Phase II study on mitoxantrone in adenoid cystic carcinomas of the head and neck

Background: Based on activity in a case report, mitoxantrone was studied in a phase II study in adenoid cystic carcinoma. Patients and methods: Patients with symptomatic and/or rapidly progressive metastatic or recurrent adenoid cystic carcinoma were eligible for this study. They were treated with mitoxantrone given intravenously by bolus injection at a dose of 14 mg/m², cycles repeated every 3 weeks. Results: Thirty-six chemotherapy-naive patients entered on trial, 4 were ineligible. A median of 6 cycles per patient were given. Leucocytopenia (in 97% of patients) was the most important side effect and tended to be cumulative. Other side effects were mainly mild to moderate and consisted of nausea (62%), vomiting (29%), alopecia (53%) and mucositis (41%). Four of 32 patients had a partial response (12%; 95% CI 4%-29%) lasting 3-13 months, 22 patients (69%) had a stable disease. Conclusion: Mitoxantrone at this dose and schedule has modest activity in adenoid cystic carcinomas.