Evidence map›Paper›PMID 26681684›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016

Concurrent or sequential letrozole with adjuvant breast radiotherapy: final results of the CO-HO-RT phase II randomized trial.

C Bourgier, S Kerns, S Gourgou, C Lemanski, M Gutowski, P Fenoglietto, G Romieu, N Crompton, J Lacombe, A Pèlegrin and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00208273 (A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT00208273 phase2completednot on this map

A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2005 to 2007Enrolled150ConditionsBreast CancerArmsLetrozole - Concomitant, Letrozole - Sequential
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
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  14. Changes in lung volume parameters regarding the received dose in the lobes of the lungs after locoregional radiotherapy of breast cancer.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology
    Article
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

13 authors at 5 institutions in 3 countries.

C BourgierInserm, U1194, Institut de Recherche en Cancérologie de Montpellier (IRCM), Cancer Institute ICM-Val d'Aurelle, Montpellier Department of Radiation Oncology, Montpellier Cancer Institute ICM-Val d'Aurelle, Montpellier, France.
S KernsUniversity of Rochester Medical Centre, Rochester Icahn School of Medicine at Mount Sinai, New York, USA.
S GourgouBiostatistics Unit, Cancer Institute ICM-Val d'Aurelle, Montpellier, France.
C LemanskiDepartment of Radiation Oncology, Montpellier Cancer Institute ICM-Val d'Aurelle, Montpellier, France.
M GutowskiDepartment of Surgery, Cancer Institute ICM-Val d'Aurelle, Montpellier, France.
P FenogliettoDepartment of Radiation Oncology, Montpellier Cancer Institute ICM-Val d'Aurelle, Montpellier, France.
G RomieuDepartment of Medical Oncology, Cancer Institute ICM-Val d'Aurelle, Montpellier, France.
N CromptonLaboratory of Non-invasive Imaging and Radiation Biology, Van Andel Research Institute, Grand Rapids, USA.
J LacombeInserm, U1194, Institut de Recherche en Cancérologie de Montpellier (IRCM), Cancer Institute ICM-Val d'Aurelle, Montpellier.
A PèlegrinInserm, U1194, Institut de Recherche en Cancérologie de Montpellier (IRCM), Cancer Institute ICM-Val d'Aurelle, Montpellier.
M OzsahinCentre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
B RosensteinMount Sinai School of Medicine and NYU School of Medicine, New York, USA.
D AzriaInserm, U1194, Institut de Recherche en Cancérologie de Montpellier (IRCM), Cancer Institute ICM-Val d'Aurelle, Montpellier Department of Radiation Oncology, Montpellier Cancer Institute ICM-Val d'Aurelle, Montpellier, France david.azria@icm.unicancer.fr.
Institut de Recherche en Cancérologie de Montpellier · FRNew York University · USUniversity Hospital of Lausanne · CHUniversity of Rochester Medical Center · USVan Andel Institute · US

Funding

Risk Prediction for Development of Adverse Effects FOllowing Radiotherapy for Prostate CancerK07CA187546 · NCI · UNIVERSITY OF ROCHESTER · PI KERNS, SARAH L. · 2015 to 2019
$649k
NCI NIH HHS K07 CA187546
6 · The paper itself

Abstract

backgroundWe present here final clinical results of the COHORT trial and both translational sub-studies aiming at identifying patients at risk of radiation-induced subcutaneous fibrosis (RISF): (i) radiation-induced lymphocyte apoptosis (RILA) and (ii) candidates of certain single-nucleotide polymorphisms (SNPs). PATIENTS AND

methodsPost-menopausal patients with stage I-II breast cancer (n = 150) were enrolled and assigned to either concurrent (arm A) or sequential radiotherapy (RT)-letrozole (arm B). Among them, 121 were eligible for RILA and SNP assays. Grade ≥2 RISF were the primary end point. Secondary end points were lung and heart events and carcinologic outcome. RILA was performed to predict differences in RISF between individuals. A genome-wide association study was performed to identify SNPs associated with RILA and RISF. Analyses were done by intention to treat.

resultsAfter a median follow-up of 74 months, 5 patients developed a grade ≥2 RISF. No significant difference was observed between arms A and B. Neither grade ≥2 lung nor symptomatic cardiac toxicity was observed. Median RILA value of the five patients who had grade ≥2 RISF was significantly lower compared with those who developed grade ≤1 RISF (6.9% versus 13%, P = 0.02). Two SNPs were identified as being significantly associated with RILA: rs1182531 (P = 4.2 × 10(-9)) and rs1182532 (P = 3.6 × 10(-8)); both located within the PHACTR3 gene on chromosome 20q13.33.

conclusionsWith long-term follow-up, letrozole can safely be delivered concomitantly with adjuvant breast RT. Translational sub-studies showed that high RILA values were correlated with patients who did not develop RISF. REGISTERED CLINICAL TRIAL: NCT00208273.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsApoptosisBreast NeoplasmsCombined Modality TherapyFemaleFibrosisGenome-Wide Association StudyHumansLetrozoleMiddle AgedNitrilesNuclear ProteinsPolymorphism, Single NucleotideRadiotherapy, AdjuvantAntineoplastic AgentsLetrozoleNitrilesNuclear ProteinsPHACTR3 protein, humanTriazolesbreast cancerradiation-induced late effectsradio-hormonotherapy

Identifiers

PMID26681684
PMCPMC4907345
OpenAlexW2246028954

What OpenQuestion holds

Textmetadata
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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.