Demographic, clinical, genetic, and outcome features of patients assigned to the EWALL-PI–defined risk groups in each of the 4 trials
| Variables . | UKALL14 . | NILG-ALL10/07 . | GIMEMA-LAL1913 . | PETHEMA-ALL-HR2011 . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SR . | HR . | P value . | SR . | HR . | P value . | SR . | HR . | P value . | SR . | HR . | P value . | |
| Total cases . | 131 . | 122 . | 63 . | 46 . | 74 . | 34 . | 68 . | 240 . | ||||
| Sex | ||||||||||||
| Female | 52 (39.7) | 48 (39) | .62 | 26 (41) | 20 (43) | .82 | 35 (47) | 10 (29) | .08 | 29 (43) | 90 (38) | .44 |
| Male | 78 (59.5) | 74 (61) | 37 (59) | 26 (57) | 39 (53) | 24 (71) | 39 (57) | 150 (63) | ||||
| Intersex | 1 (0.8) | 0 (0) | - | - | - | - | - | - | ||||
| Age, median (range), y | 39 (25-65) | 44 (25-63) | .06 | 36 (17-61) | 42 (18-67) | .69 | 33 (18-65) | 36 (18-65) | .70 | 45 (15-60) | 37 (15-60) | .001 |
| <25 | - | - | .07 | 15 (24) | 14 (30) | .03 | 22 (30) | 11 (32) | .80 | 7 (10) | 47 (20) | .05 |
| 25-39 | 68 (52) | 49 (40) | 23 (37) | 8 (17) | 24 (32) | 8 (24) | 19 (28) | 88 (37) | ||||
| 40-59 | 57 (44) | 60 (49) | 24 (38) | 18 (39) | 21 (28) | 12 (35) | 41 (60) | 102 (43) | ||||
| 60+ | 6 (5) | 13 (11) | 1 (2) | 6 (13) | 7 (9) | 3 (9) | 1 (1) | 3 (1) | ||||
| WCC, median (range), 109/L | 8.2 (0.1-338.8) | 12.2 (0.4-583.1) | .03 | 9.4 (0.4-268.0) | 15.7 (1.7-1021.4) | .23 | 6.0 (0.3-209.5) | 8.1 (0.4-347.3) | .99 | 4.0 (0.2-244.0) | 23.2 (0.6-638.0) | <.001 |
| <30 | 100 (76) | 85 (70) | .28 | 40 (63) | 31 (67) | .70 | 57 (77) | 27 (79) | .16 | 59 (87) | 127 (53) | <.001 |
| 30-49 | 7 (5) | 12 (10) | 5 (8) | 4 (9) | 6 (8) | 0 (0) | 2 (3) | 28 (12) | ||||
| 50-99 | 13 (10) | 9 (7) | 7 (11) | 2 (4) | 7 (9) | 2 (6) | 2 (3) | 30 (13) | ||||
| ≥100 | 11 (8) | 16 (13) | 11 (17) | 9 (20) | 4 (5) | 5 (15) | 5 (7) | 55 (23) | ||||
| Immunophenotype | ||||||||||||
| B cell | 88 (67) | 96 (79) | .04 | 41 (65) | 32 (70) | .62 | 54 (73) | 27 (79) | .47 | 49 (72) | 160 (67) | .40 |
| T cell | 43 (33) | 26 (21) | 22 (35) | 14 (30) | 20 (27) | 7 (21) | 19 (28) | 80 (33) | ||||
| MRD | ||||||||||||
| Negative (<0.01%) | 131 (100) | 60 (49) | <.001 | 63 (100) | 14 (30) | <.001 | 74 (100) | 11 (32) | <.001 | 68 (100) | 117 (49) | <.001 |
| Positive (≥0.01%) | 0 (0) | 62 (51) | 0 (0) | 32 (70) | 0 (0) | 23 (68) | 0 (0) | 123 (51) | ||||
| Genetic risk group | ||||||||||||
| Good | 13 (10) | 6 (5) | .13 | 3 (5) | 0 (0) | .13 | 9 (12) | 2 (6) | .50 | 5 (7) | 4 (2) | .03 |
| High | 0 (0) | 66 (54) | <.001 | 0 (0) | 17 (37) | <.001 | 0 (0) | 9 (26) | <.001 | 0 (0) | 37 (15) | <.001 |
| Outcome∗ | ||||||||||||
| Relapse | 29 (22) | 43 (35) | .02 | 20 (32) | 23 (50) | .05 | 8 (11) | 10 (29) | .02 | 14 (21) | 98 (41) | .002 |
| Death | 35 (27) | 58 (48) | <.001 | 19 (30) | 30 (65) | <.001 | 14 (19) | 9 (26) | .37 | 14 (21) | 95 (40) | .004 |
| Transplant | 72 (55) | 102 (84) | <.001 | 23 (37) | 29 (63) | .01 | 17 (23) | 12 (35) | .18 | 4 (6) | 66 (28) | <.001 |
| Survival rates at 3 y | ||||||||||||
| Cumulative incidence of relapse | 16% (11-23) | 32% (24-40) | .003 | 19% (11-30) | 46% (31-59) | .007 | 12% (5-20) | 28% (13-46) | .005 | 28% (16-42) | 46% (39-53) | .001 |
| OS | 80% (72-86) | 56% (46-64) | <.001 | 79% (67-87) | 48% (33-61) | <.001 | 80% (68-88) | 71% (51-84) | .20 | 80% (65-88) | 57% (50-64) | .01 |
| Variables . | UKALL14 . | NILG-ALL10/07 . | GIMEMA-LAL1913 . | PETHEMA-ALL-HR2011 . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SR . | HR . | P value . | SR . | HR . | P value . | SR . | HR . | P value . | SR . | HR . | P value . | |
| Total cases . | 131 . | 122 . | 63 . | 46 . | 74 . | 34 . | 68 . | 240 . | ||||
| Sex | ||||||||||||
| Female | 52 (39.7) | 48 (39) | .62 | 26 (41) | 20 (43) | .82 | 35 (47) | 10 (29) | .08 | 29 (43) | 90 (38) | .44 |
| Male | 78 (59.5) | 74 (61) | 37 (59) | 26 (57) | 39 (53) | 24 (71) | 39 (57) | 150 (63) | ||||
| Intersex | 1 (0.8) | 0 (0) | - | - | - | - | - | - | ||||
| Age, median (range), y | 39 (25-65) | 44 (25-63) | .06 | 36 (17-61) | 42 (18-67) | .69 | 33 (18-65) | 36 (18-65) | .70 | 45 (15-60) | 37 (15-60) | .001 |
| <25 | - | - | .07 | 15 (24) | 14 (30) | .03 | 22 (30) | 11 (32) | .80 | 7 (10) | 47 (20) | .05 |
| 25-39 | 68 (52) | 49 (40) | 23 (37) | 8 (17) | 24 (32) | 8 (24) | 19 (28) | 88 (37) | ||||
| 40-59 | 57 (44) | 60 (49) | 24 (38) | 18 (39) | 21 (28) | 12 (35) | 41 (60) | 102 (43) | ||||
| 60+ | 6 (5) | 13 (11) | 1 (2) | 6 (13) | 7 (9) | 3 (9) | 1 (1) | 3 (1) | ||||
| WCC, median (range), 109/L | 8.2 (0.1-338.8) | 12.2 (0.4-583.1) | .03 | 9.4 (0.4-268.0) | 15.7 (1.7-1021.4) | .23 | 6.0 (0.3-209.5) | 8.1 (0.4-347.3) | .99 | 4.0 (0.2-244.0) | 23.2 (0.6-638.0) | <.001 |
| <30 | 100 (76) | 85 (70) | .28 | 40 (63) | 31 (67) | .70 | 57 (77) | 27 (79) | .16 | 59 (87) | 127 (53) | <.001 |
| 30-49 | 7 (5) | 12 (10) | 5 (8) | 4 (9) | 6 (8) | 0 (0) | 2 (3) | 28 (12) | ||||
| 50-99 | 13 (10) | 9 (7) | 7 (11) | 2 (4) | 7 (9) | 2 (6) | 2 (3) | 30 (13) | ||||
| ≥100 | 11 (8) | 16 (13) | 11 (17) | 9 (20) | 4 (5) | 5 (15) | 5 (7) | 55 (23) | ||||
| Immunophenotype | ||||||||||||
| B cell | 88 (67) | 96 (79) | .04 | 41 (65) | 32 (70) | .62 | 54 (73) | 27 (79) | .47 | 49 (72) | 160 (67) | .40 |
| T cell | 43 (33) | 26 (21) | 22 (35) | 14 (30) | 20 (27) | 7 (21) | 19 (28) | 80 (33) | ||||
| MRD | ||||||||||||
| Negative (<0.01%) | 131 (100) | 60 (49) | <.001 | 63 (100) | 14 (30) | <.001 | 74 (100) | 11 (32) | <.001 | 68 (100) | 117 (49) | <.001 |
| Positive (≥0.01%) | 0 (0) | 62 (51) | 0 (0) | 32 (70) | 0 (0) | 23 (68) | 0 (0) | 123 (51) | ||||
| Genetic risk group | ||||||||||||
| Good | 13 (10) | 6 (5) | .13 | 3 (5) | 0 (0) | .13 | 9 (12) | 2 (6) | .50 | 5 (7) | 4 (2) | .03 |
| High | 0 (0) | 66 (54) | <.001 | 0 (0) | 17 (37) | <.001 | 0 (0) | 9 (26) | <.001 | 0 (0) | 37 (15) | <.001 |
| Outcome∗ | ||||||||||||
| Relapse | 29 (22) | 43 (35) | .02 | 20 (32) | 23 (50) | .05 | 8 (11) | 10 (29) | .02 | 14 (21) | 98 (41) | .002 |
| Death | 35 (27) | 58 (48) | <.001 | 19 (30) | 30 (65) | <.001 | 14 (19) | 9 (26) | .37 | 14 (21) | 95 (40) | .004 |
| Transplant | 72 (55) | 102 (84) | <.001 | 23 (37) | 29 (63) | .01 | 17 (23) | 12 (35) | .18 | 4 (6) | 66 (28) | <.001 |
| Survival rates at 3 y | ||||||||||||
| Cumulative incidence of relapse | 16% (11-23) | 32% (24-40) | .003 | 19% (11-30) | 46% (31-59) | .007 | 12% (5-20) | 28% (13-46) | .005 | 28% (16-42) | 46% (39-53) | .001 |
| OS | 80% (72-86) | 56% (46-64) | <.001 | 79% (67-87) | 48% (33-61) | <.001 | 80% (68-88) | 71% (51-84) | .20 | 80% (65-88) | 57% (50-64) | .01 |
P values comparing relapse, death and transplant are from a χ2 test which does not factor in censoring.