Phase II study of mitoxantrone in advanced squamous cell carcinoma of the head and neck. A Southeastern Cancer Study Group trial.

A phase II study of mitoxantrone in squamous cell carcinoma of head and neck origin was conducted. Fifty-three evaluable patients were treated with this agent at a dosage of 5 mg/M2/week. The majority of patients were of high performance status. Twenty-seven patients had received previous chemotherapy plus surgery and/or radiotherapy. Twenty-six had not been treated with chemotherapy previously although thirteen of these patients had prior radiotherapy and surgery, eight radiotherapy only, one surgery only, and four no previous treatment. There was only one objective response. Toxicity was relatively mild, although 45% of the patients at some time experienced at least moderate leukopenia. Further studies of this agent in this disease are not warranted.