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Reversibility of symptomatic peripheral neuropathy with bortezomib in the phase III APEX trial in relapsed multiple myeloma: impact of a dose-modification guideline

The frequency, characteristics and reversibility of bortezomib-associated peripheral neuropathy were evaluated in the phase III APEX (Assessment of Proteasome Inhibition for Extending Remissions) trial in patients with relapsed myeloma, and the impact of a dose-modification guideline on peripheral n...

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Main Authors: Richardson, Paul G. (Author) , Sonneveld, Pieter (Author) , Schuster, Michael W. (Author) , Stadtmauer, Edward A. (Author) , Facon, Thierry (Author) , Harousseau, Jean-Luc (Author) , Ben-Yehuda, Dina (Author) , Lonial, Sagar (Author) , Goldschmidt, Hartmut (Author) , Reece, Donna (Author) , Bladé, Joan (Author) , Boccadoro, Mario (Author) , Cavenagh, Jamie D. (Author) , Boral, Anthony L. (Author) , Esseltine, Dixie-Lee (Author) , Wen, Patrick Y. (Author) , Amato, Anthony A. (Author) , Anderson, Kenneth C. (Author) , San Miguel, Jesus (Author)
Format: Article (Journal)
Language:English
Published: 19 February 2009
In: British journal of haematology
Year: 2009, Volume: 144, Issue: 6, Pages: 895-903
ISSN:1365-2141
DOI:10.1111/j.1365-2141.2008.07573.x
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/j.1365-2141.2008.07573.x
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Author Notes:Paul G. Richardson, Pieter Sonneveld, Michael W. Schuster, Edward A. Stadtmauer, Thierry Facon, Jean-Luc Harousseau, Dina Ben-Yehuda, Sagar Lonial, Hartmut Goldschmidt, Donna Reece, Joan Bladé, Mario Boccadoro, Jamie D. Cavenagh, Anthony L. Boral, Dixie-Lee Esseltine, Patrick Y. Wen, Anthony A. Amato, Kenneth C. Anderson and Jesus San Miguel
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Summary:The frequency, characteristics and reversibility of bortezomib-associated peripheral neuropathy were evaluated in the phase III APEX (Assessment of Proteasome Inhibition for Extending Remissions) trial in patients with relapsed myeloma, and the impact of a dose-modification guideline on peripheral neuropathy severity and reversibility was assessed. Patients received bortezomib 1.3 mg/m(2) (days 1, 4, 8, 11, eight 21-d cycles, then days 1, 8, 15, 22, three 35-d cycles); bortezomib was held, dose-reduced or discontinued depending on peripheral neuropathy severity, according to a protocol-specified dose-modification guideline. Overall, 124/331 patients (37%) had treatment-emergent peripheral neuropathy, including 30 (9%) with grade >or=3; incidence and severity were not affected by age, number/type of prior therapies, baseline glycosylated haemoglobin level, or diabetes history. Grade >or=3 incidence appeared lower versus phase II trials (13%) that did not specifically provide dose-modification guidelines. Of patients with grade >or=2 peripheral neuropathy, 58/91 (64%) experienced improvement or resolution to baseline at a median of 110 d, including 49/72 (68%) who had dose modification versus 9/19 (47%) who did not. Efficacy did not appear adversely affected by dose modification for grade >or=2 peripheral neuropathy. Bortezomib-associated peripheral neuropathy is manageable and reversible in most patients with relapsed myeloma. Dose modification using a specific guideline improves peripheral neuropathy management without adversely affecting outcome.
Item Description:Gesehen am 14.01.2022
Physical Description:Online Resource
ISSN:1365-2141
DOI:10.1111/j.1365-2141.2008.07573.x

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