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Table 3 Treatment outcomes

From: Early vs. late MRD response- and risk-based treatment intensification of childhood acute lymphoblastic leukemia: a prospective pilot study from Saudi Arabia

Outcome variable

5-years OS ± SE

p

5-years EFS ± SE

p

5-years CIR ± SE

p

Overall

89.5 ± 4.0%

 

87.6 ± 4.3%

 

7.1 ± 3.5%

 

 B-cell ALL

90.5 ± 2.4%

 

88.7 ± 2.6%

 

6.4 ± 2.0%

 

 T-cell ALL

86.0 ± 6.2%

 

83.2 ± 7.2%

 

7.4 ± 4.0%

 

NCI risk

≤ 0.05

 

≤ 0.05

  

 Standard risk

94.2 ± 2.0%

 

91.9 ± 2.4%

 

5.4 ± 1.9%

 

 High risk

81.6 ± 6.1%

 

81.2 ± 6.0%

 

8.9 ± 3.8%

 

WBC count

≤ 0.05

 

≤ 0.05

 

≤ 0.05

 < 50 × 109/L

94.5 ± 1.9%

 

92.3 ± 2.3%

 

5.2 ± 1.8%

 

 ≥ 50 × 109/L

79.0 ± 7.1%

 

78.5 ± 7.0%

 

10.3 ± 4.5%

 

Extra-medullary status, B-cell

≤ 0.05

 No

90.8 ± 2.4%

 

88.8 ± 2.7%

 

6.5 ± 2.1%

 

 Yes

88.4 ± 10.8%

 

86.0 ± 8.9%

 

4.9 ± 5.2%

 

Extra-medullary status, T-cell

 No

89.3 ± 6.6%

 

86.0 ± 7.6%

 

3.6 ± 3.7%

 

 Yes

73.3 ± 18.1%

 

72.7 ± 18.5%

 

27.3 ± 18.5%

 

Cytogenetic subtype

≤ 0.05

    

 Normal

92.8 ± 4.4%

 

90.5 ± 4.7%

 

4.6 ± 2.9%

 

 ETV6/RUNX1

95.9 ± 4.2%

 

92.7 ± 5.4%

 

3.5 ± 3.6%

 

 Hyperdiploidy

93.1 ± 3.3%

 

90.1 ± 3.7%

 

5.6 ± 2.6%

 

 MLLR

60.7 ± 34.6%

 

55.4 ± 29.6%

 

25.8 ± 22.1%

 

 t(1;19)/TCF3-PBX1

65.0 ± 31.5%

 

58.7 ± 25.8%

 

31.2 ± 23.7%

 

 Others

90.3 ± 4.3%

 

88.5 ± 4.4%

 

6.5 ± 3.1%

 

Cytogenetic group

≤ 0.05

 

≤ 0.05

 

≤ 0.05

 MLLR + t(1;19)

63.1 ± 23.6%

 

57.2 ± 20.2%

 

29.5 ± 17.1%

 

 All others

92.5 ± 2.1%

 

90.0 ± 2.5%

 

4.4 ± 1.8%

 

Day 15 bone marrow

≤ 0.05

 

≤ 0.05

 

≤ 0.05

 M1

92.5 ± 2.1%

 

91.1 ± 2.3%

 

5.1 ± 1.7%

 

 M2

63.0 ± 26.9%

 

55.9 ± 29.6%

 

34.6 ± 25.5%

 

 M3

46.9 ± 53.9%

 

40.1 ± 54.1%

 

23.8 ± 27.8%

 

Day 15 MRD

≤ 0.05

 

≤ 0.05

 

≤ 0.05

 < 0.01%

93.6 ± 2.8%

 

91.9 ± 3.1%

 

5.6 ± 2.5%

 

 ≥ 0.01%

79.1 ± 7.4%

 

74.7 ± 8.3%

 

15.0 ± 6.2%

 

MRD transition (D15 → D29)

≤ 0.05

 

≤ 0.05

  

 N → N

94.6 ± 2.6%

 

92.9 ± 2.9%

 

5.7 ± 2.5%

 

 Y → N

83.1 ± 7.2%

 

77.4 ± 8.4%

 

16.0 ± 7.0%

 

 Y → Y

71.2 ± 20.1%

 

71.1 ± 20.1%

 

10.0 ± 11.0%

 

Rapidity of response

≤ 0.05

 

≤ 0.05

 

≤ 0.05

 RER

92.8 ± 2.1%

 

91.5 ± 2.3%

 

5.2 ± 1.8%

 

 SER

72.3 ± 14.7%

 

66.0 ± 16.2%

 

20.0 ± 11.8%

 

Post-induction regimen

≤ 0.05

    

 Arm A

94.0 ± 2.3%

 

91.8 ± 2.6%

 

5.7 ± 2.1%

 

 Arm B

91.1 ± 4.8%

 

89.5 ± 4.8%

 

2.9 ± 2.2%

 

 Arm C

80.1 ± 7.6%

 

79.3 ± 7.5%

 

12.0 ± 5.4%

 

Arm assignment history

≤ 0.05

 

≤ 0.05

 

≤ 0.05

 A → A

94.2 ± 2.2%

 

92.5 ± 2.5%

 

5.1 ± 2.0%

 

 A → C

90.3 ± 10.2%

 

83.1 ± 13.2%

 

8.0 ± 8.5%

 

 B → B

93.5 ± 4.0%

 

91.9 ± 4.0%

 

2.6 ± 2.0%

 

 B → C

56.7 ± 0.26%

 

52.2 ± 27.1%

 

41.4 ± 25.1%

 

 C → C

93.6 ± 6.3%

 

91.6 ± 4.8%

 

2.5 ± 2.6%

 

Gender

 Female

86.7 ± 4.1%

 

85.4 ± 4.2%

 

6.6 ± 2.6%

 

 Male

92.5 ± 2.8%

 

90.4 ± 3.1%

 

7.7 ± 2.8%

 

Gender vs. treatment arm, female

≤ 0.05

 

≤ 0.05

 

≤ 0.05

 Arm A

93.6 ± 3.4%

 

91.1 ± 3.7%

 

5.9 ± 3.0%

 

 Arm B

86.0 ± 8.2%

 

85.3 ± 7.2%

 

2.6 ± 2.7%

 Arm C

71.3 ± 15.3%

 

69.7 ± 15.1%

 

17.2 ± 11.3%

 

Gender vs. treatment arm, male

 Arm A

94.4 ± 3.0%

 

92.4 ± 3.2%

 

6.8 ± 3.1%

 

 Arm B

100.0 ± 0.0%

 

95.4 ± 4.8%

 

4.4 ± 4.6%

 

 Arm C

85.7 ± 7.9%

 

85.1 ± 7.5%

 

11.5 ± 6.6%

 

Down syndrome

 No

90.8 ± 2.4%

 

88.8 ± 2.7%

 

6.8 ± 2.1%

 

 Yes

89.0 ± 10.8%

 

85.9 ± 8.3%

 

0.0%

 
  1. OS overall survival, EFS event-free survival, CIR cumulative incidence of relapse, SE standard error, p, p-value, only significant values are shown. Extra-medullary status: No no extra-medullary disease. Yes, extra-medullary (CNS, testes) site involved. MLLR, MLL rearrangement, RER rapid early response, SER slow early response, MRD minimal residual disease. MRD transition (D15 → D29), MRD kinetics from day 15 to day 29 of induction: “N → N”: day 15 MRD % < 0.01%, day 29 < 0.01%; “Y → N”: day 15 ≥ 0.01%, day 29 < 0.01%; “Y → Y”: day 15