Evidence map›Paper›PMID 34614209›Full record

Trial reportCancer2022

Fatigue and endocrine symptoms among women with early breast cancer randomized to endocrine versus chemoendocrine therapy: Results from the TAILORx patient-reported outcomes substudy.

Sofia F Garcia, Robert J Gray, Joseph A Sparano, Amye J Tevaarwerk, Ruth C Carlos, Betina Yanez, Ilana F Gareen, Timothy J Whelan, George W Sledge, David Cella and 1 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.3field-weighted citation impact, top 41% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Development and validation of a machine learning model to predict moderate-to-severe cancer-related fatigue in breast cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  5. Article
  6. Article
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

11 authors at 9 institutions in 2 countries.

Sofia F GarciaDepartment of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.ORCID 0000-0003-3300-385X
Robert J GrayDana-Farber Cancer Institute, Boston, Massachusetts.
Joseph A SparanoMontefiore Medical Center, New York, New York.
Amye J TevaarwerkUniversity of Wisconsin, Madison, Wisconsin.ORCID 0000-0002-8087-5119
Ruth C CarlosUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.ORCID 0000-0001-7055-7662
Betina YanezDepartment of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.ORCID 0000-0003-1503-0600
Ilana F GareenCenter for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.
Timothy J WhelanJuravinski Cancer Center at Hamilton Health Sciences, Hamilton, Ontario, Canada.
George W SledgeStanford Cancer Institute, Palo Alto, California.
David CellaDepartment of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
Lynne I WagnerWake Forest University Health Sciences, Winston-Salem, North Carolina.ORCID 0000-0001-9685-4796
Northwestern University · USBrown University · USECOG-ACRIN Cancer Research Group · USJuravinski Cancer Centre · CAMontefiore Medical Center · USPalo Alto Institute · USUniversity of Michigan · USUniversity of Wisconsin–Madison · USWake Forest University · US

Funding

ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
Montefiore Academic Community NCORP ProgramUG1CA189859 · NCI · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI Balazs Halmos, Della Makower · 2014 to 2026
$10.8M
Northwestern University Lead Academic Participating Site Supplement Year 2UG1CA233320 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B, MATEI, DANIELA E · 2019 to 2025
$5.5M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
National Clinical Trials Network Research at the University of WisconsinUG1CA233277 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Lisa M Barroilhet, Andrew M. Baschnagel · 2019 to 2026
$4.9M
Breast Cancer Research FoundationCanadian Cancer Society 704970ECOG-ACRIN Cancer Research GroupGenomic HealthKomen FoundationNCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180863NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA233160NCI NIH HHS UG1 CA233277NCI NIH HHS UG1 CA233320
6 · The paper itself

Abstract

backgroundTAILORx (Trial Assigning Individualized Options for Treatment) prospectively assessed fatigue and endocrine symptoms among women with early-stage hormone receptor-positive breast cancer and a midrange risk of recurrence who were randomized to endocrine therapy (E) or chemotherapy followed by endocrine therapy (CT+E).

methodsParticipants completed the Functional Assessment of Chronic Illness Therapy-Fatigue, the Patient-Reported Outcomes Measurement Information System-Fatigue Short Form, and the Functional Assessment of Cancer Therapy-Endocrine Symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Linear regression was used to model outcomes on baseline symptoms, treatment, and other factors.

resultsParticipants (n = 458) in both treatment arms reported greater fatigue and endocrine symptoms at early follow-up in comparison with the baseline. The magnitude of change in fatigue was significantly greater for the CT+E arm than the E arm at 3 and 6 months but not at 12, 24, or 36 months. The CT+E arm reported significantly greater changes in endocrine symptoms from the baseline to 3 months in comparison with the E arm; change scores were not significantly different at later time points. Endocrine symptom trajectories by treatment differed by menopausal status, with the effect larger and increasing for postmenopausal patients.

conclusionsAdjuvant CT+E was associated with greater increases in fatigue and endocrine symptoms at early time points in comparison with E. These differences lessened over time, and this demonstrated early chemotherapy effects more than long-term ones. Treatment arm differences in endocrine symptoms were more evident in postmenopausal patients. LAY SUMMARY: Participants in TAILORx (Trial Assigning Individualized Options for Treatment) with early-stage hormone receptor-positive breast cancer and an intermediate risk of recurrence were randomly assigned to endocrine or chemoendocrine therapy. Four hundred fifty-eight women reported fatigue and endocrine symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Both groups reported greater symptoms at early follow-up versus the baseline. Increases in fatigue were greater for the chemoendocrine group than the endocrine group at 3 and 6 months but not later. The chemoendocrine group reported greater changes in endocrine symptoms in comparison with the endocrine group at 3 months but not later.

Indexed as

Breast NeoplasmsChemotherapy, AdjuvantFatigueFemaleHumansPatient Reported Outcome Measuresbreast neoplasmsdrug therapyfatiguehormonespatient-reported outcomes

Identifiers

PMID34614209
PMCPMC8776586
OpenAlexW3202961772

What OpenQuestion holds

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Registered trials

None linked

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.