Phase II trial of hyperfractionated accelerated split-course radiochemotherapy with 5-FU and Cis-DDP in advanced head and neck cancer: results and toxicity.

BACKGROUND: . Simultaneous radiochemotherapy resulted in a significant benefit improving both local control and overall survival in advanced head and neck cancer. In this phase II study the efficacy and toxicity of a hyperfractionated accelerated split course radiotherapy with simultaneous application of 5-FU and cisplatin were evaluated in patients with locally advanced tumors of the oral cavity, oro- and hypopharynx. PATIENTS AND METHODS: . Between 1991 and 2002 the study recruited 45 patients. 41 (92%) presented with stage IV, 2 (4%) with stage II and III tumors, respectively. Radiation was delivered twice daily by a single dose of 1.5 Gy to a median total dose of 72 Gy with a 1 week break scheduled at 30 Gy. Chemotherapy consisting of 5-FU (800 mg/m(2)/d i.v.) and cisplatin (20 mg/m(2)/d i.v. bolus) was administered during the 1st and 5th treatment week.
RESULTS: . Overall survival, cause-specific survival, locoregional tumor-free survival and distant metastasis-free survival were 53%, 65%, 77% and 73%, respectively, at 3 years. Mean follow-up was 21 months. Neutropenia was the only grade-4 toxicity that occurred in 2 patients.
CONCLUSION: . This regimen is effective and safe, however, distant relapses clearly exceed local failure rates. Future studies have to contemplate the implementation of new chemotherapeutic agents and the feasibility and efficacy of maintenance chemotherapy.