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A randomized comparison of radiotherapy with a radiotherapy–chemotherapy combination in stage IV carcinoma of the head and neck

Between 1975 and 1978, 23 patients with Stage IV, unresectable, squamous cell carcinoma of the head and neck were randomized to receive radiotherapy (RT, 11 patients), or radiotherapy‐chemotherapy (RT & CT, 12 patients). The response rate for the 12 RT & CT patients was four complete remissions (CR) and four partial remissions (PR); the 11 RT patients had one CR and three PR. The presence of a responses (CR or PR) significantly enhanced the median survival (14 vs. 5 months; P = 0.005). The duration of objectives remission was longer among the RT & CT patients when compared with RT patients (6 vs. 2.3 months, P = 0.18). The median survival of the RT & CT group was 12 months compared with 5.6 months for the RT group (P = 0.13). One RT & CT patient remains alive with disease at 44 months, one RT patient remains alive without disease at 30 months. The present chemotherapy regimen did not modify the pattern of failure and only marginally increased patient survival. It did, however, increase the response rate. The authors plan to reactivate the trial with modification in the induction chemotherapy and the addition of postradiation maintenance CT consisting of sequential bleomycin and cis‐platinum.