Thomas Marcuzzo1, Fabiola Giudici2, Elisa Ober3, Clara Rizzardi4, Cristina Bottin1, Fabrizio Zanconati4. 1. Department of Medical, Surgical and Health Science - University of Trieste, Strada di Fiume 447, 34149 Trieste, Italy. 2. Department of Medical, Surgical and Health Science - University of Trieste, Strada di Fiume 447, 34149 Trieste, Italy. Electronic address: fgiudici@units.it. 3. UCO di Anatomia e Istologia Patologica - Azienda Sanitaria Universitaria Integrata di Trieste, Strada di Fiume 447, 34149 Trieste, Italy. 4. Department of Medical, Surgical and Health Science - University of Trieste, Strada di Fiume 447, 34149 Trieste, Italy; UCO di Anatomia e Istologia Patologica - Azienda Sanitaria Universitaria Integrata di Trieste, Strada di Fiume 447, 34149 Trieste, Italy.
Abstract
AIM: Her2 protein is the key marker determining the choice of Herceptin therapy after a diagnosis of breast cancer. Its evaluation is made in most laboratories by immunohistochemistry, and interpreted by a pathologist using an optical microscope, a process subject to inter-observer variability, particularly for samples scored as equivocal (2+). Software analysis products have been introduced, seeking to reduce this variability. In this study, we compared the results of both traditional evaluation and a specific software package (VISIA Imaging) to those from fluorescent in situ hybridization (FISH). MATERIALS AND METHODS: We selected 176 cases of invasive breast cancer sampled during 2012-2014 that were classified as equivocal after evaluation of Her2 immunohistochemistry, and that were also evaluated by FISH. Each tissue slide was scanned with a digital D-Sight Fluo 2.0 microscope and analysed with VISIA Imaging S.r.l. software. The final results were categorised as follows: negative (0-1+), equivocal (2+), or positive (3+). Then each result was compared to that obtained by FISH. RESULT: The digital method confirmed 85 samples (48.3%) as equivocal (2+), while 23 (15.1%) were reclassified as negative (1+) and 44 (28.9%) as positive (3+). Of the 176 cases, 24 (13.6%) were not suitable for digital analysis (inadequate). Of 67 reclassified cases (1+ or 3+), 62 were in agreement with FISH results (concordance rate 92.5%). The sensitivity and specificity of the digital method were 100% and 82%, respectively. CONCLUSION: The application of this analysis software led to an improvement in the interpretation of cases classified as equivocal, decreasing the need for FISH and increasing diagnostic certainty.
AIM: Her2 protein is the key marker determining the choice of Herceptin therapy after a diagnosis of breast cancer. Its evaluation is made in most laboratories by immunohistochemistry, and interpreted by a pathologist using an optical microscope, a process subject to inter-observer variability, particularly for samples scored as equivocal (2+). Software analysis products have been introduced, seeking to reduce this variability. In this study, we compared the results of both traditional evaluation and a specific software package (VISIA Imaging) to those from fluorescent in situ hybridization (FISH). MATERIALS AND METHODS: We selected 176 cases of invasive breast cancer sampled during 2012-2014 that were classified as equivocal after evaluation of Her2 immunohistochemistry, and that were also evaluated by FISH. Each tissue slide was scanned with a digital D-Sight Fluo 2.0 microscope and analysed with VISIA Imaging S.r.l. software. The final results were categorised as follows: negative (0-1+), equivocal (2+), or positive (3+). Then each result was compared to that obtained by FISH. RESULT: The digital method confirmed 85 samples (48.3%) as equivocal (2+), while 23 (15.1%) were reclassified as negative (1+) and 44 (28.9%) as positive (3+). Of the 176 cases, 24 (13.6%) were not suitable for digital analysis (inadequate). Of 67 reclassified cases (1+ or 3+), 62 were in agreement with FISH results (concordance rate 92.5%). The sensitivity and specificity of the digital method were 100% and 82%, respectively. CONCLUSION: The application of this analysis software led to an improvement in the interpretation of cases classified as equivocal, decreasing the need for FISH and increasing diagnostic certainty.
Authors: Meghan Hupp; Sarah Williams; Brian Dunnette; Katelyn M Tessier; Elizabeth L Courville Journal: Hum Pathol Date: 2018-08-30 Impact factor: 3.466
Authors: Manuel António Campos; Sofia Macedo; Margarida Sá Fernandes; Ana Pestana; Joana Pardal; Rui Batista; João Vinagre; Agostinho Sanches; Armando Baptista; José Manuel Lopes; Paula Soares Journal: Genes (Basel) Date: 2020-07-06 Impact factor: 4.096