Analysis of Herpes Zoster Events Among Bortezomib-Treated Patients in the Phase III APEX Study
- 10 October 2008
- journal article
- research article
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 26 (29), 4784-4790
- https://doi.org/10.1200/jco.2007.14.9641
Abstract
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). 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. 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. 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.Keywords
This publication has 21 references indexed in Scilit:
- The high incidence of varicella herpes zoster with the use of bortezomib in 10 patientsAmerican Journal of Hematology, 2006
- Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 studyBlood, 2006
- Bortezomib after dose-reduced allogeneic stem cell transplantation for multiple myeloma to enhance or maintain remission statusExperimental Hematology, 2006
- Immune parameters in multiple myeloma patients: influence of treatment and correlation with opportunistic infectionsLeukemia & Lymphoma, 2006
- Bortezomib or High-Dose Dexamethasone for Relapsed Multiple MyelomaThe New England Journal of Medicine, 2005
- Preventing Varicella-Zoster DiseaseClinical Microbiology Reviews, 2005
- A phase 2 study of two doses of bortezomib in relapsed or refractory myelomaBritish Journal of Haematology, 2004
- Clinical and Molecular Pathogenesis of Varicella Virus InfectionViral Immunology, 2003
- Thalidomide as an anti‐cancer agentJournal of Cellular and Molecular Medicine, 2002
- HERPES SIMPLEX AND HERPES ZOSTER IN NEOPLASIAThe Lancet, 1974