Evidence map›Paper›PMID 20521052›Full record

ArticleCancer chemotherapy and pharmacology2011

A phase I open-label study evaluating the cardiovascular safety of sorafenib in patients with advanced cancer.

Anthony W Tolcher, Leonard J Appleman, Geoffrey I Shapiro, Alain C Mita, Frank Cihon, Arthur Mazzu, Pavur R Sundaresan

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00259129 (Effect of BAY 43-9006), which is not on this map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT00259129 phase1completednot on this map

Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients

TypeinterventionalSponsorBayerRan2005 to 2008Enrolled53ConditionsNeoplasmsArmsSorafenib (Nexavar, BAY43-9006)
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Trial
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  9. Review
  10. Cardiac complications of cancer therapies.Advances in cancer research · 2022
    Article
  11. Cardiotoxic effects of angiogenesis inhibitors.Clinical science (London, England : 1979) · 2021
    Review
  12. Review
  13. Review
  14. Article
  15. Electrophysiologic Toxicity of Chemoradiation.Current oncology reports · 2018
    Review
  16. Review
  17. Article
  18. Article
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  20. 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

7 authors.

Anthony W TolcherSTART (South Texas Accelerated Research Therapeutics), 4319 Medical Drive, Suite 205, San Antonio, TX 78229, USA. atolcher@start.stoh.com
Leonard J Appleman
Geoffrey I Shapiro
Alain C Mita
Frank Cihon
Arthur Mazzu
Pavur R Sundaresan

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo characterize the cardiovascular profile of sorafenib, a multitargeted kinase inhibitor, in patients with advanced cancer.

methodsFifty-three patients with advanced cancer received oral sorafenib 400 mg bid in continuous 28-day cycles in this open-label study. Left ventricular ejection fraction (LVEF) was evaluated using multigated acquisition scanning at baseline and after 2 and 4 cycles of sorafenib. QT/QTc interval on the electrocardiograph (ECG) was measured in triplicate with a Holter 12-lead ECG at baseline and after 1 cycle of sorafenib. Heart rate (HR) and blood pressure (BP) were obtained in duplicate at baseline and after 1 and 4 cycles of sorafenib. Plasma pharmacokinetic data were obtained for sorafenib and its 3 main metabolites after 1 and 4 cycles of sorafenib.

resultsLVEF (SD) mean change from baseline was -0.8 (±8.6) LVEF(%) after 2 cycles (n = 31) and -1.2 (±7.8) LVEF(%) after 4 cycles of sorafenib (n = 24). The QT/QTc mean changes from baseline observed at maximum sorafenib concentrations (t(max)) after 1 cycle (n = 31) were small (QTcB: 4.2 ms; QTcF: 9.0 ms). Mean changes observed after 1 cycle in BP (n = 31) and HR (n = 30) at maximum sorafenib concentrations (t(max)) were moderate (up to 11.7 mm Hg and -6.6 bpm, respectively). No correlation was found between the AUC and C(max) of sorafenib and its main metabolites and any cardiovascular parameters.

conclusionsThe effects of sorafenib on changes in QT/QTc interval on the ECG, LVEF, BP, and HR were modest and unlikely to be of clinical significance in the setting of advanced cancer treatment.

Indexed as

AgedAntineoplastic AgentsArea Under CurveBenzenesulfonatesBlood PressureElectrocardiography, AmbulatoryFemaleHeart RateHumansMaleMiddle AgedNeoplasmsNiacinamidePhenylurea CompoundsPyridinesSorafenibAntineoplastic AgentsBenzenesulfonatesNiacinamidePhenylurea CompoundsPyridinesSorafenib

Identifiers

PMID20521052
PMCPMC3064895

What OpenQuestion holds

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Registered trials

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.