Evidence map›Paper›PMID 17540023›Full record

Trial reportRadiation oncology (London, England)2007

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

Nicole L Simone, Benjamin P Soule, Lynn Gerber, Elizabeth Augustine, Sharon Smith, Rosemary M Altemus, James B Mitchell, Kevin A Camphausen

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Radiation oncology (London, England), 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05704166 (Pirfenidone Versus Placebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following Hypofractionated Radiotherapy in Breast Cancer Patients), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
1.5field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05704166 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Pirfenidone Versus Placebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following Hypofractionated Radiotherapy in Breast Cancer Patients (PRILI): A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating

TypeinterventionalSponsorFujian Medical University Union HospitalRan2023 to 2026Enrolled214ConditionsAcute Lung Injury, PreventionArmsPirfenidone/Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 53 citations in OpenAlex.

  1. Imatinib mesylate for the treatment of steroid-refractory sclerotic-type cutaneous chronic graft-versus-host disease.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2015
    Trial
  2. Review
  3. Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Nicole L SimoneRadiation Oncology Branch, National Cancer Institute, National Institutes of Health, 9000 Rockville Pike, Building 10-CRC, Room B2-3561, Bethesda, Maryland 20892, USA. simonen@mail.nih.gov
Benjamin P Soule
Lynn Gerber
Elizabeth Augustine
Sharon Smith
Rosemary M Altemus
James B Mitchell
Kevin A Camphausen
National Cancer Institute · USNational Institutes of Health · USGeorge Mason University · US

Funding

Modulation of Therapeutic ResponseZIASC006321 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI MITCHELL, JAMES · 2009 to 2025
$17.3M
MODULATION OF THERAPEUTIC RESPONSEZ01SC006321 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI MITCHELL, JAMES B · 1996 to 2008
$1.1M
Intramural NIH HHS
6 · The paper itself

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.

Indexed as

Administration, OralAntineoplastic AgentsCohort StudiesFibrosisHumansMaleMiddle AgedPain MeasurementPilot ProjectsProspective StudiesPyridonesRadiation InjuriesRadiotherapyTreatment OutcomeAntineoplastic AgentspirfenidonePyridones

Identifiers

PMID17540023
PMCPMC1891306
OpenAlexW2099817511

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.