Objectives To evaluate the anti‐tumour activity and safety of anti‐programmed death receptor‐1 (PD‐1) antibody plus epidermal growth factor receptor blockade combined with platinum‐based chemotherapy (PEP) as first‐line therapy for stage IV penile squamous cell carcinoma (PSCC). Patients and Methods We conducted a retrospective review of 17 patients with stage IV PSCC undergoing first‐line PEP at Sun Yat‐sen University Cancer Center between January 2018 and September 2021. Clinical responses were assessed using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression‐free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method. Adverse events (AEs) were graded according to Common Terminology Criteria for Adverse Events version 5.0. Results Of 17 patients who received first‐line PEP, 13 were observed to have partial responses. Twelve patients subsequently received consolidated surgery. Nine of these achieved pN0 status, of whom six with locally advanced PSCC achieved pathological complete response. The median (range) follow‐up time was 24.87 (3.63–29.40) months. Median PFS and median OS were not reached, with 2‐year PFS and OS rates being 68.4% (95% confidence interval [CI] 48.7–96.1) and 62.9% (95% CI 41.6–95), respectively. Eight patients experienced Grade 3 or 4 treatment‐related AEs. No Grade 5 AEs or death associated with treatment was observed. Conclusions Anti‐PD‐1 antibody plus epidermal growth factor receptor blockade and platinum‐based chemotherapy showed promising anti‐tumour activity, acceptable toxicity, and satisfying long‐term survival for stage IV PSCC. Larger clinical trials are needed to validate our findings.

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