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Table 1 QUAZAR AML-001 baseline characteristics (safety-evaluable population)

From: Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial

Parameter

Oral azacitidine (N = 236)

Placebo (N = 233)

Age, years, median (range)

68 (55‒86)

68 (55‒82)

ECOG PS score, n (%)

  

0

116 (49.2)

111 (47.6)

1

99 (41.9)

105 (45.1)

2‒3

21 (8.9)

17 (7.3)

De novo AML, n (%)

211 (89.4)

215 (92.3)

WHO AML classification, n (%)

  

Not otherwise specified

147 (62.3)

144 (61.8)

Myelodysplasia-related changes

49 (20.8)

42 (18.0)

Recurrent genetic abnormalities

38 (16.1)

46 (19.7)

Therapy-related

2 (0.8)

0

NCCN cytogenetic risk at diagnosis, n (%)

  

Intermediate

202 (85.6)

202 (86.7)

Poor

34 (14.4)

31 (13.3)

Response after induction, n (%)

  

CR

185 (78.4)

197 (84.5)

Cri

51 (21.6)

36 (15.5)

Received consolidation, n (%)

  

Yes

184 (78.0)

191 (82.0)

1 cycle

110 (46.6)

101 (43.3)

2 cycles

69 (29.2)

77 (33.0)

3 cycles

5 (2.1)

13 (5.6)

No

52 (22.0)

42 (18.0)

Reason ineligible for transplanta

  

Age

154 (65)

152 (65)

Comorbidities

52 (22)

50 (21)

Performance status

14 (6)

9 (4)

No available donor

37 (16)

35 (15)

Patient decision

19 (8)

32 (14)

Unfavorable cytogenetics

6 (3)

10 (4)

Other

28 (12)

21 (9)

Time from induction to randomization, months, median (range)

3.9 (1.4‒8.8)

4.0 (1.3‒15.1)

Time from CR/CRi to randomization, days, median (range)

84 (7‒154b)

86 (7‒263b)

Bone marrow blasts, percent, median (range)

2.0 (0.0‒5.0)

2.0 (0.0‒6.5c)

MRD + at randomization,d n (%)

102 (43.2)

115 (49.4)

ANC, 109/L, median (range)

3.0 (0.3b‒15.9)

2.8 (0.5‒9.6)

Hemoglobin, g/dL, median (range)

11.3 (7.5‒15.9)

10.8 (7.7‒14.9)

Platelets, 109/L, median (range)

154 (22‒801)

179 (16b‒636)

WBC, 109/L, median (range)

4.9 (0.8‒18.7)

4.5 (1.3‒12.6)

  1. Safety-evaluable patients received at least 1 dose of study drug
  2. AML acute myeloid leukemia, ANC absolute neutrophil count, CR complete remission, CRi CR with incomplete blood count recovery, ECOG PS Eastern Cooperative Oncology Group performance status, MRD measurable residual disease, NCCN National Comprehensive Cancer Network, WBC white blood cells, WHO World Health Organization
  3. aA patient may have had more than 1 reason for ineligibility
  4. bTwo patients in each treatment arm enrolled beyond the 4-month (± 7 days) inclusion window from the time of achieving CR/CRi (protocol violations)
  5. cPatients may have had multiple visits between screening and randomization. All patients met relevant eligibility criteria at the screening visit
  6. dCentral assessment by flow cytometry, using a ≥ 0.1% MRD-positive threshold
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Journal of Hematology & Oncology

ISSN: 1756-8722

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