Characteristics of AML12 patients in the ATRA randomization
| . | Total . | ATRA vs no ATRA, n (%) . | FLT3/ITD status, n (%) . | NPM1 status, n (%) . | CEPBA status, n (%) . | MN1 level, n (%) . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ATRA . | No ATRA . | P . | WT . | Mutant . | P . | WT . | Mutant . | P . | WT . | Mutant . | P . | Below median . | Above median . | P . | ||
| Overall | 1075 | 540 | 535 | 455 | 137 | 385 | 207 | 388 | 35 | 97 | 98 | |||||
| Age, y | .8* | .6* | .02* | .4* | .4* | |||||||||||
| 0-14 | 1 | 1 (< .5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| 15-29 | 157 | 81 (15) | 76 (14) | 78 (17) | 16 (12) | 77 (20) | 17 (8) | 58 (15) | 8 (23) | 18 (19) | 20 (20) | |||||
| 30-39 | 183 | 91 (17) | 92 (17) | 71 (16) | 28 (20) | 63 (16) | 36 (17) | 73 (19) | 2 (6) | 13 (13) | 16 (16) | |||||
| 40-49 | 259 | 129 (24) | 130 (24) | 112 (25) | 34 (25) | 84 (22) | 62 (30) | 100 (26) | 6 (17) | 23 (24) | 26 (27) | |||||
| 50-59 | 432 | 216 (40) | 216 (40) | 174 (38) | 53 (39) | 142 (37) | 85 (41) | 141 (36) | 16 (46) | 36 (37) | 31 (32) | |||||
| 60+ | 43 | 22 (4) | 21 (4) | 20 (4) | 6 (4) | 19 (5) | 7 (3) | 16 (4) | 3 (9) | 7 (7) | 5 (5) | |||||
| Median (range) | 48 (14-68) | 47 (14-68) | 48 (15-67) | 47 (15-67) | 47 (15-68) | 46 (15-68) | 48 (15-64) | 46 (15-68) | 52 (16-67) | 47 (17-64) | 46 (19-68) | |||||
| Sex | .4 | .2 | .2 | .16 | .2 | |||||||||||
| Female | 540 | 264 (49) | 276 (52) | 222 (49) | 75 (55) | 186 (48) | 111 (54) | 203 (52) | 14 (40) | 52 (54) | 44 (45) | |||||
| Male | 535 | 276 (51) | 259 (48) | 233 (51) | 62 (45) | 199 (52) | 96 (46) | 185 (48) | 21 (60) | 45 (46) | 54 (55) | |||||
| Diagnosis | .2 | .1 | < .001 | .8 | .18 | |||||||||||
| De novo | 970 | 481 (89) | 489 (91) | 407 (89) | 129 (94) | 336 (87) | 200 (97) | 350 (90) | 31 (89) | 89 (92) | 84 (86) | |||||
| Secondary | 105 | 59 (11) | 46 (9) | 48 (11) | 8 (6) | 49 (13) | 7 (3) | 38 (10) | 4 (11) | 8 (8) | 14 (14) | |||||
| WBC | .04* | < .001* | < .001* | .5* | .6* | |||||||||||
| < 10 | 494 | 229 (42) | 265 (50) | 219 (49) | 25 (19) | 191 (51) | 53 (27) | 144 (38) | 7 (21) | 31 (33) | 47 (50) | |||||
| 10-49.9 | 333 | 177 (34) | 156 (30) | 142 (32) | 52 (39) | 111 (29) | 83 (42) | 129 (34) | 18 (53) | 42 (44) | 25 (27) | |||||
| 50-99.9 | 120 | 64 (12) | 56 (11) | 44 (10) | 29 (22) | 40 (11) | 33 (17) | 52 (14) | 6 (18) | 15 (16) | 6 (6) | |||||
| 100+ | 103 | 56 (11) | 47 (9) | 39 (9) | 26 (20) | 35 (9) | 30 (15) | 51 (14) | 3 (9) | 7 (7) | 16 (17) | |||||
| Missing | 25 | 14 | 11 | 11 | 5 | 8 | 8 | 12 | 1 | 2 | 4 | |||||
| Median (range) | 12.55 (0.3-559) | 13.95 (0.5-559) | 10.0 (0.3-348) | 10.25 (0.3-502) | 39.15 (0.9-559) | 9.7 (0.3-502) | 28.4 (0.7-559) | 19.45 (0.4-559) | 26.95 (3.7-275) | 21.6 (0.7-310) | 10.8 (0.5-275) | |||||
| Performance status | .8* | .7* | .2* | .03* | .8* | |||||||||||
| WHO 0 | 716 | 361 (67) | 355 (66) | 291 (64) | 87 (64) | 254 (66) | 124 (60) | 228 (59) | 28 (80) | 57 (59) | 56 (57) | |||||
| WHO 1 | 273 | 137 (25) | 136 (25) | 128 (28) | 38 (28) | 101 (26) | 65 (31) | 120 (31) | 6 (17) | 32 (33) | 36 (37) | |||||
| WHO 2 | 36 | 17 (3) | 19 (4) | 17 (4) | 3 (2) | 13 (3) | 7 (3) | 16 (4) | 0 | 3 (3) | 3 (3) | |||||
| WHO 3 | 42 | 21 (4) | 21 (4) | 15 (3) | 8 (6) | 14 (4) | 9 (4) | 20 (5) | 1 (3) | 4 (4) | 2 (2) | |||||
| WHO 4 | 8 | 4 (1) | 4 (1) | 4 (1) | 1 (1) | 3 (1) | 2 (1) | 4 (1) | 0 | 1 (1) | 1 (1) | |||||
| Cytogenetics | .8 | < .001 | < .001 | .1 | < .001 | |||||||||||
| Favorable | 118 | 62 (14) | 56 (13) | 61 (16) | 5 (5) | 66 (20) | 0 | 52 (16) | 0 | 7 (9) | 16 (20) | |||||
| NK | 420 | 218 (51) | 202 (49) | 155 (41) | 78 (73) | 96 (30) | 137 (85) | 153 (48) | 16 (64) | 50 (63) | 26 (33) | |||||
| Other intermediate | 180 | 90 (21) | 90 (22) | 92 (24) | 19 (18) | 92 (28) | 19 (12) | 71 (22) | 7 (28) | 18 (23) | 20 (25) | |||||
| Adverse | 128 | 60 (14) | 68 (16) | 69 (18) | 5 (5) | 69 (21) | 5 (3) | 46 (14) | 2 (8) | 5 (6) | 18 (23) | |||||
| Unknown | 229 | 110 | 119 | 78 | 30 | 62 | 46 | 66 | 10 | 17 | 18 | |||||
| FAB type | .8 | .006 | .03 | .13 | .2 | |||||||||||
| M0 | 60 | 31 (6) | 29 (6) | 36 (9) | 7 (6) | 37 (11) | 6 (3) | 28 (8) | 1 (3) | 0 | 8 (9) | |||||
| M1 | 204 | 107 (22) | 97 (20) | 75 (18) | 30 (24) | 67 (19) | 38 (20) | 66 (19) | 11 (33) | 24 (26) | 20 (22) | |||||
| M2 | 282 | 137 (28) | 145 (31) | 131 (32) | 34 (27) | 108 (31) | 57 (30) | 109 (31) | 15 (45) | 31 (34) | 32 (36) | |||||
| M4 | 192 | 98 (20) | 94 (20) | 80 (20) | 26 (21) | 65 (19) | 41 (22) | 75 (21) | 3 (9) | 17 (18) | 15 (17) | |||||
| M5 | 126 | 71 (14) | 55 (12) | 41 (10) | 25 (20) | 34 (10) | 32 (17) | 48 (14) | 3 (9) | 11 (12) | 8 (9) | |||||
| M6 | 55 | 24 (5) | 31 (7) | 29 (7) | 2 (2) | 22 (6) | 9 (5) | 14 (4) | 0 | 5 (5) | 3 (3) | |||||
| M7 | 23 | 10 (2) | 13 (3) | 6 (1) | 0 | 3 (1) | 3 (2) | 4 (1) | 0 | 1 (1) | 1 (1) | |||||
| Bilineage | 2 | 1 (< .5) | 1 (< .5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| RAEB-t | 22 | 13 (3) | 9 (2) | 12 (3) | 1 (1) | 9 (3) | 4 (2) | 8 (2) | 0 | 3 (3) | 2 (2) | |||||
| Other/unknown | 109 | 48 | 61 | 45 | 12 | 40 | 17 | 36 | 2 | 5 | 9 | |||||
| H-DAT | 536 | 270 (50) | 266 (50) | 1.0 | 246 (54) | 63 (47) | .18 | 210 (55) | 99 (49) | .14 | 205 (54) | 16 (47) | 0.5 | 44 (46) | 58 (60) | 0.05 |
| S-DAT | 531 | 266 (50) | 265 (50) | 207 (46) | 69 (53) | 171 (45) | 105 (51) | 177 (46) | 18 (53) | 52 (54) | 39 (40) | |||||
| FLT3 ITD WT | 455 | 238 (76) | 217 (78) | 0.5 | 337 (88) | 118 (57) | < .001 | 292 (75) | 28 (80) | .5 | 68 (72) | 70 (79) | .3 | |||
| ITD mutant | 137 | 76 (24) | 61 (22) | 48 (12) | 89 (43) | 96 (25) | 7 (20) | 26 (28) | 19 (21) | |||||||
| NPM1 WT | 385 | 201 (64) | 184 (66) | .6 | 337 (74) | 48 (35) | < .001 | 240 (62) | 28 (80) | .03 | 46 (49) | 75 (84) | < .001 | |||
| NPM1 mutant | 207 | 113 (36) | 94 (34) | 118 (26) | 89 (65) | 148 (38) | 7 (20) | 48 (51) | 14 (16) | |||||||
| CEBPA WT | 388 | 214 (91) | 174 (92) | .8 | 292 (91) | 96 (93) | .5 | 240 (90) | 148 (95) | .03 | 74 (91) | 75 (91) | 1.0 | |||
| CEBPA mutant | 35 | 20 (9) | 15 (8) | 28 (9) | 7 (7) | 28 (10) | 7 (5) | 7 (9) | 7 (9) | |||||||
| MN1 low | 97 | 54 (50) | 43 (49) | .9 | 68 (49) | 26 (58) | .3 | 46 (38) | 48 (77) | < .001 | 74 (50) | 7 (50) | 1.0 | |||
| MN1 high | 98 | 54 (50) | 44 (51) | 70 (51) | 19 (42) | 75 (62) | 14 (23) | 75 (50) | 7 (50) | |||||||
| . | Total . | ATRA vs no ATRA, n (%) . | FLT3/ITD status, n (%) . | NPM1 status, n (%) . | CEPBA status, n (%) . | MN1 level, n (%) . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ATRA . | No ATRA . | P . | WT . | Mutant . | P . | WT . | Mutant . | P . | WT . | Mutant . | P . | Below median . | Above median . | P . | ||
| Overall | 1075 | 540 | 535 | 455 | 137 | 385 | 207 | 388 | 35 | 97 | 98 | |||||
| Age, y | .8* | .6* | .02* | .4* | .4* | |||||||||||
| 0-14 | 1 | 1 (< .5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| 15-29 | 157 | 81 (15) | 76 (14) | 78 (17) | 16 (12) | 77 (20) | 17 (8) | 58 (15) | 8 (23) | 18 (19) | 20 (20) | |||||
| 30-39 | 183 | 91 (17) | 92 (17) | 71 (16) | 28 (20) | 63 (16) | 36 (17) | 73 (19) | 2 (6) | 13 (13) | 16 (16) | |||||
| 40-49 | 259 | 129 (24) | 130 (24) | 112 (25) | 34 (25) | 84 (22) | 62 (30) | 100 (26) | 6 (17) | 23 (24) | 26 (27) | |||||
| 50-59 | 432 | 216 (40) | 216 (40) | 174 (38) | 53 (39) | 142 (37) | 85 (41) | 141 (36) | 16 (46) | 36 (37) | 31 (32) | |||||
| 60+ | 43 | 22 (4) | 21 (4) | 20 (4) | 6 (4) | 19 (5) | 7 (3) | 16 (4) | 3 (9) | 7 (7) | 5 (5) | |||||
| Median (range) | 48 (14-68) | 47 (14-68) | 48 (15-67) | 47 (15-67) | 47 (15-68) | 46 (15-68) | 48 (15-64) | 46 (15-68) | 52 (16-67) | 47 (17-64) | 46 (19-68) | |||||
| Sex | .4 | .2 | .2 | .16 | .2 | |||||||||||
| Female | 540 | 264 (49) | 276 (52) | 222 (49) | 75 (55) | 186 (48) | 111 (54) | 203 (52) | 14 (40) | 52 (54) | 44 (45) | |||||
| Male | 535 | 276 (51) | 259 (48) | 233 (51) | 62 (45) | 199 (52) | 96 (46) | 185 (48) | 21 (60) | 45 (46) | 54 (55) | |||||
| Diagnosis | .2 | .1 | < .001 | .8 | .18 | |||||||||||
| De novo | 970 | 481 (89) | 489 (91) | 407 (89) | 129 (94) | 336 (87) | 200 (97) | 350 (90) | 31 (89) | 89 (92) | 84 (86) | |||||
| Secondary | 105 | 59 (11) | 46 (9) | 48 (11) | 8 (6) | 49 (13) | 7 (3) | 38 (10) | 4 (11) | 8 (8) | 14 (14) | |||||
| WBC | .04* | < .001* | < .001* | .5* | .6* | |||||||||||
| < 10 | 494 | 229 (42) | 265 (50) | 219 (49) | 25 (19) | 191 (51) | 53 (27) | 144 (38) | 7 (21) | 31 (33) | 47 (50) | |||||
| 10-49.9 | 333 | 177 (34) | 156 (30) | 142 (32) | 52 (39) | 111 (29) | 83 (42) | 129 (34) | 18 (53) | 42 (44) | 25 (27) | |||||
| 50-99.9 | 120 | 64 (12) | 56 (11) | 44 (10) | 29 (22) | 40 (11) | 33 (17) | 52 (14) | 6 (18) | 15 (16) | 6 (6) | |||||
| 100+ | 103 | 56 (11) | 47 (9) | 39 (9) | 26 (20) | 35 (9) | 30 (15) | 51 (14) | 3 (9) | 7 (7) | 16 (17) | |||||
| Missing | 25 | 14 | 11 | 11 | 5 | 8 | 8 | 12 | 1 | 2 | 4 | |||||
| Median (range) | 12.55 (0.3-559) | 13.95 (0.5-559) | 10.0 (0.3-348) | 10.25 (0.3-502) | 39.15 (0.9-559) | 9.7 (0.3-502) | 28.4 (0.7-559) | 19.45 (0.4-559) | 26.95 (3.7-275) | 21.6 (0.7-310) | 10.8 (0.5-275) | |||||
| Performance status | .8* | .7* | .2* | .03* | .8* | |||||||||||
| WHO 0 | 716 | 361 (67) | 355 (66) | 291 (64) | 87 (64) | 254 (66) | 124 (60) | 228 (59) | 28 (80) | 57 (59) | 56 (57) | |||||
| WHO 1 | 273 | 137 (25) | 136 (25) | 128 (28) | 38 (28) | 101 (26) | 65 (31) | 120 (31) | 6 (17) | 32 (33) | 36 (37) | |||||
| WHO 2 | 36 | 17 (3) | 19 (4) | 17 (4) | 3 (2) | 13 (3) | 7 (3) | 16 (4) | 0 | 3 (3) | 3 (3) | |||||
| WHO 3 | 42 | 21 (4) | 21 (4) | 15 (3) | 8 (6) | 14 (4) | 9 (4) | 20 (5) | 1 (3) | 4 (4) | 2 (2) | |||||
| WHO 4 | 8 | 4 (1) | 4 (1) | 4 (1) | 1 (1) | 3 (1) | 2 (1) | 4 (1) | 0 | 1 (1) | 1 (1) | |||||
| Cytogenetics | .8 | < .001 | < .001 | .1 | < .001 | |||||||||||
| Favorable | 118 | 62 (14) | 56 (13) | 61 (16) | 5 (5) | 66 (20) | 0 | 52 (16) | 0 | 7 (9) | 16 (20) | |||||
| NK | 420 | 218 (51) | 202 (49) | 155 (41) | 78 (73) | 96 (30) | 137 (85) | 153 (48) | 16 (64) | 50 (63) | 26 (33) | |||||
| Other intermediate | 180 | 90 (21) | 90 (22) | 92 (24) | 19 (18) | 92 (28) | 19 (12) | 71 (22) | 7 (28) | 18 (23) | 20 (25) | |||||
| Adverse | 128 | 60 (14) | 68 (16) | 69 (18) | 5 (5) | 69 (21) | 5 (3) | 46 (14) | 2 (8) | 5 (6) | 18 (23) | |||||
| Unknown | 229 | 110 | 119 | 78 | 30 | 62 | 46 | 66 | 10 | 17 | 18 | |||||
| FAB type | .8 | .006 | .03 | .13 | .2 | |||||||||||
| M0 | 60 | 31 (6) | 29 (6) | 36 (9) | 7 (6) | 37 (11) | 6 (3) | 28 (8) | 1 (3) | 0 | 8 (9) | |||||
| M1 | 204 | 107 (22) | 97 (20) | 75 (18) | 30 (24) | 67 (19) | 38 (20) | 66 (19) | 11 (33) | 24 (26) | 20 (22) | |||||
| M2 | 282 | 137 (28) | 145 (31) | 131 (32) | 34 (27) | 108 (31) | 57 (30) | 109 (31) | 15 (45) | 31 (34) | 32 (36) | |||||
| M4 | 192 | 98 (20) | 94 (20) | 80 (20) | 26 (21) | 65 (19) | 41 (22) | 75 (21) | 3 (9) | 17 (18) | 15 (17) | |||||
| M5 | 126 | 71 (14) | 55 (12) | 41 (10) | 25 (20) | 34 (10) | 32 (17) | 48 (14) | 3 (9) | 11 (12) | 8 (9) | |||||
| M6 | 55 | 24 (5) | 31 (7) | 29 (7) | 2 (2) | 22 (6) | 9 (5) | 14 (4) | 0 | 5 (5) | 3 (3) | |||||
| M7 | 23 | 10 (2) | 13 (3) | 6 (1) | 0 | 3 (1) | 3 (2) | 4 (1) | 0 | 1 (1) | 1 (1) | |||||
| Bilineage | 2 | 1 (< .5) | 1 (< .5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| RAEB-t | 22 | 13 (3) | 9 (2) | 12 (3) | 1 (1) | 9 (3) | 4 (2) | 8 (2) | 0 | 3 (3) | 2 (2) | |||||
| Other/unknown | 109 | 48 | 61 | 45 | 12 | 40 | 17 | 36 | 2 | 5 | 9 | |||||
| H-DAT | 536 | 270 (50) | 266 (50) | 1.0 | 246 (54) | 63 (47) | .18 | 210 (55) | 99 (49) | .14 | 205 (54) | 16 (47) | 0.5 | 44 (46) | 58 (60) | 0.05 |
| S-DAT | 531 | 266 (50) | 265 (50) | 207 (46) | 69 (53) | 171 (45) | 105 (51) | 177 (46) | 18 (53) | 52 (54) | 39 (40) | |||||
| FLT3 ITD WT | 455 | 238 (76) | 217 (78) | 0.5 | 337 (88) | 118 (57) | < .001 | 292 (75) | 28 (80) | .5 | 68 (72) | 70 (79) | .3 | |||
| ITD mutant | 137 | 76 (24) | 61 (22) | 48 (12) | 89 (43) | 96 (25) | 7 (20) | 26 (28) | 19 (21) | |||||||
| NPM1 WT | 385 | 201 (64) | 184 (66) | .6 | 337 (74) | 48 (35) | < .001 | 240 (62) | 28 (80) | .03 | 46 (49) | 75 (84) | < .001 | |||
| NPM1 mutant | 207 | 113 (36) | 94 (34) | 118 (26) | 89 (65) | 148 (38) | 7 (20) | 48 (51) | 14 (16) | |||||||
| CEBPA WT | 388 | 214 (91) | 174 (92) | .8 | 292 (91) | 96 (93) | .5 | 240 (90) | 148 (95) | .03 | 74 (91) | 75 (91) | 1.0 | |||
| CEBPA mutant | 35 | 20 (9) | 15 (8) | 28 (9) | 7 (7) | 28 (10) | 7 (5) | 7 (9) | 7 (9) | |||||||
| MN1 low | 97 | 54 (50) | 43 (49) | .9 | 68 (49) | 26 (58) | .3 | 46 (38) | 48 (77) | < .001 | 74 (50) | 7 (50) | 1.0 | |||
| MN1 high | 98 | 54 (50) | 44 (51) | 70 (51) | 19 (42) | 75 (62) | 14 (23) | 75 (50) | 7 (50) | |||||||
Test for trend.