Analysis: Capecitabine Shows Clinical Activity in Advanced Head and Neck Cutaneous SCC

Key Takeaways

• Neoadjuvant capecitabine produced clinical tumor regression in 67% of patients with advanced cutaneous squamous cell carcinoma of the head and neck (cSCCHN), according to results from a brief report in JAMA Dermatology.

• Five of 12 surgically treated patients (42%) achieved a complete pathologic response following treatment.

• No grade 3 or higher capecitabine-related adverse events were reported, supporting its tolerability in an older patient population.

Neoadjuvant capecitabine demonstrated encouraging clinical and pathologic responses in patients with advanced cutaneous squamous cell carcinoma of the head and neck (cSCCHN), according to findings from a prospective case series published online in JAMA Dermatology.

Study researchers evaluated 15 consecutive patients with advanced cSCCHN treated at 2 academic centers, focusing on whether neoadjuvant capecitabine could provide tumor downstaging and disease control while patients awaited definitive surgery.

Capecitabine Achieves Tumor Regression With Limited Toxicity

Patients received 2 cycles of capecitabine according to the CAPTURE (Capecitabine Prior to Tumor Resection in ENT Oncology) protocol. Surgical resection was performed within 1 to 2 weeks after treatment completion.

The cohort had a mean age of 77 years, reflecting the older population commonly affected by advanced cSCCHN. Clinical tumor regression was observed in 10 of 15 patients (67%). Among patients who underwent surgery, 5 achieved a complete pathologic response, representing 42% of the cohort.

Notably, 2 patients experienced complete clinical responses and ultimately avoided surgery, opting instead for radiotherapy. Five patients did not respond to treatment, including 1 individual whose disease progressed to metastatic cSCC. Investigators reported no grade 3 or higher capecitabine-related toxic effects, suggesting the oral fluoropyrimidine was well tolerated despite the advanced age of the study population.

The authors suggested neoadjuvant capecitabine may offer a practical bridge to surgery, especially for patients facing surgical wait times or for those who are not candidates for immunotherapy.

“NC demonstrated significant tumor regression and pathologic response without severe treatment-related toxic effects,” the authors wrote. “NC may be an effective treatment option for providing disease control and tumor downstaging in patients with advanced cSCCHN.”¹

Source

Haidar S, Mlynarek A, Lefrancois P, et al. JAMA Dermatology. Published online May 27, 2026. doi:10.1001/jamadermatol.2026.1331