Ten-year results of randomized trial comparing radiotherapy and concomitant bleomycin to radiotherapy alone in epidermoid carcinomas of the oropharynx: experience of the European Organization for Research and Treatment of Cancer.

This trial of treatment for head and neck carcinoma was initiated in 1973 by the European Organization for Research and Treatment of Cancer. Its purpose was to investigate the value of single-agent chemotherapy with bleomycin (BLM) given during the course of a conventional treatment by external radiotherapy (RT) compared to treatment by external RT alone. In this randomized study, we compared treatment results in 2 groups of patients with squamous cell carcinoma of the oropharynx (T2, T3, and T4; International Union Against Cancer classification). One group of 92 patients was treated by RT at the prescribed dose of 70 Gy. The other group of 107 patients received radiation according to the same protocol and simultaneously received im injection of BLM at a dose of 15 mg twice a week, 2 hours prior to the session of RT, for a total dose of 150 mg in 5 weeks. The occurrence of local toxic effects (i.e., mucositis and epidermatitis) was significantly greater in the RT-BLM group (RT-BLM, 72%, vs. RT, 21%). Primary tumor response 6 weeks after completion of RT was the same in both arms of the study (RT, 68%, vs. RT-BLM, 67%). The 6-year survival rate was 24% (RT-BLM) versus 22% (RT). Long-term analysis (10 yr) is given.