What question did this study set out to answer?

This study aims to evaluate the effectiveness of PD-1 blockade as a non-operative therapy for locally advanced head and neck cutaneous squamous cell cancer.

May 31, 2026

Nonoperative Management of Locally Advanced Resectable Cutaneous Squamous Cell Cancer of the Head and Neck with PD-1 Blockade

Key Points

This study aims to evaluate the effectiveness of PD-1 blockade as a non-operative therapy for locally advanced head and neck cutaneous squamous cell cancer.
Single-institution retrospective study from 2018 to 2023
Patients treated with cemiplimab, either neoadjuvant followed by surgery or monotherapy
Primary endpoint was objective radiological and clinical response rate.
Two-year disease-specific survival (DSS) for monotherapy was 90% (95% CI, 80–100%)
Two-year DSS for neoadjuvant therapy with surgery was 95% (95% CI, 86–100%)
Higher tumor-infiltrating lymphocytes associated with better responses (p=0.005).

Abstract

Abstract Purpose: Neoadjuvant PD-1 blockade has shown marked efficacy before surgery in patients with head and neck cutaneous squamous cell cancer (CSCC). However, the potential for PD-1 blockade as a definitive, non-operative therapy remains uncertain. Patients and Methods: We conducted a single-institution retrospective study(2018–2023)of patients with locally advanced resectable stage III/IV CSCC treated with cemiplimab. Patients received neoadjuvant cemiplimab followed by surgery or cemiplimab monotherapy without surgery. The primary endpoint was objective radiological (assessed using iRECIST)and clinical response rate; secondary endpoints included disease-specific survival (DSS),progression-free probability(PFP),histopathologic response, and exploratory genomic biomarkers. Results: Fifty-one patients received cemiplimab monotherapy alone (median age;78.8 years) and 21 received neoadjuvant cemiplimab followed by surgery (median age;73 years). The 2-year DSS and PFP for cemiplimab monotherapy were 90% (95% CI, 80–100%) and 82% (95% CI, 72–94%), respectively. The 2-year DSS and PFP for neoadjuvant cemiplimab with surgery were 95% (95% CI, 86–100%) and 78% (95% CI, 62–100%), respectively. Tumor-infiltrating lymphocytes (TILs) were higher in patients with complete or partial response than in patients with progressive or stable disease (p=0.005, q=0.026), with absent TILs more frequent in non-responders. Tumor mutational burden was greater in complete (55.7) and partial (14.9) response than in progressive disease (4.9; p=0.02, q=0.04). Conclusions: n this retrospective, non-randomized cohort, definitive-intent cemiplimab monotherapy was associated with durable disease control in selected patients with locally advanced resectable head and neck CSCC. This study provides a promising real-world organ preservation experience for patients with advanced head and neck CSCC treated with cemiplimab monotherapy that does not compromise oncologic outcomes.

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