Efficacy of a viral load-based, risk-adapted, preemptive treatment strategy for prevention of cytomegalovirus disease after hematopoietic cell transplantation.
Efficacy of a viral load-based, risk-adapted, preemptive treatment strategy for prevention of cytomegalovirus disease after hematopoietic cell transplantation.
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DOI：
10.1016/j.bbmt.2012.05.015
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发表时间：
2012-11
影响因子：
4.3
通讯作者：
Boeckh, Michael
中科院分区：
文献类型：
--
作者：
Green, Margaret L.;Leisenring, Wendy;Stachel, Daniel;Pergam, Steven A.;Sandmaier, Brenda M.;Wald, Anna;Corey, Lawrence;Boeckh, Michael
巨细胞病毒 (CMV) 监测和先发性治疗是造血细胞移植 (HCT) 受者预防 CMV 疾病最常用的策略。 2007 年，我们通过定量 PCR 监测针对有 CMV 疾病风险的患者推出了 CMV 预防策略，治疗阈值由患者风险因素确定。患者（N = 367）在血浆病毒载量≥500拷贝/ml时接受先发性治疗，如果接受≥1mg/kg泼尼松或抗T细胞治疗则在≥100拷贝/ml，或者检测到病毒载量较基线增加≥5倍时接受先发性治疗。与 2007 年之前接受基于抗原血症的监测（n=690）并针对任何阳性水平启动先发性治疗的患者相比，基于风险适应的 PCR 策略导致抗病毒药物的使用相似，并且在多变量模型中 CMV 疾病、毒性和非复发死亡率 (NRM) 的风险相似。 PCR 组到第 100 天时 CMV 疾病的累积发生率为 5.2%，而抗原血症组为 5.8%（1 年：PCR 组为 9.1%，抗原血症组为 9.6%）。 PCR 组中的突破性 CMV 疾病主要发生在胃肠道 (GI)（15/19 例，79%）。然而，与 CMV 肺炎不同，CMV 胃肠道疾病与 NRM 增加无关（调整后的风险比为 1.19，P=0.7 [胃肠道疾病] vs. 8.18，P<0.001 [肺炎]）。因此，向基于 CMV 病毒载量和宿主危险因素的先发性治疗策略的转变成功地预防了 CMV 疾病，而没有增加接受先发性治疗的患者比例和可归因的毒性。基于 PCR 的先发制人疗法中的突破性疾病发生率较低，主要表现为胃肠道疾病，更有可能对抗病毒治疗有反应。
Cytomegalovirus (CMV) surveillance and preemptive therapy is the most commonly used strategy for CMV disease prevention in hematopoietic cell transplant (HCT) recipients. In 2007, we introduced a CMV prevention strategy for those patients at risk for CMV disease using quantitative PCR surveillance, with treatment thresholds determined by patient risk factors. Patients (N=367) received preemptive therapy either at a plasma viral load of ≥500 copies/ml, at ≥100 copies/ml if receiving ≥ 1 mg/kg of prednisone or anti-T cell therapies, or if a ≥ 5-fold viral load increase from baseline was detected. Compared to patients prior to 2007 undergoing antigenemia-based surveillance (n=690) with preemptive therapy initiated for any positive level, the risk-adapted PCR based strategy resulted in similar use of antiviral agents, and similar risks of CMV disease, toxicity and non-relapse mortality (NRM) in multivariable models. The cumulative incidence of CMV disease by day 100 was 5.2% in the PCR group compared to 5.8% in the antigenemia group (1 year: 9.1% PCR vs 9.6% antigenemia). Breakthrough CMV disease in the PCR group was predominantly in the gastrointestinal (GI) tract (15/19 cases, 79%). However, unlike CMV pneumonia, CMV GI disease was not associated with increased NRM (adjusted hazard ratio 1.19, P=0.7 [GI disease] vs. 8.18, P<0.001 [pneumonia]). Thus, the transition to a preemptive therapy strategy based on CMV viral load and host risk factors successfully prevented CMV disease without increasing the proportion of patients receiving preemptive therapy and attributable toxicity. Breakthrough disease in PCR-based preemptive therapy occurs at a low incidence and presents primarily as GI disease which is more likely to be responsive to antiviral therapy.
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影响因子：
20.3
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