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Fludarabine, arabinosyl cytosine and idarubicin (FLAI) for remission induction in poor-risk acute myeloid leukemia.

Abstract
Progress in treatment of acute myeloid leukemia (AML) is slow and treatment intensification alone has limited effects, particularly in poor-risk cases. Poor-risk cases, that are identified mainly by prior history, leukemic cell mass and cytogenetic abnormalities, share multiple mechanisms of drug resistance that are responsible for treatment failure. Since Pgp-mediated resistance to anthracycline can be reduced with Idarubicin (IDA) and resistance to arabinosyl cytosine (AC) can be reduced with Fludarabine (FLUDA), we tested a combination of high dose AC (2000 mg/sqm, 5 doses), FLUDA (30 mg/sqm, 5 doses) and IDA (12 mg/sqm, 3 doses) for remission induction and consolidation in 45 consecutive cases of poor-risk AML. The complete remission (CR) rate was 71% after the first course and 82% overall, with a projected 2-year survival and relapse-free survival of 44% and 50% respectively. Non-hematologic toxicity was very mild, that is very important in elderly patients, but hemopoietic toxicity was substantial, with a time to hematologic recovery of 3 to 4 weeks and two cases of death in CR. Peripheral blood stem cells (PBSC) could be mobilized and collected successfully only in 11 cases. This three-drug combination is effective and has a limited non-hematologic toxicity, but FLUDA may increase the difficulty of obtaining PBSC early after remission induction.
AuthorsD Russo, G Pricolo, M Michieli, A Michelutti, D Raspadori, A Bertone, L Marin, I Pierri, A Bucalossi, E Zuffa, A De Vivo, P Mazza, M Gobbi, F Lauria, A Zaccaria, M Baccarani
JournalLeukemia & lymphoma (Leuk Lymphoma) Vol. 40 Issue 3-4 Pg. 335-43 (Jan 2001) ISSN: 1042-8194 [Print] United States
PMID11426555 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Cytarabine
  • Vidarabine
  • fludarabine
  • Idarubicin
Topics
  • Acute Disease
  • Adolescent
  • Adult
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, toxicity)
  • Cohort Studies
  • Cytarabine (administration & dosage, toxicity)
  • Disease-Free Survival
  • Female
  • Humans
  • Idarubicin (administration & dosage, toxicity)
  • Leukemia, Myeloid (complications, drug therapy, mortality)
  • Male
  • Middle Aged
  • Pancytopenia (chemically induced)
  • Pilot Projects
  • Remission Induction
  • Salvage Therapy
  • Survival Analysis
  • Survival Rate
  • Vidarabine (administration & dosage, analogs & derivatives, toxicity)

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