Evidence map›Paper›PMID 34995128›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108).

Seema A Khan, Fengmin Zhao, Lori J Goldstein, David Cella, Mark Basik, Mehra Golshan, Thomas B Julian, Barbara A Pockaj, Christine A Lee, Wajeeha Razaq and 9 more

Erratum issuedOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 107 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 5 pooled it
15.2field-weighted citation impact, top 1% 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

107 citing papers in PubMed, 5 syntheses or guidelines pooled it, 168 citations in OpenAlex.

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47 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 17 institutions in 2 countries.

Seema A KhanNorthwestern University, Chicago, IL.ORCID 0000-0002-6307-2023
Fengmin ZhaoDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.
Lori J GoldsteinAlbert Einstein Medical Center, Philadelphia, PA.ORCID 0000-0002-6542-3421
David CellaRobert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.ORCID 0000-0002-9881-4541
Mark BasikJewish General Hospital Lady Davis Institute, McGill University, Montréal, QC, Canada.ORCID 0000-0002-2633-5410
Mehra GolshanYale School of Medicine, Yale Cancer Center, New Haven, CT.
Thomas B JulianThe Allegheny Health Network Cancer Institute, Pittsburgh, PA.
Barbara A PockajMayo Clinic, Phoenix, AZ.
Christine A LeeSwedish Medical Center, Seattle, WA.ORCID 0000-0002-7529-8134
Wajeeha RazaqUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK.
Joseph A SparanoMontefiore Medical Center, Bronx, NY.ORCID 0000-0002-9031-2010
Gildy V BabieraUniversity of Texas MD Anderson Cancer Center, Houston, TX.
Irene A DyEisenhower Medical Center, Rancho Mirage, CA.
Sarika JainNorthwestern University, Chicago, IL.
Paula SilvermanCase Western Reserve University, Cleveland, OH.ORCID 0000-0001-7818-8793
Carla S FisherIndiana University School of Medicine, Indianapolis, IN.
Amye J TevaarwerkUniversity of Wisconsin Carbone Cancer Center, Madison, WI.ORCID 0000-0002-8087-5119
Lynne I WagnerWake Forest University Health Sciences, Winston Salem, NC.ORCID 0000-0001-9685-4796
George W SledgeStanford University School of Medicine, Stanford, CA.ORCID 0000-0003-0297-0775
Northwestern University · USAllegheny Health Network · USCase Western Reserve University · USDana-Farber Cancer Institute · USEinstein Medical Center Philadelphia · USEisenhower Medical Center · USIndiana University School of MedicineJewish General Hospital · CAMayo Clinic Hospital · USMontefiore Medical Center · USStanford University · USSwedish Medical Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of Oklahoma Health Sciences Center · USUniversity of Wisconsin Carbone Cancer Center · USWake Forest University · USYale Cancer Center · 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 DAWN HERSHMAN, PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
The Pacific Cancer Research Consortium (PCRC), an NCORP Community SiteUG1CA189953 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI Alison Katherine Conlin, Charles Drescher · 2014 to 2026
$27.4M
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical TrialsUG1CA233193 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Muhammad Furqan, Debra L. Richardson · 2019 to 2026
$13.7M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP) UG1UG1CA233329 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KELLY K HUNT, CHELSEA Camille PINNIX · 2019 to 2026
$11.1M
NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA189953NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233193NCI NIH HHS UG1 CA233234NCI NIH HHS UG1 CA233277NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233329NCI NIH HHS UG1 CA233341
6 · The paper itself

Abstract

purposeDistant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results.

methodsWomen presenting with metastatic breast cancer and an intact primary tumor received systemic therapy for 4-8 months; if no disease progression occurred, they were randomly assigned to locoregional therapy for the primary site (surgery and radiotherapy per standards for nonmetastatic disease) or continuing sysmetic therapy. The primary end point was OS; locoregional control and quality of life were secondary end points. The trial design provided 85% power to detect a 19.3% absolute difference in the 3-year OS rate in randomly assigned patients. The stratified log-rank test and Cox proportional hazards model were used to compare OS between arms. Cumulative incidence of locoregional progression was compared using Gray's test. Quality-of-life assessment used standard instruments.

resultsOf 390 participants enrolled, 256 were randomly assigned: 131 to continued systemic therapy and 125 to early locoregional therapy. The 3-year OS was 67.9% without and 68.4% with early locoregional therapy (hazard ratio = 1.11; 90% CI, 0.82 to 1.52;

conclusionEarly locoregional therapy for the primary site did not improve survival in patients presenting with metastatic breast cancer. Although it was associated with improved locoregional control, this had no overall impact on quality of life.

Indexed as

Breast NeoplasmsFemaleHumansProportional Hazards ModelsQuality of LifeSurvival Rate

Identifiers

PMID34995128
PMCPMC8937009
OpenAlexW4205202585

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.