| Analysis of herpes zoster events among bortezomib-treated patients in the phase III APEX study. | |
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MedLine Citation:
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PMID: 18711175 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: The aim of this subset analysis was to determine if bortezomib treatment is associated with increased incidence of varicella-zoster virus (VZV) reactivation in patients with relapsed multiple myeloma (MM). PATIENTS AND METHODS: Incidence of herpes zoster was evaluated in 663 patients with relapsed MM from the phase III APEX trial comparing single-agent bortezomib with high-dose dexamethasone. RESULTS: Bortezomib was associated with a significantly higher incidence of herpes zoster compared with dexamethasone treatment (13%, 42 of 331 v 5%, 15 of 332; P = .0002). Most herpes zoster infections were grade 1/2; incidences of grade 3/4 events (1.8% v 1.5%) and infections considered serious adverse events (1.5% v 0.9%) were similar between treatment arms, and no herpes zoster-related deaths occurred. Neither the time to onset of the herpes event nor the patients' absolute lymphocyte counts at baseline differed significantly between arms. VZV reactivation was the only herpes viral event noted to be significantly elevated in the bortezomib treatment group compared with the dexamethasone treatment group (P = .0002). The incidence of non-VZV-related herpes viral infections was comparable between arms. No additional risk factors for herpes zoster reactivation were identified. CONCLUSION: Further studies are needed to explain these observations and their implications; however, for patients treated with bortezomib or bortezomib-containing regimens, the risk of VZV reactivation should be monitored and routine use of antiviral prophylaxis considered. |
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Authors:
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Asher Chanan-Khan; Pieter Sonneveld; Michael W Schuster; Edward A Stadtmauer; Thierry Facon; Jean-Luc Harousseau; Dina Ben-Yehuda; Sagar Lonial; Hartmut Goldschmidt; Donna Reece; Rachel Neuwirth; Kenneth C Anderson; Paul G Richardson |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2008-08-18 |
Journal Detail:
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Title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology Volume: 26 ISSN: 1527-7755 ISO Abbreviation: J. Clin. Oncol. Publication Date: 2008 Oct |
Date Detail:
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Created Date: 2008-10-09 Completed Date: 2008-11-18 Revised Date: 2009-04-30 |
Medline Journal Info:
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Nlm Unique ID: 8309333 Medline TA: J Clin Oncol Country: United States |
Other Details:
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Languages: eng Pagination: 4784-90 Citation Subset: IM |
Affiliation:
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Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263, USA. asher.chanan-khan@roswellpark.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Antineoplastic Agents
/
adverse effects*,
pharmacology Boronic Acids / adverse effects*, pharmacology Herpes Zoster / chemically induced* Humans Multiple Myeloma / drug therapy* Pyrazines / adverse effects*, pharmacology Recurrence Virus Activation / drug effects |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Boronic Acids; 0/Pyrazines; 0/bortezomib |
| Comments/Corrections | |
Comment In:
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J Clin Oncol. 2009 May 1;27(13):2293-4; author reply 2294-6
[PMID:
19307496
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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