Characteristics, treatment response, and outcomes of the study cohort
| . | All patients with Ph– BCP-ALL (n = 1091) . | Patients with KMT2A-r BCP-ALL (n = 141) . | ||||
|---|---|---|---|---|---|---|
| KMT2A-r BCP-ALL . | Other BCP-ALL . | P value . | KMT2A::AFF1 . | Other KMT2A-r . | P value . | |
| Number of patients (%) | 141 (12.9) | 950 (87.1) | 121 (85.8) | 20 (14.2) | ||
| Patient-related characteristics | ||||||
| Median age, y (range) | 42.0 (18.4-59.4) | 36.8 (15.2-59.9) | .02 | 41.7 (18.4-59.4) | 46.2 (21.1-58) | .24 |
| Sex, M:F (ratio) | 62:79 (0.78) | 542:408 (1.3) | .005 | 53:68 (0.8) | 9:11 (0.8) | .99 |
| Disease-related characteristics | ||||||
| Median WBC, x 109/L (range) | 94.4 (1-712) | 6.3 (0-396) | <.0001 | 116 (2-712) | 14.7 (1-216) | .0002 |
| CNS involvement (%) | 10/140 (7.1) | 60/944 (6.4) | .71 | 8/120 (6.7) | 2/20 (10.0) | .64 |
| EGIL classification | 119 (100) | 805 (100) | <.0001 | 103 (100) | 16 (100) | .53 |
| Pro-B (I) | 89 (74.8) | 115 (14.3) | 78 (75.7) | 11 (68.8) | ||
| Common (II) | 4 (3.4) | 538 (66.9) | 3 (2.9) | 1 (6.2) | ||
| Pre-B (III) | 25 (21.0) | 138 (17.1) | 21 (20.4) | 4 (25.0) | ||
| Mature (IV) | 1 (0.8) | 14 (1.7) | 1 (1.0) | 0 (0.0) | ||
| Response-related characteristics | ||||||
| Poor early PB blast clearance | 22/141 (15.6) | 151/945 (16.0) | .99 | 19/121 (15.7) | 3/20 (15.0) | .99 |
| Poor early BM blast clearance | 34/128 (26.6) | 376/895 (42.0) | .001 | 31/110 (28.2) | 3/18 (16.7) | .40 |
| Late CR (achieved after induction 2) | 2/131 (1.5) | 34/875 (3.9) | .22 | 1/112 (0.89) | 1/19 (5.3) | .27 |
| CR (after induction 1 or 2) | 131/141 (92.9) | 875/950 (92.1) | .87 | 112/121 (92.6) | 19/20 (95.0) | .99 |
| Postremission treatment | ||||||
| HSCT in CR1 | 64/131 (48.9) | 265/875 (30.3) | <.0001 | 57/112 (50.9) | 7/19 (36.8) | .32 |
| Postremission outcome | ||||||
| 5-y CIR, % (95% CI) | 40.7 (32.7-49.9) | 33.7 (30.3-37.2) | .02 | 43.0 (34.2-52.9) | 27.6 (12.4-54.5) | .18 |
| 5-y DFS, % (95% CI) | 50.3 (41.1-58.8) | 55.5 (51.7-59.0) | .07 | 49.3 (39.4-58.5) | 56.5 (31.2-75.5) | .36 |
| 5-y OS, % (95% CI) | 53.3 (44.5-61.4) | 59.9 (56.2-63.3) | .02 | 51.4 (41.9-60.2) | 64.6 (39.7-81.3) | .21 |
| . | All patients with Ph– BCP-ALL (n = 1091) . | Patients with KMT2A-r BCP-ALL (n = 141) . | ||||
|---|---|---|---|---|---|---|
| KMT2A-r BCP-ALL . | Other BCP-ALL . | P value . | KMT2A::AFF1 . | Other KMT2A-r . | P value . | |
| Number of patients (%) | 141 (12.9) | 950 (87.1) | 121 (85.8) | 20 (14.2) | ||
| Patient-related characteristics | ||||||
| Median age, y (range) | 42.0 (18.4-59.4) | 36.8 (15.2-59.9) | .02 | 41.7 (18.4-59.4) | 46.2 (21.1-58) | .24 |
| Sex, M:F (ratio) | 62:79 (0.78) | 542:408 (1.3) | .005 | 53:68 (0.8) | 9:11 (0.8) | .99 |
| Disease-related characteristics | ||||||
| Median WBC, x 109/L (range) | 94.4 (1-712) | 6.3 (0-396) | <.0001 | 116 (2-712) | 14.7 (1-216) | .0002 |
| CNS involvement (%) | 10/140 (7.1) | 60/944 (6.4) | .71 | 8/120 (6.7) | 2/20 (10.0) | .64 |
| EGIL classification | 119 (100) | 805 (100) | <.0001 | 103 (100) | 16 (100) | .53 |
| Pro-B (I) | 89 (74.8) | 115 (14.3) | 78 (75.7) | 11 (68.8) | ||
| Common (II) | 4 (3.4) | 538 (66.9) | 3 (2.9) | 1 (6.2) | ||
| Pre-B (III) | 25 (21.0) | 138 (17.1) | 21 (20.4) | 4 (25.0) | ||
| Mature (IV) | 1 (0.8) | 14 (1.7) | 1 (1.0) | 0 (0.0) | ||
| Response-related characteristics | ||||||
| Poor early PB blast clearance | 22/141 (15.6) | 151/945 (16.0) | .99 | 19/121 (15.7) | 3/20 (15.0) | .99 |
| Poor early BM blast clearance | 34/128 (26.6) | 376/895 (42.0) | .001 | 31/110 (28.2) | 3/18 (16.7) | .40 |
| Late CR (achieved after induction 2) | 2/131 (1.5) | 34/875 (3.9) | .22 | 1/112 (0.89) | 1/19 (5.3) | .27 |
| CR (after induction 1 or 2) | 131/141 (92.9) | 875/950 (92.1) | .87 | 112/121 (92.6) | 19/20 (95.0) | .99 |
| Postremission treatment | ||||||
| HSCT in CR1 | 64/131 (48.9) | 265/875 (30.3) | <.0001 | 57/112 (50.9) | 7/19 (36.8) | .32 |
| Postremission outcome | ||||||
| 5-y CIR, % (95% CI) | 40.7 (32.7-49.9) | 33.7 (30.3-37.2) | .02 | 43.0 (34.2-52.9) | 27.6 (12.4-54.5) | .18 |
| 5-y DFS, % (95% CI) | 50.3 (41.1-58.8) | 55.5 (51.7-59.0) | .07 | 49.3 (39.4-58.5) | 56.5 (31.2-75.5) | .36 |
| 5-y OS, % (95% CI) | 53.3 (44.5-61.4) | 59.9 (56.2-63.3) | .02 | 51.4 (41.9-60.2) | 64.6 (39.7-81.3) | .21 |
Poor early PB blast clearance at day 8 is defined by ≥1x 109/L blast. Poor early BM blast clearance at day 15 is defined by ≥5% blasts.
BM, bone marrow; CNS, central nervous system; EGIL, European Group for the Immunological Characterization of Leukemias; F, female; M, male; PB, peripheral blood.