Thirty-nine patients (28 men and 11 women, ages 43 to 83 years) with advanced head and neck epidermoid carcinoma (33 had relapsed from previous radiotherapy) were treated with a three-day bleomycin administration (30 by continuous intravenous infusion and nine by subcutaneous route) followed on the fifth day by intravenous administration of cyclophosphamide + methotrexate + 5-fluorouracil (Bleo-CMF). This drug schedule was based on the cell cycle synchrony principle. Twenty-one of 39 patients (54%) responded (seven complete, 14 partial remission) lasting from 4 to 20 months. The median duration of survival for complete remission, partial remission, and disease progression was 15, ten, and four months, respectively. The Bleo-CMF was well tolerated with minimal toxicity. The effectiveness of this regimen in previously irradiated patients compels us to pursue its application in a randomized study as an adjuvant for Stages III and IV head and neck cancer following maximum eradication of the local disease by surgery and/or radiotherapy.

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