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. 2024 Jul 17;16(14):2567.
doi: 10.3390/cancers16142567.

Reduced Dose of Post-Transplant Cyclophosphamide with Tacrolimus for the Prevention of Graft-versus-Host Disease in HLA-Matched Donor Peripheral Blood Stem Cell Transplants: A Prospective Pilot Study

Alex Juárez  1 , María Queralt Salas  1 , Alexandra Pedraza  2 , María Suárez-Lledó  1   3 , Luís Gerardo Rodríguez-Lobato  1   3 , María Teresa Solano  1 , Anna Serrahima  1 , Meritxell Nomdedeu  2 , Joan Cid  3   4 , Miquel Lozano  3   4 , Paola Charry  3   4 , Jordi Arcarons  1 , Noemí Llobet  1 , Laura Rosiñol  1   3   5 , Francesc Fernández-Avilés  1   3   5 , Montserrat Rovira  1   3   5 , Carmen Martínez  1   3   5
Affiliations

Reduced Dose of Post-Transplant Cyclophosphamide with Tacrolimus for the Prevention of Graft-versus-Host Disease in HLA-Matched Donor Peripheral Blood Stem Cell Transplants: A Prospective Pilot Study

Alex Juárez et al. Cancers (Basel). .

Abstract

PTCY 50 mg/kg/day on days +3/+4 is an excellent strategy to prevent GVHD. However, its use is associated with adverse outcomes such as delayed engraftment, increased risk of infection, and cardiac complications. This pilot study evaluates the efficacy and toxicity of a reduced dose of PTCY (40 mg/kg/day) combined with tacrolimus in 22 peripheral blood HLA-matched alloHSCT patients. At day +100, the cumulative incidences of grade II-IV and III-IV acute GVHD were 18.2% and 4.5%, respectively. No grade IV acute GVHD or steroid-refractory disease was observed. The cumulative incidences of all-grade and moderate-severe chronic GVHD at 1-year were 11.4% and 6.4%, respectively. No patient died from transplant-related complications. Two-year OS and RFS were 77.1% and 58.3%, respectively. All patients engrafted, with neutrophil and platelet recovery occurring at a median of 15 (IQR 14-16) and 16 days (IQR 12-23), respectively. The cumulative incidences of bloodstream bacterial infections, polyomavirus BK hemorrhagic cystitis, HHV6 reactivation, CMV reactivation, and fungal infections were 13.6%, 9.1%, 9.1%, 4.6%, and 6%, respectively. Only one early cardiac event was observed. These results suggest that PTCY 40 mg/kg/day on a +3/+4 schedule provides adequate immunosuppression to allow for engraftment and prevent clinically significant GVHD with a low toxicity profile.

Keywords: GVHD; allogeneic hematopoietic stem cell transplantation; graft-versus-host disease; post-transplant cyclophosphamide; reduced-dose PTCY.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Cumulative incidence of grade II–IV (A) and III–IV (B) acute GVHD, and moderate-severe chronic GVHD (C) after alloHSCT.
Figure 1
Figure 1
Cumulative incidence of grade II–IV (A) and III–IV (B) acute GVHD, and moderate-severe chronic GVHD (C) after alloHSCT.
Figure 2
Figure 2
Estimated probabilities of overall survival (A) and relapse-free survival (B).
See this image and copyright information in PMC

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