Analysis of herpes zoster events among bortezomib-treated patients in the phase III APEX study
Analysis of herpes zoster events among bortezomib-treated patients in the phase III APEX study
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DOI：
10.1200/jco.2007.14.9641
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发表时间：
2008-10-10
影响因子：
45.3
通讯作者：
Richardson, Paul G.
中科院分区：
文献类型：
--
作者：
Chanan-Khan, Asher;Sonneveld, Pieter;Richardson, Paul G.
目的：本亚组分析的目的是确定硼替佐米治疗是否与复发性多发性骨髓瘤（MM）患者水痘-带状疱疹病毒（VZV）再激活发生率增加相关。患者和方法在663例复发性MM患者中评估带状疱疹的发生率，这些患者来自III期APEX试验，比较单药硼替佐米与大剂量地塞米松。结果硼替佐米与带状疱疹的发生率显著高于地塞米松治疗（13%，42/331 vs5%，15/332; P = 0.0002）。大多数带状疱疹感染为1/2级;治疗组之间3/4级事件（1.8% vs 1.5%）和被视为严重不良事件的感染（1.5% vs 0.9%）的发生率相似，未发生带状疱疹相关死亡。两组间至疱疹事件发作的时间和患者基线时的绝对淋巴细胞计数均无显著差异。VZV再激活是硼替佐米治疗组与地塞米松治疗组相比显著升高的唯一疱疹病毒事件（P = 0.002）。两组间非VZV相关疱疹病毒感染的发生率相当。未发现带状疱疹再激活的其他风险因素。结论需要进一步的研究来解释这些观察结果及其意义;然而，对于接受硼替佐米或含硼替佐米方案治疗的患者，应监测VZV再激活的风险，并考虑常规使用抗病毒预防。
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.