Evidence map›Paper›PMID 27138575›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016

Phase III Trial Evaluating Letrozole As First-Line Endocrine Therapy With or Without Bevacizumab for the Treatment of Postmenopausal Women With Hormone Receptor-Positive Advanced-Stage Breast Cancer: CALGB 40503 (Alliance).

Maura N Dickler, William T Barry, Constance T Cirrincione, Matthew J Ellis, Mary Ellen Moynahan, Federico Innocenti, Arti Hurria, Hope S Rugo, Diana E Lake, Olwen Hahn and 5 more

Open access · greenAbstract 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, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 9 pooled it
15.1field-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

58 citing papers in PubMed, 9 syntheses or guidelines pooled it, 127 citations in OpenAlex.

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  6. Review of concepts in therapeutic decision-making in HER2-negative luminal metastatic breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
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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

15 authors at 1 institution in 1 country.

Maura N DicklerMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN. dicklerm@mskcc.org.
William T BarryMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Constance T CirrincioneMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Matthew J EllisMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Mary Ellen MoynahanMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Federico InnocentiMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Arti HurriaMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Hope S RugoMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Diana E LakeMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Olwen HahnMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Bryan P SchneiderMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Debasish TripathyMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Lisa A CareyMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Eric P WinerMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Clifford A HudisMaura N. Dickler, Mary Ellen Moynahan, Diana E. Lake, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; William T. Barry, Dana-Farber Cancer Institute; Eric P. Winer, Dana-Farber/Partners Cancer Care, Boston, MA; Constance T. Cirrincione, Duke University, Durham, NC; Matthew J. Ellis, Baylor College of Medicine; Debasish Tripathy, The University of Texas MD Anderson Cancer Center, Houston, TX; Federico Innocenti and Lisa A. Carey, University of North Carolina at Chapel Hill, Chapel Hill, NC; Arti Hurria, City of Hope, Duarte; Hope S. Rugo, University of California at San Francisco, San Francisco, CA; Olwen Hahn, Alliance for Clinical Trials in Oncology, Chicago, IL; and Bryan P. Schneider, Indiana University School of Medicine, Indianapolis, IN.
Dana-Farber Cancer Institute · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 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
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
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
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
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP)U10CA180858 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUNT, KELLY K, PINNIX, CHELSEA CAMILLE · 2014 to 2018
$5.6M
Network Lead Academic Participating Site: Memorial Sloan-Kettering Cancer CenterU10CA180791 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI AGHAJANIAN, CAROL, MORRIS, MICHAEL J · 2014 to 2018
$4.6M
NCTN Lead Academic Participating Sites ApplicationU10CA180838 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A · 2014 to 2018
$2.8M
Building upon a tradition of excellence. The NCTN at Indiana UniversityU10CA180795 · NCI · INDIANA UNIVERSITY INDIANAPOLIS · PI MILLER, KATHY D. · 2014 to 2018
$2.6M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA138561NCI NIH HHS U10 CA180791NCI NIH HHS U10 CA180795NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180838NCI NIH HHS U10 CA180858NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180882NCI NIH HHS U10 CA180888
6 · The paper itself

Abstract

purposeTo investigate whether anti-vascular endothelial growth factor therapy with bevacizumab prolongs progression-free survival (PFS) when added to first-line letrozole as treatment of hormone receptor-positive metastatic breast cancer (MBC). PATIENTS AND

methodsWomen with hormone receptor-positive MBC were randomly assigned 1:1 in a multicenter, open-label, phase III trial of letrozole (2.5 mg orally per day) with or without bevacizumab (15 mg/kg intravenously once every 3 weeks) within strata defined by measurable disease and disease-free interval. This trial had 90% power to detect a 50% improvement in median PFS from 6 to 9 months. Using a one-sided α = .025, a target sample size of 352 patients was planned.

resultsFrom May 2008 to November 2011, 350 women were recruited; 343 received treatment and were observed for efficacy and safety. Median age was 58 years (range, 25 to 87 years). Sixty-two percent had measurable disease, and 45% had de novo MBC. At a median follow-up of 39 months, the addition of bevacizumab resulted in a significant reduction in the hazard of progression (hazard ratio, 0.75; 95% CI, 0.59 to 0.96; P = .016) and a prolongation in median PFS from 15.6 months with letrozole to 20.2 months with letrozole plus bevacizumab. There was no significant difference in overall survival (hazard ratio, 0.87; 95% CI, 0.65 to 1.18; P = .188), with median overall survival of 43.9 months with letrozole versus 47.2 months with letrozole plus bevacizumab. The largest increases in incidence of grade 3 to 4 treatment-related toxicities with the addition of bevacizumab were hypertension (24% v 2%) and proteinuria (11% v 0%).

conclusionThe addition of bevacizumab to letrozole improved PFS in hormone receptor-positive MBC, but this benefit was associated with a markedly increased risk of grade 3 to 4 toxicities. Research on predictive markers will be required to clarify the role of bevacizumab in this setting.

Indexed as

PostmenopauseAdultAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsDisease-Free SurvivalFemaleHumansLetrozoleMiddle AgedNitrilesTreatment OutcomeAngiogenesis InhibitorsAntineoplastic AgentsBevacizumabLetrozoleNitrilesTriazoles

Identifiers

PMID27138575
PMCPMC5012690
OpenAlexW2346624277

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.