Influence of cyclosporine A trough level on acute graft versus host disease prophylaxis in pediatric allo- hematopoietic stem cell transplantation

Abstract

Purpose Cyclosporine A (CsA) is the cornerstone prophylactic drug for graft versus host disease (GVHD) in allogeneic hematopoietic stem cell transplantation (allo-HSCT); however, its optimal trough level is yet to be determined. Therefore, in this study, we focused on the CsA trough levels and estimated their association with acute GvHD (aGVHD) risk in a consecutive cohort of 72 pediatric patients receiving allo-HSCT. Method The trough CsA level was monitored 3–4 times in a week via mass spectrometry analysis during medication. The occurrence of GVHD, the trough of CsA level before and after allo-HSCT and other clinical information were recorded. Results The cumulative incidence of aGVHD at 100 days was 19.44% for grade I and 23.61% for grades II–IV. Multivariable Cox regression analysis revealed that the optimal trough CsA level for aGVHD prophylaxis was >119 ng/mL, 146–214.5g/mL, >123.25 ng/mL, and 100.2–166 ng/mL on the −3rd day, 3rd day, 1st week, and 2nd month after HSCT, respectively. None of the cutoff values for CsA were significantly associated with the survival outcome. Conclusion Our findings indicate that adequate management of CsA levels during the engraftment period might improve the clinical outcomes for pediatric patients undergoing hematopoietic stem cell transplantation. Clinical trial registration: China Clinical Trial Registration Center (ChiCTR2000034702). Registered 15 July 2020.