Evidence map›Paper›PMID 25967143›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2015

Effects of Adjuvant Sorafenib and Sunitinib on Cardiac Function in Renal Cell Carcinoma Patients without Overt Metastases: Results from ASSURE, ECOG 2805.

Naomi B Haas, Judith Manola, Bonnie Ky, Keith T Flaherty, Robert G Uzzo, Christopher J Kane, Michael Jewett, Lori Wood, Christopher G Wood, Michael B Atkins and 3 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% 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

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Cardiotoxic effects of angiogenesis inhibitors.Clinical science (London, England : 1979) · 2021
    Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Longitudinal and dynamic measurement invariance of the FACIT-Fatigue scale: an application of the measurement model of derivatives to ECOG-ACRIN study E2805.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018
    Article
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

13 authors at 5 institutions in 2 countries.

Naomi B HaasUniversity of Pennsylvania, Philadelphia, Pennsylvania. Naomi.haas@uphs.upenn.edu.
Judith ManolaDana Farber Cancer Institute, Boston, Massachusetts.
Bonnie KyUniversity of Pennsylvania, Philadelphia, Pennsylvania.
Keith T FlahertyUniversity of Pennsylvania, Philadelphia, Pennsylvania.
Robert G UzzoFox Chase Cancer Center, Philadelphia, Pennsylvania.
Christopher J KaneUniversity of California at San Diego, San Diego, California.
Michael JewettUniversity of Toronto, Toronto, Canada.
Lori WoodQueen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada.
Christopher G WoodThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael B AtkinsBeth Israel Deaconess Hospital, Boston, Massacheusetts.
Janice J DutcherOur Lady of Mercy Cancer Center, New York Medical College, Bronx, New York.
George WildingCarbone Cancer Center, University of Wisconsin, Madison, Wisconsin.
Robert S DiPaolaRutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.
University of Pennsylvania · USDana-Farber Cancer Institute · USFox Chase Cancer Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of Toronto · CA

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
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, MITCHELL D. SCHNALL · 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
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 CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
NCIC Foreign AccrualsU10CA077202 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI EISENHAUER, ELIZABETH · 1998 to 2013
$14.6M
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 CA077202NCI NIH HHS CA105409NCI NIH HHS CA180794NCI NIH HHS CA180820NCI NIH HHS CA180821NCI NIH HHS CA180863NCI NIH HHS CA180867NCI NIH HHS CA31946NCI NIH HHS N01 CA032102NCI NIH HHS P30 CA016672NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA077202NCI NIH HHS U10 CA105409NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189828
6 · The paper itself

Abstract

purposeSunitinib and sorafenib are used widely in the treatment of renal cell carcinoma (RCC). These agents are associated with a significant incidence of cardiovascular (CV) dysfunction and left ventricular ejection fraction (LVEF) declines, observed largely in the metastatic setting. However, in the adjuvant population, the CV effects of these agents remain unknown. We prospectively defined the incidence of cardiotoxicity among resected, high-risk RCC patients treated with these agents. EXPERIMENTAL

designSunitinib, sorafenib, or placebo was administered for up to 12 months in patients with high-risk, resected RCC. LVEF was measured by multigated acquisition (MUGA) scans at standard intervals. Additional CV adverse events were reported according to NCI Common Terminology Criteria for Adverse Events (CTCAE).

resultsAmong 1,943 patients randomized, 1,599 had at least 1 post-baseline MUGA. Within 6 months, 21 patients (1.3%) experienced a cardiac event, defined as an LVEF decline from baseline that was >15% and below the institutional lower limit of normal. Nine of 513 patients (1.8%) were on sunitinib, 7 of 508 (1.4%) on sorafenib, and 5 of 578 (0.9%) on placebo (P = 0.28 and 0.56 comparing sunitinib and sorafenib to placebo, respectively). With dose interruption or adjustment, 16 of the 21 recovered their LVEF to >50%. The incidence of symptomatic heart failure, arrhythmia, or myocardial ischemia did not differ among groups.

conclusionsIn the adjuvant setting, we prospectively define low incidence of cardiotoxicity with sunitinib and sorafenib. These findings may be related to close CV monitoring, or potentially to fewer CV comorbidities in our nonmetastatic population.

Indexed as

AdultAgedAntineoplastic AgentsCarcinoma, Renal CellCardiovascular DiseasesChemotherapy, AdjuvantDouble-Blind MethodFemaleHeart FailureHumansIndolesKidney NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm MetastasisAntineoplastic AgentsIndolesNiacinamidePhenylurea CompoundsPyrrolesSorafenibSunitinib

Identifiers

PMID25967143
PMCPMC4573791
OpenAlexW1907991309

What OpenQuestion holds

Textmetadata
LicenceTDM
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.