Effect of MRD and treatment on the outcome of UKALL2003 patients with BCP ALL stratified by genetic risk group
| Genetic risk group . | Number (%) of patients . | 5-y rate (%) or HR (99% CI), P value . | ||
|---|---|---|---|---|
| EFS . | Relapse risk . | OS . | ||
| GR | ||||
| Total | 561 (100) | 94 (90-96) | 4 (2-7) | 97 (94-98) |
| MRD risk group* | ||||
| Low | 244 (43) | 97 (91-99) | 2 (0-7) | 99 (95-100) |
| High | 176 (31) | 91 (83-96) | 7 (3-15) | 95 (88-98) |
| HR vs LR | 3.45 (1.34-8.9), .01 | 5.49 (1.55-19.48), .008 | 4.77 (0.99-22.97), .05 | |
| Indeterminate | 141 (25) | 91(82-96) | 4 (1-12) | 94 (86-98) |
| Treatment regimen | ||||
| Regimen A | 350 (62) | 94 (90-97) | 3 (1-8) | 98 (95-99) |
| Regimen B | 113 (20) | 93 (83-97) | 4 (1-15) | 94 (82-98) |
| Regimen C | 98 (17) | 91 (80-96) | 6 (2-17) | 94 (83-98) |
| Regimen A vs B | 0.78 (0.33-1.89), .6 | 0.73 (0.22-2.37), .6 | 0.32 (0.10-0.99), .05 | |
| Regimen C vs B | 1.45 (0.54-3.90), .5 | 1.68 (0.47-5.97), .4 | 0.94 (0.29-3.09), .9 | |
| MRD HR† | ||||
| Regimen A/B | 92 (62) | 90 (78-96) | 8 (3-20) | 95 (83-99) |
| Regimen C | 56 (38) | 94 (77-99) | 4 (1-23) | 94 (75-99) |
| Regimen C vs A/B | 0.75 (0.23-2.49), .6 | 0.73 (0.18-2.93), .7 | 1.19 (0.27-5.31), .8 | |
| PR | ||||
| MRD risk group* | 181 (100) | 79 (69-85) | 17 (10-26) | 83 (73-89) |
| LR | 58 (32) | 94 (76-99) | 6 (1-24) | 92 (69-98) |
| HR | 86 (48) | 68 (52-80) | 26 (15-42) | 77 (62-87) |
| HR vs LR | 5.21 (1.82-14.95), .002 | 3.94 (1.34-11.59), .01 | 5.36 (1.6-17.98), .007 | |
| IR | 37 (20) | 78 (54-91) | 15 (5-40) | 81 (57-92) |
| Treatment regimen | ||||
| Regimen A | 46 (25) | 83 (61-94) | 15 (5-38) | 84 (60-94) |
| Regimen B | 59 (33) | 86 (70-94) | 7 (2-24) | 86 (68-94) |
| Regimen C | 76 (42) | 69 (51-81) | 26 (15-45) | 79 (64-89) |
| Regimen A vs B | 1.29 (0.48-3.44), .6 | 2.30 (0.67-7.86), .2 | 0.96 (0.33-2.76), .9 | |
| Regimen C vs B | 2.30 (1.02-5.18), .04 | 3.69 (1.24-10.97), .02 | 1.74 (0.75-4.03) .2 | |
| MRD HR‡ | ||||
| Regimen A/B | 25 (41) | 68 (38-86) | 22 (7-54) | 71 (41-88) |
| Regimen C | 20 (59) | 67 (29-87) | 33 (13-71) | 81 (38-96) |
| Regimen C vs A/B | 0.80 (0.28-2.32), .7 | 1.29 (0.39-4.23), .7 | 0.78 (0.30-2.03), .3 | |
| Genetic risk group . | Number (%) of patients . | 5-y rate (%) or HR (99% CI), P value . | ||
|---|---|---|---|---|
| EFS . | Relapse risk . | OS . | ||
| GR | ||||
| Total | 561 (100) | 94 (90-96) | 4 (2-7) | 97 (94-98) |
| MRD risk group* | ||||
| Low | 244 (43) | 97 (91-99) | 2 (0-7) | 99 (95-100) |
| High | 176 (31) | 91 (83-96) | 7 (3-15) | 95 (88-98) |
| HR vs LR | 3.45 (1.34-8.9), .01 | 5.49 (1.55-19.48), .008 | 4.77 (0.99-22.97), .05 | |
| Indeterminate | 141 (25) | 91(82-96) | 4 (1-12) | 94 (86-98) |
| Treatment regimen | ||||
| Regimen A | 350 (62) | 94 (90-97) | 3 (1-8) | 98 (95-99) |
| Regimen B | 113 (20) | 93 (83-97) | 4 (1-15) | 94 (82-98) |
| Regimen C | 98 (17) | 91 (80-96) | 6 (2-17) | 94 (83-98) |
| Regimen A vs B | 0.78 (0.33-1.89), .6 | 0.73 (0.22-2.37), .6 | 0.32 (0.10-0.99), .05 | |
| Regimen C vs B | 1.45 (0.54-3.90), .5 | 1.68 (0.47-5.97), .4 | 0.94 (0.29-3.09), .9 | |
| MRD HR† | ||||
| Regimen A/B | 92 (62) | 90 (78-96) | 8 (3-20) | 95 (83-99) |
| Regimen C | 56 (38) | 94 (77-99) | 4 (1-23) | 94 (75-99) |
| Regimen C vs A/B | 0.75 (0.23-2.49), .6 | 0.73 (0.18-2.93), .7 | 1.19 (0.27-5.31), .8 | |
| PR | ||||
| MRD risk group* | 181 (100) | 79 (69-85) | 17 (10-26) | 83 (73-89) |
| LR | 58 (32) | 94 (76-99) | 6 (1-24) | 92 (69-98) |
| HR | 86 (48) | 68 (52-80) | 26 (15-42) | 77 (62-87) |
| HR vs LR | 5.21 (1.82-14.95), .002 | 3.94 (1.34-11.59), .01 | 5.36 (1.6-17.98), .007 | |
| IR | 37 (20) | 78 (54-91) | 15 (5-40) | 81 (57-92) |
| Treatment regimen | ||||
| Regimen A | 46 (25) | 83 (61-94) | 15 (5-38) | 84 (60-94) |
| Regimen B | 59 (33) | 86 (70-94) | 7 (2-24) | 86 (68-94) |
| Regimen C | 76 (42) | 69 (51-81) | 26 (15-45) | 79 (64-89) |
| Regimen A vs B | 1.29 (0.48-3.44), .6 | 2.30 (0.67-7.86), .2 | 0.96 (0.33-2.76), .9 | |
| Regimen C vs B | 2.30 (1.02-5.18), .04 | 3.69 (1.24-10.97), .02 | 1.74 (0.75-4.03) .2 | |
| MRD HR‡ | ||||
| Regimen A/B | 25 (41) | 68 (38-86) | 22 (7-54) | 71 (41-88) |
| Regimen C | 20 (59) | 67 (29-87) | 33 (13-71) | 81 (38-96) |
| Regimen C vs A/B | 0.80 (0.28-2.32), .7 | 1.29 (0.39-4.23), .7 | 0.78 (0.30-2.03), .3 | |
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 (n = 28) who were allocated regimen C on the basis of an SER defined by percentage of blasts in the bone marrow at day 8 (regimen B) or day 15 (regimen A) were excluded.
Patients who were allocated regimen C on the basis of an SER (n = 18) or CYTO-HR (n = 23) were excluded.