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

Research output: Contribution to journalArticle

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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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Autologous Transplantation
Acute Myeloid Leukemia
Young Adult
Cell Transplantation
Consolidation
Daunorubicin
Cytarabine
Disease-Free Survival
Intention to Treat Analysis
gemtuzumab
Cytogenetics
Blood
Blood Cells
Stem Cells
Survival Rate
Tissue Donors
Survival

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

Cite this

Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin. / Fernandez, Hugo F.; Sun, Zhuoxin; Litzow, Mark R; Luger, Selina M.; Paietta, Elisabeth M.; Racevskis, Janis; Dewald, Gordon; Ketterling, Rhett P.; Rowe, Jacob M.; Lazarus, Hillard M.; Tallman, Martin S.

In: Blood, Vol. 117, No. 20, 19.05.2011, p. 5306-5313.

Research output: Contribution to journalArticle

Fernandez, HF, Sun, Z, Litzow, MR, Luger, SM, Paietta, EM, Racevskis, J, Dewald, G, Ketterling, RP, Rowe, JM, Lazarus, HM & Tallman, MS 2011, 'Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin', Blood, vol. 117, no. 20, pp. 5306-5313. https://doi.org/10.1182/blood-2010-09-309229
Fernandez, Hugo F. ; Sun, Zhuoxin ; Litzow, Mark R ; Luger, Selina M. ; Paietta, Elisabeth M. ; Racevskis, Janis ; Dewald, Gordon ; Ketterling, Rhett P. ; Rowe, Jacob M. ; Lazarus, Hillard M. ; Tallman, Martin S. / Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin. In: Blood. 2011 ; Vol. 117, No. 20. pp. 5306-5313.
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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.",
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AU - Luger, Selina M.

AU - Paietta, Elisabeth M.

AU - Racevskis, Janis

AU - Dewald, Gordon

AU - Ketterling, Rhett P.

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