[Chemotherapy or chemotherapy and radiotherapy in advanced head and neck tumors. A prospective, randomized study...

Initial combination drug regimens containing Cisplatin in patients with stage III and IV head and neck cancer produce a high percentage of clinical response. We initiated the current trial to assess the role of multimodality treatment (CT plus RT) versus CT alone in eliciting tumour response rates, and the duration of tumour free survival. Patients were randomised to CT followed by RT (arm A: 36 patients) or CT alone (arm B: 44 patients). Of 96 patients entered into this study 80 are evaluable at the time of analysis. There were 13 women and 67 men with a median age of 52 years and a median performance status of 90%. All of them presented measurable stage T4N0-3M0-1 or T3N2-3M0-1 carcinomas. The chemotherapy consisted of Cisplatinum, Bleomycin and Methotrexate and was given in 2 cycles over 35 days. Local radiotherapy with 6,000 rad followed. In arm B, 3 cycles of chemotherapy were given without radiotherapy. The overall tumour responses after CT were 75% in arm B, and 70% in arm A. After RT the tumour response fell to 59%. Median tumour remission was 4 months and median survival 11 months. Toxic effects were mild mainly consisting of alopecia, nausea and vomiting. Myelotoxicity was moderate, but significant renal or ototoxic side effects did not occur. 10 cases of Bleomycin related pulmonary fibrosis were found. Our main findings show that patients receiving 2 cycles of CT do not have a statistically shorter survival compared to those who were treated by CT plus RT.