Evidence map›Paper›PMID 24324739›Full record

ArticlePloS one2013

Added value of HER-2 amplification testing by multiplex ligation-dependent probe amplification in invasive breast cancer.

Chantal C H J Kuijpers, Cathy B Moelans, Henk-Jan van Slooten, Anja Horstman, John W J Hinrichs, Shaimaa Al-Janabi, Paul J van Diest, Mehdi Jiwa

Abstract readValidation Study
In one paragraph

Article in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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

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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

2 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

8 authors.

Chantal C H J KuijpersSymbiant Pathology Expert Centre, Alkmaar, The Netherlands.
Cathy B Moelans
Henk-Jan van Slooten
Anja Horstman
John W J Hinrichs
Shaimaa Al-Janabi
Paul J van Diest
Mehdi Jiwa

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHER-2 is a prognostic and predictive marker, but as yet no technique is perfectly able to identify patients likely to benefit from HER-2 targeted therapies. We aimed to prospectively assess the added value of first-line co-testing by IHC, and multiplex ligation-dependent probe amplification (MLPA) and chromogenic in situ hybridization (CISH).

methodsAs local validation, HER-2 MLPA and CISH were compared in 99 breast cancers. Next, we reviewed 937 invasive breast cancers, from 4 Dutch pathology laboratories, that were prospectively assessed for HER-2 by IHC and MLPA (and CISH in selected cases).

resultsThe validation study demonstrated 100% concordance between CISH and MLPA, if both methods were assessable and conclusive (81.8% of cases). Significant variation regarding percentages IHC 0/1+ and 2+ cases was observed between the laboratories (p<0.0001). Overall concordance between IHC and MLPA/CISH was 98.1% (575/586) (Kappa = 0.94). Of the IHC 3+ cases, 6.7% failed to reveal gene amplification, whereas 0.8% of the IHC 0/1+ cases demonstrated gene amplification. Results remained discordant after retrospective review in 3/11 discordant cases. In the remaining 8 cases the original IHC score was incorrect or adapted after repeated IHC staining.

conclusionsMLPA is a low-cost and quantitative high-throughput technique with near perfect concordance with CISH. The use of MLPA in routinely co-testing all breast cancers may reduce HER-2 testing variation between laboratories, may serve as quality control for IHC, will reveal IHC 0/1+ patients with gene amplification, likely responsive to trastuzumab, and identify IHC 3+ cases without gene amplification that may respond less well.

Indexed as

Gene AmplificationBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleHumansImmunohistochemistryIn Situ HybridizationMultiplex Polymerase Chain ReactionNeoplasm InvasivenessNetherlandsReproducibility of ResultsERBB2 protein, humanErb-b2 Receptor Tyrosine Kinases

Identifiers

PMID24324739
PMCPMC3852761

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