Abstract |
Calcineurin inhibitors (CNIs) form the foundation of current graft-versus-host disease (GVHD) prophylaxis regimens. We hypothesized that a CNI-free regimen consisting of post- transplantation cyclophosphamide (PTCy) and brief-course sirolimus would reduce chronic GVHD and nonrelapse mortality (NRM) after reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation (PBSCT). Twenty-six patients (median age, 61 years) underwent unmanipulated PBSCT from an 8/8 locus-matched donor (matched related donor, n = 17; natched unrelated donor, n = 9). GVHD prophylaxis consisted of PTCy and brief-course sirolimus. Donor engraftment occurred in all patients. The cumulative incidence (CI) of grade II-IV acute GVHD, grade III-IV acute GVHD, and chronic GVHD was 46%, 15%, and 31% respectively. One-year NRM was 4%. The median time to immunosuppression discontinuation was day +138. With a median follow-up of 20 months, the estimated 2-year overall survival was 71%, estimated disease-free survival was 64%, and estimated relapse incidence was 32%. In patients with a lymphoid malignancy (eg, chronic lymphoblastic leukemia, non-Hodgkin lymphoma, Hodgkin disease), 2-year disease-free survival was 100%, and there were no relapses. Good immune reconstitution was evidenced by low cytomegalovirus reactivation rate of 21% (4 of 19 at-risk patients). GVHD prophylaxis with PTCy and sirolimus achieves consistent donor engraftment, low rates of chronic GVHD and NRM, and excellent outcomes in recipients of HLA-identical related and unrelated donor allogeneic PBSCT.
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Authors | Scott R Solomon, Melissa Sanacore, Xu Zhang, Stacey Brown, Kent Holland, Lawrence E Morris, Asad Bashey |
Journal | Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
(Biol Blood Marrow Transplant)
Vol. 20
Issue 11
Pg. 1828-34
(Nov 2014)
ISSN: 1523-6536 [Electronic] United States |
PMID | 25064745
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Copyright | Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Calcineurin Inhibitors
- Immunosuppressive Agents
- Cyclophosphamide
- Sirolimus
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Topics |
- Adult
- Aged
- Calcineurin Inhibitors
(administration & dosage)
- Cyclophosphamide
(administration & dosage)
- Disease-Free Survival
- Female
- Graft vs Host Disease
(prevention & control)
- Hematologic Neoplasms
(therapy)
- Hematopoietic Stem Cell Transplantation
(adverse effects, methods)
- Humans
- Immunosuppressive Agents
(administration & dosage)
- Male
- Middle Aged
- Peripheral Blood Stem Cell Transplantation
(adverse effects, methods)
- Prospective Studies
- Sirolimus
(administration & dosage)
- Tissue Donors
- Transplantation Chimera
- Transplantation Conditioning
(adverse effects, methods)
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