Table 2 Cox proportional hazard model for predictive impact of genomic AML classes on hazard of death or event after treatment with midostaurin in the cohort of 451 of 475 patients, in which subcategorization into genomic AML classes was possible.

From: Genomic landscape of patients with FLT3-mutated acute myeloid leukemia (AML) treated within the CALGB 10603/RATIFY trial

 

Overall survival

Event-free survival

Variable

HR [CI. 95]

p value

HR [CI. 95]

p value

Age

1.01 [0.99; 1.02]

0.357

1.00 [0.99; 1.01]

0.841

Sex

  Male

Reference

   

  Female

1.01 [0.77; 1.33]

0.940

1.34 [1.06; 1.69]

0.013

FLT3 mutation type

  TKD

Reference

   

  ITD < 0.5 allelic ratio

1.15 [0.75; 1.76]

0.533

1.36 [0.96; 1.93]

0.085

  ITD ≥ 0.5 allelic ratio

1.58 [1.09; 2.28]

0.016

1.52 [1.12; 2.05]

0.007

 ECOG (0–1 vs. 2)

1.27 [0.84; 1.91]

0.261

0.90 [0.62; 1.31]

0.595

 log2WBC

1.08 [1.00; 1.17]

0.046

1.08 [1.01; 1.16]

0.018

 Allogeneic HCT in CR1

0.59 [0.41; 0.84]

0.004

0.71 [0.48; 1.04]

0.077

NPM1

  Midostaurin vs. Placebo

0.65 [0.45; 0.93]

0.018

0.76 [0.57; 1.03]

0.077

CBF

  Midostaurin vs. Placebo

1.37 [0.23; 8.23]

0.729

0.88 [0.24; 3.29]

0.853

TP53-aneuploidy

  Midostaurin vs. Placebo

1.11 [0.32; 3.86]

0.866

0.39 [0.15; 1.02]

0.055

Chromatin-Spliceosome

  Midostaurin vs. Placebo

0.52 [0.29; 0.92]

0.026

0.48 [0.28; 0.82]

0.007

No Class

  Midostaurin vs. Placebo

0.55 [0.28; 1.07]

0.079

0.64 [0.36; 1.13]

0.123

Placebo

  CBF vs. NPM1

0.46 [0.11; 1.92]

0.289

0.77 [0.31; 1.91]

0.569

  TP53-aneuploidy vs. NPM1

1.42 [0.51; 3.93]

0.499

5.40 [2.58; 11.29]

<0.001

  Chromatin-Spliceosome vs. NPM1

2.52 [1.58; 4.03]

<0.001

2.38 [1.55; 3.66]

<0.001

  No Class vs. NPM1

2.31 [1.31; 4.05]

0.004

2.71 [1.66; 4.44]

<0.001

Midostaurin

  CBF vs. NPM1

0.99 [0.31; 3.20]

0.985

0.89 [0.32; 2.44]

0.816

  TP53-aneuploidy vs. NPM1

2.45 [1.11; 5.42]

0.027

2.74 [1.37; 5.47]

0.004

  Chromatin-Spliceosome vs. NPM1

2.02 [1.22; 3.34]

0.006

1.49 [0.96; 2.32]

0.073

  No Class vs. NPM1

1.96 [1.14; 3.36]

0.014

2.28 [1.48; 3.51]

<0.001

  1. A hazard ratio of >1 indicates a higher and a hazard ratio of <1 a lower risk of death or event, respectively.
  2. CBF Core-binding factor AML, CI. 95 95% confidence interval, CR1 first complete remission, ECOG Eastern Cooperative Oncology Group, HR hazard ratio, HCT hematopoietic cell transplantation, WBC white blood cell count.
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