High-dose intra-arterial cisplatin boost with hyperfractionated radiation therapy for advanced squamous cell carcinoma of the head and neck

Purpose: To evaluate the tolerance and efficacy of intra-arterial (IA) cisp latin boost with hyperfractionated radiation therapy (HFX-RT) in patients w ith advanced squamous cell carcinoma of the head and neck (SCCHN), patients and Methods: Forty-two patients with locally advanced primary SCCH N were treated on consecutive phase I/II studies of HFX-RT (receiving a tot al of 76.8 to 81.6 Gy, given at 1.2 Gy bid) and IA cisplatin (150 mg/m(2) r eceived at the start of and during RT boost treatment). Results: Acute grade 3 to 4 toxicities were as follows: grade 4 and grade 3 mucosal toxicity occurred in three (7%) and 31 patients (69%), respectivel y, and grade 3 hematologic, infectious, and skin events occurred in one pat ient each. Eight of 24 patients (33%) were unable to receive a second plann ed dose of IA cisplatin because of general anxiety (n = 5), nausea and/or e mesis (n = 2), or asymptomatic occlusion of an external carotid artery (n = 1). Thirty-seven patients (88%) experienced complete response (CR) at prim ary site. Twenty-nine (85%) of 34 patients presenting with nodal disease ex perienced CR. The actuarial 2-year rates of locoregional control and diseas e-specific and overall survival are 73%, 63%, and 57%, respectively, with a median active follow-vp of 30 months, Conclusion: In this highly unfavorable subset of patients, these results se em superior to previously reported chemoradiation regimens in more favorabl e patients. Use of a second dose of IA cisplatin boost was associated with increased toxicity without obvious therapeutic gain. This novel strategy al lows for an incremental increase in the treatment intensity of the HFX-RT r egimen recently established as superior to once a-day RT, (C) 2001 by Ameri can Society of Clinical Oncology.