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Comparison of the RNA-based EndoPredict multigene test between core biopsies and corresponding surgical breast cancer sections.

Author(s): Müller BM, Brase JC, Haufe F, Weber KE, Budzies J, Petry C, Prinzler J, Kronenwett R, Dietel M, Denkert C

Publication: J Clin Pathol, 2012, Vol. 65, Page 660-2

PubMed ID: 22447922 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   This study compared RNA yield and expression of EndoPredict genes in matched FFPE surgical resection and core biopsy specimens of breast carcinomas. Specimens consisted of matched FFPE core biopsies (median of four cores) and surgical resection specimens from 40 patients with ER positive, HER2 negative breast cancer. The authors state that most of the cores were obtained using 14-gauge needles under ultrasound guidance but further details of specimen acquisition and processing were not specified. The median time between biopsy and surgical resection specimens was 14 days. RNA was extracted from a single 5 µm section using the VERSANT kPCR Molecular System and stored at -80˚C. Genes were quantified using the EndoPredict multiplex real-time PCR assay. The assay quantified zinc-binding alpha-2-glycoprotein (AZGP1), baculoviral inhibitor of apoptosis repeat-containing 5 (BIRC5), 7-dehydrocholesterol reductase (DHCR7), interleukin 6 signal transducer (IL6ST), matrix gla protein (MGP), retinoblastoma binding protein 8 (RBBP8), stanniocalcin 2 (STC2), and ubiquitin conjugating enzyme E2C (UBE2C).

   Summary of Findings:

   The average cycle threshold value of the three reference genes was two cycles higher in surgical specimens than core biopsies. Levels of six EndoPredict genes (IL6ST, RBBP8, AZGP1, DHCR7, UBE2C, and BIRC5) were strongly correlated between matched core biopsies and surgical specimens (r=0.89, r=0.84, r=0.82, r= 0.77, r=0.76, and r= 0.72, respectively) and levels of the remaining 2 genes (MGP and STC2) were modestly correlated (r=0.69 and r=0.65, respectively). The EndoPredict score was very strongly correlated between matched surgical specimens and core biopsies (r=0.92). There was 95% concordance in the EndoPredict-based risk classification between matched surgical and core biopsy specimens. The two cases of discordance occurred when the risk classification was close to the cut-off value.

   Biospecimens

   • Tissue - Breast

   Preservative Types

   • Formalin

   Diagnoses:

   • Neoplastic - Carcinoma

   Platform:

   Analyte	Technology Platform
   RNA	Real-time qRT-PCR

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Real-time qRT-PCR Specific	Targeted nucleic acid	EndoPredict genes AZGP1 BIRC5 DHCR7 IL6ST MGP RBBP8 STC2 UBE2C
   Biospecimen Acquisition	Method of tissue acquisition	Core needle biopsy Surgical resection

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