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 carcinoma 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 over 6–7 weeks) and high‐dose IA cisplatin (150 mg/m2 given at the start of RT boost treatment [start of week 6]). Seventeen patients (85%) had T4 disease, and 14 (70%) had N2/ N3 disease. Results Grade 3‐5 acute toxicity was limited to one grade 4 (5%) and 14 grade 3 (70%) mucosal events. No grade 3/4 hematologic toxicity was observed. Median weight loss during therapy was 9% (range, 2%–16%). Eighteen patients had complete response (90%) at the primary site; 14 were confirmed pathologically. Among 17 patients with positive neck disease, 16 (94%) achieved complete response in the neck, including 12 of 13 patients with N2/N3 disease who underwent planned neck dissection. Active follow‐up ranges from 12 to 32 months (median, 20 months) with 11 patients alive without disease, 5 dead of disease, and 4 dead of intercurrent disease. Eighteen patients (90%) remained disease free at the primary site, and the locoregional control rate is 80%. Conclusions High‐dose IA cisplatin and concurrent HFX‐RT as used in this study is feasible and warrants further investigation. The high complete response rate and low grade 4 toxicity in this highly unfavorable subset of patients appears better than previously reported chemoradiation regimens for more favorable patients. © 2000 John Wiley & Sons, Inc. Head Neck 22: 543–549, 2000.