Evidence map›Paper›PMID 24934787›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance).

Lawrence N Shulman, Donald A Berry, Constance T Cirrincione, Heather P Becker, Edith A Perez, Ruth O'Regan, Silvana Martino, Charles L Shapiro, Charles J Schneider, Gretchen Kimmick and 5 more

Open access · bronzeAbstract readMulticenter 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, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 4 pooled it
4.1field-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

37 citing papers in PubMed, 4 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Taxanes for adjuvant treatment of early breast cancer.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Pooled it
  4. Pooled it
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  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Article
  16. De-escalation of adjuvant chemotherapy for HER2 negative breast cancer.The Lancet regional health. Western Pacific · 2021
    Article
  17. Article
  18. Antitumor activity and efficacy of shorterTherapeutic advances in medical oncology · 2020
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Lawrence N ShulmanLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY. Lawrence_Shulman@dfci.harvard.edu.
Donald A BerryLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Constance T CirrincioneLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Heather P BeckerLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Edith A PerezLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Ruth O'ReganLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Silvana MartinoLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Charles L ShapiroLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Charles J SchneiderLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Gretchen KimmickLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Harold J BursteinLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Larry NortonLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Hyman MussLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Clifford A HudisLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Eric P WinerLawrence N. Shulman, Harold J. Burstein, Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Donald A. Berry, MD Anderson Cancer Center, Houston, TX; Constance T. Cirrincione, Gretchen Kimmick, Duke University Medical Center, Durham; Hyman Muss, University of North Carolina at Chapel Hill, Chapel Hill, NC; Heather P. Becker, University of Chicago, Chicago, IL; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Ruth O'Regan, Emory University, Atlanta, GA; Silvana Martino, The Angeles Clinic and Research Institute, Los Angeles, CA; Charles L. Shapiro, The James Cancer Center, Ohio State University, Columbus, OH; Charles J. Schneider, Christiana Healthcare Services, Wilmington, DE; Larry Norton, Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY.
Christiana Care Health System · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
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
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
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
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
MEDICAL CENTER OF DELAWARE CCOPU10CA045418 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GRUBBS, STEPHEN S. · 1987 to 2014
$14.5M
NCI NIH HHS CA21115NCI NIH HHS CA25224NCI NIH HHS CA31946NCI NIH HHS CA32291NCI NIH HHS CA3360NCI NIH HHS CA33601NCI NIH HHS CA45418NCI NIH HHS CA47559NCI NIH HHS CA47577NCI NIH HHS CA77651NCI NIH HHS CA77658NCI NIH HHS N01 CA032102NCI NIH HHS P30 CA015083NCI NIH HHS P30 CA016672NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA032291NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA045418NCI NIH HHS U10 CA047559NCI NIH HHS U10 CA047577NCI NIH HHS U10 CA077651NCI NIH HHS U10 CA077658NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180838NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180882NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233180
6 · The paper itself

Abstract

purposeOptimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity. We sought to determine whether single-agent paclitaxel (T) was inferior to doxorubicin and cyclophosphamide (AC), when each was administered for four or six cycles of therapy, and whether it offered less toxicity. PATIENTS AND

methodsPatients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC, defined as the one-sided 95% upper-bound CI (UCB) of hazard ratio (HR) of T versus AC less than 1.30 for the primary end point of relapse-free survival (RFS). As a 2 × 2 factorial design, duration of therapy was also addressed and was previously reported.

resultsWith 3,871 patients enrolled onto the trial, a median follow-up period of 6.1 years, and 437 RFS events, we achieved an HR of 1.26 (one sided 95% UCB, 1.48; favoring AC does not allow a conclusion of noninferiority of T with AC; UCB > 1.3). With 266 patient deaths, the HR for overall survival (OS) was 1.27 favoring AC (UCB, 1.56). The estimated absolute advantage of AC at 5 years is 3% for RFS (91 v 88%) and 1% for OS (95 v 94%). All nine treatment-related deaths were patients receiving AC and are included in the analyses of both RFS and OS. Hematologic toxicity was more common in patients treated with AC, and neuropathy was more common in patients treated with T.

conclusionThis trial did not show noninferiority of T to AC, a conclusion that is unlikely to change with additional events and follow-up. T was less toxic than AC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleHumansLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalPaclitaxelTreatment OutcomeCyclophosphamideDoxorubicinPaclitaxel

Identifiers

PMID24934787
PMCPMC4105484
OpenAlexW2116044878

What OpenQuestion holds

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Registered trials

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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.