Table 1.

Patient demographics and baseline characteristics

CharacteristicNumber of patients (%)
Age, y
 Median (range)69 (26–83)
 ≥6040 (85)
Sex
 Male27 (57)
 Female20 (43)
Performance status
 012 (26)
 127 (57)
 28 (17)
AML diagnosis
De novo23 (49)
 Antecedent hematologic disorder21 (45)
  Prior MDS17
  Prior CMML1
  Prior PV2
  Prior ET1
 Therapy-related AML3 (6)
Bone marrow cytogenetics (n = 46)
 Gooda2 (4)
 Intermediate20 (44)
  Normal14 (30)
 Poor24 (52)
FLT3 ITD status
 Wild-type36 (77)
 Mutant10 (21)
 Unknown1 (2)
Stage of disease
 Primary refractory14 (30)
 First relapse8 (17)
 Beyond first relapse12 (25)
 Previously untreated and >60 yearsb13 (28)
Prior therapy
 Cytarabine24
 High-dose cytarabine17
 Allogeneic SCT6
 Autologous SCT1

Abbreviations: MDS, myelodysplastic syndrome; CMML, Chronic myelomonocytic leukemia; PV, polycythemia vera; ET, essential thrombocythemia; SCT, stem cell transplant.

  • aBoth patients had t(8;21). One patient was an 83-year-old gentleman with primary refractory AML that had evolved from myelodysplastic syndrome. The other patient was a 69-year-old gentleman with relapsed/refractory AML, who had received more than three prior chemotherapy regimens.

  • bOf the 13 previously untreated patients in the study (all ≥60 years old), 11 had an antecedent hematologic disorder (10 myelodysplastic syndrome, one chronic myelomonocytic leukemia). Only two patients (ages 79 and 80 years, one with complex karyotype) had untreated de novo AML and neither of these responded.