Demographic, clinical, genetic, and outcome features of MRC ALL97/99 and UKALL2003 patients with BCP-ALL stratified by genetic risk group
| Variable/category . | ALL97/99 . | UKALL2003 . | ||||
|---|---|---|---|---|---|---|
| GEN-GR, n (%) . | GEN-PR, n (%) . | P . | GEN-GR, n (%) . | GEN-PR, n (%) . | P . | |
| Total number of patients | 579 (72) | 230 (28) | — | 561 (76) | 181 (24) | — |
| Sex | ||||||
| Female | 255 (44) | 100 (44) | 1 | 262 (47) | 78 (43) | .49 |
| Male | 324 (56) | 130 (56) | 299 (53) | 103 (57) | ||
| Age (y) | ||||||
| 1-9 | 501 (87) | 150 (65) | <.001 | 465 (83) | 103 (56) | <.001 |
| 10-14 | 63 (11) | 66 (29) | 65 (11) | 48 (27) | ||
| ≥15 | 15 (3) | 14 (6) | 31 (5) | 30 (17) | ||
| WCC | ||||||
| <50 × 109/L | 498 (86) | 142 (62) | <.001 | 486 (87) | 129 (71) | <.001 |
| >50 × 109/L | 81 (14) | 88 (38) | 75 (13) | 52 (29) | ||
| NCI risk group* | ||||||
| Standard | 426 (74) | 87 (38) | <.001 | 399 (71) | 69 (37) | <.001 |
| High | 153 (26) | 143 (62) | 162 (29) | 112 (63) | ||
| Cytogenetic risk group† | ||||||
| GR | 469 (81) | 0 (0) | <.001 | 453 (81) | 0 (0) | <.001 |
| IR | 110 (19) | 157 (70) | 108 (19) | 138 (70) | ||
| HR | 0 (0) | 73 (30) | 0 (0) | 43 (30) | ||
| MRD‡ | ||||||
| LR | — | — | — | 244 (43) | 58 (32) | <.001 |
| HR | — | — | — | 176 (31) | 86 (48) | |
| IR | — | — | — | 141 (25) | 37 (20) | |
| Complete remission | ||||||
| No | 3 (1) | 5 (2) | .05 | 2 (0) | 0 (0) | 1 |
| Yes | 576 (99) | 225 (98) | 559 (100) | 181 (100) | ||
| Event | ||||||
| No | 476 (82) | 119 (52) | — | 528 (94) | 143 (79) | — |
| Yes | 103 (18) | 111 (48) | 33 (6) | 38 (21) | ||
| Relapse | ||||||
| No | 490 (85) | 133 (59) | — | 540 (97) | 153 (85) | — |
| Yes | 86 (15) | 92 (41) | 19 (3) | 28 (15) | ||
| Dead | ||||||
| No | 529 (91) | 147 (64) | — | 544 (97) | 150 (83) | — |
| Yes | 50 (9) | 83 (36) | 17 (3) | 31 (17) | ||
| Variable/category . | ALL97/99 . | UKALL2003 . | ||||
|---|---|---|---|---|---|---|
| GEN-GR, n (%) . | GEN-PR, n (%) . | P . | GEN-GR, n (%) . | GEN-PR, n (%) . | P . | |
| Total number of patients | 579 (72) | 230 (28) | — | 561 (76) | 181 (24) | — |
| Sex | ||||||
| Female | 255 (44) | 100 (44) | 1 | 262 (47) | 78 (43) | .49 |
| Male | 324 (56) | 130 (56) | 299 (53) | 103 (57) | ||
| Age (y) | ||||||
| 1-9 | 501 (87) | 150 (65) | <.001 | 465 (83) | 103 (56) | <.001 |
| 10-14 | 63 (11) | 66 (29) | 65 (11) | 48 (27) | ||
| ≥15 | 15 (3) | 14 (6) | 31 (5) | 30 (17) | ||
| WCC | ||||||
| <50 × 109/L | 498 (86) | 142 (62) | <.001 | 486 (87) | 129 (71) | <.001 |
| >50 × 109/L | 81 (14) | 88 (38) | 75 (13) | 52 (29) | ||
| NCI risk group* | ||||||
| Standard | 426 (74) | 87 (38) | <.001 | 399 (71) | 69 (37) | <.001 |
| High | 153 (26) | 143 (62) | 162 (29) | 112 (63) | ||
| Cytogenetic risk group† | ||||||
| GR | 469 (81) | 0 (0) | <.001 | 453 (81) | 0 (0) | <.001 |
| IR | 110 (19) | 157 (70) | 108 (19) | 138 (70) | ||
| HR | 0 (0) | 73 (30) | 0 (0) | 43 (30) | ||
| MRD‡ | ||||||
| LR | — | — | — | 244 (43) | 58 (32) | <.001 |
| HR | — | — | — | 176 (31) | 86 (48) | |
| IR | — | — | — | 141 (25) | 37 (20) | |
| Complete remission | ||||||
| No | 3 (1) | 5 (2) | .05 | 2 (0) | 0 (0) | 1 |
| Yes | 576 (99) | 225 (98) | 559 (100) | 181 (100) | ||
| Event | ||||||
| No | 476 (82) | 119 (52) | — | 528 (94) | 143 (79) | — |
| Yes | 103 (18) | 111 (48) | 33 (6) | 38 (21) | ||
| Relapse | ||||||
| No | 490 (85) | 133 (59) | — | 540 (97) | 153 (85) | — |
| Yes | 86 (15) | 92 (41) | 19 (3) | 28 (15) | ||
| Dead | ||||||
| No | 529 (91) | 147 (64) | — | 544 (97) | 150 (83) | — |
| Yes | 50 (9) | 83 (36) | 17 (3) | 31 (17) | ||
NCI standard risk includes patients who at diagnosis were <10 years old and had a WCC <50 × 109/L; NCI HR includes all other cases.
Cytogenetic GR (CYTO-GR) includes ETV6-RUNX1 and high hyperdiploidy (51-65 chromosomes); cytogenetic PR (CYTO-PR) includes t(9;22)(q34;q11.2)/BCR-ABL1, MLL translocations, near haploidy (<30 chromosomes), low hypodiploidy (30-39 chromosomes), intrachromosomal amplification of chromosome 21 (iAMP21), or t(17;19)(q23;p13)/HLF-TCF3; cytogenetic IR (CYTO-IR) includes all other cases with abnormal or normal cytogenetics. Cytogenetics failed or was not performed for 55 ALL97/99 and 38 UKALL2003 patients.
MRD was evaluated by real-time quantitative PCR analysis of immunoglobulin and T-cell receptor gene rearrangements as defined by the European MRD Study Group. Patients were classified by MRD at day 29 (end of induction) as HR (> 0.01%), LR (< 0.01%) or indeterminate (no sample, test failed). Patients treated on ALL97/99 were not evaluated by MRD.