Department of Pharmacy Services, UK Healthcare, Lexington, KY, USA.
Department of Pharmacy Services, UF Health Shands Cancer Hospital, Gainesville, FL, USA.
J Oncol Pharm Pract. 2022 Mar;28(2):274-281. doi: 10.1177/1078155220987623. Epub 2021 Jan 12.
Engraftment syndrome (ES) is a common complication of autologous hematopoietic cell transplantation (HCT). The difference in incidence of ES between melphalan formulations has not been widely reported throughout the literature and would allow for a more comprehensive understanding of the advantages and disadvantages of both melphalan formulations.
This retrospective, single-center, observational study evaluated 83 adult multiple myeloma and immunoglobulin light chain amyloidosis patients who received either propylene glycol-containing (PG) or propylene glycol-free (PG-free) melphalan 140 mg/m as single-agent conditioning chemotherapy for autologous HCT from May 31, 2015 to May 31, 2019. The primary outcome was to assess the incidence of ES, as defined using the Maiolino criteria, with both melphalan formulations. Secondary outcomes included an analysis of potential risk factors for the development of ES, as well as an evaluation of overall length of stay (LOS).
The incidence of ES for PG and PG-free melphalan did not differ significantly, 14/39 (35.9%) and 12/44 (27.3%) (P = 0.4), respectively. No potential risk factors for ES were identified on multivariate logistic regression analysis. A statistically significant difference in number of days to engraftment was identified for PG and PG-free melphalan, 15.56 vs. 13.82 days (P = 0.01), respectively; although, this did not translate to a decrease in LOS, 19.9 vs. 18.59 days (P = 0.14).
The incidence of ES did not differ significantly between melphalan formulations. Future research is needed to determine whether the faster time to engraftment seen with PG-free melphalan may translate to a decrease in LOS.
植入综合征 (ES) 是自体造血细胞移植 (HCT) 的常见并发症。不同美法仑制剂的 ES 发生率在文献中尚未广泛报道,这将有助于更全面地了解两种美法仑制剂的优缺点。
这项回顾性、单中心、观察性研究评估了 83 名成年多发性骨髓瘤和免疫球蛋白轻链淀粉样变性患者,他们在 2015 年 5 月 31 日至 2019 年 5 月 31 日期间接受含有丙二醇(PG)或无丙二醇(PG 自由)美法仑 140mg/m2 作为单一药物预处理化疗,用于自体 HCT。主要结局是使用 Maiolino 标准评估两种美法仑制剂的 ES 发生率。次要结局包括分析 ES 发展的潜在危险因素,以及评估总住院时间(LOS)。
PG 和 PG 自由美法仑的 ES 发生率无显著差异,分别为 14/39(35.9%)和 12/44(27.3%)(P=0.4)。多变量逻辑回归分析未发现 ES 的潜在危险因素。PG 和 PG 自由美法仑的植入时间差异有统计学意义,分别为 15.56 天和 13.82 天(P=0.01);然而,这并没有转化为 LOS 的减少,分别为 19.9 天和 18.59 天(P=0.14)。
美法仑制剂的 ES 发生率无显著差异。需要进一步的研究来确定 PG 自由美法仑更快的植入时间是否会转化为 LOS 的减少。