PHASE-II STUDY ON MITOXANTRONE IN ADENOID CYSTIC CARCINOMAS OF THE HEAD AND NECK

Background: Based on activity in a case report, mitoxantrone was studi ed in a phase II study in adenoid cystic carcinoma. Patients and metho ds: 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/m(2), cycles repeated every 3 weeks. Results: Thir ty-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 cumul ative. Other side effects were mainly mild to moderate and consisted o f nausea (62%), vomiting (29%), alopecia (53%) and mucositis (41%). Fo ur of 32 patients had a partial response (12%; 95% CI 4%-29%) lasting 3-13 months, 22 patients (69%) had a stable disease. Conclusion: Mitox antrone at this dose and schedule has modest activity in adenoid cysti c carcinomas.