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HER2 Testing in Breast Cancer: NCCN Task Force Report and Recommendations

Robert W. Carlson, Susan J. Moench, M. Elizabeth H. Hammond, Edith A. Perez, Harold J. Burstein, D. Craig Allred, Charles L. Vogel, Lori J. Goldstein, George Somlo, William J. Gradishar, Clifford A. Hudis, Mohammad Jahanzeb, Azadeh Stark, Antonio C. Wolff, Michael F. Press, Eric P. Winer, Soonmyung Paik, Britt-Marie Ljung, and for the NCCN HER2 Testing in Breast Cancer Task Force

The NCCN HER2 Testing in Breast Cancer Task Force was convened to critically evaluate the ability of the level of HER2 expression or gene amplification in breast cancer tumors to serve as a prognostic and a predictive factor in the metastatic and adjuvant settings, to assess the reliability of the methods of measuring HER2 expression or gene amplification in the laboratory, and to make recommendations regarding the interpretation of test results. The Task Force is a multidisciplinary panel of 24 experts in breast cancer representing the disciplines of medical oncology, pathology, radiation oncology, surgical oncology, epidemiology, and patient advocacy. Invited members included members of the NCCN Breast Cancer Panel and other needed experts selected solely by the NCCN. During a 2-day meeting, individual task force members provided didactic presentations critically evaluating important aspects of HER2 biology and epidemiology: HER2 as a prognostic and predictive factor; results from clinical trials in which trastuzumab was used as a targeted therapy against HER2 in the adjuvant and metastatic settings; the available testing methodologies for HER2, including sensitivity, specificity, and ability to provide prognostic and predictive information; and the principles on which HER2 testing should be based. Each task force member was charged with identifying evidence relevant to their specific expertise and presentation. Following the presentations, an evidence-based consensus approach was used to formulate recommendations relating to the pathologic and clinical application of the evidence to breast cancer patient evaluation and care. In areas of controversy, this process extended beyond the meeting to achieve consensus. The Task Force concluded that accurate assignment of the HER2 status of invasive breast cancer is essential to clinical decision making in the treatment of breast cancer in both adjuvant and metastatic settings. Formal validation and concordance testing should be performed and reported by laboratories performing HER2 testing for clinical purposes. If appropriate quality control/ assurance procedures are in place, either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) methods may be used. A tumor with an IHC score of 0 or1+, an average HER2 gene/chromosome 17 ratio of less than 1.8, or an average number of HER2 gene copies/cell of 4 or less as determined by FISH is considered to be HER2 negative. A tumor with an IHC score of 3+, an average HER2 gene/chromosome 17 ratio of greater than 2.2 by FISH, or an average number of HER2 gene copies/cell of 6 or greater is considered HER2 positive. A tumor with an IHC score of 2+ should be further tested using FISH, with HER2 status determined by the FISH result. Tumor samples with an average HER2 gene/chromosome ratio of 1.8 to 2.2 or average number of HER2 gene copies/cell in the range of greater than 4 to less than 6 are considered to be borderline, and strategies to assign the HER2 status of such samples are proposed. (JNCCN 2006;4(Suppl 3):S1–S22)

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NCCN Task Force Report: Breast Cancer in the Older Woman

Robert W. Carlson, Susan Moench, Arti Hurria, Lodovico Balducci, Harold J. Burstein, Lori J. Goldstein, William J. Gradishar, Kevin S. Hughes, Mohammad Jahanzeb, Stuart M. Lichtman, Lawrence B. Marks, Joan S. McClure, Beryl McCormick, Lisle M. Nabell, Lori J. Pierce, Mary Lou Smith, Neal S. Topham, Tiffany A. Traina, John H. Ward, and Eric P. Winer

Breast cancer is common in older women, and the segment of the U.S. population aged 65 years and older is growing rapidly. Consequently, awareness is increasing of the need to identify breast cancer treatment recommendations to assure optimal, individualized treatment of older women with breast cancer. However, the development of these recommendations is limited by the heterogeneous nature of this population with respect to functional status, social support, life expectancy, and the presence of comorbidities, and by the underrepresentation of older patients with breast cancer in randomized clinical trials. The NCCN Breast Cancer in the Older Woman Task Force was convened to provide a forum for framing relevant questions on topics that impact older women with early-stage, locally advanced, and metastatic breast cancer. The task force is a multidisciplinary panel of 18 experts in breast cancer representing medical oncology, radiation oncology, surgical oncology, geriatric oncology, geriatrics, plastic surgery, and patient advocacy. All task force members were from NCCN institutions and were identified and invited solely by NCCN. Members were charged with identifying evidence relevant to their specific expertise. During a 2-day meeting, individual members provided didactic presentations; these presentations were followed by extensive discussions during which areas of consensus and controversy were identified on topics such as defining the “older” breast cancer patient; geriatric assessment tools in the oncology setting; attitudes of older patients with breast cancer and their physicians; tumor biology in older versus younger women with breast cancer; implementation of specific interventions in older patients with breast cancer, such as curative surgery, surgical axillary staging, radiation therapy, reconstructive surgery, endocrine therapy, chemotherapy, HER2-directed therapy, and supportive therapies; and areas requiring future studies. (JNCCN 2008;6[Suppl 4]:S1–S25)

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Breast Cancer Risk Reduction

Therese B. Bevers, Deborah K. Armstrong, Banu Arun, Robert W. Carlson, Kenneth H. Cowan, Mary B. Daly, Irvin Fleming, Judy E. Garber, Mary Gemignani, William J. Gradishar, Helen Krontiras, Swati Kulkarni, Christine Laronga, Loretta Loftus, Deborah J. MacDonald, Martin C. Mahoney, Sofia D. Merajver, Ingrid Meszoely, Lisa Newman, Elizabeth Pritchard, Victoria Seewaldt, Rena V. Sellin, Charles L. Shapiro, and John H. Ward

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NCCN Guidelines® Insights: Breast Cancer, Version 4.2023

Featured Updates to the NCCN Guidelines

William J. Gradishar, Meena S. Moran, Jame Abraham, Vandana Abramson, Rebecca Aft, Doreen Agnese, Kimberly H. Allison, Bethany Anderson, Harold J. Burstein, Helen Chew, Chau Dang, Anthony D. Elias, Sharon H. Giordano, Matthew P. Goetz, Lori J. Goldstein, Sara A. Hurvitz, Rachel C. Jankowitz, Sara H. Javid, Jairam Krishnamurthy, A. Marilyn Leitch, Janice Lyons, Joanne Mortimer, Sameer A. Patel, Lori J. Pierce, Laura H. Rosenberger, Hope S. Rugo, Bryan Schneider, Mary Lou Smith, Hatem Soliman, Erica M. Stringer-Reasor, Melinda L. Telli, Mei Wei, Kari B. Wisinski, Jessica S. Young, Kay Yeung, Mary A. Dwyer, and Rashmi Kumar

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer address all aspects of management for breast cancer. The treatment landscape of metastatic breast cancer is evolving constantly. The therapeutic strategy takes into consideration tumor biology, biomarkers, and other clinical factors. Due to the growing number of treatment options, if one option fails, there is usually another line of therapy available, providing meaningful improvements in survival. This NCCN Guidelines Insights report focuses on recent updates specific to systemic therapy recommendations for patients with stage IV (M1) disease.

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Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

William J. Gradishar, Benjamin O. Anderson, Jame Abraham, Rebecca Aft, Doreen Agnese, Kimberly H. Allison, Sarah L. Blair, Harold J. Burstein, Chau Dang, Anthony D. Elias, Sharon H. Giordano, Matthew P. Goetz, Lori J. Goldstein, Steven J. Isakoff, Jairam Krishnamurthy, Janice Lyons, P. Kelly Marcom, Jennifer Matro, Ingrid A. Mayer, Meena S. Moran, Joanne Mortimer, Ruth M. O'Regan, Sameer A. Patel, Lori J. Pierce, Hope S. Rugo, Amy Sitapati, Karen Lisa Smith, Mary Lou Smith, Hatem Soliman, Erica M. Stringer-Reasor, Melinda L. Telli, John H. Ward, Jessica S. Young, Jennifer L. Burns, and Rashmi Kumar

Several new systemic therapy options have become available for patients with metastatic breast cancer, which have led to improvements in survival. In addition to patient and clinical factors, the treatment selection primarily depends on the tumor biology (hormone-receptor status and HER2-status). The NCCN Guidelines specific to the workup and treatment of patients with recurrent/stage IV breast cancer are discussed in this article.

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NCCN Guidelines® Insights: Breast Cancer, Version 4.2021

Featured Updates to the NCCN Guidelines

William J. Gradishar, Meena S. Moran, Jame Abraham, Rebecca Aft, Doreen Agnese, Kimberly H. Allison, Sarah L. Blair, Harold J. Burstein, Chau Dang, Anthony D. Elias, Sharon H. Giordano, Matthew P. Goetz, Lori J. Goldstein, Sara A. Hurvitz, Steven J. Isakoff, Rachel C. Jankowitz, Sara H. Javid, Jairam Krishnamurthy, Marilyn Leitch, Janice Lyons, Jennifer Matro, Ingrid A. Mayer, Joanne Mortimer, Ruth M. O'Regan, Sameer A. Patel, Lori J. Pierce, Hope S. Rugo, Amy Sitapati, Karen Lisa Smith, Mary Lou Smith, Hatem Soliman, Erica M. Stringer-Reasor, Melinda L. Telli, John H. Ward, Kari B. Wisinski, Jessica S. Young, Jennifer L. Burns, and Rashmi Kumar

The NCCN Guidelines for Breast Cancer include up-to-date guidelines for clinical management of patients with carcinoma in situ, invasive breast cancer, Paget disease, phyllodes tumor, inflammatory breast cancer, male breast cancer, and breast cancer during pregnancy. These guidelines are developed by a multidisciplinary panel of representatives from NCCN Member Institutions with breast cancer–focused expertise in the fields of medical oncology, surgical oncology, radiation oncology, pathology, reconstructive surgery, and patient advocacy. These NCCN Guidelines Insights focus on the most recent updates to recommendations for adjuvant systemic therapy in patients with nonmetastatic, early-stage, hormone receptor–positive, HER2-negative breast cancer.

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Breast Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology

William J. Gradishar, Meena S. Moran, Jame Abraham, Rebecca Aft, Doreen Agnese, Kimberly H. Allison, Bethany Anderson, Harold J. Burstein, Helen Chew, Chau Dang, Anthony D. Elias, Sharon H. Giordano, Matthew P. Goetz, Lori J. Goldstein, Sara A. Hurvitz, Steven J. Isakoff, Rachel C. Jankowitz, Sara H. Javid, Jairam Krishnamurthy, Marilyn Leitch, Janice Lyons, Joanne Mortimer, Sameer A. Patel, Lori J. Pierce, Laura H. Rosenberger, Hope S. Rugo, Amy Sitapati, Karen Lisa Smith, Mary Lou Smith, Hatem Soliman, Erica M. Stringer-Reasor, Melinda L. Telli, John H. Ward, Kari B. Wisinski, Jessica S. Young, Jennifer Burns, and Rashmi Kumar

The therapeutic options for patients with noninvasive or invasive breast cancer are complex and varied. These NCCN Clinical Practice Guidelines for Breast Cancer include recommendations for clinical management of patients with carcinoma in situ, invasive breast cancer, Paget disease, phyllodes tumor, inflammatory breast cancer, and management of breast cancer during pregnancy. The content featured in this issue focuses on the recommendations for overall management of ductal carcinoma in situ and the workup and locoregional management of early stage invasive breast cancer. For the full version of the NCCN Guidelines for Breast Cancer, visit NCCN.org.