Intensified induction chemotherapy in adult acute myeloid leukemia followed by high-dose chemotherapy and autologous peripheral blood stem cell transplantation: An eastern cooperative oncology group trial (E4995)

Peter A. Cassileth, Sandra J. Lee, Mark R. Litzow, Kenneth B. Miller, Edward A. Stadtmauer, Martin S. Tallman, Hillard M. Lazarus, John M. Bennett, Elisabeth Paietta, Gordon W. Dewald, Jacob M. Rowe

Research output: Contribution to journalArticle

21 Scopus citations


The feasibility of intensified therapy in adults < 61-years-old with de novo acute myeloid leukemia (AML) was evaluated by adding high-dose cytarabine (HDAC) to conventional induction therapy and in post-remission therapy prior to peripheral blood stem cell transplantation (PBSCT). Patients were treated with conventional induction therapy (daunorubicin days 1 - 3 and cytarabine days 1 - 7), followed by HDAC (2 gm/M2) every 12 h ( × 6) on days 8 - 10. Patients in complete remission (CR) with HLA-matched siblings were assigned to allogeneic PBSCT; the others received two courses of HDAC (3 gm/M2 every 12 h on days 1, 3, and 5) given 1 month apart. Peripheral blood stem cells were then harvested and infused after high-dose chemotherapy. Of 62 eligible, evaluable patients, 47 (76%) achieved CR. The mortality rate was 10% (6 patients); no deaths occurred during the two post-remission courses of HDAC. Fifteen patients were assigned to allogeneic PBSCT and 32 to autologous PBSCT. All surviving patients have been followed for more than 4 years. Including all patients scheduled to receive autoPBSCT in an intent-to-treat analysis, after a median 5-year follow-up the current, non-actuarial, four-year event-free and overall survival was 47% and 47%, respectively. Intensified induction therapy was associated with more toxicity than conventional induction therapy, and the CR rate did not improve. Nevertheless, intensive post-remission therapy was well tolerated, no treatment-related mortality occurred with autologous PBSCT, and disease-free survival and overall survival were lengthy.

Original languageEnglish (US)
Pages (from-to)55-61
Number of pages7
JournalLeukemia and Lymphoma
Issue number1
StatePublished - Jan 1 2005
Externally publishedYes



  • AML
  • Autologous stem cell transplantation
  • High-dose cytarabine
  • Intensive therapy

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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