A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome

N. Daver, H. Kantarjian, F. Ravandi, E. Estey, X. Wang, G. Garcia-Manero, E. Jabbour, M. Konopleva, S. O'Brien, S. Verstovsek, T. Kadia, C. Dinardo, S. Pierce, X. Huang, N. Pemmaraju, M. Diaz-Pines-Mateo, J. Cortes, G. Borthakur

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43 Scopus citations

Abstract

Decitabine may open the chromatin structure of leukemia cells making them accessible to the calicheamicin epitope of gemtuzumab ozogamicin (GO). A total of 110 patients (median age 70 years; range 27-89 years) were treated with decitabine and GO in a trial designed on model-based futility to accommodate subject heterogeneity: group 1: relapsed/refractory acute myeloid leukemia (AML) with complete remission duration (CRD) <1 year (N=28, 25%); group 2: relapsed/refractory AML with CRD ≥1 year (N=5, 5%); group 3: untreated AML unfit for intensive chemotherapy or untreated myelodysplastic syndrome (MDS) or untreated myelofibrosis (MF; N=57, 52%); and group 4: AML evolving from MDS or relapsed/refractory MDS or MF (N=20, 18%). Treatment consisted of decitabine 20 mg/m 2 daily for 5 days and GO 3 mg/m 2 on day 5. Post-induction therapy included five cycles of decitabine+GO followed by decitabine alone. Complete remission (CR)/CR with incomplete count recovery was achieved in 39 (35%) patients; group 1= 5/28 (17%), group 2=3/5 (60%), group 3=24/57 (42%) and group 4=7/20 (35%). The 8-week mortality in groups 3 and 4 was 16% and 10%, respectively. Common drug-related adverse events included nausea, mucositis and hemorrhage. Decitabine and GO improved the response rate but not overall survival compared with historical outcomes in untreated AML ≥60 years.

Original languageEnglish (US)
Pages (from-to)268-273
Number of pages6
JournalLeukemia
Volume30
Issue number2
DOIs
StatePublished - Feb 1 2016

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Daver, N., Kantarjian, H., Ravandi, F., Estey, E., Wang, X., Garcia-Manero, G., Jabbour, E., Konopleva, M., O'Brien, S., Verstovsek, S., Kadia, T., Dinardo, C., Pierce, S., Huang, X., Pemmaraju, N., Diaz-Pines-Mateo, M., Cortes, J., & Borthakur, G. (2016). A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome. Leukemia, 30(2), 268-273. https://doi.org/10.1038/leu.2015.244