Evidence map›Paper›PMID 29858579›Full record

ArticleLaboratory investigation; a journal of technical methods and pathology2018

Macrodissection prior to closed system RT-qPCR is not necessary for estrogen receptor and HER2 concordance with IHC/FISH in breast cancer.

Swati Gupta, Navin R Mani, Daniel E Carvajal-Hausdorf, Veerle Bossuyt, Kenneth Ho, Jodi Weidler, Wendy Wong, Brian Rhees, Michael Bates, David L Rimm

Open access · bronzeAbstract read
In one paragraph

Article in Laboratory investigation; a journal of technical methods and pathology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.5field-weighted citation impact, top 32% 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

9 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Evaluation ofCancers · 2023
    Article
  3. XPERTEcancermedicalscience · 2023
    Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. 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

10 authors at 2 institutions in 2 countries.

Swati GuptaDepartment of Pathology, Yale University School of Medicine, New Haven, CT, USA.
Navin R ManiDepartment of Pathology, Yale University School of Medicine, New Haven, CT, USA.
Daniel E Carvajal-HausdorfDepartment of Pathology, Yale University School of Medicine, New Haven, CT, USA.
Veerle BossuytDepartment of Pathology, Yale University School of Medicine, New Haven, CT, USA.
Kenneth HoDivision of Oncology Research and Development, Oncology, Cepheid, Sunnyvale, CA, USA.
Jodi WeidlerMedical and Scientific Affairs and Strategy, Oncology, Cepheid, Sunnyvale, CA, USA.
Wendy WongDivision of Oncology Research and Development, Oncology, Cepheid, Sunnyvale, CA, USA.
Brian RheesDivision of Oncology Research and Development, Oncology, Cepheid, Sunnyvale, CA, USA.
Michael BatesMedical and Scientific Affairs and Strategy, Oncology, Cepheid, Sunnyvale, CA, USA.
David L RimmDepartment of Pathology, Yale University School of Medicine, New Haven, CT, USA. david.rimm@yale.edu.
Yale University · USUniversidad del Desarrollo · CL

Funding

Yale Pathology Tissue Services Shared ResourceP30CA016359 · NCI · YALE UNIVERSITY · PI DAVID L RIMM · 1985 to 2026
$85.0M
Yale SPORE in Lung Cancer (YSILC): The Biology and Personalized Treatment of Lung CancerP50CA196530 · NCI · YALE UNIVERSITY · PI Shuangge Ma · 2015 to 2026
$31.1M
NCI NIH HHS P30 CA016359NCI NIH HHS P50 CA196530
6 · The paper itself

Abstract

An on-demand, closed RT-qPCR, the GeneXpert (GX) system, has the potential to provide biomarker information in low-resourced settings and elsewhere. We used this system with a research use only version of the Breast Cancer STRAT4 cartridge that measures the mRNA expression levels of ERBB2, ESR1, PGR, and MKi67. Here we evaluated the impact of non-macrodissected (non m-d) versus macrodissected (m-d) samples using STRAT4 on formalin-fixed, paraffin-embedded (FFPE) core needle biopsies. Two cohorts were assessed: (1) 60 FFPE infiltrating ductal carcinoma (IDCA) cases and (2) 20 FFPE IDCA cases with ductal carcinoma in situ (DCIS) with a range of HER2 expression as determined by clinical immunohistochemistry and fluorescence in situ hybridization (IHC/FISH). We observed about half of the core needle biopsy area as invasive tumor in both IDCA (mean = 51.5%) and IDCA with DCIS (mean = 53.5%) cohorts, but also found the mRNA levels were independent of tumor area. We found excellent agreement of the mRNA transcript level between the paired samples, m-d versus non m-d, for ERBB2, ESR1, PGR, and MKi67 for both the IDCA and IDCA with DCIS cohorts. No significant difference (P > 0.99) was observed when we compared the mRNA transcript level between the paired samples m-d versus non m-d. In addition, we noted a significant concordance (P < 0.001) between RT-qPCR and IHC/FISH for HER2-positivity, ER-positivity, and PR-positivity, independent of specimen dissection. These data suggest that mRNA expression for ERBB2, ESR, and PGR is sufficiently low in surrounding tissue cells such that macrodissection is not required for assessment of key breast cancer mRNA markers and is independent of the amount of input tumor. This approach may be valuable in settings lacking pathology expertise or using specimen types, such as fine-needle aspirates, where it may be challenging to separate non-tumor from tumor tissue.

Indexed as

Biomarkers, TumorBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, Intraductal, NoninfiltratingErb-b2 Receptor Tyrosine KinasesFemaleGene Expression Regulation, NeoplasticHumansImmunohistochemistryIn Situ Hybridization, FluorescenceParaffin EmbeddingPathology, ClinicalReal-Time Polymerase Chain ReactionReceptors, EstrogenReproducibility of ResultsSensitivity and SpecificityBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, Estrogen

Identifiers

PMID29858579
PMCPMC6119113
OpenAlexW2806725905

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.