Patel Khilna, Parmar Sapna, Shah Shreya, Shore Tsiporah, Gergis Usama, Mayer Sebastian, van Besien Koen
Department of Pharmacy, New York-Presbyterian Hospital, New York, New York.
Department of Pharmacy, New York-Presbyterian Hospital, New York, New York.
Biol Blood Marrow Transplant. 2016 Mar;22(3):456-61. doi: 10.1016/j.bbmt.2015.10.022. Epub 2015 Oct 31.
The objective of this study was to compare infusion-related reactions and outcomes of using subcutaneous (subQ) alemtuzumab versus intravenous (i.v.) alemtuzumab as graft-versus-host disease (GVHD) prophylaxis for matched unrelated donor stem cell transplantations. Outcomes include incidence of cytomegalovirus (CMV)/Epstein-Barr (EBV) viremia, development of CMV disease or post-transplantation lymphoproliferative disorder, fatal infections, acute and chronic GVHD, time to engraftment, relapse rate, and survival. We conducted a retrospective study of all adult matched unrelated donor stem cell transplantations patients who received fludarabine/melphalan with subQ or i.v. alemtuzumab in combination with tacrolimus as part of their conditioning for unrelated donor transplantation at New York-Presbyterian/Weill Cornell Medical Center from January 1, 2012 to March 21, 2014. Alemtuzumab was administered at a total cumulative dose of 100 mg (divided over days -7 to -3). Forty-six patients received an unrelated donor stem cell transplantation with fludarabine/melphalan and either subQ (n = 26) or i.v. (n = 20) alemtuzumab in combination with tacrolimus. Within the evaluable population, 130 subQ and 100 i.v. alemtuzumab doses were administered. For the primary outcome, ≥grade 2 infusion-related reactions occurred in 11 (8%) versus 25 (25%) infusions in the subQ and i.v. cohorts, respectively (P = .001). Overall, 12 injections (9%) in the subQ arm versus 26 infusions (26%) in the i.v. arm experienced an infusion-related reaction of any grade (P = .001). There were no significant differences between the subQ and i.v. arms in rates of reactivation of CMV/EBV, development of CMV disease or post-transplantation lymphoproliferative disorder, fatal infections, acute and chronic GVHD, relapse, or survival. Subcutaneous administration of alemtuzumab for GVHD prophylaxis was associated with fewer infusion-related reactions compared with i.v. administration in the SCT setting. Incidences of acute and chronic GVHD were similar between both arms. There was also no difference in reactivation of CMV/EBV viremia, development of CMV disease or post-transplantation lymphoproliferative disorder, fatal infections, relapse, or survival.
本研究的目的是比较皮下注射阿仑单抗与静脉注射阿仑单抗作为移植物抗宿主病（GVHD）预防措施用于匹配无关供体干细胞移植的输注相关反应和结果。结果包括巨细胞病毒（CMV）/爱泼斯坦-巴尔病毒（EBV）病毒血症的发生率、CMV疾病或移植后淋巴细胞增生性疾病的发生、致命感染、急性和慢性GVHD、植入时间、复发率和生存率。我们对2012年1月1日至2014年3月21日在纽约长老会/威尔康奈尔医学中心接受氟达拉滨/马法兰联合皮下或静脉注射阿仑单抗及他克莫司作为无关供体移植预处理一部分的所有成年匹配无关供体干细胞移植患者进行了一项回顾性研究。阿仑单抗的总累积剂量为100mg（分-7至-3天给药）。46例患者接受了氟达拉滨/马法兰联合皮下（n = 26）或静脉（n = 20）注射阿仑单抗及他克莫司的无关供体干细胞移植。在可评估人群中，皮下注射阿仑单抗130剂，静脉注射100剂。对于主要结局，皮下注射组和静脉注射组中分别有11次（8%）和25次（25%）输注发生≥2级输注相关反应（P = .001）。总体而言，皮下注射组有12次注射（9%）发生任何级别的输注相关反应，而静脉注射组有26次输注（26%）发生此类反应（P = .001）。皮下注射组和静脉注射组在CMV/EBV再激活率、CMV疾病或移植后淋巴细胞增生性疾病的发生率、致命感染、急性和慢性GVHD、复发率或生存率方面无显著差异。在干细胞移植环境中，与静脉注射相比，皮下注射阿仑单抗预防GVHD与较少的输注相关反应相关。两组的急性和慢性GVHD发生率相似。CMV/EBV病毒血症的再激活、CMV疾病或移植后淋巴细胞增生性疾病的发生、致命感染、复发率或生存率也无差异。
