Impact of the 2018 American Society of Clinical Oncology/College of American Pathologists HER2 Guideline Updates on HER2 Assessment in Breast Cancer With Equivocal HER2 Immunohistochemistry Results With Focus on Cases With HER2/CEP17 Ratio <2.0 and Average HER2 Copy Number ≥4.0 and <6.0

被引：13
作者：
Hoda, Raza S. [1 ]
Brogi, Edi [1 ]
Xu, Jin [1 ]
Ventura, Katia [1 ]
Ross, Dara S. [1 ]
Dang, Chau [2 ]
Robson, Mark [2 ]
Norton, Larry [2 ]
Morrow, Monica [3 ]
Wen, Hannah Y. [1 ]
机构：
[1] Mem Sloan Kettering Canc Ctr, Dept Pathol, 1275 York Ave, New York, NY 10065 USA
[2] Mem Sloan Kettering Canc Ctr, Dept Med, New York, NY 10065 USA
[3] Mem Sloan Kettering Canc Ctr, Dept Surg, New York, NY 10065 USA
来源：
ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE | 2020年 / 144卷 / 05期
基金：
美国国家卫生研究院;
关键词：
MICROPAPILLARY CARCINOMA; RECEPTOR; AMPLIFICATION; TRASTUZUMAB; EFFICACY;
D O I：
10.5858/arpa.2019-0307-OA
中图分类号：
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号：
1001 ;
摘要：
Context.-The American Society of Clinical Oncology/College of American Pathologists HER2 testing guideline in breast cancer was updated in 2018 to address issues on interpretation of uncommon results using dual-probe in situ hybridization according to the 2013 guideline. Objective.-To assess impact of the 2018 guideline on breast cancer with equivocal HER2 immunohistochemistry results. Design.-We retrospectively reviewed HER2 fluorescence in situ hybridization (FISH) data (HER2/CEP17 ratio and average HER2 copy number per cell) of HER2 immunohistochemistry-equivocal (2+ or 1+ to 2+) breast cancers at our center between January 2014 and May 2018 and compared HER2 FISH results according to 2013 and 2018 guidelines. Results.-A total of 1666 HER2 FISH results from 1421 patients with equivocal HER2 immunohistochemistry were reviewed. Based on the 2013 guideline, HER2 FISH results were amplified in 346 cases (20.8%), equivocal in 242 (14.5%), and nonamplified in 1078 (64.7%). Using the 2018 guideline, 258 cases (16%) were reclassified, including 242 previously equivocal test results (15%) and 16 previously positive results (1%) reclassified as negative. The subset of 2013 HER2-equivocal and 2018 HER2-nonamplified cases with HER2/CEP17 ratio lower than 2.0 and average HER2 copy number 4.0 or higher and lower than 6.0 showed higher incidence of micropapillary morphology compared with HER2-amplified cases. Despite most patients in this group not receiving HER2-targeted treatment, 96% had no evidence of disease at follow-up. Conclusions.-The 2018 guideline eliminated HER2 FISH-equivocal cases by reclassifying HER2-equivocal cases and cases with nonclassical amplification without HER2 overexpression as HER2 negative. As a consequence, we observed a considerable increase in HER2 FISH-negative cases and a slight decrease in HER2 FISH-positive cases.
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收藏
页码：597 / 601
页数：5
相关论文
共 27 条
[1]   21-Gene assay as predictor of chemotherapy benefit in HER2-negative breast cancer [J].
Geyer, Charles E., Jr. ;
Tang, Gong ;
Mamounas, Eleftherios P. ;
Rastogi, Priya ;
Paik, Soonmyung ;
Shak, Steven ;
Baehner, Frederick L. ;
Crager, Michael ;
Wickerham, D. Lawrence ;
Costantino, Joseph P. ;
Wolmark, Norman .
NPJ BREAST CANCER, 2018, 4
[2]   Open-Label, Phase II, Multicenter, Randomized Study of the Efficacy and Safety of Two Dose Levels of Pertuzumab, a Human Epidermal Growth Factor Receptor 2 Dimerization Inhibitor, in Patients With Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer [J].
Gianni, Luca ;
Llado, Anna ;
Bianchi, Giulia ;
Cortes, Javier ;
Kellokumpu-Lehtinen, Pirkko-Liisa ;
Cameron, David A. ;
Miles, David ;
Salvagni, Stefania ;
Wardley, Andrew ;
Goeminne, Jean-Charles ;
Hersberger, Veronica ;
Baselga, Jose .
JOURNAL OF CLINICAL ONCOLOGY, 2010, 28 (07) :1131-1137
[3]   Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial [J].
Hurvitz, Sara A. ;
Martin, Miguel ;
Symmans, W. Fraser ;
Jung, Kyung Hae ;
Huang, Chiun-Sheng ;
Thompson, Alastair M. ;
Harbeck, Nadia ;
Valero, Vicente ;
Stroyakovskiy, Daniil ;
Wildiers, Hans ;
Campone, Mario ;
Boileau, Jean-Francois ;
Beckmann, Matthias W. ;
Afenjar, Karen ;
Fresco, Rodrigo ;
Helms, Hans-Joachim ;
Xu, Jin ;
Lin, Yvonne G. ;
Sparano, Joseph ;
Slamon, Dennis .
LANCET ONCOLOGY, 2018, 19 (01) :115-126
[4]   Overexpression of her2/neu, estrogen and progesterone receptors in invasive micropapillary carcinoma of the breast [J].
Kuroda H. ;
Sakamoto G. ;
Ohnisi K. ;
Itoyama S. .
Breast Cancer, 2004, 11 (3) :301-305
[5]   Genomic and immunophenotypical characterization of pure micropapillary carcinomas of the breast [J].
Marchio, C. ;
Iravani, M. ;
Natrajan, R. ;
Lambros, M. B. ;
Savage, K. ;
Tamber, N. ;
Fenwick, K. ;
Mackay, A. ;
Senetta, R. ;
Di Palma, S. ;
Schmitt, F. C. ;
Bussolati, G. ;
Ellis, I. O. ;
Ashworth, A. ;
Sapino, A. ;
Reis-Filho, J. S. .
JOURNAL OF PATHOLOGY, 2008, 215 (04) :398-410
[6]   Implementation of the 2018 Human Epidermal Growth Factor Receptor 2 Guideline by American Society of Clinical Oncology/College of American Pathologists Will Reduce False-Positive Tests [J].
Martin, Vittoria ;
Valera, Alexandra ;
De Joffrey, Melissa ;
Banfi, Sara ;
Mazzucchelli, Luca .
ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE, 2019, 143 (04) :411-412
[7]   Human Epidermal Growth Factor Receptor 2 Testing by Fluorescent In Situ Hybridization: Positive or Negative? American Society of Clinical Oncology/College of American Pathologists Guidelines 2007, 2013, and 2018 [J].
Murray, Ciara ;
D'Arcy, Clare ;
Gullo, Giuseppe ;
Flanagan, Louise ;
Quinn, Cecily M. .
ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE, 2019, 143 (04) :412-413
[8]   Monosomy 17 in potentially curable HER2-amplified breast cancer: prognostic and predictive impact [J].
Page, David B. ;
Wen, Hannah ;
Brogi, Edi ;
Dure, Dana ;
Ross, Dara ;
Spinelli, Kateri J. ;
Patil, Sujata ;
Norton, Larry ;
Hudis, Clifford ;
McArthur, Heather L. .
BREAST CANCER RESEARCH AND TREATMENT, 2018, 167 (02) :547-554
[9]   Optimal treatment of early stage HER2-positive breast cancer [J].
Pernas, Sonia ;
Barroso-Sousa, Romualdo ;
Tolaney, Sara M. .
CANCER, 2018, 124 (23) :4455-4466
[10]   Invasive micropapillary carcinoma of the breast - Clinicopathologic study of 62 cases of a poorly recognized variant with highly aggressive behavior [J].
Pettinato, G ;
Manivel, CJ ;
Panico, L ;
Sparano, L ;
Petrella, G .
AMERICAN JOURNAL OF CLINICAL PATHOLOGY, 2004, 121 (06) :857-866
123