Abstract
We previously conducted a randomized, double-blind, placebo-controlled study conducted from 2000 to 2003 of palifermin, a recombinant human keratinocyte growth factor, dosed from 240 microg/kg to 720 microg/kg, in 100 allogeneic hematopoietic stem cell transplantation (HCT) recipients. Treatment with palifermin showed beneficial effects on mucositis, but no significant effect on engraftment, acute graft-versus-host disease (GVHD), or early survival. In addition to the effect of palifermin on mucosa, other pleotrophic effects, including more rapid immune reconstitution, have been seen in experimental transplant models. Therefore, we investigated whether with longer follow-up we could detect additional differences between the palifermin-treated and placebo cohorts. We found no differences in CMV or invasive fungal infections, chronic GVHD, or long-term survival between cohorts. We conclude that the benefits of palifermin appear primarily to be limited to ameliorating mucotoxicity when given to allogeneic HCT recipients.
References
Apr 30, 1997·Statistics in Medicine·D Y Lin
May 31, 2002·Blood·Dullei MinKenneth I Weinberg
Jul 2, 2002·Blood·Simona RossiGeorg A Holländer
Jan 14, 2003·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Mats RembergerOlle Ringdén
Nov 8, 2003·International Journal of Hematology·James L M FerraraTakanori Teshima
Jun 1, 2004·International Journal of Hematology·Gérard Socié
Dec 17, 2004·The New England Journal of Medicine·Ricardo SpielbergerChristos Emmanouilides
Nov 24, 2005·Blood·Onder AlpdoganMarcel R M van den Brink
Jul 13, 2006·Blood·Bruce R BlazarJames L M Ferrara
Mar 22, 2007·Blood·Ruth SeggewissDaniel C Douek
Mar 13, 2008·Blood·Ryan M KellyBruce R Blazar
Citations
Feb 14, 2012·Bone Marrow Transplantation·M H JagasiaE K Waller
Mar 18, 2010·Annals of Oncology : Official Journal of the European Society for Medical Oncology·G KobbeR Fenk
Mar 11, 2010·Blood·Ruth Seggewiss, Hermann Einsele
Feb 22, 2011·BMC Immunology·Bob MeekGerard M J Bos
Jan 4, 2013·Stem Cells Translational Medicine·Anthony D Sung, Nelson J Chao
Sep 22, 2010·Annals of Internal Medicine·John F Deeken, Louis M Weiner
Sep 19, 2012·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Judith E Raber-DurlacherUNKNOWN Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (
Aug 27, 2009·Biologics : Targets & Therapy·Andrei BaraschKen Tilashalski
May 26, 2012·Nature Reviews. Immunology·Hao Wei Li, Megan Sykes
Jun 2, 2011·Immunological Investigations·Thomas LehrnbecherThomas Klingebiel
Jul 16, 2011·Leukemia & Lymphoma·Amittha Wickrema
Jul 10, 2012·Expert Opinion on Pharmacotherapy·Andrew R Rezvani, Rainer F Storb
Mar 23, 2011·Expert Opinion on Drug Metabolism & Toxicology·Christian WeigeltGuido Kobbe
Nov 21, 2013·Journal of Cellular and Molecular Medicine·Saroj Vadhan-RajMarcel R M van den Brink
Sep 17, 2011·American Journal of Hematology·Romee RizwanMichael R Verneris
Aug 21, 2012·Annals of the New York Academy of Sciences·Lena OevermannRupert Handgretinger
Mar 21, 2015·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Diana T NguyenRicardo Spielberger
Oct 4, 2011·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Evert-Jan WilsJan J Cornelissen
May 7, 2015·Mucosal Immunology·S C Nalle, J R Turner
Jun 11, 2014·Blood·Shernan G HoltanDaniel J Weisdorf
Jun 11, 2014·Blood·Kate A MarkeyGeoffrey R Hill
Dec 17, 2016·Internal Medicine·Takanobu MorishitaMasashi Sawa
Mar 31, 2015·BMJ Supportive & Palliative Care·Lillian SungL Lee Dupuis
May 3, 2015·The Journal of Immunology : Official Journal of the American Association of Immunologists·Andrea S Henden, Geoffrey R Hill
Aug 14, 2019·Vox Sanguinis·Sofia BerglundJonas Mattsson
Jun 16, 2018·Bone Marrow Transplantation·Eric WongDavid Ritchie
Apr 4, 2009·Mycopathologia·E J Bow
Sep 8, 2020·Gut Microbes·Thomas HuesoDavid Seguy
Jul 6, 2021·Transplantation and Cellular Therapy·Wael SaberMary Horowitz
Mar 2, 2010·Immunotherapy·Jian-Ming LiEdmund K Waller
Feb 20, 2017··Anna N. YaroslavskyWendy B. London