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Efficacy and safety of bortezomib in patients with renal impairment: results from the APEX phase 3 study

Renal impairment is associated with poor prognosis in multiple myeloma (MM). This subgroup analysis of the phase 3 Assessment of Proteasome Inhibition for Extending Remissions (APEX) study of bortezomib vs high-dose dexamethasone assessed efficacy and safety in patients with relapsed MM with varying...

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Main Authors: San-Miguel, Jesús F. (Author) , Richardson, P. G. (Author) , Sonneveld, P. (Author) , Schuster, M. W. (Author) , Irwin, D. (Author) , Stadtmauer, E. A. (Author) , Facon, T. (Author) , Harousseau, J.-L. (Author) , Ben-Yehuda, D. (Author) , Lonial, S. (Author) , Goldschmidt, Hartmut (Author) , Reece, D. (Author) , Bladé, J. (Author) , Boccadoro, M. (Author) , Cavenagh, J. D. (Author) , Neuwirth, R. (Author) , Boral, A. L. (Author) , Esseltine, D.-L. (Author) , Anderson, K. C. (Author)
Format: Article (Journal)
Language:English
Published: 17 January 2008
In: Leukemia
Year: 2008, Volume: 22, Issue: 4, Pages: 842-849
ISSN:1476-5551
DOI:10.1038/sj.leu.2405087
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1038/sj.leu.2405087
Verlag, lizenzpflichtig, Volltext: https://www.nature.com/articles/2405087
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Author Notes:J.F. San-Miguel, P.G. Richardson, P. Sonneveld, M.W. Schuster, D. Irwin, E.A. Stadtmauer, T. Facon, J.-L. Harousseau, D. Ben-Yehuda, S. Lonial, H. Goldschmidt, D. Reece, J. Bladé, M. Boccadoro, J.D. Cavenagh, R. Neuwirth, A.L. Boral, D.-L. Esseltine and K.C. Anderson

MARC

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245 1 0 |a Efficacy and safety of bortezomib in patients with renal impairment  |b results from the APEX phase 3 study  |c J.F. San-Miguel, P.G. Richardson, P. Sonneveld, M.W. Schuster, D. Irwin, E.A. Stadtmauer, T. Facon, J.-L. Harousseau, D. Ben-Yehuda, S. Lonial, H. Goldschmidt, D. Reece, J. Bladé, M. Boccadoro, J.D. Cavenagh, R. Neuwirth, A.L. Boral, D.-L. Esseltine and K.C. Anderson 
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520 |a Renal impairment is associated with poor prognosis in multiple myeloma (MM). This subgroup analysis of the phase 3 Assessment of Proteasome Inhibition for Extending Remissions (APEX) study of bortezomib vs high-dose dexamethasone assessed efficacy and safety in patients with relapsed MM with varying degrees of renal impairment (creatinine clearance (CrCl) <30, 30-50, 51-80 and >80 ml min−1). Time to progression (TTP), overall survival (OS) and safety were compared between subgroups with CrCl ⩽50 ml min−1 (severe-to-moderate) and >50 ml min−1 (no/mild impairment). Response rates with bortezomib were similar (36-47%) and time to response rapid (0.7-1.6 months) across subgroups. Although the trend was toward shorter TTP/OS in bortezomib patients with severe-to-moderate vs no/mild impairment, differences were not significant. OS was significantly shorter in dexamethasone patients with CrCl ⩽50 vs >50 ml min−1 (P=0.003), indicating that bortezomib is more effective than dexamethasone in overcoming the detrimental effect of renal impairment. Safety profile of bortezomib was comparable between subgroups. With dexamethasone, grade 3/4 adverse events (AEs), serious AEs and discontinuations for AEs were significantly elevated in patients with CrCl ⩽50 vs >50 ml min−1. These results indicate that bortezomib is active and well tolerated in patients with relapsed MM with varying degrees of renal insufficiency. Efficacy/safety were not substantially affected by severe-to-moderate vs no/mild impairment. 
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