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Oral Pirfenidone in patients with chronic fibrosis resulting from radiotherapy: a pilot study

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6 pages
Fibrosis is a common side effect after treatment with ionizing radiation. Several methods to ameliorate debilitating fibrosis have been employed but without consistent results. The goal of this pilot study is to determine if Pirfenidone, a novel regulator of cytokine gene expression, has the potential to ameliorate established radiation-induced fibrosis. Methods Open label, prospective pilot study of 800 mg three times/day, orally administered Pirfenidone was administered to enrolled patients who were had completed radiation therapy and who had established radiation-induced fibrosis. Range of motion (ROM) was assessed using standard measures, and subjective measures of pain, fatigue, disability and global health were measured every three months. Results Seven patients were enrolled of whom 3 had ROM assessments of 1 site and 2 had ROM assessments of 2 sites. Of these assessments, 6 revealed increased ROM during drug intervention while 1 revealed a decreased ROM. There was an overall improvement in the mental composite score of the SF36 while physical composite score was decreased and the vitality score was unchanged. Two patients were removed from the study because of syncopal episodes. Conclusion Several patients experienced improved function of at least 25% and reported subjective improvement. Pirfenidone may benefit patients with radiation-induced fibrosis and is worthy of a larger well controlled trial.
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Radiation Oncology
BioMedCentral
Open Access Research Oral Pirfenidone in patients with chronic fibrosis resulting from radiotherapy: a pilot study 1 23 3 Nicole L Simone*, Benjamin P Soule, Lynn Gerber, Elizabeth Augustine, 1 12 Sharon Smith, Rosemary M Altemus, James B Mitchelland 1 Kevin A Camphausen
1 Address: RadiationOncology Branch, National Cancer Institute, National Institutes of Health, 9000 Rockville Pike, Building 10CRC, Room B2 2 3561, Bethesda, Maryland, 20892, USA,Radiation Biology Branch, National Cancer Institute, National Institutes of Health,9000 Rockville Pike, 3 Building 10, Room B3B69, Bethesda, Maryland, 20892, USA andCenter for Chronic Illness and Disability, Department of Global and Community Health, George Mason University, Robinson B415B, Mail Stop 5B7, 4400 University Drive, Fairfax, Virginia, 22030, USA Email: Nicole L Simone*  simonen@mail.nih.gov; Benjamin P Soule  souleb@mail.nih.gov; Lynn Gerber  ngerber1@gmu.edu; Elizabeth Augustine  augustine_elizabeth@yahoo.com; Sharon Smith  smiths@mail.nih.gov; Rosemary M Altemus  raltemus@cox.net; James B Mitchell  jbm@helix.nih.gov; Kevin A Camphausen  camphauk@mail.nih.gov * Corresponding author
Published: 31 May 2007Received: 1 March 2007 Accepted: 31 May 2007 Radiation Oncology2007,2:19 doi:10.1186/1748-717X-2-19 This article is available from: http://www.ro-journal.com/content/2/1/19 © 2007 Simone et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract Background:Fibrosis is a common side effect after treatment with ionizing radiation. Several methods to ameliorate debilitating fibrosis have been employed but without consistent results. The goal of this pilot study is to determine if Pirfenidone, a novel regulator of cytokine gene expression, has the potential to ameliorate established radiation-induced fibrosis. Methods:Open label, prospective pilot study of 800 mg three times/day, orally administered Pirfenidone was administered to enrolled patients who were had completed radiation therapy and who had established radiation-induced fibrosis. Range of motion (ROM) was assessed using standard measures, and subjective measures of pain, fatigue, disability and global health were measured every three months. Results:Seven patients were enrolled of whom 3 had ROM assessments of 1 site and 2 had ROM assessments of 2 sites. Of these assessments, 6 revealed increased ROM during drug intervention while 1 revealed a decreased ROM. There was an overall improvement in the mental composite score of the SF36 while physical composite score was decreased and the vitality score was unchanged. Two patients were removed from the study because of syncopal episodes. Conclusion:Several patients experienced improved function of at least 25% and reported subjective improvement. Pirfenidone may benefit patients with radiation-induced fibrosis and is worthy of a larger well controlled trial.
Background Fibrosis is a major cause of morbidity after treatment with ionizing radiation [13]. Manifestations of fibrosis are
usually tissue specific with effects ranging from limitation of mobility to poor wound healing and neuropathy. For example, irradiation of the brain induces gliosis whereas
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