Cisplatinum and Bleomycin for advanced or recurrent squamous cell carcinoma of the head and neck: a randomised factorial phase III controlled trial

Abstract

Summary A phase III 2x2 factorial trial of cisplatinum and bleomycin in 116 patients with recurrent or advanced squamous cell carcinoma of the head and neck is reported. Thirty percent of patients proved to be unfit for chemotherapy, and of those treated progression of tumour was the commonest “response”. However, 25% of patients achieved a partial or complete response, with no significant difference in response rates between the treated arms. The median number of courses received was 1 (range 0–6) and the commonest causes for discontinuation of treatment were renal toxicity and death. Bleomycin reduced survival, but not significantly so, whereas cisplatinum prolonged median survival significantly by 10 weeks. Significant predictors of survival, in addition to treatment by cisplatinum, were age, performance status, N status, number of courses and response of the tumor.