Prospective Pilot Study of Second Primary Tumor Prevention With Erlotinib and Celecoxib in Early‐Stage Squamous Cell Carcinoma of the Head and Neck: Long‐Term Follow‐Up

ABSTRACT Background Patients with early‐stage head and neck squamous cell carcinoma (HNSCC) have an increased risk for secondary primary tumors (SPT) after definitive treatment. The aim of this pilot trial was to investigate the safety and efficacy of erlotinib and celecoxib in preventing SPTs. Methods Ten patients with stage I/II HNSCC who completed definitive treatment received erlotinib with celecoxib for 6 months. Primary objectives were safety assessment and SPT‐free survival after completion of erlotinib and celecoxib. Secondary objectives included assessing overall survival (OS) and progression‐free survival (PFS). Results With a median follow‐up of 9 (1.7–15.3) years, the median time to SPT‐free survival was not reached. The estimated SPT‐free survival was 78.8% at 15 years. Two patients had local recurrence, but none of our subjects developed mucosal squamous cell carcinoma at any site. Conclusion All three doses of erlotinib and the fixed dose of celecoxib were well tolerated with excellent SPT‐free survival with long‐term follow‐up. Trial Registration Clinicaltrials.gov identifier: NCT00400374