INTENSIFIED REGIMEN FOR ADVANCED HEAD AND NECK SQUAMOUS-CELL CARCINOMAS

Objective: To devise an intensified treatment regimen for patients wit h advanced, resectable head and neck squamous cell carcinomas. Design: Phase I/II clinical trial consisting of perioperative cisplatin chemo radiotherapy, surgical resection, intraoperative radiotherapy, and pos toperative cisplatin chemoradiotherapy. Setting: The Ohio State Univer sity Comprehensive Cancer Center, Columbus. Patients: Thirty-seven pat ients (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 patien ts were analyzable; 11 have died (5 with distant metastases; 1 of lung carcinoma; and 5 were cancer-free); 2 experienced second primary tumo rs 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 in itial results are encouraging; the future strategy will intensify the systemic component of therapy based on results from concurrent laborat ory studies.