Evidence map›Paper›PMID 25422488›Full record

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

SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer.

George T Budd, William E Barlow, Halle C F Moore, Timothy J Hobday, James A Stewart, Claudine Isaacs, Muhammad Salim, Jonathan K Cho, Kristine J Rinn, Kathy S Albain and 10 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative 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 NCT00070564 (Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer), which is not on this map. Cited by 61 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 7 pooled it
4.0field-weighted citation impact, top 6% 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.

NCT00070564 phase3active not recruitingnot on this map

Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2003 to 2027Enrolled3,294ConditionsBreast CancerArmspegfilgrastim, AC regimen, cyclophosphamide, doxorubicin hydrochloride, paclitaxel
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 7 syntheses or guidelines pooled it, 122 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Taxanes for adjuvant treatment of early breast cancer.The Cochrane database of systematic reviews · 2019
    Pooled it
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  12. Vitamin D Insufficiency as a Risk Factor for Paclitaxel-Induced Peripheral Neuropathy in SWOG S0221.Journal of the National Comprehensive Cancer Network : JNCCN · 2023
    Trial
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1 more citing papers are in PubMed but not listed here.

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

20 authors at 2 institutions in 1 country.

George T BuddGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ. buddg@ccf.org.
William E BarlowGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Halle C F MooreGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Timothy J HobdayGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
James A StewartGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Claudine IsaacsGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Muhammad SalimGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Jonathan K ChoGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Kristine J RinnGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Kathy S AlbainGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Helen K ChewGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Gary V BurtonGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Timothy D MooreGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Gordan SrkalovicGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Bradley A McGregorGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Lawrence E FlahertyGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Robert B LivingstonGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Danika L LewGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Julie R GralowGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Gabriel N HortobagyiGeorge T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.
Georgetown University · USKirtland Air Force Base · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
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
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Catherine M. Tangen · 2014 to 2026
$115.2M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
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6 · The paper itself

Abstract

purposeTo determine the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer. PATIENTS AND

methodsA 2 × 2 factorial design was used to test two hypotheses: (1) that a novel continuous schedule of doxorubicin-cyclophosphamide was superior to six cycles of doxorubicin-cyclophosphamide once every 2 weeks and (2) that paclitaxel once per week was superior to six cycles of paclitaxel once every 2 weeks in patients with node-positive or high-risk node-negative early-stage breast cancer. With 3,250 patients, a disease-free survival (DFS) hazard ratio of 0.82 for each randomization could be detected with 90% power with two-sided α = .05. Overall survival (OS) was a secondary outcome.

resultsInterim analyses crossed the futility boundaries for demonstrating superiority of both once-per-week regimens and once-every-2-weeks regimens. After a median follow-up of 6 years, a significant interaction developed between the two randomization factors (DFS P = .024; OS P = .010) in the 2,716 patients randomly assigned in the original design, which precluded interpretation of the two factors separately. Comparing all four arms showed a significant difference in OS (P = .040) but not in DFS (P = .11), with all treatments given once every 2 weeks associated with the highest OS. This difference in OS seemed confined to patients with hormone receptor-negative/human epidermal growth factor receptor 2 (HER2) -negative tumors (P = .067), with no differences seen with hormone receptor-positive/HER2-negative (P = .90) or HER2-positive tumors (P = .40).

conclusionPatients achieved a similar DFS with any of these regimens. Subset analysis suggests the hypothesis that once-every-2-weeks dosing may be best for patients with hormone receptor-negative/HER2-negative tumors.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBreast Neoplasms, MaleChemotherapy, AdjuvantCyclophosphamideDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleFebrile NeutropeniaFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaleCyclophosphamideDoxorubicinPaclitaxel

Identifiers

PMID25422488
PMCPMC4268253
OpenAlexW2014179352

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