Evidence map›Paper›PMID 35724624›Full record

ArticleESMO open2022

Factors associated with enrolment in clinical trials among women with early-stage breast cancer.

D Presti, J Havas, D Soldato, P Lapidari, E Martin, B Pistilli, C Jouannaud, G Emile, O Rigal, M Fournier and 8 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01993498 (A Prospective Cohort to Investigate Survivorship Issues in Patients With Early Cancer), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT01993498 narecruitingnot on this map

A Prospective Cohort to Investigate Survivorship Issues in Patients With Early Cancer

TypeinterventionalSponsorUNICANCERRan2012 to 2034Enrolled14,750ConditionsBreast Cancer Nos Metastatic Recurrent, Early Lung CancerArmsblood sampling
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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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

18 authors.

D PrestiINSERM Unit 981 - Molecular Predictors and New Targets in Oncology, Gustave Roussy, Villejuif, France.
J HavasINSERM Unit 981 - Molecular Predictors and New Targets in Oncology, Gustave Roussy, Villejuif, France.
D SoldatoINSERM Unit 981 - Molecular Predictors and New Targets in Oncology, Gustave Roussy, Villejuif, France; Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genoa, Italy.
P LapidariINSERM Unit 981 - Molecular Predictors and New Targets in Oncology, Gustave Roussy, Villejuif, France; Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.
E MartinINSERM Unit 981 - Molecular Predictors and New Targets in Oncology, Gustave Roussy, Villejuif, France.
B PistilliDepartment of Medical Oncology, Gustave Roussy, Villejuif, France.
C JouannaudInstitut Jean Godinot, Reims, France.
G EmileCentre François Baclesse, Caen, France.
O RigalCentre Henri Becquerel, Rouen, France.
M FournierInstitut Bergonié, Bordeaux, France.
P SoulieInstitut de Cancérologie de L'ouest -Paul Papin, Angers, France.
M-A Mouret-ReynierCentre Jean-Perrin, Clermont Ferrand, France.
C TarpinInstitut Paoli Calmettes, Marseille, France.
M CamponeInstitut de Cancérologie de l'Ouest - Site de Nantes - Centre René Gauducheau, Nantes, France.
S GuillermetCentre Eugene Marquis, Rennes, France.
A-L MartinUNICANCER, Paris, France.
S EverhardUNICANCER, Paris, France.
A Di MeglioINSERM Unit 981 - Molecular Predictors and New Targets in Oncology, Gustave Roussy, Villejuif, France. Electronic address: Antonio.DI-MEGLIO@gustaveroussy.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trials allow development of innovative treatments and ameliorate the quality of clinical care in oncology. Data show that only a minority of patients are enrolled in clinical trials. We assessed enrolment in clinical trials and its correlates among women with early breast cancer.

methodsWe included 9516 patients with stage I-III breast cancer from the multicenter, prospective CANTO study (NCT01993498), followed-up until year 4 (Y4) post-diagnosis. We assessed factors associated with enrolment using multivariable logistic regression. In exploratory, propensity score matched analyses, we used multiple linear regression to evaluate the relationship of enrolment in clinical trials with the European Organisation for Research and Treatment of Cancer Quality Of Life (QoL) questionnaire (EORTC QLQ-C30) Summary Score and described clinical outcomes (distant disease event, invasive disease event, and death by any cause) according to enrolment.

resultsOverall, 1716 patients (18%) were enrolled in a clinical trial until Y4 post-diagnosis of breast cancer. Socioeconomic factors were not associated with enrolment. Centres of intermediate volume were most likely to enrol patients in clinical trials [versus low volume, odds ratio 1.45 (95% confidence interval (CI) 1.08-1.95), P = 0.0124]. Among 2118 propensity score matched patients, enrolment was associated with better QoL at Y4 (adjusted mean difference versus not enrolled 1.37, 95% CI 0.03-2.71, P = 0.0458), and clinical outcomes (enrolled versus not enrolled, distant disease event 7.3% versus 10.1%, P = 0.0206; invasive disease event 8.2% versus 10.5%, P = 0.0732; death by any cause 2.8% versus 3.7%, P = 0.2707).

conclusionsIn this large study, one in five patients enrolled on a clinical trial until Y4 after diagnosis of early breast cancer. Geographical and centre-related factors were significantly associated with enrolment in clinical trials. Inclusion in clinical trials seemed associated with improved QoL and clinical outcomes. Access to innovation for early-stage breast cancer patients should be encouraged and facilitated by overcoming organizational and geographical barriers to recruitment.

Indexed as

Breast NeoplasmsFemaleHumansProspective StudiesQuality of LifeSurveys and Questionnairesbreast neoplasmsclinical trialquality of lifesurvivorship

Identifiers

PMID35724624
PMCPMC9271499

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.