A phase II study examining the feasibility of long-term and low-dose oral capecitabine in newly diagnosed head and neck squamous cell carcinoma after surgery, radiation, and/or chemotherapy

Abstract

6053 Background: In advanced head and neck squamous cell carcinoma (HNSCC), the five-year survival rate is less than 40%. Although the efficacy and tolerability of continuous IV 5-Fluorouracil (5FU) therapy has been established in HNSCC, the feasibility and tolerability of long-term therapy of oral capecitabine has not been established in HNSCC. Our primary objective is to assess the feasibility of treating patients with squamous cell carcinoma of the head and neck (HNSCC) with adjuvant Capecitabine after undergone definitive treatment. The secondary objectives are to estimate time to recurrence, local-regional control and survival rates along with incidence of second primary tumors. Methods: Eligible patients with newly diagnosed locally advanced HNSCC received capecitabine 1,000 mg orally once daily for one year, after undergone definitive treatment. Patients’ compliance with oral capecitabine as will as the side effects profile was evaluated on monthly basis over the first 12 months. Feasibility, survival, progression and progression free survival were measured over 36 months. Results: Thirty five patients were enrolled in the study. 17 patients had stage IV b, 7 had stage III, and 5 had unknown primary HNSCC. All but one took at least 60% of dispensed tablets. Twenty six patients completed at least 7 months of capecitabine. Sixteen patients completed at least 10 month of capecitabine. Two years overall survival rate was 97%. Three years progression free survival was 86%. Conclusions: Adjuvant capecitabine in locally advanced HNSCC is a feasible approach with minimum side effects. A favorable 3-year progression-free survival was found as compare to historical results. We recommend a randomized phase III trail to examine the effect of one year of adjuvant capecitabine versus placebo in locally advanced HNSCC after definitive treatment. No significant financial relationships to disclose.