Comparison of CN-AML patients with and without MLL-PTD and comparison of MLL-PTD+ patients who relapsed with MLL-PTD+ patients who did not relapse
| Characteristic . | MLL-PTD . | P . | MLL-PTD+ . | P . | ||
|---|---|---|---|---|---|---|
| Negative, n=214 . | Positive, n=24 . | No relapse, n=9 . | Relapse, n=13 . | |||
| Age, y | .39 | .62 | ||||
| Median | 46 | 49 | 47 | 51 | ||
| Range | 18-59 | 22-59 | 22-59 | 23-59 | ||
| Sex, no. of males (%) | 100 (47) | 13 (54) | .52 | 5 (56) | 7 (54) | 1.00 |
| Race, n (%) | 1.00 | .16 | ||||
| White | 186 (88) | 22 (92) | 7 (78) | 13 (100) | ||
| Nonwhite | 25 (12) | 2 (8) | 2 (22) | 0 (0) | ||
| Hemoglobin, g/dL | .29 | .07 | ||||
| Median | 9.3 | 8.75 | 9.5 | 8.3 | ||
| Range | 4.6-13.6 | 6.2-11.8 | 7.8-10.3 | 6.2-11.2 | ||
| Platelet count, ×109/L | .78 | .15 | ||||
| Median | 60.5 | 64.5 | 31 | 72 | ||
| Range | 7-466 | 5-395 | 5-395 | 23-120 | ||
| WBC count, ×109/L | <.001 | .76 | ||||
| Median | 25.15 | 4.35 | 4.1 | 6.7 | ||
| Range | 0.8-295.0 | 0.8-64.2 | 0.8-27.8 | 0.9-64.2 | ||
| Blood blasts, % | .40 | .08 | ||||
| Median | 56 | 39.5 | 26 | 54 | ||
| Range | 0-97 | 5-95 | 7-75 | 10-95 | ||
| Bone marrow blasts, % | .17 | .03 | ||||
| Median | 65 | 55 | 40.5 | 66 | ||
| Range | 12-99 | 10-94 | 10-80 | 38-94 | ||
| Centrally reviewed FAB, n (%) | .04 | .83 | ||||
| M0 | 4 (3) | 1 (5) | 0 (0) | 1 (9) | ||
| M1 | 40 (27) | 5 (24) | 2 (25) | 2 (18) | ||
| M2 | 46 (32) | 10 (48) | 4 (50) | 5 (45) | ||
| M4 | 37 (25) | 2 (10) | 0 (0) | 2 (18) | ||
| M5 | 14 (10) | 0 (0) | 0 (0) | 0 (0) | ||
| M6 | 1 (1) | 2 (10) | 1 (13) | 1 (9) | ||
| Unclassified | 4 (3) | 1 (5) | 1 (13) | 0 (0) | ||
| Extramedullary involvement, n (%)* | .03 | 1.00 | ||||
| No | 146 (69) | 21 (91) | 8 (89) | 11 (92) | ||
| Yes | 65 (31) | 2 (9) | 1 (11) | 1 (8) | ||
| Lymphadenopathy, n (%) | .05 | NA | ||||
| No | 184 (86) | 24 (100) | 9 (100) | 13 (100) | ||
| Yes | 29 (14) | 0 (0) | 0 (0) | 0 (0) | ||
| FLT3-ITD, n (%) | .37 | .33 | ||||
| Absent | 139 (65) | 18 (75) | 8 (89) | 8 (62) | ||
| Present | 75 (35) | 6 (25) | 1 (11) | 5 (38) | ||
| FLT3-TKD, n (%) | 1.00 | 1.00 | ||||
| Absent | 180 (91) | 18 (95) | 6 (100) | 10 (91) | ||
| Present | 18 (9) | 1 (5) | 0 (0) | 1 (9) | ||
| NPM1, n (%) | <.001 | .12 | ||||
| Wild-type | 63 (32) | 13 (76) | 3 (50) | 9 (90) | ||
| Mutated | 136 (68) | 4 (24) | 3 (50) | 1 (10) | ||
| BAALC expression, n (%)† | .009 | .03 | ||||
| Low | 83 (54) | 3 (19) | 3 (60) | 0 (0) | ||
| High | 72 (46) | 13 (81) | 2 (40) | 9 (100) | ||
| ERG expression, n (%)‡ | .27 | .23 | ||||
| Low | 101 (64) | 12 (80) | 5 (100) | 5 (63) | ||
| High | 57 (36) | 3 (20) | 0 (0) | 3 (38) | ||
| Complete remission rate, n (%) | 177 (83) | 22 (92) | .39 | NA | NA | NA |
| Relapse rate, n (%) | 96 (54) | 13 (59) | .82 | NA | NA | NA |
| Overall survival/ | .67 | NA | NA | NA | ||
| Median, y | 3.7 | NR | NA | NA | ||
| Alive at 3 y (95% CI), % | 52 (45-59) | 50 (29-68) | NA | NA | ||
| Alive at 5 y (95% CI), % | 45 (38-52) | 50 (29-68) | NA | NA | ||
| Disease-free survival | .55 | NA | NA | NA | ||
| Median, y | 2.5 | 1.0 | NA | NA | ||
| Disease-free at 3 y (95% CI), % | 48 (40-55) | 41 (21-60) | NA | NA | ||
| Disease-free at 5 y (95% CI), % | 43 (35-51) | 41 (21-60) | NA | NA | ||
| Characteristic . | MLL-PTD . | P . | MLL-PTD+ . | P . | ||
|---|---|---|---|---|---|---|
| Negative, n=214 . | Positive, n=24 . | No relapse, n=9 . | Relapse, n=13 . | |||
| Age, y | .39 | .62 | ||||
| Median | 46 | 49 | 47 | 51 | ||
| Range | 18-59 | 22-59 | 22-59 | 23-59 | ||
| Sex, no. of males (%) | 100 (47) | 13 (54) | .52 | 5 (56) | 7 (54) | 1.00 |
| Race, n (%) | 1.00 | .16 | ||||
| White | 186 (88) | 22 (92) | 7 (78) | 13 (100) | ||
| Nonwhite | 25 (12) | 2 (8) | 2 (22) | 0 (0) | ||
| Hemoglobin, g/dL | .29 | .07 | ||||
| Median | 9.3 | 8.75 | 9.5 | 8.3 | ||
| Range | 4.6-13.6 | 6.2-11.8 | 7.8-10.3 | 6.2-11.2 | ||
| Platelet count, ×109/L | .78 | .15 | ||||
| Median | 60.5 | 64.5 | 31 | 72 | ||
| Range | 7-466 | 5-395 | 5-395 | 23-120 | ||
| WBC count, ×109/L | <.001 | .76 | ||||
| Median | 25.15 | 4.35 | 4.1 | 6.7 | ||
| Range | 0.8-295.0 | 0.8-64.2 | 0.8-27.8 | 0.9-64.2 | ||
| Blood blasts, % | .40 | .08 | ||||
| Median | 56 | 39.5 | 26 | 54 | ||
| Range | 0-97 | 5-95 | 7-75 | 10-95 | ||
| Bone marrow blasts, % | .17 | .03 | ||||
| Median | 65 | 55 | 40.5 | 66 | ||
| Range | 12-99 | 10-94 | 10-80 | 38-94 | ||
| Centrally reviewed FAB, n (%) | .04 | .83 | ||||
| M0 | 4 (3) | 1 (5) | 0 (0) | 1 (9) | ||
| M1 | 40 (27) | 5 (24) | 2 (25) | 2 (18) | ||
| M2 | 46 (32) | 10 (48) | 4 (50) | 5 (45) | ||
| M4 | 37 (25) | 2 (10) | 0 (0) | 2 (18) | ||
| M5 | 14 (10) | 0 (0) | 0 (0) | 0 (0) | ||
| M6 | 1 (1) | 2 (10) | 1 (13) | 1 (9) | ||
| Unclassified | 4 (3) | 1 (5) | 1 (13) | 0 (0) | ||
| Extramedullary involvement, n (%)* | .03 | 1.00 | ||||
| No | 146 (69) | 21 (91) | 8 (89) | 11 (92) | ||
| Yes | 65 (31) | 2 (9) | 1 (11) | 1 (8) | ||
| Lymphadenopathy, n (%) | .05 | NA | ||||
| No | 184 (86) | 24 (100) | 9 (100) | 13 (100) | ||
| Yes | 29 (14) | 0 (0) | 0 (0) | 0 (0) | ||
| FLT3-ITD, n (%) | .37 | .33 | ||||
| Absent | 139 (65) | 18 (75) | 8 (89) | 8 (62) | ||
| Present | 75 (35) | 6 (25) | 1 (11) | 5 (38) | ||
| FLT3-TKD, n (%) | 1.00 | 1.00 | ||||
| Absent | 180 (91) | 18 (95) | 6 (100) | 10 (91) | ||
| Present | 18 (9) | 1 (5) | 0 (0) | 1 (9) | ||
| NPM1, n (%) | <.001 | .12 | ||||
| Wild-type | 63 (32) | 13 (76) | 3 (50) | 9 (90) | ||
| Mutated | 136 (68) | 4 (24) | 3 (50) | 1 (10) | ||
| BAALC expression, n (%)† | .009 | .03 | ||||
| Low | 83 (54) | 3 (19) | 3 (60) | 0 (0) | ||
| High | 72 (46) | 13 (81) | 2 (40) | 9 (100) | ||
| ERG expression, n (%)‡ | .27 | .23 | ||||
| Low | 101 (64) | 12 (80) | 5 (100) | 5 (63) | ||
| High | 57 (36) | 3 (20) | 0 (0) | 3 (38) | ||
| Complete remission rate, n (%) | 177 (83) | 22 (92) | .39 | NA | NA | NA |
| Relapse rate, n (%) | 96 (54) | 13 (59) | .82 | NA | NA | NA |
| Overall survival/ | .67 | NA | NA | NA | ||
| Median, y | 3.7 | NR | NA | NA | ||
| Alive at 3 y (95% CI), % | 52 (45-59) | 50 (29-68) | NA | NA | ||
| Alive at 5 y (95% CI), % | 45 (38-52) | 50 (29-68) | NA | NA | ||
| Disease-free survival | .55 | NA | NA | NA | ||
| Median, y | 2.5 | 1.0 | NA | NA | ||
| Disease-free at 3 y (95% CI), % | 48 (40-55) | 41 (21-60) | NA | NA | ||
| Disease-free at 5 y (95% CI), % | 43 (35-51) | 41 (21-60) | NA | NA | ||
The median follow-up for the 116 of 238 patients alive is 4.7 years, ranging from 1.2 to 8.9 years. For the 199 patients who achieved CR, median disease-free survival duration for the 90 who have not relapsed is 5.4 years, ranging from 1.5 to 8.8 years.
MLL-PTD indicates partial tandem duplication of the MLL gene; WBC, white blood cell; FAB, French-American-British; FLT3-ITD, internal tandem duplication of the FLT3 gene; FLT3-TKD, tyrosine kinase domain mutation of the FLT3 gene; CI, confidence interval; NA, not applicable; and NR, not reached.
Includes involvement of the central nervous system, hepatomegaly, splenomegaly, lymphadenopathy, skin infiltrates, gum hypertrophy, and/or a mediastinal mass.
For patients on protocol 9621, cut point same as in Baldus et al.13 For patients on protocol 19808, median BAALC expression value used for cut point.
For patients on protocol 9621, cut point same as in Marcucci et al.14 For patients on protocol 19808, median ERG expression value used for cut point.