Evidence map›Paper›PMID 31790959›Full record

Trial reportBreast (Edinburgh, Scotland)2020

Decision of adjuvant chemotherapy in intermediate risk luminal breast cancer patients: A prospective multicenter trial assessing the clinical and psychological impact of EndoPredict® (EpClin) use (UCBG 2-14).

Frédérique Penault-Llorca, Fabrice Kwiatkowski, Antoine Arnaud, Christelle Levy, Marianne Leheurteur, Lionel Uwer, Olfa Derbel, Annick Le Rol, Jean-Philippe Jacquin, Christelle Jouannaud and 11 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Breast (Edinburgh, Scotland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02773004 (Prospective Multicenter Study Assessing EndoPredict®), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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.

NCT02773004 nacompletednot on this map

Prospective Multicenter Study Assessing EndoPredict® (EP) Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer With Uncertainty on the Indication of Chemotherapy Using Standard Assessments

TypeinterventionalSponsorUNICANCERRan2016 to 2017Enrolled203ConditionsBreast CancerArmsEPClin genomic test
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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  5. Review
  6. Article
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  12. Review
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  14. Review
  15. EndoPredictBreast cancer research and treatment · 2020
    Article
  16. Review
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

21 authors.

Frédérique Penault-LlorcaUniversité Clermont Auvergne, Centre Jean Perrin, Department of Biology and Pathology, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Clermont Ferrand, France.
Fabrice KwiatkowskiUniversité Clermont Auvergne, Centre Jean Perrin, Department of Biostatistics, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Clermont Ferrand, France.
Antoine ArnaudDepartment of Medical Oncology, Institut Sainte Catherine, Avignon, France.
Christelle LevyDepartment of Medical Oncology, Centre François Baclesse, Caen, France.
Marianne LeheurteurDepartment of Medical Oncology, Centre Henri Becquerel, Rouen, France.
Lionel UwerDepartment of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre Les Nancy, France.
Olfa DerbelDepartment of Medical Oncology, Hôpital Privé Jean Mermoz, Lyon, France.
Annick Le RolDepartment of Medical Oncology, Centre Hospitalier Intercommunal, Quimper, France.
Jean-Philippe JacquinDepartment of Medical Oncology, Institut de Cancérologie Lucien Newirth, Saint Priest en Jarez, France.
Christelle JouannaudDepartment of Medical Oncology, Institut Jean Godinot, Reims, France.
Nathalie Quenel-TueuxDepartment of Medical Oncology, Institut Bergonié, Bordeaux, France.
Véronique GirreDepartment of Medical Oncology, Centre Hospitalier Départemental de Vendée, La Roche sur Yon, France.
Cyril FoaDepartment of Medical Oncology, Hôpital Saint Joseph, Marseille, France.
Emmanuel GuardiolaDepartment of Medical Oncology, Centre Hospitalier de La Dracénie, Draguignan, France.
Alain LortholaryDepartment of Medical Oncology, Centre Catherine de Sienne, Nantes, France.
Stéphanie CatalaDepartment of Medical Oncology, Centre Catalan D'oncologie, Perpignan, France.
Séverine GuiuDepartment of Medical Oncology, Institut Régional Du Cancer Montpellier (ICM), Val D'Aurelle, Montpellier, France.
Alexander ValentDepartment of Biopathology, Gustave Roussy, Villejuif, France.
Diane BoinonDepartment of Supportive Care, Psycho-oncology Unit, Gustave Roussy, Villejuif, France.
Jérome LemonnierR&D UNICANCER, Paris, France.
Suzette DelalogeDepartment of Medical Oncology, Gustave Roussy, Villejuif, France. Electronic address: Suzette.delaloge@gustaveroussy.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeGenomic tests can identify ER-positive HER2-negative localized breast cancer patients who may not benefit from adjuvant chemotherapy. Such tests seem especially interesting in "intermediate" clinico-pathological risk categories. The psychological impact of the decision uncertainty in these women remains largely unexplored. We assessed the clinical and psychological impact of EndoPredict® (EpClin), a clinico-genomic test, in these patients.

methodsThis multicenter, single arm prospective study (NCT02773004) enrolled patients for which adjuvant chemotherapy was uncertain, based on predefined criteria. The primary endpoint was the proportion of change between initial adjuvant decision and final administration of chemotherapy. Secondary endpoints included post-test (Day 17) and 1-year patient reported outcomes.

resultsOne third of 200 evaluable patients had a high EpClin score (≥3.32867; 10 years cumulative risk of distance failure ≥10%). The overall change rate of chemotherapy decision was 72/200 (35.8%, 95% CI 29.2-42.4). Chemotherapy was withdrawn in 57 cases (28.4% [22.2-34.8]) and added in 15 (7.5% [3.8-11.2]. 6 changes (8%) were based on patients' decisions. Anxiety and distress levels increased at Day 17 when adding chemotherapy after the test result (p < 10

conclusionsEndoPredict ® (EpClin) is clinically useful in deciding whether or not to administer adjuvant chemotherapy in patients with intermediate risk. A single-step decision is preferable since adding chemotherapy at a later stage increases anxiety and distress.

Indexed as

Clinical Decision RulesGenes, erbB-2AdultAgedAged, 80 and overAntineoplastic AgentsAnxietyBreast NeoplasmsChemotherapy, AdjuvantClinical Decision-MakingFemaleGenetic MarkersGenetic TestingGenomicsHumansMastectomyAntineoplastic AgentsGenetic MarkersReceptors, EstrogenBreast cancerChemotherapyEndoPredict®Genomic testPatient reported outcomes

Identifiers

PMID31790959
PMCPMC7375561

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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.