Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin

Hugo F. Fernandez, Zhuoxin Sun, Mark R. Litzow, Selina M. Luger, Elisabeth M. Paietta, Janis Racevskis, Gordon Dewald, Rhett P. Ketterling, Jacob M. Rowe, Hillard M. Lazarus, Martin S. Tallman

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50 Scopus citations

Abstract

We report the results of a prospective, randomized phase 3 trial evaluating the use of gemtuzumab ozogamicin (GO) in an intensive consolidation approach in 657 patients 17-60 years of age. Patients in first complete remission (CR1) after cytarabine and standard-or high-dose daunorubicin induction received 2 cycles of consolidation with high-dose cytarabine followed by peripheral blood progenitor cell collection. The 352 patients who entered consolidation were randomized to receive GO (n = 132) or not (n = 138) and then proceeded to autologous hematopoietic cell transplantation (HCT). GO was given to 67 patients. Median follow-up was 50.9 months. Results of the intention-to-treat analysis demonstrated a 4-year disease-free survival (DFS) of 33.6% versus 35.9% (P =.54) and an overall survival (OS) of 41.3% versus 41.9% (P =.52) for those randomized to receive GO versus no GO, respectively. Patients with favorable-and intermediate-risk acute myeloid leukemia (AML) treated with high-dose daunorubicin and autologous HCT had 4-year DFS ratesof 60% and 40% and OS rates of 80% and 49.3%, respectively. For younger AML patients in CR1, autologous HCT should be considered in favorable-and intermediate-cytogenetic risk patients who do not have an allogeneic donor. The addition of a single dose of GO in this setting did not improve outcomes.

Original languageEnglish (US)
Pages (from-to)5306-5313
Number of pages8
JournalBlood
Volume117
Issue number20
DOIs
StatePublished - May 19 2011

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ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Fernandez, H. F., Sun, Z., Litzow, M. R., Luger, S. M., Paietta, E. M., Racevskis, J., Dewald, G., Ketterling, R. P., Rowe, J. M., Lazarus, H. M., & Tallman, M. S. (2011). Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin. Blood, 117(20), 5306-5313. https://doi.org/10.1182/blood-2010-09-309229