Please use this identifier to cite or link to this item: https://ninho.inca.gov.br/jspui/handle/123456789/13852
Title: A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease
Authors: Vigorito, Afonso Celso
Apperley, Jane
Flowers, Mary Evelyn Dantas
Besien, Koen Van
Elmaagacli, Ahmet
Grigg, Andrew
Reddy, Vijay
Bacigalupo, Andrea
Kolb, Hans-Jochem
Bouzas, Luis Fernando da Silva
Michallet, Mauricette
Prince, Henry Miles
Knobler, Robert
Parenti, Dennis
Gallo, Jose
Greinix, Hildegard Theresia
Keywords: Doença Crônica
Chronic Disease
Ensaio Clínico Fase II
Clinical Trial Phase II
Ensaios Clínicos Controlados não Aleatórios como Assunto
Non-Randomized Controlled Trials as Topic
Fotoferese
Photopheresis
Estudo Multicêntrico
Multicenter Study
Doença Enxerto-Hospedeiro
Graft vs Host Disease
Issue Date: Oct-2008
Abstract: Chronic graft-versus-host disease (cGVHD) is a major limitation of successful hematopoietic cell transplantation. The safety and efficacy of extracorporeal photopheresis (ECP) for 12 to 24 weeks together with standard therapy was compared with standard therapy alone in patients with cutaneous manifestations of cGVHD that could not be adequately controlled by corticosteroid treatment. The primary efficacy end point was a blinded quantitative comparison of percent change from baseline in Total Skin Score (TSS) of 10 body regions at week 12. Ninety-five patients were randomized to either ECP and standard therapy (n = 48) or standard therapy alone (n = 47). The median percentage improvement in TSS at week 12 was 14.5% for the ECP arm and 8.5% for the control arm (P = .48). The proportion of patients who had at least a 50% reduction in steroid dose and at least a 25% decrease from baseline in TSS was 8.3% in the ECP arm at week 12 and 0% in the control arm (P = .04). The nonblinded investigator assessment of skin complete or partial responses revealed a significant improvement in favor of ECP (P < .001). ECP was generally well tolerated. These results suggest that ECP may have a steroid-sparing effect in the treatment of cGVHD
URI: https://ninho.inca.gov.br/jspui/handle/123456789/13852
ISSN: 1528-0020
Appears in Collections:Hospital do Câncer I (HCI)



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