Results of phase I-II trial of concomitant hyperfractionated radiation and oral etoposide (VP-16) in patients with unresectable squamous cell carcinoma of the head and neck

Purpose: The purpose of the current study was to investigate the efficacy of concomitant oral etoposide and hyperfractionated radiation for patients with unresectable head and neck squamous cell carcinoma. Methods: A prospective nonrandomized phase I-II study was conducted using concomitant oral etoposide (50 mg/d for 13-27 days) and hyperfractionated radiotherapy (1.2 Gy twice daily to a total of 7,440 rads) for patients with unresectable squamous cell carcinoma of the head and neck. Toxicity was graded according to the NCI common toxicity criteria. Patients were followed for a minimal period of 2 years. Endpoints for follow-up were recurrence or death. Results: Seventeen patients were enrolled in the study. Grade III hematological toxicity occurred in 1 patient and moderate to severe mucositis occurred in all but 2 patients requiring a gastrostomy tube (n = 13) or intravenous fluids hydration (n = 2). One patient died of cardiac arrest unrelated to the treatment regimen. The overall response rates in patients that finished the protocol were 80% for the primary site and 100% for the neck. A complete response was observed in 47% at the primary site and 33% in the neck. Local control and disease-free survival (DFS) at an average follow-up of 3.7 years were 47% and 29%, respectively. Conclusions: Concomitant etoposide and hyperfractionated radiation is well tolerated and seems to be effective in the treatment of unresectable HNSCC with acceptable mucosal toxicity. (Am J Otolaryngol 2003;24:1-5. Copyright 2003, Elsevier Science (USA). All rights reserved.)