FACULTY COMMENTS
DR JAKUBOWIAK: The San-Miguel paper published in Leukemia
is a subset analysis from the APEX study. The conclusions
are similar to the Chanan-Khan paper, although this is from a
randomized, Phase III study.
Essentially, this analysis indicates that bortezomib is active and well tolerated in patients with different degrees of renal insufficiency. No differences in toxicity or efficacy were seen, regardless of degree of renal failure, which was a key observation.
DR LONIAL: This is an important paper because it clearly establishes
the efficacy of bortezomib in patients with renal dysfunction.
These data suggest that it’s safe to use bortezomib without dose
modification in patients with low creatinine clearances. For patients
with hepatic dysfunction, I would be more cautious. However, we
use bortezomib in patients with renal failure at full doses all the
time. Bortezomib reverses it in a fair number of patients.
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