title: A randomized trial of high- vs standard-dose mitoxantrone with cytarabine in elderly patients with acute myeloid leukemia.
abstract: To evaluate the efficacy and tolerability of a high-dose mitoxantrone-based induction regimen without consolidation therapy in patients over age 60 with newly diagnosed acute myeloid leukemia (AML), 54 patients aged 60-83 were randomized to receive mitoxantrone, either 80 mg/m2 on day 2, or 12 mg/m2 on days 1-3 in addition to cytarabine, 3 g/m2 on days 1-5. Significant toxicity included mucositis, diarrhea, transient hyperbilirubinemia and cardiac events. No difference in toxicity was observed between the two dosage regimens. Overall, 27 patients achieved a complete remission (CR), 16/28 CR in the high-dose and 11/25 in the lower-dose group. Induction death occurred in 11 patients, three in the high-dose and eight in the low-dose arm. Actuarial median survival was 6 months for the low-dose and 9 months for the high-dose group, and the respective relapse-free survival is 3 and 5 months. The observed differences in outcome were not statistically significant. patients in both arms of this trial, who received no consolidation, appear to have response and survival rates equivalent to those of standard-dose induction with repetitive consolidation. This approach might offer elderly patients equivalent outcome with fewer days of treatment, presumably enhancing quality of life.
authors.affiliation: Division of Oncology/Hematology, New York Medical College, Valhalla, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Feldman
authors.forename: K
authors.initials: K
authors.lastname: Seiter
authors.forename: L
authors.initials: L
authors.lastname: Damon
authors.forename: C
authors.initials: C
authors.lastname: Linker
authors.forename: H
authors.initials: H
authors.lastname: Rugo
authors.forename: C
authors.initials: C
authors.lastname: Ries
authors.forename: D C
authors.initials: DC
authors.lastname: Case
authors.forename: M
authors.initials: M
authors.lastname: Beer
authors.forename: T
authors.initials: T
authors.lastname: Ahmed
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007951:Leukemia, Myeloid / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D012074:Remission Induction; D016019:Survival Analysis
chemical_list: D003561:Cytarabine; D008942:Mitoxantrone