Table 1 Baseline patient characteristics.
Parameter | Gustave Roussy Cohort “7 + 7” n = 82 | MDACC Cohort “std-HMA/VEN” n = 166 | p |
|---|---|---|---|
Age | 75 [50–89] | 74 [61–89] | 0.129 |
Male | 40 (49) | 99 (60) | 0.105 |
ECOG PS | |||
0-1 | 52 (63) | 102/150 (68) | 0.480 |
2-4 | 30 (37) | 48/150 (32) | |
Comorbidities | |||
Exclusion criteria for VIALE-A clinical trial | 35/82 (44%) | NA | NA |
Participation into a clinical trial | 0/82 (0%) | 142/166 (86%) | 0.001 |
BM blast % | 40 [6–98] | 37 [2–90] | 0.129 |
WBC (x 109/L) | 3.5 [0.3–24] | 2.9 [0.3–72.6] | 0.340 |
Hemoglobin (g/dL) | 9.1 [6.6–12.0] | 9.1 [5.9–13.1] | 0.282 |
Platelets (x 109/L) | 59 [4–919] | 40 [5–368] | 0.012 |
Total bilirubin (mg/dL) | 0.58 [0.35–4.62] | 0.50 [0.20–2.70] | 0.109 |
Creatinine (mg/dL) | 0.83 [0.32–3.01] | 0.92 [0.43–3.31] | 0.149 |
Cytogenetics | |||
t(8;21) | 1/77 (1) | 0/148 (0) | 0.342 |
Diploid | 33/77 (43) | 53/148 (36) | 0.302 |
Other intermediate | 14/77 (18) | 24/148 (16) | 0.709 |
11q23 rearranged | 2/77 (3) | 3/148 (2) | 1.000 |
inv(3) | 5/77 (6) | 5/148 (3) | 0.316 |
t(6;9) | 1/77 (1) | 1/148 (1) | 1.000 |
-5/5q- | 19/77 (25) | 44/148 (30) | 0.423 |
-7/7q- | 18/77 (23) | 27/148 (18) | 0.361 |
-17/17p- | 13/77 (17) | 19/148 (13) | 0.410 |
Complex | 17/77 (22) | 58/148 (39) | 0.010 |
Mutations | |||
NPM1 | 12/82 (15) | 29/166 (17) | 0.572 |
IDH1/IDH2 | 14/80 (18) | 31/166 (19) | 0.823 |
FLT3-ITD | 11/82 (13) | 4/166 (2) | 0.001 |
RAS | 7/80 (9) | 30/124 (24) | 0.005 |
TP53 | 16/80 (20) | 51/166 (31) | 0.077 |
ELN 2017 | |||
Favorable | 12/81 (15) | 28/150 (19) | 0.352 |
Intermediate | 17/81 (21) | 21/150 (14) | |
Adverse | 52/81 (64) | 101/150 (67) | |
mPRS | |||
Higher benefit | 46/80 (58) | 56/135 (41) | 0.019 |
Intermediate benefit | 18/80 (23) | 28/135 (21) | |
Lower benefit | 16/80 (20) | 51/135 (38) | |
Prior MDS or MPN | 26 (32) | 30 (18) | 0.016 |
AML-pCT | 28 (34) | 37 (22) | 0.046 |