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. 2025 Jun;60(6):832-840.
doi: 10.1038/s41409-025-02562-w. Epub 2025 Apr 8.

GvHD prophylaxis with tacrolimus, sirolimus, and mycophenolate mofetil after reduced intensity conditioning hematopoietic stem cell allogeneic transplantation

L Lopez-Corral  1 , C Blázquez-Goñi  2 , E Pérez-López  3 , F M Martín-Domínguez  2 , A Cabero Martínez  3 , N Rodríguez-Torres  3 , M Cabrero  3 , I Espigado-Tocino  4 , A A Martín López  3 , R Parody-Porras  2 , M Baile González  3 , T Caballero-Velázquez  2 , M Cortés-Rodríguez  3   5 , E Soria-Saldise  2 , A Avendaño Pita  3 , P Alcalde-Mellado  2 , A García Bacelar  3 , E Rodríguez-Arbolí  2 , M López Parra  3 , J F Falantes-González  2 , A Navarro-Bailón  3 , L Vázquez López  3 , V Escamilla-Gómez  2 , F Sánchez-Guijo  3 , J A Pérez-Simón  6
Affiliations

GvHD prophylaxis with tacrolimus, sirolimus, and mycophenolate mofetil after reduced intensity conditioning hematopoietic stem cell allogeneic transplantation

L Lopez-Corral et al. Bone Marrow Transplant. 2025 Jun.

Abstract

We present the largest prospective real-world experience in 159 patients who received the triple combination of tacrolimus/sirolimus/mycophenolate mofetil after reduced intensity conditioning allogeneic hematopoietic stem cell transplantation (RIC-alloHSCT) from matched-related (MRD), matched-unrelated (MUD) or mismatched-unrelated donors (MMURD). Despite the high-risk and elderly population, non-relapse mortality (NRM) at day +100 and 1 year was 5.1% and 8.6%. Grades 2-4 and 3-4 acute Graft-versus-host disease (GvHD) at day +180 was 30.3% and 13%, respectively. Chronic GvHD at 1 and 3 years was 23.2% and 41% and for moderate/severe was 13.2% and 26.6%, respectively. With a median follow-up of 20 months, the 1- and 3-year progression-free survival was 60% and 49%, the GvHD-free relapse-free survival was 44% and 32%, and the overall survival was 70.3% and 61%, respectively, for the entire cohort. Patients receiving allo-HSCT from MMURD showed a higher incidence of aGvHD with impact on survival endpoints. GvHD prophylaxis with the triple-drug combination tacrolimus/sirolimus/mycophenolate mofetil showed excellent results in terms of NRM, GvHD and survival in a high-risk, frail and elderly population in the context of RIC-HSCT from MRD and MUD. The subgroup of patients receiving RIC-HSCT from MMURD might probably benefit from other prophylaxis strategies.

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Conflict of interest statement

Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Cumulative incidence of Graft-versus-Host Disease (GvHD).
a Cumulative incidence of grade 2 to 4 at day +180. b Cumulative incidence of grade 3-4 acute GVHD at day +180. c Cumulative incidence of overall chronic GvHD at 3 years. d Cumulative incidence of moderate-to-severe chronic GvHD at 3 years.
Fig. 2
Fig. 2. Cumulative incidence of non-relapse mortality (NRM).
Cumulative incidence of NRM at 3 years.
Fig. 3
Fig. 3. Survival outcomes: progression-free survival (PFS), GvHD-free, relapse-free survival (GRFS), and overall survival (OS).
a Kaplan-Meier estimate of PFS. b Kaplan-Meier estimate of GRFS c Kaplan-Meier estimate of OS.
See this image and copyright information in PMC

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