A phase III of cisplatinum versus cisplatinum-etoposide for previously untreated squamous cell carcinoma of the head and neck.

136 patients with previously untreated stage III or IV squamous cell carcinoma of the head and neck entered a prospective randomized trial to compare the efficacy and toxicity of DDP vs DDP-VP 16 213 (Etoposide). 69 patients (group A) were given three courses of DDP 100 mg/m2 administered on day 1, while 67 patients (group B) were given three courses of a combination of Etoposide 100 mg/m2 per os administered on days 1 to 5 and DDP 100 mg/m2 on day 4. Objective response rate appeared to be low in both groups: in group A (60 evaluated patients) CR = 1, PR = 9; CR + PR = 14.5%, and in group B (57 evaluated patients) CR = 3, PR = 8; CR + PR = 16.4% (p greater than 0.4). One drug-related death occurred in each group. There was no difference in toxicity between the two treatments with regard to leukopenia, thrombopenia, vomiting and nephrotoxicity. Thus this schedule of oral Etoposide does not seem to increase either the efficacy or the toxicity of DDP.