Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.
Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.
Toxicol Appl Pharmacol. 2024 Oct;491:117071. doi: 10.1016/j.taap.2024.117071. Epub 2024 Aug 17.
Different prophylactic protocols are available for preventing graft-versus-host disease (GVHD) after matched sibling donor (MSD) allogeneic hematopoietic cell transplantation (allo-HCT). This study aimed to compare the effectiveness of post-transplantation cyclophosphamide plus cyclosporine A (PT-CY/CSA) versus methotrexate plus CSA (MTX/CSA) as GVHD prophylaxis protocols in adult acute myeloid leukemia (AML) patients who received peripheral blood stem cells (PBSC) from fully matched donors.
The 1-year outcomes of 89 patients treated with PT-CY/CSA and 90 patients treated with MTX/CSA who had MSD allo-HCT for AML using unmanipulated mobilized PBSC were examined and compared.
The cumulative incidence of acute GVHD at 100 days was considerably lower in the PT-CY/CSA group (4% vs 19.3%, p = 0.002), however there were no statistically significant difference in the cumulative incidence of chronic GVHD at 1-year (19.6% vs 37.4%, p = 0.053). Significant delays in neutrophil and platelet engraftments were reported in the PT-CY/CSA group (17 vs 12 days) and (13 vs 12 days), respectively (p < 0.001). The cumulative incidences of relapse (19.1% vs 13.7%, p = 0.470), overall survival (79.1% vs 77.3%, p = 0.986), non-relapse mortality (16.5% vs 16.8%, p = 0.837), and the GVHD and relapse-free survival (GRFS) (53.7% vs 46.6%, p = 0.478) did not differ statistically at 1-year.
PT-CY/CSA demonstrated a significant decrease in the rate of acute GVHD. However, it was associated with engraftment delay.
对于接受同胞供者（MSD）异基因造血细胞移植（allo-HCT）的患者，有多种预防移植物抗宿主病（GVHD）的方案。本研究旨在比较移植后环磷酰胺加环孢素 A（PT-CY/CSA）与甲氨蝶呤加 CSA（MTX/CSA）作为预防 GVHD 的方案在接受 MSDAlo-HCT 的成人急性髓细胞白血病（AML）患者中的有效性，供者来源为外周血干细胞（PBSC）。
回顾性分析了 89 例接受 PT-CY/CSA 治疗和 90 例接受 MTX/CSA 治疗的 AML 患者的临床资料，这些患者均采用未处理的动员外周血干细胞（PBSC）进行 MSDallo-HCT。
PT-CY/CSA 组 100 天急性 GVHD 的累积发生率明显较低（4%比 19.3%，p=0.002），但 1 年慢性 GVHD 的累积发生率无统计学差异（19.6%比 37.4%，p=0.053）。PT-CY/CSA 组的中性粒细胞和血小板植入延迟分别为 17 天和 13 天，明显长于 MTX/CSA 组（12 天和 12 天）（p<0.001）。复发率（19.1%比 13.7%，p=0.470）、总生存率（79.1%比 77.3%，p=0.986）、非复发死亡率（16.5%比 16.8%，p=0.837）和 GVHD 及无复发生存（GRFS）率（53.7%比 46.6%，p=0.478）在 1 年时均无统计学差异。
PT-CY/CSA 方案显著降低了急性 GVHD 的发生率，但同时也导致了植入延迟。
