Accelerating Advances in Cancer Care Research: A Lookback at the 21st Century Cures Act in 2020.

The 21st Century Cures Act (Cures Act), signed into law in 2016, was designed to advance new therapies by modernizing clinical trials, funding research initiatives, and accelerating the development and use of health information technology. To analyze the current issues in cancer care related to the implementation and impact of the Cures Act, NCCN convened a multistakeholder working group. Participants discussed the legislation's impact on the oncology community since enactment and identified the remaining gaps and challenges as experienced by stakeholders.

NCCN Policy Summit: Defining, Measuring, and Applying Quality in an Evolving Health Policy Landscape and the Implications for Cancer Care.

Quality measurement is a critical component of advancing a health system that pays for performance over volume. Although there has been significant attention paid to quality measurement within health systems in recent years, significant challenges to meaningful measurement of quality care outcomes remain. Defining cost can be challenging, but is arguably not as elusive as quality, which lacks standard measurement methods and units.

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

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.

Quality Measurement in Cancer Care: A Review and Endorsement of High-Impact Measures and Concepts.

Although oncology care has evolved, outcome assessment remains a key challenge. Outcome measurement requires identification and adoption of a succinct list of metrics indicative of high-quality cancer care for use within and across healthcare systems. NCCN established an advisory committee, the NCCN Quality and Outcomes Committee, consisting of provider experts from NCCN Member Institutions and other stakeholders, including payers and patient advocacy, community oncology, and health information technology representatives, to review the existing quality landscape and identify contemporary, relevant cancer quality and outcomes measures by reevaluating validated measures for endorsement and proposing new measure concepts to fill crucial gaps.

National Quality Forum Guidelines for Evaluating the Scientific Acceptability of Risk-adjusted Clinical Outcome Measures: A Report From the National Quality Forum Scientific Methods Panel.

: Quality measurement is at the heart of efforts to achieve high-quality surgical and medical care at a lower cost. Without accurate quality measures, it is not possible to appropriately align incentives with quality. The aim of these National Quality Forum (NQF) guidelines is to provide measure developers and other stakeholders with guidance on the standards used by the NQF to evaluate the scientific acceptability of performance measures.

A phase II study of imatinib mesylate and letrozole in patients with hormone receptor-positive metastatic breast cancer expressing c-kit or PDGFR-β.

Background Imatinib mesylate is a potent inhibitor of the Abl, KIT and platelet derived growth factor (PDGF) receptor tyrosine kinases. Preclinical data suggest that combining imatinib mesylate with anti-estrogen therapy may be synergistic in hormone receptor-positive breast cancer. We report results of the first phase II trial evaluating the efficacy of the novel combination of imatinib mesylate and letrozole in the treatment of postmenopausal women with metastatic breast cancer.

Redefining Quality Measurement in Cancer Care.

Quality measurement in oncology is increasing in significance as payment schemes shift from volume to value. As demand for quality measures increases, challenges in the development of quality measures, standardization across measures, and the limitations of health information technology have become apparent. Moreover, the time and financial burden associated with developing, tracking, and reporting quality measures are substantial.

Value-Based Breast Cancer Care: A Multidisciplinary Approach for Defining Patient-Centered Outcomes.

Purpose: Value in healthcare-i.e., patient-centered outcomes achieved per healthcare dollar spent-can define quality and unify performance improvement goals with health outcomes of importance to patients across the entire cycle of care.

Variations in Proton Therapy Coverage in the State of Texas: Defining Medical Necessity for a Safe and Effective Treatment.

Purpose: The definition of medical necessity and indications for coverage of proton beam therapy (PBT) for the treatment of cancer can vary greatly among different professional societies (PSs) and payors. Variations in policies introduce substantial inefficiencies and limit access for patients who may clinically benefit from PBT. The purpose of this study was to analyze differences in medical necessity and coverage policies among payors and a PS.

Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature.

Background: Many phase II trials investigated the combination of Gemcitabine (G) and Vinorelbine (V) in the treatment of metastatic breast cancer (MBC) with variable outcomes. This study was conducted to explore whether this combination was effective and tolerable in MBC patients who were heavily pretreated with anthracyclines and taxanes.

Methods: A phase I study was conducted first to establish the maximum tolerated dose (MTD) of the G and V combination in MBC patients.

Assessing Compliance With Established Pneumonia Core Measures at a Comprehensive Cancer Center.

Healthcare organizations use Pneumonia Core Measures (PCMs) to ensure delivery of high-quality care. In this study, a multidisciplinary team was organized to optimize care and enhance compliance in a comprehensive cancer emergency center. We performed a four-phase study, three of which were interventional: intense education regarding PCM; microbiologic analysis of the pathogens responsible for the pneumonias; development and implementation of an institutional pneumonia algorithm and order set.

Opportunities for improvement: experience at one institution.

In spring of 2011, 11 NCCN Member Institutions were invited to participate in an opportunity to use the NCCN Breast Oncology Outcomes Database to identify opportunities for improvement in the quality of patient care in breast cancer and to implement measures that would target such improvement. The identified measures focused on the administration of treatment that is concordant with selected sections in the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer or timely access to and administration of care. Each institution chose their project based on the individual opportunities specific to that institution.

Developing a system to track meaningful outcome measures in head and neck cancer treatment.

Background: The health care industry, including consumers, providers, and payers of health care, recognize the importance of developing meaningful, patient-centered measures. This article describes our experience using an existing electronic medical record largely based on free text formats without structured documentation, in conjunction with tumor registry abstraction techniques, to obtain and analyze data for use in clinical improvement and public reporting.

Methods: We performed a retrospective analysis of 2467 previously untreated patients treated with curative intent who presented with laryngeal, pharyngeal, or oral cavity cancer in order to develop a system to monitor and report meaningful outcome metrics of head and neck cancer treatment.

Phase III trial evaluating weekly paclitaxel versus docetaxel in combination with capecitabine in operable breast cancer.

Purpose: We investigated whether capecitabine and docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) or weekly paclitaxel (WP) followed by FEC would improve relapse-free survival (RFS) in operable breast cancer.

Patients And Methods: In this single-institution study, patients with clinical stages I to IIIC breast cancer were randomly assigned on a 1:1 basis to WP 80 mg/m(2) for 12 weeks followed by fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2) (FEC-100) every 3 weeks for four cycles or docetaxel 75 mg/m(2) on day 1 and capecitabine (XT) 1,500 mg/m(2) on days 1 through 14 every 3 weeks for four cycles followed by FEC for four cycles and stratified by timing of chemotherapy (preoperative v adjuvant). Accrual was stopped short of 930 patients on the basis of a Bayesian predictive calculation that additional accrual would be unlikely to change the qualitative comparison of the two regimens.

Assessing the continuum of event-based biosurveillance through an operational lens.

This research follows the Updated Guidelines for Evaluating Public Health Surveillance Systems, Recommendations from the Guidelines Working Group, published by the Centers for Disease Control and Prevention nearly a decade ago. Since then, models have been developed and complex systems have evolved with a breadth of disparate data to detect or forecast chemical, biological, and radiological events that have a significant impact on the One Health landscape. How the attributes identified in 2001 relate to the new range of event-based biosurveillance technologies is unclear.

Phase III randomized trial of dose intensive neoadjuvant chemotherapy with or without G-CSF in locally advanced breast cancer: long-term results.

Objective: To compare the pathologic complete response (pCR) rate of patients treated with 5-fluorouracil (5-FU), doxorubicin, and cyclophosphamide (FAC) versus dose-intense FAC plus G-CSF in the neoadjuvant setting and to compare the delivered dose intensity, disease-free survival (DFS) and overall survival (OS) times, and toxicity between treatment arms in patients with breast cancer.

Methods: Patients were randomized to receive preoperative FAC (5-FU, 500 mg/m(2); doxorubicin, 50 mg/m(2); cyclophosphamide, 500 mg/m(2)) every 21 days for four cycles or dose-intense FAC (5-FU, 600 mg/m(2); doxorubicin, 60 mg/m(2); cyclophosphamide, 1,000 mg/m(2)) plus G-CSF every 18 days for four cycles.

Results: Two hundred two patients were randomly assigned.

Developing a transfer center in a tertiary cancer center: streamlining access and communication to accommodate increasing demand for service.

Hospital-to-hospital transfers in a tertiary cancer center present an unusual set of problems involving a diverse group of acutely ill patients with highly specialized needs. The level and urgency of care required and the costs of providing optimal management often are exceedingly high. We present the administrative issues involved during a major revamping and streamlining of the Transfer Center at The University of Texas MD Anderson Cancer Center.

The implications of the 2010 Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act on cancer care delivery.

In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act. This legislation attempts to address cost control and improve the quality of healthcare in the United States. Cancer is a major health problem in the United States and the leading cause of death for Americans under the age of 80.

Improving cancer care through public reporting of meaningful quality measures.

Historically, quality measures for cancer have followed a different route than overall quality measures in the health care system. Many specialized cancer treatment centers were exempt from standard reporting on quality measures because of the complexity of cancer. Additionally, it has been difficult to create meaningful quality measures for cancer because the disease can strike so many different organs; is discovered at and progresses through different stages; and is treated using different modalities, such as surgery, radiation, and chemotherapy.

A method for defining value in healthcare using cancer care as a model.

Value-based healthcare delivery is being discussed in a variety of healthcare forums. This concept is of great importance in the reform of the US healthcare delivery system. Defining and applying the principles of value-based competition in healthcare delivery models will permit future evaluation of various delivery applications.

Potential impact of tumor registry rule changes for recording inflammatory breast cancer.

Background: New tumor registry rules for abstracting multiple primaries and histologies include 1 specifically for inflammatory breast cancer (IBC), which states that the International Classification for Oncology (ICD-O) histology code 8530 (3) for IBC should be used only when it is on the pathology report. IBC is typically clinically diagnosed. The purpose of this project is to determine the potential impact of this new rule on identifying IBC cases by searching on the ICD-O histology code.

Comparative genomics reveals mechanism for short-term and long-term clonal transitions in pandemic Vibrio cholerae.

Vibrio cholerae, the causative agent of cholera, is a bacterium autochthonous to the aquatic environment, and a serious public health threat. V. cholerae serogroup O1 is responsible for the previous two cholera pandemics, in which classical and El Tor biotypes were dominant in the sixth and the current seventh pandemics, respectively.

Using response to primary chemotherapy to select postoperative therapy: long-term results from a prospective phase II trial in locally advanced primary breast cancer.

Purpose: This study sought to quantify the extent of downstaging after preoperative chemotherapy for stage III breast cancer, to assess the feasibility of breast-conserving therapy (BCT) after preoperative chemotherapy, to determine the effectiveness of this multimodal treatment as measured by disease-free survival (DFS) and overall survival (OS), and to evaluate toxicities.

Patients And Methods: Patients were treated with 4 preoperative courses of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC). They were then evaluated for response to go to mastectomy or BCT.

NCCN Task Force Report: Oral chemotherapy.

Oral chemotherapy is emerging as a new option for well-selected patients who can manage potentially complex oral regimens and self-monitor for potential complications. If a choice between oral and parenteral therapy is available, patients may opt for oral chemotherapy because it is more convenient to administer, allows them to avoid multiple office visits, and gives them a sense of control over their own cancer care. Whether these potential advantages are maintained in regimens that combine oral and parenteral drugs is less clear.

Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer.

Background: Previous studies have evaluated 3-week and weekly docetaxel schedules in patients with metastatic breast cancer (MBC). The varying efficacy results and toxicity profiles noted in these earlier studies led to a comparison of the schedules to determine which was safer and more efficacious.

Methods: A phase 3 clinical trial was conducted in patients with MBC who were treated with docetaxel either every 3 weeks or once weekly to determine and compare response rate and duration, time to disease progression, progression-free survival (PFS), overall survival (OS), and toxicity.