NCCN Framework for Resource Stratification: A Framework for Providing and Improving Global Quality Oncology Care.

More than 14 million new cancer cases and 8.2 million cancer deaths are estimated to occur worldwide on an annual basis. Of these, 57% of new cancer cases and 65% of cancer deaths occur in low- and middle-income countries. Disparities in available resources for health care are enormous and staggering. The WHO estimates that the United States and Canada have 10% of the global burden of disease, 37% of the world's health workers, and more than 50% of the world's financial resources for health; by contrast, the African region has 24% of the global burden of disease, 3% of health workers, and less than 1% of the world's financial resources for health. This disparity is even more extreme with cancer. NCCN has developed a framework for stratifying the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to help health care systems in providing optimal care for patients with cancer with varying available resources. This framework is modified from a method developed by the Breast Health Global Initiative. The NCCN Framework for Resource Stratification (NCCN Framework) identifies 4 resource environments: basic resources, core resources, enhanced resources, and NCCN Guidelines, and presents the recommendations in a graphic format that always maintains the context of the NCCN Guidelines. This article describes the rationale for resource-stratified guidelines and the methodology for developing the NCCN Framework, using a portion of the NCCN Cervical Cancer Guideline as an example.

NCCN Roundtable: What Are the Characteristics of an Optimal Clinical Practice Guideline?

Much has changed in the treatment of cancer since the first NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) were rolled out for 8 different tumor types in November 1996. NCCN Guidelines now include involved algorithms often containing multiple treatment alternatives and detailed pathways of care that depend on more-specific patient characteristics and molecular tumor diagnostics. With 47 different individual NCCN panels, all members of the cancer care team are now better informed than ever to guide patients through the often complex decision-making required to improve the odds of successful outcomes. At the NCCN 20th Annual Conference, a distinguished panel assembled to take a closer look at these invaluable clinical practice guidelines, first glancing backward to how it all started and then forward to explore the key ingredients of trustworthy guidelines.

Optimizing the Clinical Utility of Biomarkers in Oncology: The NCCN Biomarkers Compendium.

CONTEXT: The rapid development of commercial biomarker tests for oncology indications has led to confusion about which tests are clinically indicated for oncology care. By consolidating biomarker testing information recommended within National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Biomarkers Compendium aims to ensure that patients have access to appropriate biomarker testing based on the evaluations and recommendations of the expert NCCN panel members. OBJECTIVES: To present the recently launched NCCN Biomarkers Compendium. DATA SOURCES: Biomarker testing information recommended within NCCN Clinical Treatment Guidelines as well as published resources for genetic and biological information. CONCLUSIONS: The NCCN Biomarkers Compendium is a continuously updated resource for clinicians who need access to relevant and succinct information about biomarker testing in oncology and is linked directly to the recommendations provided within the NCCN Clinical Practice Guidelines.

NCCN Working Group report: designing clinical trials in the era of multiple biomarkers and targeted therapies.

Defining treatment-susceptible or -resistant populations of patients with cancer through the use of genetically defined biomarkers has revolutionized cancer care in recent years for some disease/patient groups. Research continues to show that histologically defined diseases are diverse in their expression of unique mutations or other genetic alterations, however, which presents opportunities for the development of personalized cancer treatments, but increased difficulty in testing these therapies, because potential patient populations are divided into ever smaller numbers. To address some of the growing challenges in biomarker development and clinical trial design, NCCN assembled a group of experts across specialties and solid tumor disease types to begin to define the problems and to consider alternate ways of designing clinical trials in the era of multiple biomarkers and targeted therapies. Results from that discussion are presented, focusing on issues of clinical trial design from the perspective of statisticians, clinical researchers, regulators, pathologists, and information developers.

International adaptations of NCCN Clinical Practice Guidelines in Oncology.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) are evidence- and consensus-based clinical practice guidelines addressing malignancies that affect more than 97% of all patients with cancer in the United States. The NCCN Guidelines are used extensively in the United States and globally. Use of the guidelines outside the United States has driven the need to adapt the guidelines based on local, regional, or national resources. The NCCN Guidelines Panels created, vetted, and continually update the NCCN Guidelines based on published scientific data on cancer detection, diagnosis, and treatment efficacy. The guidelines are developed within the context of commonly available resources, methods of payment, societal and cultural expectations, and governmental regulations as they exist in the United States. Although many of the cancer management recommendations contained in the NCCN Guidelines apply broadly from a global perspective, not all do. Disparities in availability and access to health care exist among countries, within countries, and among different social groups in the same country, especially regarding resources for cancer prevention, early detection, and treatment. In addition, different drug approval and payment processes result in regional variation in availability of and access to cancer treatment, especially highly expensive agents and radiation therapy. Differences in cancer risk, predictive biomarker expression, and pharmacogenetics exist across ethnic and racial groups, and therefore across geographic locations. Cultural and societal expectations and requirements may also require modification of NCCN Guidelines for use outside the United States. This article describes the adaptation process, using the recent Latin American adaptation of the 2013 NCCN Guidelines for Colorectal Cancer as an example.

Cervical cancer screening.

These NCCN Guidelines Insights focus on recent recommendations for cervical cancer screening and management of abnormal screening tests. When the NCCN Panel convened to update the NCCN Guidelines for Cervical Cancer Screening, they decided to adopt and endorse guidelines from other organizations to avoid duplication of effort. Therefore, in July 2013, after review and validation of consensus guidelines from the American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology, the NCCN Guidelines for Cervical Cancer Screening were discontinued.

The process of NCCN guidelines adaptation to the Middle East and North Africa region.

The NCCN developed clinical practice guidelines for oncology that set the standard of cancer care in the United States. Because of wide acceptance of, need for, and interest in standardized treatment practices across the world, NCCN launched initiatives to help international groups adapt these guidelines. This article describes the initiative in the Middle East and North Africa (MENA) region. A group of oncology experts and key opinion leaders were assembled into 7 specific committees to develop treatment guidelines for breast cancer, lung cancer, colon cancer, prostate cancer, hepatobiliary cancer, lymphoma, and palliative care. The committees reviewed the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to identify any modifications required for them to be more applicable to the MENA region based on available evidence and regional experience. These modifications were discussed with NCCN experts and summarized for each specific area. The development of these guidelines generated a strong interest in the region to develop more evidence-based practice and create further networking and collaboration.

Practice patterns and guideline adherence of medical oncologists in managing patients with early breast cancer.

BACKGROUND: Studies of adherence to breast cancer guidelines have often focused on primary therapies, but concordance with other guideline recommendations has not been examined as extensively. This study assesses the knowledge and practice patterns of medical oncologists in the United States to inform education and quality improvement initiatives that can improve breast cancer care. METHODS: A survey containing case vignettes and related questions was developed to examine oncologists' clinical decision-making in evaluating and treating women with early breast cancer. The instrument was distributed to a random sample of 742 oncologists in the United States and yielded 205 responses (27.6% response rate). Responses from 184 practicing medical oncologists were analyzed relative to the 2007 NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. RESULTS: Most oncologists made guideline-consistent choices in clarifying indeterminate human epidermal growth factor 2 (HER2) status (85%), initial treatment for early breast cancer (95%), and postsurgical management of locally advanced breast cancer (82%). Guideline-discordant choices were seen in the lack of clip placement before neoadjuvant chemotherapy (36%), unnecessary use of PET scanning for initial assessment (34%), inappropriate assessment of menopausal status (33%), inappropriate use of tumor markers (22%), and use of chest imaging (16%) during posttherapeutic surveillance. CONCLUSIONS: Oncologists often make guideline-consistent choices, but discordant clinical decisions may occur in important aspects of care for early breast cancer. Broadening the diffusion and adoption of guideline recommendations is an important mechanism for addressing these gaps and may substantially improve the quality of breast cancer care.

NCCN Task Force Report: Management of dermatologic and other toxicities associated with EGFR inhibition in patients with cancer.

This NCCN Task Force Report describes the management of dermatologic and ocular toxicities that occur in patients treated with epidermal growth factor receptor (EGFR) inhibitors. Task force members are from NCCN member institutions and include oncologists, dermatologists, an ophthalmologist, and a mid-level oncology provider. This report describes commonly used therapies that the task force agreed are appropriate standards of care for dermatologic and ophthalmologic toxicities associated with EGFR inhibitors, which generally are supported only by anecdotal evidence. Few recommendations are evidence based; however, some commonly used therapies have data supporting their use. Conclusions from completed clinical trials are generally limited by the small numbers of patients enrolled. The information in this report is based on available published data on treating toxicities associated with EGFR inhibitors, data from treatment of clinically similar toxicities from different etiologies, and expert opinion among the NCCN Task Force members.

NCCN Task Force Report: breast cancer in the older woman.

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.

American Society of Clinical Oncology/National Comprehensive Cancer Network Quality Measures.

PURPOSE: The National Cancer Policy Board recommended the creation of quality measures and a national reporting system in 1999. Representatives from the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) collaborated to create metrics suitable for national performance measurement. METHODS: Content and methodology experts nominated by ASCO and NCCN met to select and refine metrics for breast, colon, and rectal cancer based on National Initiative for Cancer Care Quality and NCCN measures and NCCN and ASCO guidelines. Measures were selected based on their impact on disease free and overall survival, the degree to which opportunities for improvement exist, and the feasibility of data collection. RESULTS: Three breast cancer measures and four colorectal cancer measures were chosen. Measures for breast cancer included adjuvant hormone therapy for hormone receptor-positive tumors, chemotherapy for hormone receptor-negative cancer, and radiation after lumpectomy. Colorectal measures included adjuvant radiation and chemotherapy for rectal cancer, and adjuvant chemotherapy for colon cancer. All but one were recommended as accountability measures and one for quality improvement (removal and examination of 12 or more lymph nodes in colon cancer). Specifications were developed for each measure using tumor registries as the data source. CONCLUSION: ASCO/NCCN measures can be implemented by health systems, provider groups or payors for improvement or accountability using local tumor registries to furnish data on staging and treatment.