TABLE 1.
Characteristic | n (%) | Mean (± SD) |
---|---|---|
Median age, yearsa | 11.0 (1.0–18.0) | |
Gender | ||
Male | 25 (86.2) | |
Female | 4 (13.8) | |
Treatment protocol | ||
BFM86 | 2 (6.9) | |
BFM90 | 9 (31.0) | |
BFM95 | 9 (31.0) | |
ICBFM02 | 9 (31.0) | |
MTX dose, mg/m2 | ||
2000 | 1 (3.5) | |
5000 | 28 (96.5) | |
Any cycle with delayed MTX clearance | 14 (46.7) | |
Cmax, μmol/lb | 49.9 (± 31.2) | |
AUC1, μmol*h/lc | 323.3 (± 250.6) | |
AUC2, μmol*h/lc | 356.8 (± 215.6) | |
AUC3, μmol*h/ld | 297.7 (± 202.0) | |
AUC4, μmol*h/le | 418.4 (± 340.2) | |
Treatment outcome | ||
First remission | 21 (72.4) | |
Eventf | 8 (27.6) |
AUC = area under the time-concentration curve after first (1), second (2), third (3), and fourth (4) application; BFM = Berlin-Frankfurt-Münster; Cmax = maximal MTX plasma concentration; ICBFM = intercontinental Berlin-Frankfurt-Münster; MTX = methotrexate; SD = standard deviation
Age is presented as median (range);
Data missing for 2 (6.9%) patients;
Data missing for 8 (27.6%) patients;
Data missing for 11 (37.9%) patients;
Data missing for 10 (34.5%) patients;
Event was defined as disease relapse at any site, death from any cause, or the occurrence of second malignant neoplasm