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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