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. Author manuscript; available in PMC: 2013 Sep 1.
Published in final edited form as: Cancer. 2012 Jan 17;118(17):4321–4330. doi: 10.1002/cncr.27378

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.

a

The percent decrease is the decrease from the MTX level prior to glucarpidase to the first level obtained after glucarpidase administration.

b

The percent decrease is the decrease from the MTX level prior to glucarpidase to the first level obtained after glucarpidase administration.

c

Recovery of renal function was defined as the return of serum creatinine to ≤1.5 times the pretreatment (baseline) level.