Table 1.
Characteristics of 20 patients at the time they received glucarpidase for delayed methotrexate clearance out of 1,141 patients who received HDMTX.
| All Patients | Osteosarcoma | ALL | Other | |
|---|---|---|---|---|
| Percent (No.) of patients who received glucarpidase | 1.8% (20 of 1,141) | 8% (6 of 75) | 1.3% (10 of 741) | 1.2% (4 of 325) |
| Age (years) | ||||
| Median | 12.1 | 11.7 | 6.5 | 19.2 |
| Range | 4.1 – 20.4 | 10.7 – 20.4 | 4.6 – 18.7 | 4.1 – 20.2 |
| Gender | ||||
| Female | 6 | 3 | 2 | 1 |
| Male | 14 | 3 | 8 | 3 |
| MTX dosing | ||||
| Dose (g/m2) | ||||
| Median | 5.696 | 12 | 5 | 6.109 |
| Range | 3.338 – 12 | 12 | 3.352 – 8 | 3.338 – 8 |
| Infusion duration (hrs) | ||||
| Median | 18 | 4 | 24 | 11 |
| Range | 4 – 24 | 4 – 6 | 4 – 24 | 4 – 20 |
| Course where toxicity occurred | ||||
| Median | 3 | 5 | 2 | 1 |
| Range | 1 – 8 | 1 – 8 | 1 – 4 | 1 – 2 |
| Glucarpidase | ||||
| Number of doses | 24 | 8 | 10 | 6 |
| 1st Dose (units/kg) | ||||
| Median | 51.6 | 59 | 50.8 | 39.3 |
| Range | 13 – 65.6 | 15 – 65.6 | 13 – 63 | 21 – 65 |
| Time to 1st glucarpidase dose (hrs) | ||||
| Median | 45.9 | 30 | 47.8 | 45.9 |
| Range | 26.3 – 95 | 28 – 46.5 | 26.3 – 95 | 28.8 – 48 |
| MTX decrease measured by TDx (%) a | ||||
| Median | 80 | 82.4 | 78.4 | 85.9 |
| Range | 61.9 – 95.9 | 71.1 – 93.2 | 61.9 – 94.6 | 70.5 – 95.9 |
| MTX decrease measured by HPLC (%) b | ||||
| Median | 99.6 | 99.5 | 99.7 | - |
| Range | 99.2 – 99.9 | 99.2 – 99.6 | 99.6 – 99.9 | - |
| Plasma MTX concentrations by TDx | ||||
| 20 – 24 hrs post-MTX (M) | ||||
| Median | 138.0 | 353.1 | 114.42 | 99.2 |
| Range | 29.2 – 462.9 | 158.8 – 462.9 | 65.7 – 222.1 | 29.2 – 258 |
| Prior to glucarpidase (M) | ||||
| Median | 29.1 | 267.3 | 18.1 | 54.6 |
| Range | 1.3 – 590.6 | 32.2 – 590.6 | 1.3 – 222.1 | 16.5 – 239.8 |
| Time to complete MTX excretion (hrs) | ||||
| Median | 355 | 407 | 344 | 415 |
| Range | 244 – 763 | 295 – 763.2 | 245 – 497 | 259.2 – 540 |
| Serum Creatinine (mg/dL) | ||||
| Prior to glucarpidase | ||||
| Median | 1.9 | 2.3 | 1.8 | 1.5 |
| Range | 0.6 – 3.5 | 1.6 – 2.8 | 0.6 – 2.8 | 1.2 – 3.5 |
| % increase from baseline | ||||
| Median | 258.3 | 325.0 | 258.3 | 196.7 |
| Range | 33.3 – 566.7 | 155.6 – 500.0 | 133.3 – 566.7 | 33.3 – 400.0 |
| Max | ||||
| Median | 2.2 | 2.7 | 1.8 | 4.9 |
| Range | 0.8 – 9.6 | 2.1 – 3.7 | 0.8 – 2.3 | 1.3 – 9.6 |
| Recovery of Renal Function (days) c | ||||
| Median | 21 | 26 | 24 | 20 |
| Range | 7 – 56 | 17 – 34 | 8 – 56 | 7 – 42 |
HDMTX, high-dose methotrexate; MTX, methotrexate; TDx, fluorescence polymerization immunoassay; HPLC, high performance liquid chromatography; g, grams; m2, meters2, hrs, hours; ALL, acute lymphoblastic leukemia.
The percent decrease is the decrease from the MTX level prior to glucarpidase to the first level obtained after glucarpidase administration.
The percent decrease is the decrease from the MTX level prior to glucarpidase to the first level obtained after glucarpidase administration.
Recovery of renal function was defined as the return of serum creatinine to ≤1.5 times the pretreatment (baseline) level.