Phase II Clinical Trial of Etanercept Plus Extracorporeal Photopheresis GVHD Prophylaxis Following Unrelated Donor Reduced Intensity Transplant

Biology of Blood and Marrow Transplantation(2015)

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摘要
s / Biol Blood Marrow Transplant 21 (2015) S322eS354 S337 GVHD grading but were included for the other analyses. Initial treatment included beginning or increasing systemic steroids (69%), continuing calcineurin inhibitors (64%) or beginning topical treatment (52%). Additional treatment was added within the first 28 days for 31% patients. Median lines of treatment for the total duration of follow-upwere 1 (range 0-4). Of the evaluable patients, 63/85 and 56/66 had a clinical response (CR/PR) at 28 days and at 180 days respectively. 36% developed recurrence of LA GVHD after a documented CR. 26% developed chronic GVHD after LA GVHD at a median of 169 (range 25-383) days after diagnosis of LA GVHD. Median number of hospital days in the first 6 months after the diagnosis of LA GVHD was 15 (range 1-120) days. 25% had discontinued immunosuppressive therapy (IST) at the time of last follow-up with the median duration of IST being 12.8 (range 6.1-24.7) months after HCT. 9% relapsed and 22% died with themain causes of death being GVHD, infection ormulti organ failure. Median failure free survival (FFS) as defined by absence of relapse, death, addition of new IST or development of chronic GVHD was 3.6 months (95% CI: 1.7-6.8) (Figure). Median overall survival (OS) was 25.3 months. No patient/transplant or GVHD related factors emerged as significant predictors for FFS or OS in univariate analysis. Conclusions: The overall incidence of LA GVHD is low, but it is associated with prolonged immunosuppression, poor failure free and overall survival.
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