Evidence map›Paper›PMID 36346687›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

Triple-Negative PAM50 Non-Basal Breast Cancer Subtype Predicts Benefit from Extended Adjuvant Capecitabine.

Karama Asleh, Ana Lluch, Angela Goytain, Carlos Barrios, Xue Q Wang, Laura Torrecillas, Dongxia Gao, Manuel Ruiz-Borrego, Samuel Leung, José Bines and 11 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00130533 (Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.5field-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.

NCT00130533 phase3completednot on this map

Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients

TypeinterventionalSponsorSpanish Breast Cancer Research GroupRan2006 to 2017Enrolled876ConditionsBreast CancerArmsCapecitabine
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. FOXC1 Expression Predicts Capecitabine Efficacy in Patients with Triple-Negative Breast Cancer from the GEICAM_CIBOMA Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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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

21 authors at 11 institutions in 8 countries.

Karama AslehDepartment of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, Canada.ORCID 0000-0002-2873-7253
Ana LluchGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0003-2766-407X
Angela GoytainDepartment of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, Canada.ORCID 0000-0003-3991-8321
Carlos BarriosCentro de Pesquisa Clínica Hospital São Lucas da PUCRS, Porto Alegre, Brazil.ORCID 0000-0001-6021-667X
Xue Q WangDepartment of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, Canada.ORCID 0000-0002-7249-1908
Laura TorrecillasLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0003-1302-4389
Dongxia GaoDepartment of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, Canada.ORCID 0000-0002-7779-4967
Manuel Ruiz-BorregoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0002-1181-5622
Samuel LeungDepartment of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, Canada.ORCID 0000-0003-0138-7254
José BinesLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0003-2465-8854
Ángel Guerrero-ZotanoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0003-0318-9120
Jose Ángel García-SáenzGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-6880-0301
Juan Miguel CejalvoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0002-8755-8626
Jesus HerranzGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0002-7385-1311
Roberto TorresLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0002-1397-4993
Juan de la Haba-RodriguezGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-5111-1702
Francisco AyalaGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-6311-920X
Henry GómezLACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.ORCID 0000-0002-3415-9701
Federico RojoGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-9989-0290
Torsten O NielsenDepartment of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, Canada.ORCID 0000-0003-3769-2517
Miguel MartinGEICAM, Spanish Breast Cancer Group, Madrid, Spain.ORCID 0000-0001-9237-3231
University of British Columbia · CAEastern Cooperative Oncology Group · USHospital Clínico Universitario de Valencia · ESFundación Instituto Valenciano de Oncología · ESGEICAM – Spanish Breast Cancer Group · ESHospital General Universitario Gregorio Marañón · ESHospital General Universitario Morales Meseguer · ESHospital Universitario Virgen del Rocío · ESInstituto de Investigación Sanitaria del Hospital Clínico San Carlos · ESInstituto de Salud Carlos III · ESInstituto Maimónides de Investigación Biomédica de Córdoba · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePredictive biomarkers for capecitabine benefit in triple-negative breast cancer (TNBC) have been recently proposed using samples from phase III clinical trials, including non-basal phenotype and biomarkers related to angiogenesis, stroma, and capecitabine activation genes. We aimed to validate these findings on the larger phase III GEICAM/CIBOMA clinical trial. EXPERIMENTAL

designTumor tissues from patients with TNBC randomized to standard (neo)adjuvant chemotherapy followed by capecitabine versus observation were analyzed using a 164-gene NanoString custom nCounter codeset measuring mRNA expression. A prespecified statistical plan sought to verify the predictive capacity of PAM50 non-basal molecular subtype and tested the hypotheses that breast tumors with increased expression of (meta)genes for cytotoxic cells, mast cells, endothelial cells, PDL2, and 38 individual genes benefit from adjuvant capecitabine for distant recurrence-free survival (DRFS; primary endpoint) and overall survival.

resultsOf the 876 women enrolled in the GEICAM/CIBOMA trial, 658 (75%) were evaluable for analysis (337 with capecitabine and 321 without). Of these cases, 553 (84%) were profiled as PAM50 basal-like whereas 105 (16%) were PAM50 non-basal. Non-basal subtype was the most significant predictor for capecitabine benefit [HRcapecitabine, 0.19; 95% confidence interval (CI), 0.07-0.54; P < 0.001] when compared with PAM50 basal-like (HRcapecitabine, 0.9; 95% CI, 0.63-1.28; P = 0.55; Pinteraction<0.001, adjusted P value = 0.01). Analysis of biological processes related to PAM50 non-basal subtype revealed its enrichment for mast cells, extracellular matrix, angiogenesis, and features of mesenchymal stem-like TNBC subtype.

conclusionsIn this prespecified correlative analysis of the GEICAM/CIBOMA trial, PAM50 non-basal status identified patients with early-stage TNBC most likely to benefit from capecitabine.

Indexed as

Breast NeoplasmsTriple Negative Breast NeoplasmsAdjuvants, ImmunologicAntineoplastic Combined Chemotherapy ProtocolsCapecitabineChemotherapy, AdjuvantEndothelial CellsFemaleHumansAdjuvants, ImmunologicCapecitabine

Identifiers

PMID36346687
PMCPMC9873250
OpenAlexW4308523453

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.