Integration of safe initial combination chemotherapy (without cisplatin) with a high response rate and local therapy for untreated stage III and IV epidermoid cancer of the head and neck: 5-year survival data.

This prospective study has established the effectiveness and safety of two courses of a combination of vincristine, bleomycin, methotrexate, 5-FU, and hydrocortisone with a folinic acid "rescue" given over 24 hours on Days 1 and 14 prior to surgery and/or radiotherapy in 93 patients with advanced (stage III and IV) untreated epidermoid cancer of the head and neck. Of 91 patients evaluated on Day 28 for chemotherapy response, 58 (64%) had a partial remission and 33 (36%) were classified as nonresponders, although 12 had a minimal response of 20%-30%. After completion of local therapy, 73% of the chemotherapy responders achieved complete remission compared with only 48% of the nonresponders (P = 0.005). Forty-seven percent of the patients achieving complete remission were alive at 5 years compared with only 4% of those with residual disease after local therapy. Response to chemotherapy is a good prognostic sign. Side effects were minimal and there was 100% patient compliance.