Yazarlar : Vallejo C, Batlle M, Vazquez L et al

Yayın : Haematologica

Yayın Yılı : 2014

Pubmed Linki : http://www.docguide.com/phase-iv-open-label-study-efficacy-and-safety-deferasirox-after-allogeneic-stem-cell-transplantation?tsid=5

Konu : Kemik İliği Nakli

Literatür İçeriği :  This is the first prospective study of deferasirox in adult allogeneic hematopoietic stem cell transplant recipients with transfusional iron overload in hematologic malignancies. Patients at least 6 months post-transplant were treated with deferasirox at a starting dose of 10 mg/kg/day for 52 weeks or until serum ferritin was ≤400 ng/mL on two consecutive determinations. Thirty patients were enrolled and 22 patients completed the study. A significant reduction from baseline in median serum ferritin and in liver iron concentration at 52 weeks was observed in the overall population (1440 to 755.5 ng/mL, P=0.002; and 14.5 to 4.6 mg Fe/g dw, P=0.0007, respectively). Serum ferritin reduction in patients without deferasirox discontinuation was significantly greater than was found in those who prematurely discontinued the treatment (1541 to 581 ng/mL versus 1416 to 1486 ng/mL, P=0.008). Drug-related adverse events, reported in 17 patients (56.7%), were mostly mild to moderate in severity. There were no drug-related serious adverse events. Increase in serum creatinine>33% compared to baseline and greater than the upper limit of normal on two consecutive visits occurred in 12 patients (40.0%). Increase in alanine aminotransferase exceeding 10 x upper limit of normal occurred in 2 patients (6.7%) with active graft versus host disease, both of which resolved. In this prospective study, deferasirox provided significant reduction in serum ferritin and liver iron concentration over one year of treatment in allogeneic hematopoietic stem cell transplant recipients with iron overload. Additionally, the majority of adverse events related to deferasirox were mild or moderate in severity.

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