Mitoxantrone and Cytosine Arabinoside as First-Line Therapy in Elderly Patients with Acute Myeloid Leukemia

Abstract

Since May 1986, we have treated 98 patients with acute myeloid leukemia (AML) on a protocol consisting of induction with mitoxantrone (10 mg/m²) for 4 days and cytosine arabinoside (Ara-C) (100 mg/m²bd) for 5 days and consolidation with 1 or 2 courses of mitoxantrone for 2 days and Ara-C for 5 days at the same dosages. Maintenance therapy with cyclophosphamide and 6-thioguanine administered orally was optional. The age range was 60–79 years, with a median of 68 years. There were 54 males and 44 females. Results from tests on 90 patients were evaluated for response; 58 patients (64%) achieved a complete remission (CR) (Fig. 1). Of 72 patients with de novo AML, 52 (72%) achieved CR; also, 15 patients had a documented preexisting myelodysplastic syndrome, of whom 6 (40%) achieved CR. The median time to CR was 29 days (range, 12–88 days). In the CR group, 34 of 58 (59%) patients have relapsed and the median disease-free survival is 14 months, with an overall median survival of 20 months. The median survival in all 98 patients recruited is 12 months, with an actuarial survival of 28% at 3 years. Non-haematological toxicity was mild to moderate in severity and the treatment was generally well tolerated. Responders enjoyed a good quality of life. We conclude that a combination of mitoxantrone and Ara-C is an effective and well-tolerated regimen in elderly patients with AML.