Characteristics of 198 patients with high-risk childhood acute lymphoblastic leukemia according to their eligibility criteria
| . | (1) Resistant to protocol Ia . | (2) t(9,22) . | (3) Infants t(4;11) or CD10− . | (4) PPR only . | Total . | % . |
|---|---|---|---|---|---|---|
| Total (%) | 42* (21.2) | 26 (13.1) | 11 (5.6) | 119 (60.1) | 198 | — |
| Sex | ||||||
| Male | 30 | 18 | 4 | 69 | 121 | 61.1 |
| Female | 12 | 8 | 7 | 50 | 77 | 38.9 |
| Age, y | ||||||
| Younger than 1 | 3 | 0 | 11 | 5 | 19 | 9.6 |
| 1 to 5 | 19 | 17 | 0 | 77 | 113 | 57.1 |
| 6 to 9 | 9 | 7 | 0 | 18 | 34 | 17.2 |
| 10 to 17 | 11 | 2 | 0 | 19 | 32 | 16.1 |
| WBC count, /μL | ||||||
| Less than 20 000 | 15 | 9 | 2 | 38 | 64 | 32.3 |
| 20 000 to 99 999 | 14 | 15 | 3 | 51 | 83 | 41.9 |
| 100 000 or more | 13 | 2 | 6 | 30 | 51 | 25.8 |
| Immunophenotype | ||||||
| Non-T | 32 | 26 | 11 | 85 | 154 | 77.8 |
| T | 10 | 0 | 0 | 34 | 44 | 22.2 |
| Prednisone response | ||||||
| Good | 16 | 23 | 6 | 0 | 45 | 22.7 |
| Poor | 24 | 3 | 5 | 119 | 151 | 76.3 |
| Unknown | 2 | 0 | 0 | 0 | 2 | 1.0 |
| CNS involvement | ||||||
| Negative | 40 | 26 | 11 | 113 | 190 | 96.0 |
| Positive | 0 | 0 | 0 | 6 | 6 | 3.0 |
| Unknown | 2 | 0 | 0 | 0 | 2 | 1.0 |
| t(9,22) | ||||||
| Nonpositive | 38 | 0 | 11 | 119 | 168 | 84.8 |
| Positive | 4 | 26 | 0 | 0 | 30 | 15.2 |
| t(4,11) | ||||||
| Nonpositive | 41 | 26 | 4 | 118 | 189 | 95.5 |
| Positive | 1 | 0 | 7 | 1 | 9 | 4.5 |
| . | (1) Resistant to protocol Ia . | (2) t(9,22) . | (3) Infants t(4;11) or CD10− . | (4) PPR only . | Total . | % . |
|---|---|---|---|---|---|---|
| Total (%) | 42* (21.2) | 26 (13.1) | 11 (5.6) | 119 (60.1) | 198 | — |
| Sex | ||||||
| Male | 30 | 18 | 4 | 69 | 121 | 61.1 |
| Female | 12 | 8 | 7 | 50 | 77 | 38.9 |
| Age, y | ||||||
| Younger than 1 | 3 | 0 | 11 | 5 | 19 | 9.6 |
| 1 to 5 | 19 | 17 | 0 | 77 | 113 | 57.1 |
| 6 to 9 | 9 | 7 | 0 | 18 | 34 | 17.2 |
| 10 to 17 | 11 | 2 | 0 | 19 | 32 | 16.1 |
| WBC count, /μL | ||||||
| Less than 20 000 | 15 | 9 | 2 | 38 | 64 | 32.3 |
| 20 000 to 99 999 | 14 | 15 | 3 | 51 | 83 | 41.9 |
| 100 000 or more | 13 | 2 | 6 | 30 | 51 | 25.8 |
| Immunophenotype | ||||||
| Non-T | 32 | 26 | 11 | 85 | 154 | 77.8 |
| T | 10 | 0 | 0 | 34 | 44 | 22.2 |
| Prednisone response | ||||||
| Good | 16 | 23 | 6 | 0 | 45 | 22.7 |
| Poor | 24 | 3 | 5 | 119 | 151 | 76.3 |
| Unknown | 2 | 0 | 0 | 0 | 2 | 1.0 |
| CNS involvement | ||||||
| Negative | 40 | 26 | 11 | 113 | 190 | 96.0 |
| Positive | 0 | 0 | 0 | 6 | 6 | 3.0 |
| Unknown | 2 | 0 | 0 | 0 | 2 | 1.0 |
| t(9,22) | ||||||
| Nonpositive | 38 | 0 | 11 | 119 | 168 | 84.8 |
| Positive | 4 | 26 | 0 | 0 | 30 | 15.2 |
| t(4,11) | ||||||
| Nonpositive | 41 | 26 | 4 | 118 | 189 | 95.5 |
| Positive | 1 | 0 | 7 | 1 | 9 | 4.5 |
Eligibility criteria are in hierarchical order. Thus, column (1) counts all patients who were resistant to induction (protocol Ia) regardless of the remaining features and so on for the subsequent columns. Consequently, column (4) identifies the patients who were defined as HR only because of their poor response to prednisone (they achieved CR and were negative for t(9;22) or t(4;11) translocation, PPR-only).
Of these 42 patients (2.8% of the entire AIEOP-ALL95 study population) who were at high risk because of failure to achieve CR after protocol Ia, 2 presented as standard risk, 14 as intermediate risk, and 26 already as high risk according to other criteria.