Objective: To devise an intensified treatment regimen for patients with advanced, resectable head and neck squamous cell carcinomas.
Design: Phase I/II clinical trial consisting of perioperative cisplatin chemoradiotherapy, surgical resection, intraoperative radiotherapy, and postoperative cisplatin chemoradiotherapy.
Setting: The Ohio State University Comprehensive Cancer Center, Columbus.
Patients: Thirty-seven patients (median age, 63 years) with advanced oral cavity, oropharyngeal, or hypopharyngeal carcinomas.
Results: The range of time at risk was 1 to 30 months (median, 21 months). Thirty of the 37 registered patients were analyzable; 11 have died (5 with distant metastases; 1 of lung carcinoma; and 5 were cancer-free); 2 experienced second primary tumors in the oral cavity (out of or adjacent to the previous radiotherapy portals). Treatment compliance was excellent (92%), morbidity was low, and excellent locoregional control was achieved.
Conclusions: The initial results are encouraging; the future strategy will intensify the systemic component of therapy based on results from concurrent laboratory studies.