24-hour combination chemotherapy without cisplatin in patients with recurrent or metastatic head and neck cancer.

Sixty-three patients with advanced histologically proven squamous cell carcinomas of the head and neck, considered untreatable other than by chemotherapy, received a combination of vincristine, bleomycin, methotrexate, 5-fluorouracil, and hydrocortisone administered over 24 hours, followed by a folinic acid rescue, every 3 weeks. Fifty-seven patients had received prior radiotherapy and 78% of recurrences were within the radiation field. Sixty-one patients were assessable for response to chemotherapy and 25 (41%) achieved objective responses. Side effects from 167 courses of chemotherapy were minimal and were present only in 38% of patients. There were no cases of bone marrow depression and no drug-induced deaths. Patient compliance was 98%. Chemotherapy responders had a longer median duration of survival of 11.9 months (with four patients still alive at 10, 22, 30, and 90 months) compared with 4.96 months for nonresponders (with two patients alive at 7 and 15 months), p less than 0.001. Ten of 24 chemotherapy responders went on to surgery and eight achieved a complete remission (CR), while only 6/36 nonresponders underwent salvage surgery and all became disease-free. Patients achieving a complete remission had improved survival (median 24.5 months). The presence of metastatic disease was a poor prognostic sign; only 8/30 (27%) responded to chemotherapy and none subsequently achieved complete remission. This safe drug protocol appears to benefit only a small subset of patients, namely those who respond to chemotherapy rendering their tumors operable, but is of no general value in this group of previously irradiated patients since 92% of all patients treated were dead at 2 years.