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).
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