CSCC-HN patients amenable to curative-intent surgery received two cycles of neoadjuvant PD-1 inhibition. The primary endpoint was ORR per RECIST 1.1. Secondary endpoints included pathologic response [pathologic complete response (pCR) or major pathologic response (MPR; ≤10% viable tumor)], safety, DSS, DFS, and OS. Exploratory endpoints included immune biomarkers of response.
Of 20 patients enrolled, 7 had recurrent disease. While only 6 patients [30%; 95% confidence interval (CI), 11.9–54.3] had partial responses by RECIST, 15 patients (75%; 95% CI, 50.9–91.3) had a pCR (n = 11) or MPR (n = 4). No SAEs ocurred during or after the neoadjuvant treatment. At a median follow-up of 22.6 months (95% CI, 21.7–26.1), one patient progressed and died, one died without disease, and two developed recurrence. The 12-month DSS, DFS, and OS rates were 95% (95% CI, 85.9–100), 89.5% (95% CI, 76.7–100), and 95% (95% CI, 85.9–100), respectively. Gene expression studies revealed an inflamed tumor microenvironment in patients with pCR or MPR, and CyTOF analyses demonstrated a memory CD8+ T-cell cluster enriched in patients with pCR.
Neoadjuvant immunotherapy in locoregionally advanced, resectable CSCC-HN is safe and induces a high pathologic response rate. Pathologic responses were associated with an inflamed tumor microenvironment.