TABLE 2A.
10‐year CI of an SMN and competing events and event‐free survival according to the initial characteristics
| Secondary malignancies | Competing events | Event‐free survival | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Parameters | Pts. | Events | 10‐year CI | p‐Value | Events | 10‐year CI | p‐Value | 10‐year EFS | p‐value |
| All patients | 1487 | 19 | 1.1% ± 0.3% | 328 | 24.0% ± 1.2% | 75.0 ± 1.2% | |||
| Trial | |||||||||
| ALL‐BFM‐A 81 | 141 | 1 | 0.7% ± 0.7% | 0.202 | 59 | 42.8% ± 4.2% | <0.001 | 56.5 ± 4.2% | <0.001 |
| ALL‐A 84 | 127 | 5 | 0.0% ± 0.0% | 44 | 34.2% ± 4.2% | 65.8 ± 4.2% | |||
| ALL‐BFM‐A 86 | 142 | 3 | 1.4% ± 1.0% | 33 | 22.6% ± 3.5% | 76.0 ± 3.6% | |||
| ALL‐BFM‐A 90 | 256 | 3 | 1.3% ± 0.7% | 61 | 24.1% ± 2.7% | 74.7 ± 2.7% | |||
| ALL‐BFM‐A 95 | 230 | 1 | 0.4% ± 0.4% | 48 | 21.1% ± 2.7% | 78.5 ± 2.7% | |||
| ALL‐BFM‐A 2000 | 591 | 6 | 2.2% ± 1.3% | 83 | 18.3% ± 2.0% | 79.5 ± 2.4% | |||
| Earlier era (81, 84, 86) | 410 | 9 | 0.7% ± 0.4% | 0.983 | 136 | 33.1% ± 2.3% | <0.001 | 66.2 ± 2.4% | <0.001 |
| Later era (90, 95, 2000) | 1077 | 10 | 1.3% ± 0.4% | 192 | 20.5% ± 1.4% | 78.3 ± 1.4% | |||
| Gender | |||||||||
| Male | 826 | 9 | 1.0% ± 0.4% | 0.544 | 185 | 24.6% ± 1.6% | 0.82 | 74.4 ± 1.6% | 0.939 |
| Female | 661 | 10 | 1.2% ± 0.5% | 143 | 23.1% ± 1.7% | 75.7 ± 1.8% | |||
| Age (years) | |||||||||
| < 1 | 25 | 0 | 0.0% ± 0.0% | 0.559 | 16 | 65.3% ± 9.7% | <0.001 | 34.7 ± 9.7% | <0.001 |
| 1–10 | 1126 | 14 | 0.9% ± 0.3% | 213 | 20.6% ± 1.3% | 78.5 ± 1.3% | |||
| ≥10 | 336 | 5 | 1.7% ± 0.9% | 98 | 32.2% ± 2.8% | 65.8 ± 2.8% | |||
| WBC count (G/L) | |||||||||
| < 20.0 | 959 | 12 | 1.0% ± 0.3% | 0.033 | 181 | 20.9% ± 1.4% | <0.001 | 78.1 ± 1.4% | <0.001 |
| 20.0–50.0 | 226 | 0 | 0.0% ± 0.0% | 52 | 24.4% ± 3.0% | 75.6 ± 3.0% | |||
| ≥50.0 | 302 | 7 | 2.1% ± 1.1% | 94 | 33.2% ± 2.8% | 64.7 ± 2.9% | |||
| CNS disease | |||||||||
| Negative | 1425 | 17 | 1.0% ± 0.3% | 0.595 | 308 | 23.5% ± 1.2% | 0.027 | 75.5 ± 1.2% | 0.015 |
| Positive | 49 | 1 | 0.0% ± 0.0% | 16 | 34.1% ± 7.0% | 65.9 ± 7.0% | |||
| Immunophenotype | |||||||||
| BCP‐ALL | 1237 | 16 | 1.1% ± 0.3% | 0.929 | 256 | 22.8% ± 1.3% | 0.1 | 76.1 ± 1.3% | 0.097 |
| T‐ALL | 198 | 3 | 1.0% ± 0.9% | 49 | 25.6% ± 3.2% | 73.5 ± 3.3% | |||
| Genetics | |||||||||
| ETV6::RUNX1 | |||||||||
| Positive | 264 | 4 | 1.9% ± 0.9% | 0.416 | 27 | 12.5% ± 2.4% | <0.001 | 85.6 ± 2.5% | <0.001 |
| Negative | 953 | 9 | 1.1% ± 0.4% | 196 | 22.6% ± 1.4% | 76.3 ± 1.5% | |||
| TCF3::PBX1 | |||||||||
| Positive | 37 | 0 | 0.0% ± 0.0% | 0.531 | 4 | 11.6 ± 5.5% | 0.26 | 88.4 ± 5.5% | 0.215 |
| Negative | 1180 | 13 | 1.3% ± 0.4% | 219 | 20.7 ± 1.3% | 78.0 ± 1.3% | |||
| BCR::ABL1 | |||||||||
| Positive | 24 | 0 | 0.0% ± 0.0% | 0.637 | 14 | 67.4% ± 11.3% | <0.001 | 32.6 ± 11.3% | <0.001 |
| Negative | 1193 | 13 | 1.3% ± 0.4% | 209 | 19.5% ± 1.2% | 79.2 ± 1.3% | |||
| KMT2A‐rearrangement | |||||||||
| Positive | 31 | 1 | 0.0% ± 0.0% | 0.38 | 10 | 33.8% ± 8.8% | 0.029 | 66.2 ± 8.8% | 0.012 |
| Negative | 1186 | 12 | 1.3% ± 0.4% | 213 | 20.0% ± 1.3% | 78.6 ± 1.3% | |||
| High‐hyperdiploidy | |||||||||
| Positive | 292 | 2 | 1.2% ± 0.8% | 0.521 | 44 | 17.5% ± 2.5% | 0.062 | 81.3 ± 2.6% | 0.048 |
| Negative | 820 | 10 | 1.3% ± 0.5% | 161 | 21.9% ± 1.6% | 76.8 ± 1.6% | |||
Note: Analyses were only performed for those parameters with available results.
Abbreviations: BCP, B‐cell precursor; CI, cumulative incidence; CNS, central nervous system; EFS, event‐free survival; Pts, patients; SMN, secondary malignant neoplasm; WBC count, white blood cell count.