Phase II study of high-dose mitoxantrone in the treatment of recurrent squamous cell carcinoma of the head and neck.

Sixteen consenting patients with squamous-cell carcinoma of the head and neck recurrent after surgery and irradiation were treated with i.v. mitoxantrone. The mitoxantrone dose given to most patients was 16 mg/m2. Two patients older than 70 years old and one performance status 3 patient received a slightly lower dose (14 mg/m2). Two patients who died less than 3 weeks after treatment were considered unevaluable for response. Of the 14 evaluable patients, eight (57%) were stable (including three with tumor shrinkage less than 50%) and six (43%) failed. There were no major responses. Most treatment courses resulted in granulocytopenia, but this was rapidly reversible and not associated with major infections. Other toxicity was generally mild to moderate. Based on this study, we conclude that mitoxantrone has minimal activity against squamous-cell carcinoma of the head and neck. Studies of the drug in other tumor types at doses of 16 mg/m2 or higher may be warranted.