Clinical-biological features and related outcome (EFS [SE] estimated at 5 years from diagnosis) in 312 Philadelphia-negative ALL patients according to HR criteria, in hierarchical order
. | HR criteria in hierarchical order . | 5-y EFS (SE) . | P . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
(1) MRD-HR . | (2) Resistant IA . | (3) t(4;11) . | (4) PPR . | (5) Total . | ||||||||
n . | % . | n . | % . | n . | % . | n . | % . | n . | % . | |||
Total | 132 | 42.3 | 17 | 5.4 | 11 | 3.5 | 152 | 48.7 | 312 | 58.9% (2.8)* | ||
Gender | .03 | |||||||||||
Male | 85 | 64.4 | 6 | 35.3 | 6 | 54.6 | 102 | 67.1 | 199 | 63.8 | 54.5% (3.6) | |
Female | 47 | 35.6 | 11 | 64.7 | 5 | 45.4 | 50 | 32.9 | 113 | 36.2 | 66.8% (4.5) | |
Age | <.001 | |||||||||||
1-5 y | 56 | 42.4 | 9 | 52.9 | 3 | 27.3 | 95 | 62.5 | 163 | 52.2 | 66.4% (3.7) | |
6-9 y | 31 | 23.5 | 3 | 17.7 | 2 | 18.2 | 27 | 17.8 | 63 | 20.2 | 58.7% (6.2) | |
10-17 y | 45 | 34.1 | 5 | 29.4 | 6 | 54.5 | 30 | 19.7 | 86 | 27.6 | 45.1% (5.4) | |
WBC count (per μL)† | .19 | |||||||||||
<20 000 | 55 | 41.7 | 9 | 52.9 | 0 | 39 | 25.8 | 103 | 33.1 | 59.4% (4.9) | ||
≥20 000 to <100 000 | 39 | 29.5 | 5 | 29.4 | 3 | 27.3 | 66 | 43.7 | 113 | 36.3 | 62.5% (4.6) | |
≥100 000 | 38 | 28.8 | 3 | 17.7 | 8 | 72.7 | 46 | 30.5 | 95 | 30.6 | 53.6% (5.1) | |
Immunophenotype | .008 | |||||||||||
BCP | 86 | 65.2 | 4 | 23.5 | 11 | 100.0 | 106 | 69.7 | 207 | 66.4 | 63.9% (3.4) | |
T-cell | 46 | 34.8 | 13 | 76.5 | 0 | 46 | 30.3 | 105 | 33.6 | 49.3% (4.9) | ||
Translocation | ||||||||||||
t(4;11) | 5 | 3.8 | 0 | 11 | 100.0 | 0 | 16 | 5.1 | 43.8% (12.4) | |||
TEL/AML1 | 4 | 3.0 | 0 | 0 | 9 | 5.9 | 13 | 4.2 | 69.2% (12.8) | |||
DNA index† | .03 | |||||||||||
≥1.16 and <1.6 | 7 | 5.7 | 1 | 6.3 | 0 | 23 | 15.8 | 31 | 10.5 | 79.3% (7.6) | ||
<1.16 or ≥1.6 | 116 | 94.3 | 15 | 93.7 | 11 | 100.0 | 123 | 84.2 | 265 | 89.5 | 57.7% (3.0) | |
Response to PDN† | .005 | |||||||||||
PGR | 87 | 66.4 | 8 | 50.0 | 8 | 72.7 | 0 | 103 | 33.2 | 48.1% (5.0) | ||
PPR | 44 | 33.6 | 8 | 50.0 | 3 | 27.3 | 152 | 100.0 | 207 | 66.8 | 64.9% (3.3) | |
Resistant to IA‡ | .006 | |||||||||||
Yes | 15 | 11.4 | 17 | 100.0 | 0 | 0 | 32 | 10.3 | 40.6% (8.7) | |||
No | 117 | 88.6 | 0 | 11 | 100.0 | 150 | 100.0 | 278 | 89.7 | 61.2% (2.9) | ||
MRD classification† | <.001 | |||||||||||
SR | 0 | 1 | 20.0 | 0 | 23 | 19.7 | 24 | 9.2 | 100.0%‡ | |||
IR | 0 | 4 | 80.0 | 5 | 100.0 | 94 | 80.3 | 103 | 39.8 | 66.9% (4.7) | ||
HR | 132 | 100.0 | 0 | 0 | 0 | 132 | 51.0 | 45.9% (4.4) |
. | HR criteria in hierarchical order . | 5-y EFS (SE) . | P . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
(1) MRD-HR . | (2) Resistant IA . | (3) t(4;11) . | (4) PPR . | (5) Total . | ||||||||
n . | % . | n . | % . | n . | % . | n . | % . | n . | % . | |||
Total | 132 | 42.3 | 17 | 5.4 | 11 | 3.5 | 152 | 48.7 | 312 | 58.9% (2.8)* | ||
Gender | .03 | |||||||||||
Male | 85 | 64.4 | 6 | 35.3 | 6 | 54.6 | 102 | 67.1 | 199 | 63.8 | 54.5% (3.6) | |
Female | 47 | 35.6 | 11 | 64.7 | 5 | 45.4 | 50 | 32.9 | 113 | 36.2 | 66.8% (4.5) | |
Age | <.001 | |||||||||||
1-5 y | 56 | 42.4 | 9 | 52.9 | 3 | 27.3 | 95 | 62.5 | 163 | 52.2 | 66.4% (3.7) | |
6-9 y | 31 | 23.5 | 3 | 17.7 | 2 | 18.2 | 27 | 17.8 | 63 | 20.2 | 58.7% (6.2) | |
10-17 y | 45 | 34.1 | 5 | 29.4 | 6 | 54.5 | 30 | 19.7 | 86 | 27.6 | 45.1% (5.4) | |
WBC count (per μL)† | .19 | |||||||||||
<20 000 | 55 | 41.7 | 9 | 52.9 | 0 | 39 | 25.8 | 103 | 33.1 | 59.4% (4.9) | ||
≥20 000 to <100 000 | 39 | 29.5 | 5 | 29.4 | 3 | 27.3 | 66 | 43.7 | 113 | 36.3 | 62.5% (4.6) | |
≥100 000 | 38 | 28.8 | 3 | 17.7 | 8 | 72.7 | 46 | 30.5 | 95 | 30.6 | 53.6% (5.1) | |
Immunophenotype | .008 | |||||||||||
BCP | 86 | 65.2 | 4 | 23.5 | 11 | 100.0 | 106 | 69.7 | 207 | 66.4 | 63.9% (3.4) | |
T-cell | 46 | 34.8 | 13 | 76.5 | 0 | 46 | 30.3 | 105 | 33.6 | 49.3% (4.9) | ||
Translocation | ||||||||||||
t(4;11) | 5 | 3.8 | 0 | 11 | 100.0 | 0 | 16 | 5.1 | 43.8% (12.4) | |||
TEL/AML1 | 4 | 3.0 | 0 | 0 | 9 | 5.9 | 13 | 4.2 | 69.2% (12.8) | |||
DNA index† | .03 | |||||||||||
≥1.16 and <1.6 | 7 | 5.7 | 1 | 6.3 | 0 | 23 | 15.8 | 31 | 10.5 | 79.3% (7.6) | ||
<1.16 or ≥1.6 | 116 | 94.3 | 15 | 93.7 | 11 | 100.0 | 123 | 84.2 | 265 | 89.5 | 57.7% (3.0) | |
Response to PDN† | .005 | |||||||||||
PGR | 87 | 66.4 | 8 | 50.0 | 8 | 72.7 | 0 | 103 | 33.2 | 48.1% (5.0) | ||
PPR | 44 | 33.6 | 8 | 50.0 | 3 | 27.3 | 152 | 100.0 | 207 | 66.8 | 64.9% (3.3) | |
Resistant to IA‡ | .006 | |||||||||||
Yes | 15 | 11.4 | 17 | 100.0 | 0 | 0 | 32 | 10.3 | 40.6% (8.7) | |||
No | 117 | 88.6 | 0 | 11 | 100.0 | 150 | 100.0 | 278 | 89.7 | 61.2% (2.9) | ||
MRD classification† | <.001 | |||||||||||
SR | 0 | 1 | 20.0 | 0 | 23 | 19.7 | 24 | 9.2 | 100.0%‡ | |||
IR | 0 | 4 | 80.0 | 5 | 100.0 | 94 | 80.3 | 103 | 39.8 | 66.9% (4.7) | ||
HR | 132 | 100.0 | 0 | 0 | 0 | 132 | 51.0 | 45.9% (4.4) |
BCP, B-cell precursor; IR, intermediate risk; PDN, prednisone; SR, standard risk.
The 5-year EFS (SE) in the non-HR patients (n = 1687) treated in Italy in AIEOP-BFM ALL 2000 was 83.0% (0.9), with a survival of 93.0% (0.6).
A relapse occurred at 6.3 years from diagnosis.
WBC: 1 not known; DNA index: 16 not known; Response to PDN: 2 not known; Resistant to IA: 2 not applicable; MRD classification: 53 not known.