Results of a 2-arm, phase 2 clinical trial using post-transplantation cyclophosphamide for the prevention of graft-versus-host disease in haploidentical donor and mismatched unrelated donor hematopoietic stem cell transplantation.
Cancer
; 122(21): 3316-3326, 2016 Nov 15.
Article
in En
| MEDLINE
| ID: mdl-27404668
ABSTRACT
BACKGROUND:
High-dose, post-transplantation cyclophosphamide (PTCy) to prevent graft-versus-host disease (GVHD) has improved outcomes in haploidentical (HAPLO) stem cell transplantation (SCT). However, it remains unclear whether this strategy is effective in SCT from 1-antigen human leukocyte antigen (HLA)-mismatched unrelated donors (9/10 MUD) and how the outcomes of these patients compare with those of haploidentical transplantation recipients.METHODS:
A parallel, 2-arm, nonrandomized phase 2 clinical trial was conducted of melphalan-based reduced-intensity conditioning with PTCy, tacrolimus, and mycophenolate mofetil to prevent GVHD in patients with high-risk hematologic malignancies who underwent HAPLO (n = 60) or 9/10 MUD (n = 46) SCT.RESULTS:
The 1-year overall and progression-free survival rates were 70% and 60%, respectively, in the HAPLO arm and 60% and 47%, respectively, in the 9/10 MUD arm. The day +100 cumulative incidence of grade II to IV acute GVHD and grade III to IV acute GVHD was 28% and 3%, respectively, in the HAPLO arm and 33% and 13%, respectively, in the 9/10 MUD arm. The 2-year cumulative incidence of chronic GVHD was 24% in the HAPLO arm and 19% in the 9/10 MUD arm. The 1-year cumulative incidence of nonrelapse mortality was 21% in the HAPLO arm and 31% in the 9/10 MUD arm, and the 1-year relapse rate was 19% in the HAPLO arm and 25% in the 9/10 MUD arm.CONCLUSIONS:
Although this was a nonrandomized study and could not serve as a direct comparison between the 2 groups, the authors conclude that PTCy-based GVHD prophylaxis is effective for both HAPLO and 9/10 MUD SCTs. Prospective randomized trials will be required to compare the efficacies of alternative donor options for patients lacking HLA-matched donors. Cancer 2016;1223316-3326. © 2016 American Cancer Society.Key words
Full text:
1
Database:
MEDLINE
Therapeutic Methods and Therapies TCIM:
Terapias_biologicas
/
Peloideterapia
Main subject:
Hematopoietic Stem Cell Transplantation
/
Hematologic Neoplasms
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Cyclophosphamide
/
Unrelated Donors
/
Graft vs Host Disease
/
Immunosuppressive Agents
Type of study:
Clinical_trials
/
Etiology_studies
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Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Language:
En
Journal:
Cancer
Year:
2016
Type:
Article