|
|
Blood, 1 October 2008, Vol. 112, No. 7, pp. 2667-2674.
Prepublished online as a Blood First Edition Paper on July 11, 2008; DOI 10.1182/blood-2008-03-141481.
 Previous Article | Next Article 
Submitted March 12, 2008
Accepted June 24, 2008
A Multicenter Prospective Phase II Randomized Study of Extracorporeal Photopheresis for Treatment of Chronic Graft-versus-Host Disease
Mary E.D. Flowers*, Jane F Apperley, Koen van Besien, Ahmet Elmaagacli, Andrew Grigg, Vijay Reddy, Andrea Bacigalupo, Hans-Jochem Kolb, Luis Bouzas, Mauricette Michallet, H.Miles Prince, Robert Knobler, Dennis Parenti, Jose Gallo, and Hildegard T Greinix
Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA, United States
Division of Investigative Science, Imperial College School of Medicine, London, United Kingdom
Section of Hematology/Oncology, University of Chicago, Chicago, IL, United States
Klinik und Poliklinik fur Knochenmarktransplantation, University Hospital Essen, Essen, Germany
Clinical Haematology and Medical Oncology, Royal Melbourne Hospital, Melbourne, Australia
Division of Hematology Oncology, University of Florida, Gainesville, FL, United States
Ospedale S. Martino, S.Martino's Hospital, Genova, Italy
Department of Medicine, Ludwig-Maximilians-University of Munich, Munich, Germany
National Cancer Institute, (CEMO), Rio de Janeiro, Brazil
Leukemia Unit, Edouard Herriot Hospital, University of Lyon, Lyon, France
Dept of Hm & Med. Onc., Peter MacCallum Cancer Centre, Melbourne, Australia
Department of Dermatology, University of Vienna, Vienna, Austria
CR&D, Therakos, Exton, NJ, United States
Department of Internal Medicine I, Bone Marrow Transplantation Unit, Medical University of Vienna, Vienna, Germany
* Corresponding author; email: mflowers{at}fhcrc.org.
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 -24 weeks, together with standard therapy was compared to standard therapy alone in patients with cutaneous manifestations of cGVHD that could not be adequately controlled by corticosteroid treatment. The primary efficacy endpoint was a blinded quantitative comparison of percent change from baseline in skin assessment score (Total Skin Score; TSS) of 10 body regions at Week 12. Ninety-five patients were randomized to receive either ECP and standard therapy (n = 48) or standard therapy alone (n = 47). The median percentage improvement in TSS from baseline to Week 12 was 14.5% for the ECP arm and 10.4% for the control arm (p = 0.51). The proportion of patients who had at least a 25% decrease from baseline in TSS and at least a 50% reduction in steroid dose was 9.8% in the ECP arm at Week 12 and 0% in the control arm (p = 0.04). The non-blinded investigator assessment of skin complete or partial responses revealed a significant improvement in favor of ECP (p<0.0001). ECP was generally well tolerated. These results suggest that ECP may have a significant steroid-sparing effect in the treatment of cGVHD.Clinical trials registered at www.ClinicalTrials.gov as NCT00054613.
 CiteULike  Connotea  Del.icio.us  Digg  Reddit  Technorati What's this?
Related Article in Blood Online:
-
Shedding some LIGHT on chronic GVHD
- David A. Jacobsohn
Blood 2008 112: 2593-2594.
[Full Text]
[PDF]
This article has been cited by other articles:
|
|
|
|
 
D. A. Jacobsohn, A. L. Gilman, A. Rademaker, B. Browning, M. Grimley, L. Lehmann, E. R. Nemecek, K. Thormann, K. R. Schultz, and G. B. Vogelsang
Evaluation of pentostatin in corticosteroid-refractory chronic graft-versus-host disease in children: a Pediatric Blood and Marrow Transplant Consortium study
Blood,
November 12, 2009;
114(20):
4354 - 4360.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Olivieri, F. Locatelli, M. Zecca, A. Sanna, M. Cimminiello, R. Raimondi, G. Gini, N. Mordini, A. Balduzzi, P. Leoni, et al.
Imatinib for refractory chronic graft-versus-host disease with fibrotic features
Blood,
July 16, 2009;
114(3):
709 - 718.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
