P016 Oxaliplatin, Folinic Acid, and 5-Fluorouracil (OFF) in Recurrent Advanced Head and Neck Cancer: A Phase 2 Trial

Abstract

Objectives: Cyclooxygenase-2 (COX-2) overexpression in locally advanced head and neck cancer and preclinical benefit for COX-2 inhibitors with radiotherapy (RT) led us to study weekly doublet chemotherapy, daily radiotherapy, and celecoxib. Follow-up data on response and tolerability at a median of 20.5 months are presented. Methods: Eligibility: stage III or IV squamous cell cancer of oral cavity, oropharynx, hypopharynx, larynx; performance status 0, 1, 2; adequate hepatic, hematologic, renal function; and no prior radiotherapy/chemotherapy for this site. Treatment: weekly docetaxel (T), 12.5 mg/m, and cisplatin (P), 20 mg/m intravenously, on day 1 for 6 weeks; and RT, single fraction, on days 1-5 for 7 weeks or to total standard dose (70 Gy); and celecoxib (C), 400 twice daily by mouth. Feeding tubes were placed prophylactically. Results: Median age (7 patients), 52 years (36-69 years), 3 women. Sites: 4 tonsil, 2 base of tongue, and 1 supraglottic larynx. The study ended at cohort 1 as maximum tolerated dose had been achieved. Median time to completion of radiation therapy was 52 days (49-67 days). The response rate of the 6 evaluable patients was 100%. G-tube independence was achieved in 3 of 4 patients evaluable at 6 months (plus 1 death and 1 salvage surgery); the fourth was independent at 7 months. At the median follow-up of 20.5 months, 3 patients are alive in complete remission, 1 patient had surgical salvage at 6 months, 1 relapsed at 13 months, and 1 had response but noncancer death at 4.5 months. No patient developed metastatic disease. Conclusion: Combination of the COX-2 inhibitor C with concurrent RT and weekly T and P was feasible with toxic effects and response comparable to other concomitant therapies for locally advanced head and neck cancer.