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Pilot Phase II Trial of Neoadjuvant Immunotherapy in Locoregionally Advanced, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck.
- Source :
-
Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Aug 15; Vol. 27 (16), pp. 4557-4565. Date of Electronic Publication: 2021 Jun 29. - Publication Year :
- 2021
-
Abstract
- Purpose: 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.<br />Patients and Methods: 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.<br />Results: 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, 14 patients (70%; 95% CI, 45.7-88.1) had a pCR ( n = 11) or MPR ( n = 3). 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 <superscript>+</superscript> T-cell cluster enriched in patients with pCR.<br />Conclusions: 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.<br /> (©2021 American Association for Cancer Research.)
- Subjects :
- Aged
Female
Head and Neck Neoplasms pathology
Head and Neck Neoplasms surgery
Humans
Male
Middle Aged
Neoadjuvant Therapy
Neoplasm Staging
Pilot Projects
Skin Neoplasms pathology
Skin Neoplasms surgery
Squamous Cell Carcinoma of Head and Neck pathology
Squamous Cell Carcinoma of Head and Neck surgery
Head and Neck Neoplasms drug therapy
Immune Checkpoint Inhibitors therapeutic use
Immunotherapy
Skin Neoplasms drug therapy
Squamous Cell Carcinoma of Head and Neck drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1557-3265
- Volume :
- 27
- Issue :
- 16
- Database :
- MEDLINE
- Journal :
- Clinical cancer research : an official journal of the American Association for Cancer Research
- Publication Type :
- Academic Journal
- Accession number :
- 34187851
- Full Text :
- https://doi.org/10.1158/1078-0432.CCR-21-0585