Abstract
Fifty-two consecutive patients, affected by large T2 (greater than 3 cm), T3, T4, N0, or N1 previously untreated squamous cell carcinoma of the head and neck, entered this phase I-II study. Treatment consisted of a continuous 8-day infusion on the following daily schedule: cisplatin 25 mg and bleomycin 15 mg administered for 4 and 20 hours, respectively. Technical-related toxicities were 1 case each of coagulation and displacement of the catheter and 1 case of reversible monoparesis of the contralateral arm. Drug-related relevant toxicities accounted for 4 cass of grade 3 or 4 leukopenia and 2 cases of peripheral palsy of the 7th and 12th cranial nerve, respectively. Forty-five of 50 evaluable patients obtained an objective response. In particular, 13 patients obtained a complete response, 22 a partial response greater than or equal to 75%, and 10 a partial response greater than or equal to 50%. Furthermore, 5 of 31 patients showed a complete pathologic disappearance of the tumor, whereas in 12 of 31 only a microscopic residue was found.
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