Systematic review of defibrotide studies in the treatment of veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS)

Bone Marrow Transplantation
Paul RichardsonSelim Corbacioglu

Abstract

Veno-occlusive disease (VOD), also called sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of hematopoietic stem cell transplantation (HSCT) conditioning or high-dose nontransplant chemotherapy. VOD/SOS with multi-organ dysfunction (MOD) is associated with a mortality rate of > 80%. Defibrotide (25 mg/kg/day) is approved to treat hepatic VOD/SOS with renal or pulmonary dysfunction post HSCT in the United States and to treat severe hepatic VOD/SOS in patients > 1 month of age in the European Union. A random effects model was used for pooling data from 17 systematically chosen defibrotide studies. For patients in these reports (n = 2598), and those in the subset of 10 reports of patients treated with ~ 25 mg/kg/day (n = 1691), estimated Day + 100 survival rates were 54% and 56%, respectively. Among those patients treated with ~ 25 mg/kg/day, estimated Day + 100 survival was 44% among patients with MOD and 71% in patients without MOD; survival was 41% and 70%, respectively, for the population of patients receiving any dose of defibrotide. Safety results were not pooled owing to differences in reporting methodology but were generally consistent with the known tolerability profile of defibrotide....Continue Reading

References

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Citations

Oct 11, 2019·Precision Clinical Medicine·Qinqin PuMin Wu
Apr 23, 2020·Frontiers in Immunology·Francesca BonifaziAntonio Colecchia
Oct 11, 2020·American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons·Varun MehraShreyans Gandhi
Nov 5, 2019·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Clinton LewisVincent T Ho
Apr 11, 2021·Transplantation and Cellular Therapy·Pierre-Edouard DebureauxSandrine Valade
May 1, 2021·Journal of Personalized Medicine·Nicolas WaespeMarc Ansari
Jul 14, 2021·Bone Marrow Transplantation·Thomas LuftAleksandar Radujkovic
Nov 4, 2021·Pediatric Radiology·Anneloes E BohteMaarten H Lequin
Dec 14, 2021·The Korean Journal of Internal Medicine·Seom Gim KongHo Sup Lee

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Clinical Trials Mentioned

NCT02851407

Software Mentioned

StataSE
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