Evidence map›Paper›PMID 27002507›Full record

ArticleBreast cancer research and treatment2016

Equivalence of MammaPrint array types in clinical trials and diagnostics.

Inès Beumer, Anke Witteveen, Leonie Delahaye, Diederik Wehkamp, Mireille Snel, Christa Dreezen, John Zheng, Arno Floore, Guido Brink, Bob Chan and 4 more

Abstract read
In one paragraph

Article in Breast cancer research and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 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.

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

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  20. Cold Ischemia Score: An mRNA Assay for the Detection of Extended Cold Ischemia in Formalin-Fixed, Paraffin-Embedded Tissue.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2019
    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

14 authors.

Inès BeumerAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Anke WitteveenAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Leonie DelahayeAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Diederik WehkampAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Mireille SnelAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Christa DreezenAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
John ZhengAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Arno FlooreAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Guido BrinkAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Bob ChanAgendia Inc, 22 Morgan, Irvine, CA 92618, USA.
Sabine LinnDivisions of Molecular Pathology and Medical Oncology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Rene BernardsAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Laura van 't VeerAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Annuska GlasAgendia NV, Science Park 406, 1098 XH, Amsterdam, The Netherlands. annuska.glas@agendia.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

MammaPrint is an FDA-cleared microarray-based test that uses expression levels of the 70 MammaPrint genes to assess distant recurrence risk in early-stage breast cancer. The prospective RASTER study proved that MammaPrint Low Risk patients can safely forgo chemotherapy, which is further subject of the prospective randomized MINDACT trial. While MammaPrint diagnostic results are obtained from mini-arrays, clinical trials may be performed on whole-genome arrays. Here we demonstrate the equivalence and reproducibility of the MammaPrint test. MammaPrint indices were collected for breast cancer samples: (i) on both customized certified array types (n = 1,897 sample pairs), (ii) with matched fresh and FFPE tissues (n = 552 sample pairs), iii) for control samples replicated over a period of 10 years (n = 11,333), and iv) repeated measurements (n = 280). The array type indicated a near perfect Pearson correlation of 0.99 (95 % CI: 0.989-0.991). Paired fresh and FFPE samples showed an excellent Pearson correlation of 0.93 (95 % CI 0.92-0.94), in spite of the variability introduced by intratumoral tissue heterogeneity. Control samples showed high consistency over 10 year's time (overall reproducibility of 97.4 %). Precision and repeatability are overall 98.2 and 98.3 %, respectively. Results confirm that the combination of the near perfect correlation between array types, excellent equivalence between tissue types, and a very high stability, precision, and repeatability demonstrate that results from clinical trials (such as MINDACT and I-SPY 2) are equivalent to current MammaPrint FFPE and fresh diagnostics, and can be used interchangeably.

Indexed as

Breast NeoplasmsEarly Detection of CancerFemaleGene Expression ProfilingHumansNeoplasm Recurrence, LocalProspective StudiesReproducibility of ResultsSurvival AnalysisTissue Array AnalysisTissue PreservationBreast cancerClinical prognostic valueDiagnostic microarray testI-SPYMammaPrintMINDACT

Identifiers

PMID27002507
PMCPMC4819553

What OpenQuestion holds

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LicenceCC BY-NC
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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.