Table 5.
Protocol 85-01 Outcome by Patient Characteristics
| Event-free Survival ± SE (%) | Overall Survival ± SE (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Protocol | N | 5-yr EFS | 10-yr EFS | 12-yr EFS | p-value | 5-yr OS | 10-yr OS | 12-yr OS | p-value |
| Overall | 220 | 78.4 ± 2.8 | 77.9 ± 2.8 | 77.9 ± 2.8 | 83.9 ± 2.5 | 80.9 ± 2.7 | 80.9 ± 2.7 | ||
| Immunophenotype | |||||||||
| B-precursor | 200 | 79.3 ± 2.9 | 78.7 ± 2.9 | 78.7 ± 2.9 | 0.262 | 85.3 ± 2.5 | 82.0 ± 2.8 | 82.0 ± 2.8 | 0.122 |
| T cell | 20 | 70.0 ± 10.3 | 70.0 ± 10.3 | 70.0 ± 10.3 | 70.0 ± 10.3 | 70.0 ± 10.3 | 70.0 ± 10.3 | ||
| B-precursor† | |||||||||
| NCI Standard | 130 | 84.4 ± 3.2 | 84.4 ± 3.2 | 84.4 ± 3.2 | 0.035 | 89.8 ± 2.7 | 88.1 ± 2.9 | 88.1 ± 2.9 | 0.015 |
| NCI High | 60 | 71.6 ± 5.8 | 69.8 ± 6.0 | 69.8 ± 6.0 | 79.9 ± 5.2 | 72.7 ± 5.9 | 72.7 ± 5.9 | ||
| T-lineage† | |||||||||
| NCI Standard | 6 | 83.3 ± 15.2 | 83.3 ± 15.2 | 83.3 ± 15.2 | 0.356 | 83.3 ± 15.2 | 83.3 ± 15.2 | 83.3 ± 15.2 | 0.354 |
| NCI High | 14 | 64.3 ± 12.8 | 64.3 ± 12.8 | 64.3 ± 12.8 | 64.3 ± 12.8 | 64.3 ± 12.8 | 64.3 ± 12.8 | ||
| Sex | |||||||||
| Male | 116 | 74.7 ± 4.1 | 73.8 ± 4.1 | 73.8 ± 4.1 | 0.198 | 83.4 ± 3.5 | 78.7 ± 3.9 | 78.7 ± 3.9 | 0.552 |
| Female | 104 | 82.6 ± 3.7 | 82.6 ± 3.7 | 82.6 ± 3.7 | 84.5 ± 3.6 | 83.5 ± 3.7 | 83.5 ± 3.7 | ||
| Age at Diagnosis | |||||||||
| <1 year | 10 | 60.0 ± 15.5 | 60.0 ± 15.5 | 60.0 ± 15.5 | 0.122 | 60.0 ± 15.5 | 60.0 ± 15.5 | 60.0 ± 15.5 | 0.043 |
| 1–9 years | 168 | 80.7 ± 3.1 | 80.0 ± 3.1 | 80.0 ± 3.1 | 86.1 ± 2.7 | 84.2 ± 2.8 | 84.2 ± 2.8 | ||
| ≥10 years | 42 | 73.7 ± 6.8 | 71.2 ± 7.0 | 71.2 ± 7.0 | 80.8 ± 6.1 | 72.6 ± 7.1 | 72.6 ± 7.1 | ||
| WBC (× 109/L) | |||||||||
| <10 | 98 | 86.6 ± 3.5 | 85.5 ± 3.6 | 85.5 ± 3.6 | 0.0004 | 90.7 ± 3.0 | 88.4 ± 3.3 | 88.4 ± 3.3 | 0.0002 |
| 10–49 | 77 | 76.2 ± 4.9 | 76.2 ± 4.9 | 76.2 ± 4.9 | 84.0 ± 4.2 | 79.7 ± 4.7 | 79.7 ± 4.7 | ||
| 50–99 | 18 | 83.3 ± 8.8 | 83.3 ± 8.8 | 83.3 ± 8.8 | 83.3 ± 8.8 | 83.3 ± 8.8 | 83.3 ± 8.8 | ||
| ≥100 | 27 | 51.9 ± 9.6 | 51.9 ± 9.6 | 51.9 ± 9.6 | 59.3 ± 9.5 | 55.6 ± 9.6 | 55.6 ± 9.6 | ||
| CNS leukemia | |||||||||
| CNS-3 | 4 | 50.0 ± 25.0 | 50.0 ± 25.0 | 50.0 ± 25.0 | 0.057 | 50.0 ± 25.0 | 50.0 ± 25.0 | 50.0 ± 25.0 | 0.035 |
| Other | 216 | 79.0 ± 2.8 | 78.4 ± 2.8 | 78.4 ± 2.8 | 84.5 ± 2.5 | 81.5 ± 2.7 | 81.5 ± 2.7 | ||
| t(9;22) | |||||||||
| Present | 3 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.0 | <0.0001 | 33.3 ± 27.2 | 33.3 ± 27.2 | 33.3 ± 27.2 | 0.011 |
| All others | 217 | 79.5 ± 2.8 | 79.0 ± 2.8 | 79.0 ± 2.8 | 84.6 ± 2.5 | 81.6 ± 2.7 | 81.6 ± 2.7 | ||
| DFCI Risk Group | |||||||||
| Standard | 82 | 88.8 ± 3.5 | 88.8 ± 3.5 | 88.8 ± 3.5 | 0.003 | 93.7 ± 2.7 | 92.4 ± 3.0 | 92.4 ± 3.0 | 0.0008 |
| High/Very High | 138 | 72.4 ± 3.8 | 71.6 ± 3.9 | 71.6 ± 3.9 | 78.1 ± 3.5 | 74.2 ± 3.8 | 74.2 ± 3.8 | ||
†
Excludes and infants <1 year age.