Evidence map›Paper›PMID 26077235›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Long-Term Follow-Up of the E1199 Phase III Trial Evaluating the Role of Taxane and Schedule in Operable Breast Cancer.

Joseph A Sparano, Fengmin Zhao, Silvana Martino, Jennifer A Ligibel, Edith A Perez, Tom Saphner, Antonio C Wolff, George W Sledge, William C Wood, Nancy E Davidson

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03201861 (Phase 3 Study of Weekly Paclitaxel in Combination With Cisplatin as Adjuvant Chemotherapy for Early Stage Human Epidermal Growth Factor Receptor-2), which is not on this map. Cited by 93 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 8 pooled it
9.3field-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.

NCT03201861 phase3recruitingnot on this mapstarted 2017, after this paper: background citation

Phase 3 Study of Weekly Paclitaxel in Combination With Cisplatin as Adjuvant Chemotherapy for Early Stage Human Epidermal Growth Factor Receptor-2 (HER2) Negative Breast Cancer in High-risk Women

TypeinterventionalSponsorRenJi HospitalRan2017 to 2027Enrolled762ConditionsTubular Breast Cancer, Mucinous Breast Cancer, Invasive Duct Carcinoma of BreastArmsPaclitaxel, Cisplatin, EC to docetaxel or paclitaxel
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 8 syntheses or guidelines pooled it, 220 citations in OpenAlex.

  1. Pooled it
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  4. Taxanes for adjuvant treatment of early breast cancer.The Cochrane database of systematic reviews · 2019
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  11. Tailored Dose-Dense Versus Standard Adjuvant Chemotherapy for High-Risk Early Breast Cancer: End-of-Study Results of the Randomized PANTHER Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
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  20. Anthracyclines in Early Breast Cancer: The ABC Trials-USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 (NRG Oncology).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017
    Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Joseph A SparanoJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA. jsparano@montefiore.org.
Fengmin ZhaoJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
Silvana MartinoJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
Jennifer A LigibelJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
Edith A PerezJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
Tom SaphnerJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
Antonio C WolffJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
George W SledgeJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
William C WoodJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
Nancy E DavidsonJoseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
Dana-Farber Cancer Institute · US

Funding

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
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
WORD PROCESSORP30CA013330 · NCI · YESHIVA UNIVERSITY · PI STEVEN C. ALMO · 1985 to 2026
$111.2M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
NCI Community Oncology Research Program (NCORP) - Community SitesUG1CA190140 · NCI · AURORA HEALTH CARE, INC. · PI Sigrun Hallmeyer, THOMAS J SAPHNER · 2014 to 2026
$20.0M
Montefiore Academic Community NCORP ProgramUG1CA189859 · NCI · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI Balazs Halmos, Della Makower · 2014 to 2026
$10.8M
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer CenterUG1CA233184 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ADAM M BRUFSKY, John Munn Kirkwood · 2019 to 2026
$7.7M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCI NIH HHS CA180790NCI NIH HHS CA180794NCI NIH HHS CA180795NCI NIH HHS CA180802NCI NIH HHS CA180816NCI NIH HHS CA180820NCI NIH HHS CA180821NCI NIH HHS CA180844NCI NIH HHS CA180864NCI NIH HHS CA180867NCI NIH HHS CA180888NCI NIH HHS CA189859NCI NIH HHS CA190140NCI NIH HHS P30 CA013330NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180795NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180816NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180844NCI NIH HHS U10 CA180864NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA190140NCI NIH HHS UG1 CA233184NCI NIH HHS UG1 CA233196
6 · The paper itself

Abstract

purposeTo determine long-term outcomes in a clinical trial evaluating the role of taxane type and schedule in operable breast cancer and evaluate the impact of obesity and black race on outcome. PATIENTS AND

methodsA total of 4,954 eligible women with stage II to III breast cancer treated with four cycles of doxorubicin plus cyclophosphamide were randomly assigned to receive paclitaxel or docetaxel every 3 weeks for four doses or weekly for 12 doses using a 2 × 2 factorial design. The primary end point was disease-free survival (DFS). Results are expressed as hazard ratios (HRs) from Cox proportional hazards models. All P values are two sided.

resultsWhen compared with the standard every-3-week paclitaxel arm, after a median follow-up of 12.1 years, DFS significantly improved and overall survival (OS) marginally improved only for the weekly paclitaxel (HR, 0.84; P = .011 and HR, 0.87; P = .09, respectively) and every-3-week docetaxel arms (HR, 0.79; P = .001 and HR, 0.86; P = .054, respectively). Weekly paclitaxel improved DFS and OS (HR, 0.69; P = .010 and HR, 0.69; P = .019, respectively) in triple-negative breast cancer. For hormone receptor-positive, human epidermal growth factor receptor 2-nonoverexpressing disease, no experimental arm improved OS, and black race and obesity were associated with increased risk of breast cancer recurrence and death.

conclusionImproved outcomes initially observed for weekly paclitaxel were qualitatively similar but quantitatively less pronounced with longer follow-up, although exploratory analysis suggested substantial benefit in triple-negative disease. Further research is required to understand why obesity and race influence clinical outcome in hormone receptor-positive disease.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDisease-Free SurvivalDocetaxelDoxorubicinDrug Administration ScheduleFemaleFollow-Up StudiesHumansLongitudinal StudiesMiddle AgedNeoplasm StagingCyclophosphamideDocetaxelDoxorubicinPaclitaxelTaxoids

Identifiers

PMID26077235
PMCPMC4500829
OpenAlexW2114397636

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.