Evidence map›Paper›PMID 38236702›Full record

ArticleCancer2024

Adjuvant platinum versus capecitabine for residual, invasive, triple-negative breast cancer: Patient-reported outcomes in ECOG-ACRIN EA1131.

Karen L Smith, Fengmin Zhao, Ingrid A Mayer, Amye J Tevaarwerk, Sofia F Garcia, Carlos L Arteaga, William F Symmans, Ben H Park, Brian L Burnette, Della F Makower and 15 more

Registry-linked trialOpen access · bronzeAbstract readComparative Study
In one paragraph

Article in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02445391 (A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 36% 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.

NCT02445391 phase3active not recruitingnot on this map

A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy

TypeinterventionalSponsorECOG-ACRIN Cancer Research GroupRan2015 to 2031Enrolled415ConditionsEstrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor NegativeArmsCapecitabine, Carboplatin, Cisplatin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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

25 authors at 20 institutions in 1 country.

Karen L SmithSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.
Fengmin ZhaoDana Farber Cancer Institute, Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Biostatistics Center, Boston, Massachusetts, USA.
Ingrid A MayerVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Amye J TevaarwerkMayo Clinic Comprehensive Cancer Center, Rochester, Minnesota, USA.ORCID https://orcid.org/0000-0002-8087-5119
Sofia F GarciaNorthwestern University Feinberg School of Medicine, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0003-3300-385X
Carlos L ArteagaUniversity of Texas Southwestern Simmons Cancer Center, Dallas, Texas, USA.
William F SymmansThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Ben H ParkVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Brian L BurnetteCancer Research of Wisconsin and Northern Michigan (CROWN) NCORP, Green Bay, Wisconsin, USA.
Della F MakowerMontefiore Medical Center, Bronx, New York, USA.
Margaret BlockAlegent Health Bergan Mercy Medical Center, Omaha, Nebraska, USA.
Kimberly A MorleySt Joseph Mercy Hospital, Ann Arbor, Michigan, USA.
Chirag R JaniPhoebe Putney Memorial Hospital, Albany, Georgia, USA.
Craig MescherMetro-Minnesota Community Oncology Research Consortium, St Louis Park, Minnesota, USA.
Shabana J DewaniColumbus Oncology and Hematology Associates Inc., Columbus, Ohio, USA.
Ursa Brown-GlabermanUniversity of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, USA.
Lisa E FlaumNorthwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Erica L MayerDana-Farber Cancer Institute, Boston, Massachusetts, USA.
William M SikovWomen and Infants Hospital of Rhode Island, Providence, Rhode Island, USA.
Eve T RodlerUniversity of California, Davis, Davis, California, USA.
Angela M DeMicheleUniversity of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, USA.
Joseph A SparanoIcahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, New York, USA.ORCID https://orcid.org/0000-0002-9031-2010
Antonio C WolffSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.
Kathy D MillerIndiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, USA.
Lynne I WagnerWake Forest University Health Sciences, Winston-Salem, North Carolina, USA.ORCID https://orcid.org/0000-0001-9685-4796
Johns Hopkins University · USNorthwestern University · USVanderbilt University Medical Center · USAmerican College of Radiology · USColumbus Oncology and Hematology Associates · USDana-Farber Cancer Institute · USHarold C. Simmons Comprehensive Cancer CenterIndiana University Health · USMayo Clinic · USMetro-Minnesota Community Oncology Research Consortium · USMontefiore Medical Center · USNebraska Medical Center · USPhoebe Putney Memorial Hospital · USThe University of Texas MD Anderson Cancer Center · USTisch Hospital · USTrinity Health Ann Arbor Hospital · USUniversity of California, Davis · USUniversity of New Mexico · USUniversity of Pennsylvania · USUniversity of Wisconsin–Green Bay · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Metro-Minnesota Community Oncology Research Consortium (MMCORC)UG1CA189863 · NCI · PARK NICOLLET INSTITUTE · PI JOLEEN M HUBBARD, Yan Ji · 2014 to 2026
$43.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
The NCI Community Oncology Research Program: The New Mexico NCORPUG1CA189856 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI Carolyn Y. Muller, Bernard Tawfik · 2014 to 2026
$20.6M
Cancer Research of Wisconsin and Northern Michigan (CROWN) ConsortiumUG1CA239769 · NCI · ST. VINCENT HOSPITAL · PI Anthony J Jaslowski · 2019 to 2026
$15.8M
Georgia CaResUG1CA189851 · NCI · AUGUSTA UNIVERSITY · PI Anand P Jillella · 2014 to 2026
$13.3M
NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189809NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189851NCI NIH HHS UG1 CA189856NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA189863NCI NIH HHS UG1 CA189954NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233270NCI NIH HHS UG1 CA233277NCI NIH HHS UG1 CA233302NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233329NCI NIH HHS UG1 CA233340NCI NIH HHS UG1 CA239769
6 · The paper itself

Abstract

backgroundPatient-reported outcomes (PROs) are a better tool for evaluating the experiences of patients who have symptomatic, treatment-associated adverse events (AEs) compared with clinician-rated AEs. The authors present PROs assessing health-related quality of life (HRQoL) and treatment-related neurotoxicity for adjuvant capecitabine versus platinum on the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) EA1131 trial (ClinicalTrials.gov identifier NCT02445391).

methodsParticipants completed the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) and the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale (platinum arm only) at baseline, cycle 3 day 1 (C3D1), 6 months, and 15 months. Because of early termination, power was insufficient to test the hypothesis that HRQoL, as assessed by the NFBSI-16 treatment side-effect (TSE) subscale, would be better at 6 and 15 months in the capecitabine arm; all analyses were exploratory. Means were compared by using t-tests or the Wilcoxon rank-sum test, and proportions were compared by using the χ

resultsTwo hundred ninety-six of 330 eligible patients provided PROs. The mean NFBSI-16 TSE subscale score was lower for the platinum arm at baseline (p = .02; absolute difference, 0.6 points) and for the capecitabine arm at C3D1 (p = .04; absolute difference, 0.5 points), but it did not differ at other times. The mean change in TSE subscale scores differed between the arms from baseline to C3D1 (platinum arm, 0.15; capecitabine arm, -0.72; p = .03), but not from baseline to later time points. The mean decline in Functional Assessment of Cancer Therapy-Gynecologic Oncology Group neurotoxicity subscale scores exceeded the minimal meaningful change (1.38 points) from baseline to each subsequent time point (all p < .05).

conclusionsDespite the similar frequency of clinician-rated AEs, PROs identified greater on-treatment symptom burden with capecitabine and complemented clinician-rated AEs by characterizing patients' experiences during chemotherapy.

Indexed as

CapecitabinePatient Reported Outcome MeasuresQuality of LifeTriple Negative Breast NeoplasmsAdultAgedChemotherapy, AdjuvantFemaleHumansMiddle AgedNeoplasm, ResidualPlatinumCapecitabinePlatinumadjuvant therapycapecitabineneuropathypatient‐reported outcomesplatinumquality of lifetriple‐negative breast cancer

Identifiers

PMID38236702
PMCPMC11078225
OpenAlexW4390986332

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.