title: Low-dose cytarabine plus aclarubicin for patients with previously untreated acute myeloid leukemia or high-risk myelodysplastic syndrome ineligible for standard-dose cytarabine plus anthracycline.
abstract: BACKGROUND
  In order to assess the role of the combination of low-dose cytarabine (Ara-C) plus aclarubicin (CA) in remission induction for patients with untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), we retrospectively analyzed the efficacy and safety of CA.
  
  
  METHODS
  Data of twenty patients with untreated AML or high-risk MDS who were ineligible for standard-dose Ara-C plus anthracycline and received CA as remission-induction therapy were analyzed. CA consisted of low-dose Ara-C (10 mg/m(2), subcutaneous injection every 12 hours, for 14 days) and aclarubicin (14 mg/m(2) for patients <70 years old and 10 mg/m(2) for patients ≥70 years old in a one-hour infusion for 4 days). Granulocyte colony-stimulating factor (G-CSF) was used from day 1 of CA to white blood cell count (WBC) recovery, except for patients with initial WBC of more than 20.0×10(3)/mm(3).
  
  
  RESULTS
  Eleven patients (55%) achieved complete remission. All four patients whose WBC were ≥20.0×10(3)/mm(3) and did not receive G-CSF were refractory to CA. The predicted 2-year overall survival rate and median survival duration of all 20 patients were 37.9% and 363 days, respectively. The predicted 1-year relapse-free survival (RFS) rate and median duration of RFS of 11 patients who achieved complete remission were 30.3% and 332 days, respectively. Only one patient died due to transfusion-related acute lung injury. No patients died due to severe infections.
  
  
  CONCLUSIONS
  CA combination with G-CSF as remission-induction therapy is promising and well-tolerated in patients with previously untreated AML or high-risk MDS who are ineligible for standard-dose Ara-C plus anthracycline without leukocytosis. In order to improve RFS, intensive postremission chemotherapy or allogeneic hematopoietic stem cell transplantation should be introduced.
authors.affiliation: Department of Hematology and Immunology, Kanazawa Medical University, Ishikawa, Japan. tfukus@kanazawa-med.ac.jp
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Fukushima
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kawabata
authors.forename: Toshioki
authors.initials: T
authors.lastname: Sawaki
authors.forename: Tomomi
authors.initials: T
authors.lastname: Satoh
authors.forename: Takuji
authors.initials: T
authors.lastname: Nakamura
authors.forename: Haruka
authors.initials: H
authors.lastname: Iwao
authors.forename: Akio
authors.initials: A
authors.lastname: Nakajima
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Sakai
authors.forename: Miyuki
authors.initials: M
authors.lastname: Miki
authors.forename: Yoshimasa
authors.initials: Y
authors.lastname: Fujita
authors.forename: Masao
authors.initials: M
authors.lastname: Tanaka
authors.forename: Takafumi
authors.initials: T
authors.lastname: Kawanami
authors.forename: Yasufumi
authors.initials: Y
authors.lastname: Masaki
authors.forename: Toshiro
authors.initials: T
authors.lastname: Okazaki
authors.forename: Hisanori
authors.initials: H
authors.lastname: Umehara
mesh_terms: D015250:Aclarubicin / Q000008:administration & dosage; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*
chemical_list: D018943:Anthracyclines; D003561:Cytarabine; D015250:Aclarubicin