Evidence map›Paper›PMID 31339827›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.

Hyman B Muss, Mei-Yin C Polley, Donald A Berry, Heshan Liu, Constance T Cirrincione, Maria Theodoulou, Ann M Mauer, Alice B Kornblith, Ann H Partridge, Lynn G Dressler and 18 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
3.7field-weighted citation impact, top 5% 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

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
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  8. Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
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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

28 authors at 17 institutions in 2 countries.

Hyman B MussUniversity of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
Mei-Yin C PolleyAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
Donald A BerryAlliance Statistics and Data Center, The University of Texas MD Anderson Cancer Center, Houston, TX.
Heshan LiuAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
Constance T CirrincioneRobert H Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL.
Maria TheodoulouMemorial Sloan Kettering Cancer Center, New York, NY.
Ann M MauerAdvocate Illinois Masonic Medical Center, Chicago, IL.
Alice B KornblithDana-Farber/Partners CancerCare, Boston, MA.
Ann H PartridgeAdvocate Illinois Masonic Medical Center, Chicago, IL.
Lynn G DresslerUniversity of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
Harvey J CohenDuke Cancer Institute, Duke University, Durham, NC.
Patricia A KartcheskeRobert H Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL.
Edith A PerezMayo Clinic, Jacksonville, FL.
Antonio C WolffSidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD.
Julie R GralowUniversity of Washington Seattle Cancer Alliance, Seattle, WA.
Harold J BursteinDana-Farber/Partners CancerCare, Boston, MA.
Ahmad A MahmoodDuke Cancer Institute, Duke University, Durham, NC.
Linda M SuttonDuke Cancer Institute, Duke University, Durham, NC.
Gustav MagrinatCone Health Cancer Center, Greensboro, NC.
Barbara A ParkerMoores Cancer Center, University of California San Diego, La Jolla, CA.
Ronald D HartHarold Alfond Center for Cancer Care, Augusta, ME.
Debjani GrenierSt Boniface General Hospital, Winnipeg, Manitoba, Canada.
Arti HurriaCity of Hope Comprehensive Cancer Center, Duarte, CA.
Aminah JatoiMayo Clinic, Rochester, MN.
Larry NortonMemorial Sloan Kettering Cancer Center, New York, NY.
Clifford A HudisMemorial Sloan Kettering Cancer Center, New York, NY.
Eric P WinerDana-Farber/Partners CancerCare, Boston, MA.
Lisa CareyUniversity of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
Duke Medical Center · USMemorial Sloan Kettering Cancer Center · USUniversity of North Carolina at Chapel Hill · USAdvocate Illinois Masonic Medical Center · USCancerCare · USMayo Clinic · USNorthwestern University · USCity of Hope · USCone Health · USDana-Farber/Harvard Cancer Center · USJacksonville College · USMayo Clinic in Arizona · USSeattle Cancer Care Alliance · USSidney Kimmel Cancer Center · USSt. Boniface Hospital · CAThe University of Texas MD Anderson Cancer Center · USUniversity of California, San Diego · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
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
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI XIWEI WU · 1985 to 2026
$86.3M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
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 Role of Id Proteins in Breast TumorigenesisP01CA094060 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI GIANCOTTI, FILIPPO G · 2002 to 2018
$39.4M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
NCATS NIH HHS UL1 TR003167NCI NIH HHS P01 CA094060NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA033572NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180857NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180882NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233328
6 · The paper itself

Abstract

purposeOlder women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years. PATIENTS AND

methodsPatients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS.

resultsThe design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80;

conclusionWith longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor-negative disease. Competing risks in this older population dilute overall survival benefits.

Indexed as

AgedAged, 80 and overAge FactorsAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineChemotherapy, AdjuvantCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFluorouracilHumansMethotrexateSurvival RateAntimetabolites, AntineoplasticCapecitabineCyclophosphamideDoxorubicinFluorouracilMethotrexate

Identifiers

PMID31339827
PMCPMC6900836
OpenAlexW2963041253

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.