Evidence map›Paper›PMID 26909792›Full record

Trial reportBreast cancer research and treatment2016

Prognostic ability of EndoPredict compared to research-based versions of the PAM50 risk of recurrence (ROR) scores in node-positive, estrogen receptor-positive, and HER2-negative breast cancer. A GEICAM/9906 sub-study.

Miguel Martin, Jan C Brase, Amparo Ruiz, Aleix Prat, Ralf Kronenwett, Lourdes Calvo, Christoph Petry, Philip S Bernard, Manuel Ruiz-Borrego, Karsten E Weber and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00129922 (Phase III Study to Compare 6 Courses of FEC), which is not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 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.

NCT00129922 phase3completednot on this map

Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients

TypeinterventionalSponsorSpanish Breast Cancer Research GroupRan1999 to 2007Enrolled1,289ConditionsBreast CancerArmspaclitaxel, Fluorouracil, Epirubicin, Cyclophosphamide
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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.

Miguel MartinDepartment of Medical Oncology, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutente de Madrid, Calle Maiquez 7, Madrid, Spain. mmartin@geicam.org.
Jan C BraseSividon Diagnostics GmbH, Cologne, Germany.
Amparo RuizDepartment of Medical Oncology, Valencian Institute of Oncology (IVO), Valencia, Spain.
Aleix PratTranslational Genomics Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Ralf KronenwettSividon Diagnostics GmbH, Cologne, Germany.
Lourdes CalvoDepartment of Medical Oncology, A Coruña University Hospital Complex, A Coruña, Spain.
Christoph PetrySividon Diagnostics GmbH, Cologne, Germany.
Philip S BernardSolid Tumor Molecular Diagnostics Laboratory, ARUP Laboratories, Utah, USA.
Manuel Ruiz-BorregoDepartment of Medical Oncology, Virgen del Rocio University Hospital, Seville, Spain.
Karsten E WeberSividon Diagnostics GmbH, Cologne, Germany.
César A RodriguezDepartment of Medical Oncology, Salamanca University Hospital-IBSAL, Salamanca, Spain.
Isabel M AlvarezDepartment of Medical Oncology, Donostia University Hospital, Donostia, Spain.
Miguel A SeguiDepartment of Medical Oncology, Parc Tauli University Hospital, Sabadell, Spain.
Charles M PerouLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Maribel CasasSpanish Breast Cancer Research Group (GEICAM), Madrid, Spain.
Eva CarrascoSpanish Breast Cancer Research Group (GEICAM), Madrid, Spain.
Rosalía CaballeroSpanish Breast Cancer Research Group (GEICAM), Madrid, Spain.
Alvaro Rodriguez-LescureDepartment of Medical Oncology, Elche University General Hospital, Elche, Spain.

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Deborah F. Tate · 1985 to 2026
$201.5M
NCI NIH HHS P30 CA016086
6 · The paper itself

Abstract

There are several prognostic multigene-based tests for managing breast cancer (BC), but limited data comparing them in the same cohort. We compared the prognostic performance of the EndoPredict (EP) test (standardized for pathology laboratory) with the research-based PAM50 non-standardized qRT-PCR assay in node-positive estrogen receptor-positive (ER+) and HER2-negative (HER2-) BC patients receiving adjuvant chemotherapy followed by endocrine therapy (ET) in the GEICAM/9906 trial. EP and PAM50 risk of recurrence (ROR) scores [based on subtype (ROR-S) and on subtype and proliferation (ROR-P)] were compared in 536 ER+/HER2- patients. Scores combined with clinical information were evaluated: ROR-T (ROR-S, tumor size), ROR-PT (ROR-P, tumor size), and EPclin (EP, tumor size, nodal status). Patients were assigned to risk-categories according to prespecified cutoffs. Distant metastasis-free survival (MFS) was analyzed by Kaplan-Meier. ROR-S, ROR-P, and EP scores identified a low-risk group with a relative better outcome (10-year MFS: ROR-S 87 %; ROR-P 89 %; EP 93 %). There was no significant difference between tests. Predictors including clinical information showed superior prognostic performance compared to molecular scores alone (10-year MFS, low-risk group: ROR-T 88 %; ROR-PT 92 %; EPclin 100 %). The EPclin-based risk stratification achieved a significantly improved prediction of MFS compared to ROR-T, but not ROR-PT. All signatures added prognostic information to common clinical parameters. EPclin provided independent prognostic information beyond ROR-T and ROR-PT. ROR and EP can reliably predict risk of distant metastasis in node-positive ER+/HER2- BC patients treated with chemotherapy and ET. Addition of clinical parameters into risk scores improves their prognostic ability.

Indexed as

Antineoplastic Agents, HormonalBreast NeoplasmsChemotherapy, AdjuvantErb-b2 Receptor Tyrosine KinasesFemaleHumansKaplan-Meier EstimatePrognosisReceptors, EstrogenRisk AssessmentTreatment OutcomeAntineoplastic Agents, HormonalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenBreast cancerChemotherapyEndoPredictPAM50Prognosis

Identifiers

PMID26909792
PMCPMC4788691

What OpenQuestion holds

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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.