A Phase 2 Study of Docetaxel and Capecitabine in Advanced Squamous Cell Carcinoma of the Head and Neck

Background: Docetaxel and capecitabine combination have not previously been studied in advanced head and neck squamous cell carcinoma (HNSCC). This study aimed to evaluate the combination’s safety and efficacy in this population. Materials and methods: In this single-arm phase 2 trial, patients with advanced HNSCC received docetaxel 75 mg/m 2 intravenously on day 1 in combination with oral capecitabine 800 to 1000 mg/m 2 twice daily from days 1 to 14 of a 3-week cycle, until either progression or toxicity. Results: A total of 14 patients were enrolled in the trial. All participants were men, with a median age of 66 years (range, 47-80). Twelve patients (86%) had received prior chemotherapy. Among the 9 evaluable patients, 1 patient achieved a partial response, 6 had stable disease, and 2 had progression. The median progression-free survival was 4.9 months (95% CI, 1.1-8.2), and the median overall survival was 8.7 months (95% CI, 4.8-17.0). The regimen had an acceptable safety profile. The trial was terminated early due to a change in the standard of care with the introduction of immunotherapy. Conclusions: Despite the trial’s early termination, the combination demonstrated a decent disease stability rate with acceptable toxicity. This regimen can be considered for patients with good functional status.