Evidence map›Paper›PMID 22744818›Full record

ArticleThe oncologist2012

Influence of the American ODAC statement on Austrian bevacizumab prescribing practice for metastatic breast cancer.

Matthias Preusser, Gerhard Fülöp, Anna Sophie Berghoff, Harald Heinzl, Guenther G Steger, Richard Greil, Christoph C Zielinski, Rupert Bartsch

Open access · bronzeAbstract read
In one paragraph

Article in The oncologist, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
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  4. Review
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

8 authors at 5 institutions in 1 country.

Matthias PreusserDepartment of Medicine I, Medical University of Vienna General Hospital, Waehringer, Austria.
Gerhard Fülöp
Anna Sophie Berghoff
Harald Heinzl
Guenther G Steger
Richard Greil
Christoph C Zielinski
Rupert Bartsch
Medical University of Vienna · ATComprehensive Cancer Center Vienna · ATGesundheit Österreich · ATParacelsus Medical University · ATVienna General Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundResults of trial E2100 led to the accelerated approval of bevacizumab as first-line therapy for patients with metastatic breast cancer (MBC) in the U.S. in February 2008. Based on results from subsequent trials, the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) issued a statement proposing to withdraw the license for bevacizumab in July 2010, whereas bevacizumab approval for MBC was not withdrawn in Europe. In this nationwide survey, we investigated the influence of the discrepancy between the ODAC and European Medicines Agency (EMA) positions on the prescription practice of bevacizumab for MBC in Austria during the period January 2006 to June 2011.

methodsThe absolute number of bevacizumab administrations for MBC patients per month in all Austrian hospitals within the mentioned time frame was retrieved from a comprehensive national database. Bevacizumab prescription numbers for other malignancies were retrieved in order to rule out that a change in bevacizumab prescribing practice might reflect general changes in Austrian health care policy.

resultsA steady increase in bevacizumab use was seen from January 2006 to June 2010 (42 versus 1,357 administrations per month) for MBC. Thereafter, a significant decline in bevacizumab prescriptions for MBC became evident, with numbers dropping to 842 in March 2011 and 662 in June 2011. Bevacizumab prescriptions showed only minor variations in control cohorts.

conclusionsThe Austrian bevacizumab prescribing practice in MBC patients was significantly influenced by the ODAC statement issued in July 2010, whereas the EMA position was accepted to a lesser degree.

Indexed as

Angiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAustriaBevacizumabBreast NeoplasmsDrug ApprovalDrug PrescriptionsEuropean UnionFemaleHumansNeoplasm MetastasisUnited StatesAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedBevacizumab

Identifiers

PMID22744818
PMCPMC3399659
OpenAlexW2103023067

What OpenQuestion holds

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Registered trials

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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.