title: Treatment of patients with recurrent and primary refractory acute myelogenous leukemia using mitoxantrone and intermediate-dose cytarabine: a pharmacologically based regimen.
abstract: BACKGROUND
  Although chemotherapy can achieve a high rate of disease remission induction in patients with newly diagnosed acute myelogenous leukemia (AML), patients with recurrent or refractory AML generally have a poorer rate of response. This study assessed the utility of mitoxantrone and intermediate-dose cytarabine (Ara-C) in the treatment of patients with recurrent or refractory AML.
  
  
  METHODS
  Forty-seven patients with recurrent or refractory AML were treated with Ara-C, 0.5 gm/m2, intravenously (i.v.) every 12 hours x 12 doses on Days 1-6 and mitoxantrone, 5 mg/m2, i.v. on Days 1-5.
  
  
  RESULTS
  Twenty-nine of the 47 patients (62%) achieved a complete response. The median duration of disease remission was 112 days (range, 29 days- 8 years). Of the 25 patients age > or = 60 years, 19 (76%) had a complete disease remission and the median duration of disease remission in this group was 114 days (range, 33-370 days), although all patients subsequently developed a disease recurrence. The chemotherapy generally was well tolerated, with a mean duration of neutropenia of 31 days and a mean duration of thrombocytopenia of 33 days. Three patients died of infectious complications between 23-26 days after the initiation of chemotherapy, 1 patient died of sudden cardiac arrest 13 days after the initiation of chemotherapy, and 1 patient developed cutaneous desquamation. Three patients developed acute cerebellar dysfunction.
  
  
  CONCLUSIONS
  The use of mitoxantrone and Ara-C is effective in the treatment of patients with recurrent and refractory AML. The subgroup of patients age > or = 60 years also had a high rate of disease remission induction with this regimen, and the regimen generally was well tolerated.
authors.affiliation: Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: D W
authors.initials: DW
authors.lastname: Sternberg
authors.forename: W
authors.initials: W
authors.lastname: Aird
authors.forename: D
authors.initials: D
authors.lastname: Neuberg
authors.forename: L
authors.initials: L
authors.lastname: Thompson
authors.forename: K
authors.initials: K
authors.lastname: MacNeill
authors.forename: P
authors.initials: P
authors.lastname: Amrein
authors.forename: L N
authors.initials: LN
authors.lastname: Shulman
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002423:Cause of Death; D002526:Cerebellar Diseases / Q000139:chemically induced; D003561:Cytarabine / Q000008:administration & dosage* / Q000009:adverse effects; D016757:Death, Sudden, Cardiac / Q000209:etiology; D018572:Disease-Free Survival; D003875:Drug Eruptions / Q000209:etiology; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage* / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D003561:Cytarabine; D008942:Mitoxantrone