Evidence map›Paper›PMID 42859303›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2026

EORTC QLQ-C30 symptom components and their functional correlates during adjuvant chemotherapy for early breast cancer: a multivariate analysis. Data from GEICAM/2003-02 study.

Andrea Blasco, Roberto Pastor-Barriuso, Pilar Zamora-Auñón, Miguel Martín, Javier Salvador Bofill, Cristina Reboredo, María Marín, Agustín Barnadas, Mireia Margeli, José Manuel López-Vega and 8 more

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

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00129389 (Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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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.

NCT00129389 phase3completednot on this map

Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients

TypeinterventionalSponsorSpanish Breast Cancer Research GroupRan2003 to 2013Enrolled1,925ConditionsBreast CancerArmsFluorouracil, Doxorubicin, Cyclophosphamide, Paclitaxel
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

18 authors.

Andrea BlascoGEICAM Spanish Breast Cancer Group, Madrid, Spain. andrea.blascon@estudiante.uam.es.ORCID http://orcid.org/0009-0005-4277-4180
Roberto Pastor-BarriusoNational Center for Epidemiology, Instituto de Salud Carlos III, Madrid, Spain.
Pilar Zamora-AuñónGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Miguel MartínGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Javier Salvador BofillGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Cristina ReboredoGEICAM Spanish Breast Cancer Group, Madrid, Spain.
María MarínGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Agustín BarnadasGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Mireia MargeliGEICAM Spanish Breast Cancer Group, Madrid, Spain.
José Manuel López-VegaGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Ainhara LahuertaGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Angel GuerreroGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Sonia ServitjaGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Isabel AlvarezGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Enrique ArandaGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Eduardo Martínez de DueñasGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Francisco CarabantesGEICAM Spanish Breast Cancer Group, Madrid, Spain.
Virginia LopeGEICAM Spanish Breast Cancer Group, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeUnderstanding how multiple symptoms jointly impact functioning is essential for interpreting patient-reported outcomes (PROs) in oncology. We aimed to characterize the main dimensions underlying change-from-baseline (CFB) in symptom scores during adjuvant chemotherapy for early breast cancer, and to examine their associations with functional outcomes. PATIENTS AND

methodsWe analyzed EORTC QLQ-C30 CFB scores from 820 patients enrolled in the GEICAM/2003-02 trial. Principal component analysis (PCA) was used to summarize correlated symptom changes into a smaller number of components, and graphical LASSO network modelling was applied to explore relationships among Health-Related Quality of Life (HRQoL) domains. Associations between components and functional scales and global health status were assessed using Spearman correlations.

resultsThree components were identified in the pooled sample, explaining 53.6% of the variance: a dominant general symptom burden component, a gastrointestinal component, and a diarrhea-specific component. The general component, primarily defined by fatigue, pain, appetite loss, insomnia, nausea/vomiting and dyspnea, showed consistent negative correlations with all functional scales and global health status. Similar patterns were observed across treatment arms, although gastrointestinal-related components differed. Graphical LASSO identified fatigue as the symptom most strongly connected to functional impairment.

conclusionSymptom changes during chemotherapy are not independent, but follow a multivariate structured pattern in which a general symptom burden, anchored by fatigue, plays a central role in functional decline. These findings suggest that multivariate approaches may provide a complementary exploratory framework for summarizing correlated patterns of treatment-related burden and generating hypotheses regarding PROs. Trial registration number ClinTrials.gov: GEICAM/2003-02: NCT00129389.

Indexed as

Breast NeoplasmsPatient Reported Outcome MeasuresQuality of LifeAdultAgedChemotherapy, AdjuvantFatigueFemaleHumansMiddle AgedMultivariate AnalysisPrincipal Component AnalysisSurveys and QuestionnairesSymptom BurdenEORTC QLQ-C30Patient-reported outcomesPrincipal component analysisSymptom burden

Identifiers

PMID42859303
PMCPMC13653878

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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.