Kurt A Schalper1, Sudha Kumar, Pei Hui, David L Rimm, Peter Gershkovich. 1. From the Department of Pathology, Yale School of Medicine, New Haven, Connecticut (Drs Schalper, Kumar, Hui, Rimm, and Gershkovich) and Servicio de Anatomia Patologica, Clinica Alemana de Santiago, Chile (Dr Schalper).
Abstract
CONTEXT: In 2007 the American Society of Clinical Oncology/College of American Pathologists made new recommendations for HER2 testing and redefined HER2 positivity. OBJECTIVE: To analyze results from simultaneous HER2 testing with immunohistochemistry and fluorescence in situ hybridization (FISH) in 2590 invasive breast carcinomas between 2002 and 2010, using 2 scoring systems. DESIGN: Cases from between 2002 and 2006 were scored by using original US Food and Drug Administration criteria (N = 1138) and those from between 2007 and 2010 were evaluated according to American Society of Clinical Oncology/College of American Pathologists criteria (N = 1452). Concordance between testing methods and clinicopathologic associations were determined. RESULTS: Overall concordance between immunohistochemistry/FISH in the 9-year period was 96.2% (κ = 0.82), and positive concordance was lower. After 2007, the proportion of HER2/neu-positive and HER2/neu-negative cases was not significantly changed when using immunohistochemistry (10.5% versus 8.9%, P = .22 and 69.4% versus 63%, P = .13, respectively), but the number of equivocal cases was higher (19.9% versus 28%, P < .001). While the proportion of negative cases by FISH remained unchanged after 2007 (86.5% versus 88.2%, P = .76), the number of positive cases was lower (13.4% versus 9.2%, P < .001). In addition, 38 cases (2.6%) were FISH equivocal, 16 of which were also equivocal by immunohistochemistry. Overall, immunohistochemistry/FISH concordance was 95.9% between 2002 and 2006 (κ = 0.82) and 96.4% after 2007 (κ = 0.82). However, an approximately 13% lower positive assay concordance was noted in the last period. CONCLUSIONS: Application of American Society of Clinical Oncology/College of American Pathologists recommendations is associated with comparable overall immunohistochemistry/FISH concordance, reduced positive concordance, and increased equivocal results.
CONTEXT: In 2007 the American Society of Clinical Oncology/College of American Pathologists made new recommendations for HER2 testing and redefined HER2 positivity. OBJECTIVE: To analyze results from simultaneous HER2 testing with immunohistochemistry and fluorescence in situ hybridization (FISH) in 2590 invasive breast carcinomas between 2002 and 2010, using 2 scoring systems. DESIGN: Cases from between 2002 and 2006 were scored by using original US Food and Drug Administration criteria (N = 1138) and those from between 2007 and 2010 were evaluated according to American Society of Clinical Oncology/College of American Pathologists criteria (N = 1452). Concordance between testing methods and clinicopathologic associations were determined. RESULTS: Overall concordance between immunohistochemistry/FISH in the 9-year period was 96.2% (κ = 0.82), and positive concordance was lower. After 2007, the proportion of HER2/neu-positive and HER2/neu-negative cases was not significantly changed when using immunohistochemistry (10.5% versus 8.9%, P = .22 and 69.4% versus 63%, P = .13, respectively), but the number of equivocal cases was higher (19.9% versus 28%, P < .001). While the proportion of negative cases by FISH remained unchanged after 2007 (86.5% versus 88.2%, P = .76), the number of positive cases was lower (13.4% versus 9.2%, P < .001). In addition, 38 cases (2.6%) were FISH equivocal, 16 of which were also equivocal by immunohistochemistry. Overall, immunohistochemistry/FISH concordance was 95.9% between 2002 and 2006 (κ = 0.82) and 96.4% after 2007 (κ = 0.82). However, an approximately 13% lower positive assay concordance was noted in the last period. CONCLUSIONS: Application of American Society of Clinical Oncology/College of American Pathologists recommendations is associated with comparable overall immunohistochemistry/FISH concordance, reduced positive concordance, and increased equivocal results.
Authors: David D Stenehjem; Minkyoung Yoo; Sudhir K Unni; Mukul Singhal; Hillevi Bauer; Kim Saverno; Cheng Quah; Anthony Masaquel; Diana I Brixner Journal: Breast Cancer (Dove Med Press) Date: 2014-10-29
Authors: Simon Peter Gampenrieder; Gabriel Rinnerthaler; Christoph Tinchon; Andreas Petzer; Marija Balic; Sonja Heibl; Clemens Schmitt; August Felix Zabernigg; Daniel Egle; Margit Sandholzer; Christian Fridolin Singer; Florian Roitner; Christopher Hager; Johannes Andel; Michael Hubalek; Michael Knauer; Richard Greil Journal: Breast Cancer Res Date: 2021-12-14 Impact factor: 6.466
Authors: Konstantinos Venetis; Edoardo Crimini; Elham Sajjadi; Chiara Corti; Elena Guerini-Rocco; Giuseppe Viale; Giuseppe Curigliano; Carmen Criscitiello; Nicola Fusco Journal: Front Mol Biosci Date: 2022-03-15