|
|
With EMI at diagnosis (n=123) |
Without EMI at diagnosis (n=590) |
|
|
With EMI at relapse (n= 64) |
Without EMI at relapse (n= 191) |
|
Trials |
|
|
|
|
|
|
|
|
AAML0531 |
628 |
117 |
511 |
|
220 |
57 |
163 |
|
AAML03P1 |
85 |
6 |
79 |
|
35 |
7 |
28 |
|
EMI types |
|
|
|
|
|
|
|
|
CNS only |
|
36 |
|
|
|
35 |
|
|
MS only |
|
75 |
|
|
|
16 |
|
|
CNS and MS |
|
12 |
|
|
|
13 |
|
|
Gender, male/female |
377/336 |
69/54 |
308/282 |
0.4313 |
137/118 |
36/28 |
101/90 |
0.6398 |
Age, years, n (%) |
|
|
|
|
|
|
|
|
≤ 2 |
128 (18.0) |
38 (30.9) |
90
(15.3) |
<0.0001 |
50 (19.6) |
23 (35.9) |
27 (14.1) |
<0.0001 |
> 2, ≤ 14 |
385 (54.0) |
56 (45.5) |
329 (55.8) |
0.0383 |
130 (51.0) |
27 (42.2) |
103 (53.9) |
0.1040 |
>14 |
200 (28.1) |
29 (23.6) |
171 (29.0) |
0.2248 |
75
(29.4) |
14 (21.9) |
61 (31.9) |
0.1263 |
Laboratory tests |
|
|
|
|
|
|
|
|
WBC ≥100×109/L, n
(%) |
157 (22.0) |
24 (19.5) |
133 (22.5) |
0.4607 |
66 (25.9) |
23
(35.9) |
43 (22.5) |
0.0338 |
Median WBC, ×109/L (range) |
31.6 (0.2-827.2) |
27.0
(1.6-446) |
32.6 (0.2-827.2) |
0.8580 |
40.9 (0.2-519) |
63.9 (2-519) |
32.7 (0.2-402) |
0.0715 |
Median BM blast, % (range) |
71.0 (0-100) |
70.0 (0-100) |
71.0 (6-100) |
0.4923 |
72.0 (0-100) |
70.0 (0-96) |
74.1 (14-100) |
0.1885 |
Median PB blast, % (range) |
45.0 (0-98) |
41.0 (0-97) |
45.0 (0-98) |
0.3533 |
49.5 (0-98) |
57.6 (0-97) |
46.5 (0-98) |
0.3217 |
FAB classification, n (%) |
|
|
|
|
|
|
|
|
M0 |
21 (2.9) |
2 (1.6) |
19 (3.2) |
0.5104a
|
12 (4.7) |
2 (3.1) |
10 (5.2) |
0.7271 |
M1 |
90 (12.6) |
8 (6.5) |
82 (13.9) |
0.0247 |
29 (11.4) |
3 (4.7) |
26
(13.6) |
0.0516 |
M2 |
175 (24.5) |
33 (26.8) |
142 (24.1) |
0.5174 |
49 (19.2) |
7 (10.9) |
42 (22.0) |
0.0521 |
M4 |
177 (24.8) |
31 (25.2) |
146 (24.7) |
0.9149 |
69 (27.1) |
21
(32.8) |
48 (25.1) |
0.2312 |
M5 |
156 (21.9) |
40 (32.5) |
116 (19.7) |
0.0017 |
66 (25.9) |
25
(39.1) |
41 (21.5) |
0.0054 |
M6 |
12 (1.7) |
1 (0.8) |
11 (1.9) |
0.6604a
|
6 (2.4) |
0 (0.0) |
6 (3.1) |
0.3378 |
M7 |
36 (5.0) |
3 (2.4) |
33 (5.6) |
0.1461 |
8 (3.1) |
2 (3.1) |
6
(3.1) |
0.9948 |
NOS |
46 (6.5) |
5 (4.1) |
41 (6.9) |
0.2363 |
16 (6.3) |
4 (6.3) |
12
(6.3) |
0.9925 |
Gene mutation, n (%) |
|
|
|
|
|
|
|
|
CEBPA + |
39 (5.5) |
3 (2.4) |
36 (6.1) |
0.1042 |
8 (3.1) |
3 (4.7) |
5
(2.6) |
0.6834 |
WT1+ |
44 (6.2) |
5 (4.1) |
39 (6.6) |
0.2859 |
20 (7.8) |
5 (7.8) |
15
(7.9) |
0.9916 |
FLT3_ITD+ |
122 (17.1) |
18 (14.6) |
104 (17.6) |
0.4227 |
47 (18.4) |
6 (9.4) |
41 (21.5) |
0.0308 |
NPM1+ |
61 (8.6) |
6 (4.9) |
55 (9.3) |
0.1090 |
14 (5.5) |
3 (4.7) |
11 (5.8) |
0.9931 |
FLT3_ITD/NPM1 status |
|
|
|
|
|
|
|
|
FLT3_ITD+/NPM1+ |
25 (3.5) |
5 (4.1) |
20 (3.4) |
0.9196a
|
7 (2.7) |
1 (1.6) |
6 (3.1) |
0.8204 |
FLT3_ITD+/NPM1- |
97 (13.6) |
13 (10.6) |
84 (14.2) |
0.2804 |
40
(15.7) |
5 (7.8) |
35 (18.3) |
0.0454 |
FLT3_ITD-/NPM1+ |
36 (5.0) |
1 (0.8) |
35 (5.9) |
0.0183 |
7 (2.7) |
2
(3.1) |
5 (2.6) |
0.8298 |
FLT3_ITD-/NPM1- |
555 (77.8) |
104 (84.6) |
451 (76.4) |
0.0488 |
201
(78.8) |
56 (87.5) |
145 (75.9) |
0.0496 |
KIT+, +/-
|
47/153
|
8/31
|
39/122
|
0.6239
|
21/35
|
5/11
|
16/24
|
0.5412
|
Karyotype, n (%) |
|
|
|
|
|
|
|
|
Complex karyotype |
122 (17.1) |
26
(21.1) |
96 (16.3) |
0.1923 |
54 (21.2) |
20 (31.3) |
34 (17.8) |
0.0227 |
Normal karyotype |
172 (24.1) |
15 (12.2) |
157 (26.6) |
0.0007 |
49
(19.2) |
3 (4.7) |
46 (24.1) |
0.0007 |
t(8;21) |
111 (15.6) |
26 (21.1) |
85 (14.4) |
0.0610 |
24 (9.4) |
4
(6.3) |
20 (10.5) |
0.3169 |
inv(16) |
96 (13.5) |
14 (11.4) |
82 (13.9) |
0.4571 |
35 (13.7) |
11
(17.2) |
24 (12.6) |
0.3524 |
del5q/del7q/-5/-7 |
39 (5.5) |
6 (4.9) |
33 (5.6) |
0.7510 |
14 (5.5) |
2 (3.1) |
12 (6.3) |
0.5204 |
trisomy8/trisomy21 |
90 (12.6) |
18 (14.6) |
72 (12.2) |
0.4603 |
33
(12.9) |
10 (15.6) |
23 (12.0) |
0.4598 |
Minus X/Minus Y |
59 (8.3) |
12 (9.8) |
47 (8.0) |
0.5122 |
14 (5.5) |
4
(6.3) |
10 (5.2) |
0.7578 |
Gene fusion, n(%) |
|
|
|
|
|
|
|
|
KMT2A rearrangements |
130 (18.2) |
34 (27.6) |
96 (16.3) |
0.0030 |
66
(25.9) |
25 (39.1) |
41 (21.5) |
0.0054 |
NUP98 fusions |
45 (6.3) |
6 (4.9) |
39 (6.6) |
0.4724 |
15 (5.9) |
1
(1.6) |
14 (7.3) |
0.1645 |
Others |
|
|
|
|
|
|
|
|
EMI at diagnosis |
|
|
|
|
58 (22.7) |
24 (37.5) |
34 (17.8) |
0.0011 |