Evidence map›Paper›PMID 38531002›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Randomized, Double-Blind Phase III Study of Pazopanib Versus Placebo in Patients With Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease After Metastasectomy: ECOG-ACRIN E2810.

Leonard J Appleman, Se Eun Kim, Wayne B Harris, Sumanta K Pal, Michael R Pins, Jill Kolesar, Neeraj Agarwal, Rahul A Parikh, Daniel A Vaena, Christopher W Ryan and 8 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
4.6field-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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  13. Latest progress in molecular biology and treatment in genitourinary tumours.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Review
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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

18 authors at 17 institutions in 1 country.

Leonard J ApplemanUPMC Hillman Cancer Center, Pittsburgh, PA.ORCID 0000-0003-4951-7388
Se Eun KimDana-Farber Cancer Institute, Boston, MA.
Wayne B HarrisEmory University and Atlanta VA Medical Center, Atlanta, GA.
Sumanta K PalCity of Hope Comprehensive Cancer Center, Duarte, CA.ORCID 0000-0002-1712-0848
Michael R PinsRosalind Franklin University, Chicago, IL.
Jill KolesarUniversity of Kentucky, Lexington, KY.ORCID 0000-0001-8575-4546
Neeraj AgarwalHuntsman Cancer Institute, University of Utah, Salt Lake City, UT.ORCID 0000-0003-1076-0428
Rahul A ParikhUniversity of Kansas, Kansas City, KS.ORCID 0000-0002-3372-7914
Daniel A VaenaWest Cancer Center, Germantown, TN.ORCID 0000-0001-5389-9193
Christopher W RyanUniversity of Oregon Health & Science University, Portland, OR.
Mehmood HashmiStormont-Vail HealthCare, Topeka, KS.
Brian A CostelloMayo Clinic, Rochester, MN.ORCID 0000-0003-1753-5928
David CellaNorthwestern University Feinberg School of Medicine, Chicago, IL.ORCID 0000-0002-9881-4541
Janice P DutcherOur Lady of Mercy, Bronx, NY.ORCID 0000-0002-2267-9187
Robert S DiPaolaUniversity of Kentucky, Lexington, KY.
Naomi B HaasAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA.ORCID 0000-0001-8907-7968
Lynne I WagnerWake Forest University, Winston-Salem, NC.ORCID 0000-0001-9685-4796
Michael A CarducciKimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
University of Kentucky · USCity of Hope · USDana-Farber Cancer Institute · USEmory University · USLady of Mercy Medical Center · USMayo Clinic in Arizona · USNorthwestern University · USOregon Health & Science University · USRosalind Franklin University of Medicine and Science · USSidney Kimmel Comprehensive Cancer Center · USStormont Vail Health · USUniversity of Kansas · USUniversity of Pennsylvania · USUniversity of Utah · USUPMC Hillman Cancer Center · USWake Forest University · USWest Cancer Center · US

Funding

ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
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
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
The University of Kansas Cancer Center's- MCA Rural NCORP- extensionUG1CA239767 · NCI · UNIVERSITY OF KANSAS MEDICAL CENTER · PI GARY C. DOOLITTLE, Priyanka Sharma · 2019 to 2026
$13.2M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
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
Winship National Clinical Trials Network Lead Academic Participating SiteUG1CA233247 · NCI · EMORY UNIVERSITY · PI Ashesh Jani, NABIL F SABA · 2019 to 2026
$6.0M
Huntsman Cancer Institute/ University of Utah Network Lead Academic Participating Site ApplicationUG1CA233178 · NCI · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Matthew Poppe, Heloisa Prado Soares · 2019 to 2026
$4.9M
NCTN LAPS at Johns HopkinsUG1CA233196 · NCI · JOHNS HOPKINS UNIVERSITY · PI DEBORAH K ARMSTRONG, Julie Renee Brahmer · 2019 to 2026
$4.6M
NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233178NCI NIH HHS UG1 CA233184NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233247NCI NIH HHS UG1 CA239767
6 · The paper itself

Abstract

purposePatients with no evidence of disease (NED) after metastasectomy for renal cell carcinoma are at high risk of recurrence. Pazopanib is an inhibitor of vascular endothelial growth factor receptor and other kinases that improves progression-free survival in patients with metastatic RCC (mRCC). We conducted a randomized, double-blind, placebo-controlled multicenter study to test whether pazopanib would improve disease-free survival (DFS) in patients with mRCC rendered NED after metastasectomy. PATIENTS AND

methodsPatients with NED after metastasectomy were randomly assigned 1:1 to receive pazopanib 800 mg once daily versus placebo for 52 weeks. The study was designed to observe an improvement in DFS from 25% to 45% with pazopanib at 3 years, corresponding to 42% reduction in the DFS event rate.

resultsFrom August 2012 to July 2017, 129 patients were enrolled. The study was unblinded after 83 DFS events (92% information). The study did not meet its primary end point. An updated analysis at 60.5-month median follow-up from random assignment (95% CI, 59.3 to 71.0) showed that the 3-year DFS was 27.4% (95% CI, 17.9 to 41.7) for pazopanib and 21.9% (95% CI, 13.3 to 36.2) for placebo. Hazard ratio (HR) for DFS was 0.90 ([95% CI, 0.60 to 1.34];

conclusionPazopanib did not improve DFS as the primary end point compared with blinded placebo in patients with mRCC with NED after metastasectomy. In addition, there was a concerning trend favoring placebo in OS.

Indexed as

Carcinoma, Renal CellIndazolesKidney NeoplasmsMetastasectomyPyrimidinesSulfonamidesAdultAgedAged, 80 and overAngiogenesis InhibitorsDisease-Free SurvivalDouble-Blind MethodFemaleHumansMaleMiddle AgedAngiogenesis InhibitorsIndazolespazopanibPyrimidinesSulfonamides

Identifiers

PMID38531002
PMCPMC11514296
OpenAlexW4393259381

What OpenQuestion holds

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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.