Evidence map›Paper›PMID 26844275›Full record

Trial reportEBioMedicine2015

Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial.

David Azria, Olivier Riou, Florence Castan, Tan Dat Nguyen, Karine Peignaux, Claire Lemanski, Jean-Léon Lagrange, Youlia Kirova, Eric Lartigau, Yazid Belkacemi and 11 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in EBioMedicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00893035 (Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis), which is not on this map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed
4.1field-weighted citation impact, top 5% 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.

NCT00893035 completednot on this map

Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.

TypeobservationalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2006 to 2019Enrolled885ConditionsBreast Cancer, Prostate Cancer
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 116 citations in OpenAlex.

  1. Trial
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  10. Radiation-induced brachial plexopathy in a patient withReports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2026
    Article
  11. Article
  12. Review
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  17. Hype or hope? A review of challenges in balancing tumor control and treatment toxicity in breast cancer from the perspective of the radiation oncologist.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 13 institutions in 2 countries.

David AzriaMontpellier Cancer Institute (ICM), Montpellier Cancer Research Institute (IRCM), University of Montpellier, Montpellier, France.
Olivier RiouMontpellier Cancer Institute (ICM), Montpellier Cancer Research Institute (IRCM), University of Montpellier, Montpellier, France.
Florence CastanMontpellier Cancer Institute (ICM), Montpellier Cancer Research Institute (IRCM), University of Montpellier, Montpellier, France.
Tan Dat NguyenInstitut Jean Godinot, Reims, France.
Karine PeignauxCentre GF Leclerc, Dijon, France.
Claire LemanskiMontpellier Cancer Institute (ICM), Montpellier Cancer Research Institute (IRCM), University of Montpellier, Montpellier, France.
Jean-Léon LagrangeAP-HP Henri Mondor, Créteil, France.
Youlia KirovaInstitut Curie, Paris, France.
Eric LartigauCentre Oscar Lambret, Lille, France.
Yazid BelkacemiAP-HP Henri Mondor, Créteil, France.
Céline BourgierMontpellier Cancer Institute (ICM), Montpellier Cancer Research Institute (IRCM), University of Montpellier, Montpellier, France.
Sofia RiveraGustave Roussy, Villejuif, France.
Georges NoëlCentre Paul Strauss, Strasbourg, France.
Sébastien ClippeCentre Marie Curie, Valence, France.
Françoise MornexCentre Hospitalier Lyon Sud, Pierre Bénite, France.
Christophe HennequinAP-HP Saint-Louis, Paris, France.
Andrew KramarCentre Oscar Lambret, Lille, France.
Sophie GourgouMontpellier Cancer Institute (ICM), Montpellier Cancer Research Institute (IRCM), University of Montpellier, Montpellier, France.
André PèlegrinMontpellier Cancer Institute (ICM), Montpellier Cancer Research Institute (IRCM), University of Montpellier, Montpellier, France.
Pascal FenogliettoMontpellier Cancer Institute (ICM), Montpellier Cancer Research Institute (IRCM), University of Montpellier, Montpellier, France.
Esat Mahmut OzsahinCentre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
Institut de Recherche en Cancérologie de Montpellier · FRAssistance Publique – Hôpitaux de Paris · FRCentre Oscar Lambret · FRInserm · FRUniversité de Montpellier · FRCentre Georges François Leclerc · FRCentre Hospitalier de Valence · FRHôpital Lyon Sud · FRHôpital Saint-Louis · FRInstitut Curie · FRInstitut Gustave Roussy · FRInstitut Jean Godinot · FRUniversity Hospital of Lausanne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMonocentric cohorts suggested that radiation-induced CD8 T-lymphocyte apoptosis (RILA) can predict late toxicity after curative intent radiotherapy (RT). We assessed the role of RILA as a predictor of breast fibrosis (bf +) after adjuvant breast RT in a prospective multicenter trial.

methodsA total of 502 breast-cancer patients (pts) treated by conservative surgery and adjuvant RT were recruited at ten centers. RILA was assessed before RT by flow cytometry. Impact of RILA on bf + (primary endpoint) or relapse was assessed using a competing risk method. Receiver-operator characteristic (ROC) curve analyses were also performed in intention to treat. This study is registered with ClinicalTrials.gov, number NCT00893035 and final analyses are presented here.

findingsFour hundred and fifty-six pts (90.8%) were included in the final analysis. One hundred and eight pts (23.7%) received whole breast and node irradiation. A boost dose of 10-16 Gy was delivered in 449 pts (98.5%). Adjuvant hormonotherapy was administered to 349 pts (76.5%). With a median follow-up of 38.6 months, grade ≥ 2 bf + was observed in 64 pts (14%). A decreased incidence of grade ≥ 2 bf + was observed for increasing values of RILA (p = 0.012). No grade 3 bf + was observed for patients with RILA ≥ 12%. The area under the ROC curve was 0.62. For cut-off values of RILA ≥ 20% and < 12%, sensitivity and specificity were 80% and 34%, 56% and 67%, respectively. Negative predictive value for grade ≥ 2 bf + was equal to 91% for RILA ≥ 20% and positive predictive value was equal to 22% for RILA < 12% where the overall prevalence of grade ≥ 2 bf + was estimated at 14%. A significant decrease in the risk of grade ≥ 2 bf + was found if patients had no adjuvant hormonotherapy (sHR = 0.31, p = 0.007) and presented a RILA ≥ 12% (sHR = 0.45, p = 0.002).

interpretationRILA significantly predicts the risk of breast fibrosis. This study validates the use of RILA as a rapid screening test before RT delivery and will change definitely our daily clinical practice in radiation oncology.

fundingThe French National Cancer Institute (INCa) through the "Program Hospitalier de Recherche Clinique (PHRC)".

Indexed as

AdultAgedAged, 80 and overApoptosisBiomarkers, TumorBreast NeoplasmsCD8-Positive T-LymphocytesFemaleFibrocystic Breast DiseaseFibrosisHumansIncidenceMiddle AgedNeoplasm GradingNeoplasm StagingPrognosisBiomarkers, TumorApoptosisBreast fibrosisLymphocytePredictionRadiotherapy

Identifiers

PMID26844275
PMCPMC4703704
OpenAlexW1758031426

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.