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NCCN's Commitment to Medication Safety: The Vincristine Initiative

Jessica Sugalski, F. Marc Stewart, and Robert W. Carlson

The mission of NCCN is to improve the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Improving medication safety is an important aspect of fulfilling this mission. In September 2014, the NCCN Best Practices Committee began a medication safety initiative to improve the safe use of vincristine. This article describes and discusses this initiative.

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Keynote Address: When Breath Becomes Air—As Physician Becomes Patient

Lucy Kalanithi, Heather Wakelee, and Robert W. Carlson

As part of the NCCN 22nd Annual Conference: Improving the Quality, Effectiveness, and Efficiency of Cancer Care, Lucy Kalanithi, MD, wife of now-deceased best-selling author Paul Kalanithi (When Breath Becomes Air), and Heather Wakelee, MD, Paul's oncologist, discussed—for the first time together in a public forum—Paul's experience of going from a neurosurgery resident to a patient with cancer with a terminal diagnosis. Robert Carlson, MD, moderated the discussion.

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Implementation Framework for NCCN Guidelines

Abdul Rahman Jazieh, Joan S. McClure, and Robert W. Carlson

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Adjuvant Endocrine Therapy in Hormone Receptor-Positive Postmenopausal Breast Cancer: Evolution of NCCN, ASCO, and St Gallen Recommendations

Robert W. Carlson, Clifford A. Hudis, and Kathy I. Pritchard

Endocrine therapy has a firm role in adjuvant treatment of women with hormone receptor–positive invasive breast cancer. Until recently, tamoxifen was the most commonly used adjuvant endocrine therapy in premenopausal and postmenopausal women. Several randomized clinical trials have studied the third-generation selective aromatase inhibitors (AIs) (anastrozole, letrozole, and exemestane) as adjuvant endocrine therapy in postmenopausal women. These studies compared therapy with an AI alone versus tamoxifen alone; 2 to 3 years of tamoxifen followed by switching to an AI versus continuation of tamoxifen; or extended therapy with an AI after approximately 5 years of tamoxifen therapy. No statistically significant differences in overall survival were observed. A single trial using extended treatment with an adjuvant AI suggests a small, statistically significant survival advantage in women with axillary lymph node–positive disease while showing no statistically significant decrease in survival with the use of an AI. The toxicities of the AIs are generally acceptable, with fewer endometrial cancers, gynecologic complaints, and thromboembolic events, but more bone fractures and arthralgias compared with tamoxifen alone. Three widely disseminated treatment guidelines, the National Comprehensive Cancer Network Breast Cancer Clinical Practice Guidelines in Oncology, the American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors, and the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer, now incorporate AIs in the adjuvant therapy of postmenopausal women with estrogen receptor–positive breast cancer.

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NCCN Virtual Policy Summit: Defining the “New Normal” — 2021 and the State of Cancer Care in America Following 2020

Alyssa A. Schatz, Lindsey Bandini, and Robert W. Carlson


US healthcare systems have been deeply impacted by significant societal shifts over the past several years. The COVID-19 pandemic has changed the way we interact with healthcare, political narratives have impacted how healthcare is perceived and engaged with by the public, and the United States has become increasingly aware of historic and ongoing racial injustices across all health and social systems. The watershed events experienced during the last several years play a critical role in shaping the future of cancer care for payers, providers, manufacturers, and, most importantly, patients and survivors. To explore these issues, in June 2021 NCCN convened a virtual policy summit: Defining the “New Normal” — 2021 and the State of Cancer Care in America Following 2020. This summit offered the opportunity for a varied group of stakeholders to begin to explore the impact of recent events on the current and future state of oncology in the United States. Topics included the impact of COVID-19 on cancer detection and treatment, the role of innovation in ensuring continuity of care, and efforts to create more equitable systems of care.

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NCCN Policy Summit: Innovative Solutions to Drive Down Healthcare Costs: Implications for Access to High-Quality Cancer Care

Terrell Johnson, Michelle McMurry-Heath, Ted Okon, David Rubin, and Robert W. Carlson

The cost of delivering high-quality healthcare in America now consumes 17.7% of the nation’s gross domestic product according to Centers for Medicare & Medicaid Services National Health Expenditure Data. With costs threatening to disrupt accessible and equitable care for patients, policymakers are reassessing all matters and functions of the healthcare system to excise waste, redundancies, and costly services. To explore this subjects’ impact on oncology, NCCN hosted the NCCN Policy Summit: Innovative Solutions to Drive Down Healthcare Costs: Implications for Access to High Quality Cancer Care. This virtual summit featured multidisciplinary panel discussions and keynote addresses. Seeking to address barriers to low-cost, high-quality cancer care, panelists and keynotes presented innovative policy solutions to sustain high-quality oncologic care at lower costs to the health system. This article encapsulates the discussions held during the summit and expounds upon salient points where appropriate.

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The State of Cancer Care in America: Impact of State Policy on Access to High-Quality Cancer Care

Terrell Johnson, Lindsey A.M. Bandini, Kara Martin, Lee Jones, Jennifer Carlson, Ronald S. Walters, and Robert W. Carlson

Health policy in America has shifted rapidly over the last decade, and states are increasingly exercising greater authority over health policy decision-making. This localization and regionalization of healthcare policy poses significant challenges for patients with cancer, providers, advocates, and policymakers. To identify the challenges and opportunities that lay ahead of stakeholders, NCCN hosted the 2019 Policy Summit: The State of Cancer Care in America on June 27, 2019, in Washington, DC. The summit featured multidisciplinary panel discussions to explore the implications for access to quality cancer care within a shifting health policy landscape from a patient, provider, and lawmaker perspective. This article encapsulates the discussion from this NCCN Policy Summit.

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Solid Malignancies in Individuals With Down Syndrome: A Case Presentation and Literature Review

Scott V. Bratman, Kathleen C. Horst, Robert W. Carlson, and Daniel S. Kapp

Individuals with Down syndrome (DS) are at elevated risk for acute leukemia, whereas solid tumors are uncommon, and most types, including breast cancers, have significantly lower-than-expected age-adjusted incidence rates. This article reports on a man with DS and breast cancer, thought to be the first in the literature, and presents the management of his cancer. The literature on malignancies in patients with DS is reviewed and the major epidemiologic studies that have examined the spectrum of cancer risk in individuals with DS are summarized. Potential environmental and genetic determinants of cancer risk are discussed, and the potential role of chromosomal mosaicism in cancer risk among patients with DS is explored. Trisomy of chromosome 21, which causes DS, provides an extra copy of genes with tumor suppressor or repressor functions. Recent studies have leveraged mouse and human genetics to uncover specific candidate genes on chromosome 21 that mediate these effects. In addition, global perturbations in gene expression programs have been observed, with potential effects on proliferation and self-renewal.

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Developments in Molecular Testing and Biosimilars

Katy Winckworth-Prejsnar, Elizabeth A. Nardi, Lisa Korin Lentz, Jeffrey A. Crawford, C. Lyn Fitzgerald, and Robert W. Carlson

Molecular testing and biosimilars offer the potential for increased access to targeted treatment options and reduction in healthcare costs, but come with significant challenges in ensuring patient access to innovation in cancer care while maintaining safe, effective, ethical, and affordable treatment options. As providers, payers, patients, and the larger healthcare systems become inundated with a wide variety of molecular diagnostics and an increased number of biosimilars coming to market, it will be important to understand regulatory guidance and policy implications relating to the appropriateness of molecular testing and the clinical use of biosimilars in cancer care. In September 2016, NCCN hosted the Molecular Testing and Biosimilars Policy Summit to address the challenges, issues, and opportunities in both the molecular testing and biosimilar landscapes. Keynote presentations and panelists further discussed the status and future of molecular testing and biosimilars within the oncology space, as well as patient access and education needs moving forward.

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Emerging Issues and Opportunities in Health Information Technology

Elizabeth A. Nardi, Lisa Korin Lentz, Katherine Winckworth-Prejsnar, Amy P. Abernethy, and Robert W. Carlson

When used effectively, health information technology (HIT) can transform clinical care and contribute to new research discoveries. Despite advances in HIT and increased electronic health record adoption, many challenges to optimal use, interoperability, and data sharing exist. Data standardization across systems is limited, and scanned medical note documents result in unstructured data that make reporting on quality measures for reimbursement burdensome. Different policies and initiatives, including the Health Information Technology for Economic and Clinical Health Act, the Medicare Access and CHIP Reauthorization Act, and the National Cancer Moonshot initiative, among others, all recognize the impact that HIT can have on cancer care. Given the growing role HIT plays in health care, it is vital to have effective and efficient HIT systems that can exchange information, collect credible data that is analyzable at the point of care, and improves the patient-provider relationship. In June 2016, NCCN hosted the Emerging Issues and Opportunities in Health Information Technology Policy Summit. The summit addressed challenges, issues, and opportunities in HIT as they relate to cancer care. Keynote presentations and panelists discussed moving beyond Meaningful Use, HIT readiness to support and report on quality care, the role of HIT in precision medicine, the role of HIT in the National Cancer Moonshot initiative, and leveraging HIT to improve quality of clinical care.