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“ seminal studies of GVHD prophylaxis with tacrolimus and methotrexate , which reported 42 to 49 percent incidence of grade 2-4 acute GVHD at day 100 following URD HCT .”
After a median follow-up of 368 days ( range = 51-1,275 days ), the one-year overall survival rate was 76 percent . Ten patients died because of relapse ( n = 4 ), GVHD-related complications ( n = 3 ), failure to thrive ( n = 1 ), respiratory failure secondary to infection ( n = 1 ), or interstitial pulmonary fibrosis ( n = 1 ).
Nineteen percent of patients relapsed at one year after HCT , a median of 94 days post-HCT ( range = 61-916 days ).
The one-year cumulative incidence of chronic GVHD that required systemic corticosteroid therapy was 29 percent , for a GVHD-free , relapse-free survival rate of 47 percent . This suggests “ that sufficient graft-versus-leukemia responses were preserved ,” the authors wrote .
To characterize the on-target effects of vorinostat , the researchers also conducted correlative lab tests on blood samples from study patients and a control group of HCT recipients who did not receive vorinostat . Acetylated-H3 levels appeared to be higher in vorinostat-treated patients , compared with controls ( p = 0.026 ). Levels of interleukin-6
( p = 0.028 ) and biomarkers of GVHD ( Reg3α , p = 0.041 ; soluble ST2 , p = 0.002 ) taken at day 30 post-HCT also appeared to be reduced , “ consistent with attenuated systemic inflammation ,” the authors noted .
The study is limited by the small population and the single-arm , single-center design .
The authors report no conflicts .
REFERENCE
Choi SW , Braun T , Henig I , et al . Vorinostat plus tacrolimus / methotrexate to prevent GVHD following myeloablative conditioning unrelated donor HCT . Blood . 2017 August 7 . [ Epub ahead of print ]
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