Accelerated fractionation radiotherapy and late intensification with 2 intra-arterial cisplatin infusions for locally advanced head and neck squamous cell carcinoma.

BACKGROUND This study was established to determine the maximum tolerated dose of intra-arterial cisplatin (IAC) concurrent with accelerated fractionation radiotherapy for locally advanced head and neck squamous cell carcinoma (HNSCC). METHODS We conducted a phase I study. Treatment consisted of 70 Gy/35 fractions/5.8 weeks and 2 weekly IAC infusions during the last 2 weeks. RESULTS Ten patients were recruited. Two patients had stage III, 1 had stage IVa, and 7 had stage IVb disease. Three patients received IAC at 100 mg/m(2), 3 at 125 mg/m(2), and 4 at 150 mg/m(2). Nine patients received both planned infusions. Dose-limiting toxicity occurred at 150 mg/m(2) as transient grade 4 leukopenia and prolonged grade 3 acute skin reactions. The maximum tolerated dose was 125 mg/m(2). Six patients survived disease-free at 39 to 67 months. CONCLUSIONS It was feasible to give IAC concurrent with accelerated fractionation radiotherapy for locally advanced HNSCC. The maximum tolerated dose of cisplatin was 125 mg/m(2).