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John H. Ward

NCCN has developed NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of cancer, management of complications, and screening. The NCCN Guidelines, regularly updated, are a fusion of scientific data and expert opinion from panels composed of oncology professionals from NCCN member institutions. Over time, these guidelines have become more and more accepted by the oncology community in the United States. They are also extensively used internationally. As reported by William T. McGivney, PhD, Chief Executive Officer of NCCN, the NCCN Guidelines also “have been requested by cancer care professionals in more than 115 countries.” Furthermore, the 2009 NCCN Annual Report notes that 44% of all registered users are outside the United States. In 2009, NCCN approved adapted China editions of 10 different Guidelines for the management of common cancers, and the translation of NCCN Guidelines into Japanese is currently in progress. In 2009, NCCN Guidelines programs were held in Korea, United Arab Emirates, Japan (in 2 cities), and China (in 3 cities). Thus, NCCN Guidelines are obviously filling a need internationally. The volume of data, wealth of new information, and deluge of new therapeutic agents is daunting. The fear, felt years ago, that a small group of cancer centers would dictate how cancer treatment should be managed has been replaced by acceptance of the need for a systematic way of approaching a diverse group of related diseases. Challenges in Translation Still, it is not likely that a single group of guidelines, however carefully prepared or regularly...
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Adam L. Cohen and John H. Ward

Ductal carcinoma in situ (DCIS) is a premalignant condition that, if left untreated, may progress to invasive breast cancer. After lumpectomy, DCIS can recur, and about half of recurrences are invasive. In 4 randomized trials, radiation has been shown to decrease the local recurrence rate by about half, though it does not change survival. Based on the results of 3 randomized trials, tamoxifen probably decreases cancer recurrence by about 30%, particularly in young women. Low fat diets, weight loss, and physical activity decrease invasive breast cancer recurrence and may be recommended to certain women with DCIS. Prognostic factors include age, extent of DCIS, margin status, grade, and presence of necrosis, although how these affect adjuvant therapy is unclear. Research evaluating other drugs to reduce recurrence risk and on different ways of delivering radiation continues.

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Melinda L. Telli, William J. Gradishar and John H. Ward

Advances in molecular testing have ushered in the new era of precision medicine. The 2018 publication of the TAILORx trial helped refine the use of genetic expression assays, specifically the 21-gene recurrence score, in assigning patients to endocrine therapy alone or with chemotherapy. The NCCN Guidelines for Breast Cancer explore the clinical applications of this study. The algorithm for managing the axilla in early breast cancer has been further refined, based on the presence or absence of clinical evidence of lymph node involvement. Ovarian suppression has been validated as the optimal approach in higher risk premenopausal women, based on updated analysis of the SOFT and TEXT pivotal trials. In the metastatic setting, the NCCN Guidelines further reinforce the benefit of the CDK4/6 inhibitors, extending the “preferred” recommendation to all the available agents in metastatic disease. Options in triple-negative breast cancer now include, for the first time, an immunotherapeutic agent.

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Michele Dabrowski, Kenneth Boucher, John H. Ward, Margaret M. Lovell, Angela Sandre, Janet Bloch, Lynne Carlquist, Monica Porter, Larry Norman and Saundra S. Buys

A study was conducted to describe our group's experience using the NCCN Distress Thermometer in an outpatient breast cancer clinic. The NCCN Distress Thermometer was administered to patients attending the breast cancer clinic at Huntsman Cancer Institute during a 4-month period. Effects of disease, treatment, and demographic variables on distress level were analyzed. Patients reporting high distress were contacted by a social worker to determine the cause of the distress. Two hundred and eighty-six (286) subjects completed 403 questionnaires, with 96 patients (34%) reporting high levels of distress (5 or greater on a 10-point scale). No relationship was seen between high distress and stage of disease, type of current treatment, time since diagnosis, age, or other demographic factors. Underlying mental health disorders were associated with a higher level of distress. The Distress Thermometer was a useful method to screen, triage, and prioritize patient interventions. In our experience, the tool promoted communication between the patient and the health care team, which enhanced treating psychosocial and physical symptoms. Methods to optimize the use of this screen are proposed.

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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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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Andres Forero, Sharon Hermes Giordano, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Britt-Marie Ljung, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lori J. Pierce, Elizabeth C. Reed, Mary Lou Smith, George Somlo, Neal S. Topham, John H. Ward, Eric P. Winer and Antonio C. Wolff

Overview The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer: Noninvasive and Special Situations presented here are the work of the NCCN Breast Cancer panel members. Categories of evidence and consensus were assessed and are noted in the algorithms and text. Although not explicitly stated at every decision point of the guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. These NCCN Guidelines focus on noninvasive breast cancer and special situations, such as Paget's disease, phyllodes tumor, breast cancer during pregnancy, and axillary breast cancer. Another NCCN guideline addresses invasive breast cancer (see NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines] for Breast Cancer: Invasive and Inflammatory; to view the complete and most recent version of these guidelines, visit the NCCN Web site at www.NCCN.org). The American Cancer Society estimates that 194,280 new cases of invasive breast cancer were diagnosed and 40,610 died of the disease in the United States in 2009.1 In addition, approximately 62,280 women were diagnosed with carcinoma in situ of the breast during the same year. Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The incidence of breast cancer has increased steadily in the United States over the past few decades, but breast cancer mortality seems to be declining,1,2 suggesting a benefit from early detection and more effective treatment. The origin of most breast cancer...
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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Mohammad Jahanzeb, Krystyna Kiel, Britt-Marie Ljung, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lisle M. Nabell, Lori J. Pierce, Elizabeth C. Reed, Mary Lou Smith, George Somlo, Richard L. Theriault, Neal S. Topham, John H. Ward, Eric P. Winer and Antonio C. Wolff

Breast Cancer Clinical Practice Guidelines in Oncology NCCN Categories of Evidence and Consensus Category 1: The recommendation is based on high-level evidence (e.g., randomized controlled trials) and there is uniform NCCN consensus. Category 2A: The recommendation is based on lower-level evidence and there is uniform NCCN consensus. Category 2B: The recommendation is based on lower-level evidence and there is nonuniform NCCN consensus (but no major disagreement). Category 3: The recommendation is based on any level of evidence but reflects major disagreement. All recommendations are category 2A unless otherwise noted. The Breast Cancer Clinical Practice Guidelines presented here are the work of the members of the NCCN Breast Cancer Clinical Practice Guidelines Panel. Categories of evidence were assessed and are noted on the algorithms and in the text. Although not explicitly stated at every decision point of the Guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. The full breast cancer guidelines are not printed in this issue of JNCCN, but can be accessed online at www.nccn.org. Clinical trials: The NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Overview The American Cancer Society estimated that 184,450 new cases of invasive breast cancer would be diagnosed and 40,930 patients would die of the disease in the United States in 2008.1 In addition, approximately 67,770 women will be diagnosed with carcinoma in situ of the breast during the same...
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Robert W. Carlson, D. Craig Allred, Benjamin O. Anderson, Harold J. Burstein, W. Bradford Carter, Stephen B. Edge, John K. Erban, William B. Farrar, Andres Forero, Sharon Hermes Giordano, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Britt-Marie Ljung, David A. Mankoff, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lori J. Pierce, Elizabeth C. Reed, Jasgit Sachdev, Mary Lou Smith, George Somlo, John H. Ward, Antonio C. Wolff and Richard Zellars

Overview These NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer are the work of the members of the NCCN Breast Cancer Panel. Categories of evidence and consensus were assessed and are noted in the algorithms and text. Although not explicitly stated at every decision point of the NCCN Guidelines, patient participation in prospective clinical trials is the preferred option of treatment for all stages of breast cancer. The full breast cancer guidelines are not printed in this issue of JNCCN, but can be accessed online at www.NCCN.org. The American Cancer Society estimated that 209,060 new cases of invasive breast cancer were diagnosed and 40,230 people died of breast cancer in the United States in 2010.1 In addition, approximately 54,010 women were diagnosed with carcinoma in situ of the breast during the same year. Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The incidence of breast cancer has increased steadily in the United States over the past few decades, but breast cancer mortality seems to be declining,1,2 suggesting a benefit from early detection and more effective treatment. The cause of most breast cancer cases is unknown. However, numerous risk factors for the disease have been established, including female gender, increasing patient age, family history of breast cancer at a young age, early menarche, late menopause, older age at first live birth, prolonged hormone replacement therapy, previous exposure to therapeutic chest...
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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

Breast cancer is the most commonly diagnosed cancer in American women with 209,060 and 54,010 estimated cases of invasive breast cancer and female carcinoma in situ, respectively, in 2010. Approximately 39,840 women will die of breast cancer in the United States in 2010.1Risk factors for the development of breast cancer can be grouped into categories, including familial/genetic factors (family history, known or suspected BRCA1/2, TP53, PTEN, or other gene mutation associated with breast cancer risk); factors related to demographics (e.g., age, ethnicity/race); reproductive history (age at menarche, parity, age at first live birth, age at menopause); environmental factors (prior thoracic irradiation before age 30 years [e.g., to treat Hodgkin disease], hormone replacement therapy [HRT], alcohol consumption); and other factors (e.g., number of breast biopsies, atypical hyperplasia or lobular carcinoma in situ [LCIS], breast density, body mass index).Estimating breast cancer risk for the individual woman is difficult, and most breast cancers are not attributable to risk factors other than female gender and increased age. The development of effective strategies for the reduction of breast cancer incidence has also been difficult because few of the existing risk factors are modifiable and some of the potentially modifiable risk factors have social implications extending beyond concerns for breast cancer (e.g., age at first live birth). Nevertheless, effective breast cancer risk reduction agents/strategies, such as tamoxifen, raloxifene, and risk reduction surgery, have been identified. However, women and their physicians who are considering interventions to reduce risk for breast cancer must balance the demonstrated...