A pilot phase II study of alternate day ganciclovir and foscarnet in preventing cytomegalovirus (CMV) infections in at-risk pediatric and adolescent allogeneic stem cell transplant recipients.
A pilot phase II study of alternate day ganciclovir and foscarnet in preventing cytomegalovirus (CMV) infections in at-risk pediatric and adolescent allogeneic stem cell transplant recipients.
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一项关于隔日更昔洛韦和膦甲酸预防高危儿科和青少年同种异体干细胞移植受者巨细胞病毒 (CMV) 感染的试点 II 期研究。
DOI：
10.1002/pbc.21043
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发表时间：
2007
影响因子：
3.2
通讯作者：
Cairo,MitchellS
中科院分区：
文献类型：
--
作者：
Shereck,EvanB;Cooney,Erin;vandeVen,Carmella;Della-Lotta,Phyllis;Cairo,MitchellS
背景：同种异体干细胞移植（AlloSCT）后预防更昔洛韦或氟膦酸钠可减少巨细胞病毒（CMV）疾病。更昔洛韦/膦酸钠联合治疗合并巨细胞病毒性视网膜炎的HIV患者比单一治疗更有效。我们假设，在同种异体移植后的前100天内，更昔洛韦和氟膦酸钠隔天预防巨细胞病毒是安全有效的。53名接受57次同种异体细胞移植的儿童和青少年受体，供体和/或受体CMV血清阳性，从骨髓恢复（≥ANC 750/mm3）开始，交替使用更昔洛韦（5mg /kg/48小时）和磷磷（90mg /kg/48小时），直到第100天。结果：男：女：31:22；6岁（0.8-18岁）；供体来源：相关外周血/骨髓25例，非相关成人外周血3例，非相关脐带血26例，相关脐带血3例。GVHD预防包括他克莫司/霉酚酸酯（MMF）。BM/PBSC的中位有核细胞计数和CD34细胞计数分别为7.3 × 108/kg和5.07 × 106/kg；CB分别为4.07 × 107/kg和1.69 × 105/kg。尽管II-IV级急性GVHD的概率为36.5%，但没有患者发展为系统性巨细胞病毒疾病。5%的患者有IV级血液学毒性，需要停药。25%的患者因电解质异常和/或肾功能不全而需要停药，这被认为是多因素所致。1年总生存率为58.8%。结论在受体和/或供体血清阳性的同种异体移植受者中，隔天更昔洛韦/氟膦酸钠似乎是可耐受的，并且100%有效预防巨细胞病毒全身性疾病。需要一项随机研究来确定这种方法是否优于其他CMV预防设计。儿科血癌2007；49:306-312。©2006 Wiley‐Liss, Inc。
BackgroundProphylaxis with ganciclovir or foscarnet post allogeneic stem cell transplant (AlloSCT) reduces cytomegalovirus (CMV) disease. Combination ganciclovir/foscarnet is more effective than monotherapy in HIV patients with CMV retinitis. We hypothesized that alternate day ganciclovir and foscarnet for the prevention of CMV during the first 100 days after AlloSCT would be safe and effective.ProcedureFifty‐three pediatric and adolescent AlloSCT recipients receiving 57 AlloSCTs where donors and/or recipients were CMV seropositive received ganciclovir (5 mg/kg/48 hr) alternating with foscarnet (90 mg/kg/48 hr) from myeloid recovery (≥ANC 750/mm3) until Day +100.ResultsPatients were: M:F 31:22; age 6 years (0.8–18 years); donor sources: 25 related peripheral blood/bone marrow, 3 unrelated adult peripheral blood, 26 unrelated cord blood, and 3 related cord blood. GVHD prophylaxis included tacrolimus/mycophenolate mofetil (MMF). Median‐nucleated and CD34 cell counts were 7.3 × 108/kg and 5.07 × 106/kg, respectively, for BM/PBSC; 4.07 × 107/kg and 1.69 × 105/kg, respectively, for CB. Despite a 36.5% probability of Grades II–IV acute GVHD, no patient developed systemic CMV disease. Five percent had Grade IV hematological toxicity that required discontinuation of ganciclovir. Twenty‐five percent required discontinuation of foscarnet secondary to electrolyte abnormalities and/or renal dysfunction that were presumed to be multifactorial in origin. Probability of 1‐year overall survival was 58.8%.ConclusionsAlternate day ganciclovir/foscarnet in AlloSCT recipients where recipient and/or donor is seropositive appears to be tolerable and 100% effective in preventing CMV systemic disease. A randomized study will be required to determine if this approach is superior to other CMV prophylactic designs. Pediatr Blood Cancer 2007;49:306–312. © 2006 Wiley‐Liss, Inc.