title: Concordance between HER-2 status determined by qPCR in Fine Needle Aspiration Cytology (FNAC) samples compared with IHC and FISH in Core Needle Biopsy (CNB) or surgical specimens in breast cancer patients.
abstract: Determining the status of HER2-neu amplification and overexpression in breast cancer is crucial for prognosis but mostly for treatment purposes. Standard techniques include the determination of IHC in combination with in situ hybridization techniques to confirm a HER2-neu amplification in case of IHC2+ using either a core-needle biopsy or a surgical specimen. qPCR has been also demonstrated to be able to determine HER2 status, mostly in core biopsies or in surgical specimens. Fine-needle aspiration is a reliable, quicker and less invasive technique that is widely used for diagnosis of invasive breast cancer. In this study, we assessed the performance of qPCR in invasive breast carcinomas to determine HER2-neu status by using fine-needle aspiration samples and comparing to standard IHC and FISH. From a total of 154 samples from patients who had nodular breast lesions and attended the 1-day-stop clinic at the Gustave Roussy from March 2013 to October 2014, qPCR was able to determine the HER2 status in a mean of 3.7 days (SD 3.1). The overall concordance with standard HER2-testing was very high: 97% (95% CI 0.94 to 0.99); sensitivity was 96% (0.87-1), specificity 98% (0.95-1) and positive and negative predictive values 88% (0.75-1) and 99% (0.98-1), respectively. In conclusion, our study demonstrates that qPCR performed using fine-needle aspiration samples from a primary tumour is a reliable and fast method to determine HER2/neu status in patients with early breast cancer.
authors.affiliation: Oncologia Medica, Centro Universitario Contra el Cancer, Universidad Autonoma de Nuevo Leon, Mexico.
authors.forename: Claudia
authors.initials: C
authors.lastname: Rodriguez
authors.affiliation: Departement de Biologie et Pathologie Médicales, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Voichita
authors.initials: V
authors.lastname: Suciu
authors.affiliation: Service de Biostatistique et d'Epidémiologie, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Audrey
authors.initials: A
authors.lastname: Poterie
authors.affiliation: Departement de Biologie et Pathologie Médicales, Gustave Roussy Cancer Campus, Villejuif, France; Laboratoire de Recherche Translationnelle et Centre de Ressources Biologiques, AMMICA, INSERM US23/CNRS UMS3655, Gustave Roussy Cancer Campus, France.
authors.forename: Ludovic
authors.initials: L
authors.lastname: Lacroix
authors.affiliation: Laboratoire de Recherche Translationnelle et Centre de Ressources Biologiques, AMMICA, INSERM US23/CNRS UMS3655, Gustave Roussy Cancer Campus, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Miran
authors.affiliation: Departement de Biologie et Pathologie Médicales, Gustave Roussy Cancer Campus, Villejuif, France; Laboratoire de Recherche Translationnelle et Centre de Ressources Biologiques, AMMICA, INSERM US23/CNRS UMS3655, Gustave Roussy Cancer Campus, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Boichard
authors.affiliation: Departement de Médecine, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Suzette
authors.initials: S
authors.lastname: Delaloge
authors.affiliation: Service des Opérations de Recherche Clinique, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Deneuve
authors.affiliation: Departement de Biologie et Pathologie Médicales, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Sandy
authors.initials: S
authors.lastname: Azoulay
authors.affiliation: Departement de Biologie et Pathologie Médicales, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Mathieu
authors.affiliation: Departement de Biologie et Pathologie Médicales, Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: Alexander
authors.initials: A
authors.lastname: Valent
authors.affiliation: Service de Biostatistique et d'Epidémiologie, Gustave Roussy Cancer Campus, Villejuif, France; INSERM U1018, CESP, Université Paris-Sud, Université Paris-Saclay, Villejuif, France.
authors.forename: Stefan
authors.initials: S
authors.lastname: Michiels
authors.affiliation: Departement de Médecine, Gustave Roussy Cancer Campus, Villejuif, France; INSERM U981 et Université Paris-Sud, Université Paris-Saclay, Villejuif, France.
authors.forename: Monica
authors.initials: M
authors.lastname: Arnedos
authors.affiliation: Departement de Biologie et Pathologie Médicales, Gustave Roussy Cancer Campus, Villejuif, France; Laboratoire de Recherche Translationnelle et Centre de Ressources Biologiques, AMMICA, INSERM US23/CNRS UMS3655, Gustave Roussy Cancer Campus, France. Electronic address: philippe.vielh@gustaveroussy.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Vielh
mesh_terms: D044963:Biopsy, Fine-Needle; D062005:Biopsy, Large-Core Needle; D001940:Breast / Q000473:pathology*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000235:genetics / Q000473:pathology* / Q000601:surgery*; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D008875:Middle Aged; D012372:ROC Curve; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases
keywords: Breast cancer; Cytology; Fine needle aspiration; HER2; qPCR