Oral Pirfenidone in patients with chronic fibrosis resulting from radiotherapy: a pilot studyReport as inadecuate




Oral Pirfenidone in patients with chronic fibrosis resulting from radiotherapy: a pilot study - Download this document for free, or read online. Document in PDF available to download.

Radiation Oncology

, 2:19

First Online: 31 May 2007Received: 01 March 2007Accepted: 31 May 2007

Abstract

BackgroundFibrosis 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.

MethodsOpen 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.

ResultsSeven 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.

ConclusionSeveral 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.

Electronic supplementary materialThe online version of this article doi:10.1186-1748-717X-2-19 contains supplementary material, which is available to authorized users.

Download fulltext PDF



Author: Nicole L Simone - Benjamin P Soule - Lynn Gerber - Elizabeth Augustine - Sharon Smith - Rosemary M Altemus - James B Mi

Source: https://link.springer.com/







Related documents