TABLE III.
Toxicity | ctcae grade | Toxicity description | Dosing |
---|---|---|---|
Hematologic toxicity | |||
Grade 3 |
anc: <1.0 to 0.5×109/L Platelets: <50.0 to 25.0×109/L |
Withhold until recovery to grade 2 or lower. Resume at same dose schedule. |
|
Grade 4 |
anc: <0.5×109/L Platelets: <25.0×109/L |
Withhold until recovery to grade 2 or lower. Resume at 200 mg twice dailya. |
|
Hepatotoxicity | |||
Grade 3 or 4 alt or ast elevation and Grade 1 or lower total bilirubin |
ast and alt Grade 2: >3.0 to 5.0×uln Grade 3: >5.0 to 20.0×uln Grade 4: >20.0×uln |
Withhold until recovery to grade 1 or lower. Resume at 200 mg twice dailyb. |
|
Grade 2, 3, or 4 alt or ast elevation and concurrent grade 2, 3, or 4 total bilirubin elevationc |
Bilirubin Grade 2: >1.5 to 3.0×uln Grade 3: >3.0 to 10.0×uln Grade 4: >10.0×uln |
Permanently discontinue. | |
Pneumonitis | |||
Any graded | Permanently discontinue. | ||
QTc prolongation | |||
Grade 3e | QTc ≥ 500 ms | Withhold until recovery to baseline or to a QTc ≤ 480 ms Resume at 200 mg twice dailyb,f |
|
Grade 4 | QTc ≥ 500 ms and life-threatening signs or symptoms |
Permanently discontinue. |
In case of recurrence, hold until recovery to grade 2 or lower, and then resume at 250 mg daily. Permanently discontinue in case of further grade 4 recurrence.
In case of recurrence, hold until recovery to grade 1 or lower, and then resume at 250 mg daily. Permanently discontinue in case of further grade 3 or 4 recurrence.
In the absence of cholestasis or hemolysis.
In the absence of disease progression, other pulmonary disease, infection, or radiation effect.
On at least 2 separate electrocardiograms.
Ensure that hypokalemia, hypomagnesemia, and hypocalcemia are corrected.
ctcae = U.S. National Cancer Institute Common Terminology Criteria for Adverse Events; anc = absolute neutrophil count; ast = aspartate aminotransferase; alt = alanine aminotransferase; uln = upper limit of normal.