High-dose intra-arterial cisplatin and concurrent hyperfractionated radiation therapy in patients with locally advanced primary squamous cell carcinoma of the head and neck: Report of a phase II study

Background. This phase II study evaluates the tolerability and efficacy of concurrent hyperfractionated radiation therapy (HFX-RT) and high-dose intra -arterial (IA) cisplatin in patients with locally advanced squamous cell ca rcinoma of the head and neck (SCCHN). Methods. Between December 1995 and November 1997, 20 patients with locally advanced T4/T3 SCCHN were treated with HFX-RT (76.8-79.2 Gy at 1.2 Gy bid o ver 6-7 weeks) and high-dose IA cisplatin (150 mg/m(2) given at the start o f RT boost treatment [start of week 6]). Seventeen patients (85%) had T4 di sease, and 14 (70%) had N2/N3 disease. Results. Grade 3-5 acute toxicity was limited to one grade 4 (5%) and 14 gr ade 3 (70%) mucosal events. No grade 3/4 hematologic toxicity was observed. Median weight loss during therapy was 9% (range, 2%-16%). Eighteen patient s had complete response (90%) at the primary site; 14 were confirmed pathol ogically. Among 17 patients with positive neck disease, 16 (94%) achieved c omplete response in the neck, including 12 of 13 patients with N2/N3 diseas e who underwent planned neck dissection. Active follow-up ranges from 12 to 32 months (median, 20 months) with 11 patients alive without disease, 5 de ad of disease, and 4 dead of intercurrent disease. Eighteen patients (90%) remained disease free at the primary site, and the locoregional control rat e is 80%. Conclusions. High-dose IA cisplatin and concurrent HFX-RT as used in this s tudy is feasible and warrants further investigation. The high complete resp onse rate and low grade 4 toxicity in this highly unfavorable subset of pat ients appears better than previously reported chemoradiation regimens for m ore favorable patients. (C) 2000 John Wiley & Sons, Inc.