Clinical transplantation · 2025
Sirolimus Plus Low-Exposure Calcineurin Inhibitors as an Alternative Graft-Versus-Host Disease Prophylaxis in Calcineurin Inhibitor-Intolerant Recipients: A Retrospective Study.
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Lu Yanfei, Wu Min, Wei Zhenbin, Shi Lingling, Lai Yongrong, Liu Rongrong
Аннотация
BACKGROUND: Graft-versus-host disease (GvHD) remains a major barrier to long-term survival after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Although calcineurin inhibitors (CNIs) are the cornerstone of GvHD prophylaxis, some patients cannot tolerate them, creating a critical need for alternative strategies.
OBJECTIVE: To evaluate the efficacy and safety of sirolimus plus low-exposure CNIs as an alternative GvHD prophylaxis in CNI-intolerant recipients undergoing allo-HSCT.
METHODS: We retrospectively analyzed 16 allo-HSCT recipients who received alternative GvHD prophylaxis due to CNI intolerance, evaluating GvHD incidence, survival and relapse outcomes, infectious complications, and immune reconstitution.
RESULTS: The median time to regimen initiation was 27.5 days (range, -2 to 114 days), and the median treatment duration was 53 days (range, 14-319 days). Only one patient (6.3%) experienced grade 2 acute GvHD, and none developed grade 3-4 acute GvHD. No cases of chronic GvHD were observed in the 15 evaluable patients. Over a median follow-up of 271 days (range, 58-505 days), one non-relapse mortality and three relapses (18.7%) occurred, with no relapse-related deaths. The alternative regimen was well-tolerated with manageable infections and, importantly, did not impair early T, B, or NK cell reconstitution.
CONCLUSION: For allo-HSCT recipients with CNI intolerance, this study provides the first evaluation of sirolimus combined with low-exposure CNIs as a GvHD prophylaxis. Our findings suggest this regimen is a promising and feasible alternative, although validation in larger, prospective studies is warranted.
OBJECTIVE: To evaluate the efficacy and safety of sirolimus plus low-exposure CNIs as an alternative GvHD prophylaxis in CNI-intolerant recipients undergoing allo-HSCT.
METHODS: We retrospectively analyzed 16 allo-HSCT recipients who received alternative GvHD prophylaxis due to CNI intolerance, evaluating GvHD incidence, survival and relapse outcomes, infectious complications, and immune reconstitution.
RESULTS: The median time to regimen initiation was 27.5 days (range, -2 to 114 days), and the median treatment duration was 53 days (range, 14-319 days). Only one patient (6.3%) experienced grade 2 acute GvHD, and none developed grade 3-4 acute GvHD. No cases of chronic GvHD were observed in the 15 evaluable patients. Over a median follow-up of 271 days (range, 58-505 days), one non-relapse mortality and three relapses (18.7%) occurred, with no relapse-related deaths. The alternative regimen was well-tolerated with manageable infections and, importantly, did not impair early T, B, or NK cell reconstitution.
CONCLUSION: For allo-HSCT recipients with CNI intolerance, this study provides the first evaluation of sirolimus combined with low-exposure CNIs as a GvHD prophylaxis. Our findings suggest this regimen is a promising and feasible alternative, although validation in larger, prospective studies is warranted.