Omission of day 11 methotrexate in regimen for the prophylaxis of graft-versus-host disease after haploid hematopoietic stem cell transplantation.

ABSTRACT

BACKGROUND: The regimen of cyclosporin combined with four times of short-range methotrexate is still recognized as the classic prevention regimen for acute graft-versus-host disease. Previous studies have shown that whether day 11 methotrexate is used in sibling transplantation has no effect on the incidence of acute graft-versus-host disease. However, the effect of reducing day 11 methotrexate on the incidence of acute graft-versus-host disease in haploid hematopoietic stem cell transplantation patients remains unclear. OBJECTIVE: To investigate the efficacy of the omission of day 11 methotrexate in the regimen for the prophylaxis of graft-versus-host disease in haploid hematopoietic stem cell transplantation. METHODS: The clinical data of 63 patients with malignant hematologic diseases who received haploid hematopoietic stem cell transplantation from January 2017 to December 2019 were retrospectively analyzed. The graft-versus-host disease prevention regimen was cyclosporine combined with methotrexate 15 mg/m² on day 1, 10 mg/m² on day 3, day 6 and day 11. In the observation group (n=19), oral mucositis was grade III-IV at day 11, and day 11 methotrexate was cancelled. In the control group (n=44), oral mucositis was grade 0-II at day 11, and day 11 methotrexate was applied. The implantation situation, incidence of acute graft-versus-host disease, overall survival rate, and recurrence rate of the two groups were analyzed. RESULTS AND CONCLUSION: (1) The median follow-up time was 30(3-54) months and all neutrophils were successfully implanted in both groups. The median implantation time was 12(9-29) days and 12(8-25) days, respectively, showing no significant difference (P=0.682). There was one patient with poor platelet implantation in the observation group, and four patients with poor platelet implantation in the control group. The median time of platelet implantation was 12(9-18) days and 13(9-31) days in the two groups, respectively, (P=0.71), showing no statistical difference. (2) The overall incidence of acute graft-versus-host disease was 44.4%, and grade II-IV acute graft-versus-host disease was 28.6%. The incidence of II-IV acute graft-versus-host disease in the observation group and control group was 31.5% and 27.3%, respectively, (P=0.728), and there was no statistical difference between the two groups. (3) The results showed that for haploid hematopoietic stem cell transplantation, the omission of day 11 methotrexate did not increase the incidence of acute graft-versus-host disease compared with the standard methotrexate regimen. (English) [ FROM AUTHOR] 背景：环孢素联合4次短程甲氨蝶呤方案仍是目前公认的、经典的预防急性移植物抗宿主病方案，以往研究显示在同胞全相合移植后第11 天是否应用甲氨蝶呤对于急性移植物抗宿主病的发生率没有影响，但减少第11天甲氨蝶呤对单倍体造血干细胞移植患者急性移植物抗宿主 病发生率的影响仍不清楚。 目的：探讨移植物抗宿主病预防方案中去除第11天甲氨蝶呤的应用对单倍体造血干细胞移植患者发生急性移植物抗宿主病的影响。 方法：回顾性分析 2017年1月至2019年12月接受单倍体造血干细胞移植治疗的 63例恶性血液病患者的临床资料，移植物抗宿主病预防方案 为环孢素联合甲氨蝶呤15 mg/m²(第1天)，10 mg/m2(第3，6，11天)。在第11天时发生严重口腔黏膜炎(Ⅲ-Ⅳ级)的患者，取消第4次甲氨蝶 呤应用，归为观察组，共19例；在第11天时发生轻度口腔黏膜炎(0-Ⅱ级)的患者，按标准方案继续第4次甲氨蝶呤应用，归为对照组，共 44例。对两组植入情况、急性移植物抗宿主病发生率、总体生存率及复发率进行分析。 结果与结论：①中位随访时间 30(3-54)个月，两组患者中性粒细胞全部植活，中位植入时间分别为 12(9-29) d 和12(8-25) d，差异无显著 性意义(P=0.682)；观察组1例血小板植入不良，对照组4例血小板植入不良，可分析数据两组中位植入时间分别为 12(9-18) d 和13(9-31) d， 差异无显著性意义(P=0.71)；②急性移植物抗宿主病总体发生率为 44.4%，Ⅱ-Ⅳ度急性移植物抗宿主病为28.6%；观察组及对照组Ⅱ-Ⅳ度 急性移植物抗宿主病发生率分别为31.5%，27.3%，差异无显著性意义(P=0.728)；③结果表明，对于单倍体造血干细胞移植，与标准甲氨蝶 呤预防方案比较，去除第11天甲氨蝶呤的应用并不引起急性移植物抗宿主病发生率升高。 (Chinese) [ FROM AUTHOR] Copyright of Chinese Journal of Tissue Engineering Research / Zhongguo zu zhi gong cheng yan jiu is the property of Chinese Journal of Tissue Engineering Research and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)