Clinical and biological features and related outcome (event-free survival [EFS] estimated at 5 years from diagnosis) in pB-ALL Ph− patients according to MRD classification
| . | MRD-SR . | MRD-IR . | MRD-HR . | Total, no. . | |||
|---|---|---|---|---|---|---|---|
| No. (%) . | 5-y EFS (SE) . | No. (%) . | 5-y EFS (SE) . | No. (%) . | 5-y EFS (SE) . | ||
| Total | 1348 (42.3) | 92.3 (0.9) | 1647 (51.7) | 77.6 (1.3) | 189 (5.9) | 50.1 (4.1) | 3184 |
| Sex | |||||||
| Male | 684 (40.8) | 92.3 (1.2) | 883 (52.7) | 74.9 (1.8) | 109 (6.5) | 43.5 (5.3) | 1676 |
| Female | 664 (44.0) | 92.3 (1.3) | 764 (50.7) | 80.7 (1.7) | 80 (5.3) | 59.1 (6.4) | 1508 |
| Age, y | |||||||
| 1-9 | 1165 (45.0) | 93.5 (0.9) | 1298 (81.7) | 79.0 (1.4) | 126 (7.9) | 50.2 (5.2) | 2589 |
| 10-17 | 183 (30.8) | 84.4 (3.4) | 349 (58.7) | 72.3 (2.9) | 63 (10.6) | 50.3 (6.7) | 595 |
| WBC count, ×109/L | |||||||
| Lower than 50 | 1174 (43.1) | 92.9 (0.9) | 1416 (51.9) | 79.3 (1.3) | 137 (5.0) | 49.7 (5.0) | 2727 |
| 50-100 | 104 (39.1) | 89.6 (3.3) | 137 (51.5) | 71.3 (4.5) | 25 (9.4) | 55.4 (10.1) | 266 |
| 100 or higher | 70 (36.7) | 86.1 (4.8) | 94 (49.2) | 60.7 (6.0) | 27 (14.1) | 46.6 (9.9) | 191 |
| NCI criteria* | |||||||
| Standard | 1007 (45.3) | 94.1 (0.9) | 1122 (50.5) | 80.3 (1.5) | 95 (4.3) | 49.3 (6.1) | 2224 |
| High | 341 (35.5) | 86.9 (2.2) | 525 (54.7) | 71.8 (2.4) | 94 (9.8) | 51.4 (5.4) | 960 |
| TEL/AML1 | |||||||
| Negative | 801 (36.8) | 90.6 (1.3) | 1204 (55.4) | 76.1 (1.5) | 169 (7.8) | 51.1 (4.4) | 2174 |
| Positive | 440 (57.7) | 94.9 (1.2) | 312 (40.9) | 81.7 (2.8) | 10 (1.3) | 54.9 (17.2) | 762 |
| Not known | 107 (43.2) | 94.1 (2.6) | 131 (52.8) | 80.8 (4.4) | 10 (4.0) | 30.0 (14.5) | 248 |
| DNA index | |||||||
| 1.16 or more and less than 1.6 | 218 (44.8) | 93.7 (2.1) | 262 (53.8) | 79.8 (3.1) | 7 (1.4) | 487 | |
| Less than 1.16 or 1.6 or more | 814 (40.9) | 91.4 (1.2) | 1022 (51.3) | 74.9 (1.7) | 155 (7.8) | 52.1 (4.6) | 1991 |
| Not known | 316 (44.8) | 93.8 (1.6) | 363 (51.4) | 83.4 (2.3) | 27 (3.8) | 39.2 (10.4) | 706 |
| Response to prednisone | |||||||
| Prednisone good responders | 1310 (44.1) | 92.3 (0.9) | 1524 (51.3) | 77.6 (1.3) | 138 (4.6) | 50.3 (4.9) | 2972 |
| Prednisone poor responders | 36 (17.9) | 91.8 (5.9) | 116 (57.7) | 79.2 (4.5) | 49 (24.4) | 50.5 (7.7) | 201 |
| Not known | 2 (18.2) | 7 (63.6) | 2 (18.2) | 11 | |||
| BFM 95 criteria† | |||||||
| Standard | 597 (47.3) | 94.0 (1.2) | 628 (49.7) | 83.8 (1.8) | 38 (3.0) | 42.9 (9.6) | 1263 |
| Medium | 714 (42.4) | 90.9 (1.3) | 889 (52.8) | 73.3 (1.8) | 81 (4.8) | 56.2 (6.2) | 1684 |
| High | 37 (15.6) | 92.2 (5.6) | 130 (54.9) | 77.4 (4.3) | 70 (29.5) | 47.3 (6.4) | 237 |
| Final stratification AIEOP-BFM 2000 | |||||||
| Standard | 1311 (100.0) | 92.3 (0.9) | 0 | 0 | 1311 | ||
| Intermediate | 0 | 1517 (100.0) | 77.6 (1.3) | 0 | 1517 | ||
| High | 37‡ (10.4) | 92.2 (5.6) | 130§ (36.5) | 77.4 (4.3) | 189 (53.1) | 50.1 (4.1) | 356 |
| . | MRD-SR . | MRD-IR . | MRD-HR . | Total, no. . | |||
|---|---|---|---|---|---|---|---|
| No. (%) . | 5-y EFS (SE) . | No. (%) . | 5-y EFS (SE) . | No. (%) . | 5-y EFS (SE) . | ||
| Total | 1348 (42.3) | 92.3 (0.9) | 1647 (51.7) | 77.6 (1.3) | 189 (5.9) | 50.1 (4.1) | 3184 |
| Sex | |||||||
| Male | 684 (40.8) | 92.3 (1.2) | 883 (52.7) | 74.9 (1.8) | 109 (6.5) | 43.5 (5.3) | 1676 |
| Female | 664 (44.0) | 92.3 (1.3) | 764 (50.7) | 80.7 (1.7) | 80 (5.3) | 59.1 (6.4) | 1508 |
| Age, y | |||||||
| 1-9 | 1165 (45.0) | 93.5 (0.9) | 1298 (81.7) | 79.0 (1.4) | 126 (7.9) | 50.2 (5.2) | 2589 |
| 10-17 | 183 (30.8) | 84.4 (3.4) | 349 (58.7) | 72.3 (2.9) | 63 (10.6) | 50.3 (6.7) | 595 |
| WBC count, ×109/L | |||||||
| Lower than 50 | 1174 (43.1) | 92.9 (0.9) | 1416 (51.9) | 79.3 (1.3) | 137 (5.0) | 49.7 (5.0) | 2727 |
| 50-100 | 104 (39.1) | 89.6 (3.3) | 137 (51.5) | 71.3 (4.5) | 25 (9.4) | 55.4 (10.1) | 266 |
| 100 or higher | 70 (36.7) | 86.1 (4.8) | 94 (49.2) | 60.7 (6.0) | 27 (14.1) | 46.6 (9.9) | 191 |
| NCI criteria* | |||||||
| Standard | 1007 (45.3) | 94.1 (0.9) | 1122 (50.5) | 80.3 (1.5) | 95 (4.3) | 49.3 (6.1) | 2224 |
| High | 341 (35.5) | 86.9 (2.2) | 525 (54.7) | 71.8 (2.4) | 94 (9.8) | 51.4 (5.4) | 960 |
| TEL/AML1 | |||||||
| Negative | 801 (36.8) | 90.6 (1.3) | 1204 (55.4) | 76.1 (1.5) | 169 (7.8) | 51.1 (4.4) | 2174 |
| Positive | 440 (57.7) | 94.9 (1.2) | 312 (40.9) | 81.7 (2.8) | 10 (1.3) | 54.9 (17.2) | 762 |
| Not known | 107 (43.2) | 94.1 (2.6) | 131 (52.8) | 80.8 (4.4) | 10 (4.0) | 30.0 (14.5) | 248 |
| DNA index | |||||||
| 1.16 or more and less than 1.6 | 218 (44.8) | 93.7 (2.1) | 262 (53.8) | 79.8 (3.1) | 7 (1.4) | 487 | |
| Less than 1.16 or 1.6 or more | 814 (40.9) | 91.4 (1.2) | 1022 (51.3) | 74.9 (1.7) | 155 (7.8) | 52.1 (4.6) | 1991 |
| Not known | 316 (44.8) | 93.8 (1.6) | 363 (51.4) | 83.4 (2.3) | 27 (3.8) | 39.2 (10.4) | 706 |
| Response to prednisone | |||||||
| Prednisone good responders | 1310 (44.1) | 92.3 (0.9) | 1524 (51.3) | 77.6 (1.3) | 138 (4.6) | 50.3 (4.9) | 2972 |
| Prednisone poor responders | 36 (17.9) | 91.8 (5.9) | 116 (57.7) | 79.2 (4.5) | 49 (24.4) | 50.5 (7.7) | 201 |
| Not known | 2 (18.2) | 7 (63.6) | 2 (18.2) | 11 | |||
| BFM 95 criteria† | |||||||
| Standard | 597 (47.3) | 94.0 (1.2) | 628 (49.7) | 83.8 (1.8) | 38 (3.0) | 42.9 (9.6) | 1263 |
| Medium | 714 (42.4) | 90.9 (1.3) | 889 (52.8) | 73.3 (1.8) | 81 (4.8) | 56.2 (6.2) | 1684 |
| High | 37 (15.6) | 92.2 (5.6) | 130 (54.9) | 77.4 (4.3) | 70 (29.5) | 47.3 (6.4) | 237 |
| Final stratification AIEOP-BFM 2000 | |||||||
| Standard | 1311 (100.0) | 92.3 (0.9) | 0 | 0 | 1311 | ||
| Intermediate | 0 | 1517 (100.0) | 77.6 (1.3) | 0 | 1517 | ||
| High | 37‡ (10.4) | 92.2 (5.6) | 130§ (36.5) | 77.4 (4.3) | 189 (53.1) | 50.1 (4.1) | 356 |
MRD affected outcome significantly (at the .001 level) in every subgroup.
ALL indicates acute lymphoblastic leukemia; MRD, minimal residual disease; SR, standard risk; IR, intermediate risk; HR, high risk; SE, standard error; WBC white blood cell; NCI, National Cancer Institute; BFM, Berlin-Frankfurt-Münster; and AIEOP, Associazione Italiana di Ematologia Oncologia Pediatrica.
Standard: age 1-9 years and WBC < 50 000; high: age ≥ 10 years or WBC ≥ 50 000.
High: PPR or no remission on day +33 or t(4;11); medium: no high-risk criteria, WBC ≥ 20 000 or age ≥ 6 years or T-ALL; standard: no high-risk criteria, WBC < 20 000 and age between 1 and 6 years and no T-ALL.
These patients were at high risk for no CR day +33 (n = 1) or PPR (n = 36).
These patients were at high risk for no CR day +33 (n = 8) or MLL/AF4 fusion transcript (n = 8) or PPR (n = 114).