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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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
19 February 2009
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| In: |
British journal of haematology
Year: 2009, Jahrgang: 144, Heft: 6, Pages: 895-903 |
| ISSN: | 1365-2141 |
| DOI: | 10.1111/j.1365-2141.2008.07573.x |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/j.1365-2141.2008.07573.x
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| Verfasserangaben: | 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 |
MARC
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| 245 | 1 | 0 | |a Reversibility of symptomatic peripheral neuropathy with bortezomib in the phase III APEX trial in relapsed multiple myeloma |b impact of a dose-modification guideline |c 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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| 520 | |a 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. | ||
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Antineoplastic Agents | |
| 650 | 4 | |a Boronic Acids | |
| 650 | 4 | |a Bortezomib | |
| 650 | 4 | |a Clinical Protocols | |
| 650 | 4 | |a Drug Administration Schedule | |
| 650 | 4 | |a Female | |
| 650 | 4 | |a Follow-Up Studies | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Kaplan-Meier Estimate | |
| 650 | 4 | |a Male | |
| 650 | 4 | |a Middle Aged | |
| 650 | 4 | |a Multiple Myeloma | |
| 650 | 4 | |a Peripheral Nervous System Diseases | |
| 650 | 4 | |a Pyrazines | |
| 650 | 4 | |a Recurrence | |
| 650 | 4 | |a Statistics, Nonparametric | |
| 650 | 4 | |a Survival Rate | |
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| 700 | 1 | |a Boccadoro, Mario |e VerfasserIn |4 aut | |
| 700 | 1 | |a Cavenagh, Jamie D. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Boral, Anthony L. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Esseltine, Dixie-Lee |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wen, Patrick Y. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Amato, Anthony A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Anderson, Kenneth C. |e VerfasserIn |4 aut | |
| 700 | 1 | |a San Miguel, Jesus |e VerfasserIn |4 aut | |
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