Fairview Pharmacy Services, M Health Fairview University of Minnesota Medical Center, Minneapolis, MN, USA.
Department of Pharmacy, M Health Fairview University of Minnesota Medical Center, Minneapolis, MN, USA.
J Oncol Pharm Pract. 2021 Dec;27(8):1835-1841. doi: 10.1177/1078155220970608. Epub 2020 Nov 2.
Continuous infusion (CIVI) cyclosporine (CsA) is an alternative for allograft recipients intolerant of twice daily infusions (TDI). The importance of achieving therapeutic levels of CsA early after allogeneic HCT has been demonstrated in previous studies. Our study evaluated the incidence of acute graft versus host disease (GVHD) and survival among patients receiving CIVI vs. TDI CsA during their first allogeneic HCT.
A retrospective study of adult patients undergoing first allogeneic HCT at the University of Minnesota Medical Center between 2011 and 2017. Patients were grouped according to the administration method. The primary outcome was the occurrence of acute grade II-IV GVHD by day +180. Secondary outcomes included the 1-year incidence of chronic GVHD, relapse, and overall survival.
42 patients intolerant of TDI CsA received CsA via CIVI for >48 hours for a median of 9 days (range, 3-32 days). CsA concentrations were similar between groups. We found no difference between the rates of grade II-IV acute (45% vs 53%, p = 0.59) or chronic (17% vs 30%, p = 0.20) GVHD or overall survival (57% vs 67%, p = 0.10). Subgroup analysis of patients that received myeloablative conditioning or umbilical cord blood did not reveal significant differences in GVHD or overall survival. Cumulative incidence of relapse was higher among the continuous infusion group (39% vs. 23%, p < 0.01).
Due to the finding of increased risk of relapse, cyclosporine should be administered as traditional twice daily infusion unless necessary. A prospective clinical trial is needed to confirm these results.
连续输注（CIVI）环孢素（CsA）是不耐受每日两次输注（TDI）的同种异体移植物受者的替代方法。先前的研究已经证明了在同种异体造血细胞移植后早期达到治疗性 CsA 水平的重要性。我们的研究评估了在明尼苏达大学医学中心接受 CIVI 与 TDI CsA 的患者在首次同种异体造血细胞移植期间发生急性移植物抗宿主病（GVHD）和生存的情况。
这是一项回顾性研究，纳入了 2011 年至 2017 年期间在明尼苏达大学医学中心接受首次同种异体造血细胞移植的成年患者。患者根据给药方法进行分组。主要结局是第 180 天发生急性 II-IV 级 GVHD 的情况。次要结局包括 1 年慢性 GVHD、复发和总生存率。
42 例不耐受 TDI CsA 的患者因不耐受而接受 CIVI 治疗>48 小时，中位时间为 9 天（范围为 3-32 天）。两组间 CsA 浓度相似。我们发现，两组间 II-IV 级急性（45% vs. 53%，p=0.59）或慢性（17% vs. 30%，p=0.20）GVHD 或总生存率（57% vs. 67%，p=0.10）的发生率无差异。接受清髓性或脐带血造血细胞移植的患者亚组分析也未显示 GVHD 或总生存率有显著差异。连续输注组的复发累积发生率较高（39% vs. 23%，p<0.01）。
由于发现复发风险增加，除非必要，否则应给予环孢素传统的每日两次输注。需要进行前瞻性临床试验来证实这些结果。
