HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology

被引:338
作者
Bartley, Angela N. [1 ]
Washington, Mary Kay [2 ]
Colasacco, Carol [3 ]
Ventura, Christina B. [3 ]
Ismaila, Nofisat [5 ]
Benson, Al B., III [4 ]
Carrato, Alfredo [6 ]
Gulley, Margaret L. [7 ]
Jain, Dhanpat [8 ]
Kakar, Sanjay [9 ]
Mackay, Helen J. [10 ]
Streutker, Catherine [11 ]
Tang, Laura [12 ]
Troxell, Megan [13 ]
Ajani, Jaffer A. [14 ]
机构
[1] St Joseph Mercy Hosp, Ann Arbor, MI 48104 USA
[2] Vanderbilt Univ, Med Ctr, Nashville, TN USA
[3] Coll Amer Pathologists, Northfield, MN USA
[4] Northwestern Univ, Chicago, IL 60611 USA
[5] Amer Soc Clin Oncol, Alexandria, VA USA
[6] Hosp Ramon & Cajal, Madrid, Spain
[7] Univ N Carolina, Chapel Hill, NC 27514 USA
[8] Yale Univ, Sch Med, New Haven, CT USA
[9] Univ Calif San Francisco, San Francisco, CA 94143 USA
[10] Princess Margaret Canc Ctr, Toronto, ON, Canada
[11] Univ Toronto, St Michaels Hosp, Toronto, ON, Canada
[12] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
[13] Stanford Univ, Ctr Med, Stanford, CA 94305 USA
[14] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
关键词
IN-SITU HYBRIDIZATION; FACTOR RECEPTOR 2; DEPENDENT PROBE AMPLIFICATION; POLYMERASE-CHAIN-REACTION; ADVANCED GASTRIC-CANCER; DIGITAL IMAGE-ANALYSIS; WHOLE-TISSUE SECTIONS; GENE AMPLIFICATION; BREAST-CANCER; CLINICOPATHOLOGICAL FEATURES;
D O I
10.1200/JCO.2016.69.4836
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
Context ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. Objectives To establish an evidence-based guideline for HER2 testing in patients with GEA, formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. Design The College of American Pathologists (CAP), American Society for Clinical Pathology (ASCP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. Results The Panel is proposing 11 recommendations with strong agreement from the open comment participants. Recommendations The Panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and an HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. Conclusion This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results. (C) 2016 College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology
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收藏
页码:446 / +
页数:21
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