Leveraging the Mammography Setting to Raise Awareness and Facilitate Referral to Lung Cancer Screening: A Qualitative Analysis.

PURPOSE: Despite compelling support for the benefits of low-dose CT (LDCT) screening for lung cancer among high-risk individuals, awareness of LDCT screening and uptake remain low. The aim of this project was to explore the perspectives of ACR mammography screening program directors (MPDs) regarding efforts to raise LDCT screening awareness and appropriate referrals by identifying high-risk individuals participating in routine mammography. METHODS: MPDs were recruited from ACR-accredited mammography facilities to participate in semistructured interviews after the completion of an online survey. Interviews were conducted over the telephone, recorded, transcribed, and subsequently reviewed for accuracy. Twenty MPDs were interviewed, and 18 interviews were transcribed and included in the thematic analysis. A theme codebook was developed, and all interviews were coded using NVivo by two trained reviewers. RESULTS: Key themes were organized into four broad domains: (1) general attitudes toward the integration of LDCT screening, (2) identifying mammography patients at high risk for lung cancer, (3) counseling about LDCT screening, and (4) strategies to identify high-risk women and increase awareness and knowledge of LDCT screening. Overall, MPDs recognized the benefits of integrating mammography and LDCT screening and were receptive to educating and referring women for LDCT screening. However, training and workflow changes are needed to ensure successful implementation. CONCLUSIONS: Qualitative data suggest that MPDs are amenable to leveraging the mammography setting to engage women about LDCT screening; however, additional tools, training, and/or staffing may be necessary to leverage the full potential of reaching women at high risk for lung cancer within the context of mammographic screening.

Pulmonary Carcinosarcoma: A Surveillance, Epidemiology, and End Results (SEER) Analysis.

INTRODUCTION: Pulmonary carcinosarcoma (PC) is a rare malignant neoplasm composed of epithelial and mesenchymal components. It accounts for < 1% of thoracic cancers and is not fully understood. This study examined Surveillance, Epidemiology, and End Results (SEER) data to describe demographic and clinical characteristics of patients with PC and assessed survival outcomes by treatment modality and stage. PATIENTS AND METHODS: SEER data were reviewed to identify patients diagnosed with primary PC (1973-2012). Overall survival (OS) and disease-specific survival (DSS) were analyzed by univariate/multivariable Cox proportional hazards models and Kaplan-Meier methods. RESULTS: A total of 411 patients were included. Median age was 67 (range, 24-96) years. Disease stage at the time of initial diagnosis was known for 74.7% of the identified patients (307/411). Of these patients, 23.1% had localized disease. Survival was significantly better for patients with localized disease (OS: 31 vs. 6 months, P < .001; DSS: 54 vs. 8 months, P < .001). Additionally, patients who received surgery alone had significantly improved OS (20 months; P < .001) and DSS (32 months; P < .001) compared to patients who received combined surgery and radiotherapy (OS: 7 months; DSS: 8 months) or radiotherapy alone (OS: 4 months; DSS: 4 months). CONCLUSION: Treatment with surgery alone resulted in superior survival outcomes compared to other treatment modality combinations, regardless of patient age and disease stage. Within the limitations of this study, providers may wish to consider these findings when devising patient treatment plans.

Critical Aspects of a Sustainable Clinical Research Program in the Community-Based Oncology Practice.

Increasing enrollment into clinical trials is a top priority across the field of oncology. Because the vast majority of those afflicted with cancer receive their care in the community, creating strong clinical research programs in the community-based setting is important. This article comprehensively outlines the most important elements of creating and sustaining a successful community-based research program. Establishing a clear mission and defining the scope of the research program in collaboration with key physicians and administrative leadership are critical to success. Standard operating procedures should detail operational processes. Ensuring sound financial planning and protected physician time are crucial for a healthy program. Providing mentorship opportunities to investigators and other team members will provide necessary guidance for junior investigators and long-term program stability. Prioritizing provider and patient volunteer engagement through education and awareness will potentially improve enrollment and research ownership. Incorporating administrative and clinical research staff and health care providers, including physicians, advanced practice providers, and pharmacists, will result in a multidisciplinary and unified approach and may also promote research as a routine part of patient care. Regular safety and scientific meetings will reduce regulatory complications and, most importantly, improve patient care. Other keys to a successful program include establishing a diverse trial portfolio, collaboration between different institutions, and ensuring appropriate technological infrastructure. Serial programmatic review provides opportunities to refine suboptimal practices and recognize successful strategies. Community-based research programs are critical to improve access to optimal cancer care. Implementation of successful programs is possible with a collaborative and multidisciplinary approach.

Treatment Decisions for Advanced Non-Squamous Non-Small Cell Lung Cancer: Patient and Physician Perspectives on Maintenance Therapy.

INTRODUCTION: Advanced non-small cell lung cancer (NSCLC) is a severe disease with burdensome symptoms and traditionally poor outcomes. The treatment of advance disease is based on chemotherapy, with the recent addition of immunotherapy. Patients who respond to initial treatment can opt to receive maintenance therapy (MT). It is important to understand why patients with advanced NSCLC choose to accept or refuse therapy, and how physician recommendations play into this decision-making process. This study characterized patient and physician decision-making regarding treatment for patients with advanced non-squamous NSCLC in the USA using the example of MT. METHODS AND MATERIALS: This study employed multiple approaches: patient interviews, a patient survey, and a physician survey. Qualitative interviews were conducted among patients who had been offered MT to identify factors influencing treatment decision-making. The patient survey explored the decision-making process and quantified challenges and motivators for receiving MT. The physician survey included a discrete choice experiment to understand the relationship between physician treatment recommendations and patient characteristics. RESULTS: Interviewed patients (n = 10) were motivated to receive MT in the hope of extending their lives and being proactive against their cancer, and they anticipated reduced adverse effects compared with first-line therapy. Surveyed patients (n = 77) described several deterrents to receiving therapy; the most prominent was severity of adverse effects, which was an influencing factor for 34% of patients. The major motivator for receiving therapy was the potential to extend life, which influenced 97% of patients. A total of 100 oncologists participated in the physician survey. Patients' lack of treatment motivation/inconvenience, disease progression, presence of severe renal co-morbidities, and older age decreased the likelihood of physicians recommending the use of MT. CONCLUSION: This study identified challenges and motivators influencing advanced NSCLC patients' decisions to accept or refuse therapy, as well as patient and disease characteristics associated with physician's treatment recommendations for MT.

Implementing Precision Medicine Programs and Clinical Trials in the Community-Based Oncology Practice: Barriers and Best Practices.

There has been a rapid uptick in the pace of oncology precision medicine advancements over the past several decades as a result of increasingly sophisticated technology and the ability to study more patients through innovative trial designs. As more precision oncology approaches are developed, the need for precision medicine trials is increasing in the community setting, where most patients with cancer are treated. However, community-based practices, as well as some academic centers, may face unique barriers to implementing precision medicine programs and trials within their communities. Such challenges include understanding the tissue needs of molecular tests (e.g., tumor, blood), identifying which molecular tests are best used and when tissue should be tested, interpreting the test results and determining actionability, understanding the role of genetic counseling and/or follow-up testing, determining clinical trial eligibility, and assessing patient attitudes and financial concerns. The purpose of this article is to provide guidance to community-based oncology practices currently conducting clinical trials who want to expand their research program to include precision medicine trials. Here, we describe the core components of precision medicine programs and offer best practices for successful implementation of precision medicine trials in community-based practices.

Clinical Pathways and the Patient Perspective in the Pursuit of Value-Based Oncology Care.

The art of practicing oncology has evolved substantially in the past 5 years. As more and more diagnostic tests, biomarker-directed therapies, and immunotherapies make their way to the oncology marketplace, oncologists will find it increasingly difficult to keep up with the many therapeutic options. Additionally, the cost of cancer care seems to be increasing. Clinical pathways are a systematic way to organize and display detailed, evidence-based treatment options and assist the practitioner with best practice. When selecting which treatment regimens to include on a clinical pathway, considerations must include the efficacy and safety, as well as costs, of the therapy. Pathway treatment regimens must be continually assessed and modified to ensure that the most up-to-date, high-quality options are incorporated. Value-based models, such as the ASCO Value Framework, can assist providers in presenting economic evaluations of clinical pathway treatment options to patients, thus allowing the patient to decide the overall value of each treatment regimen. Although oncologists and pathway developers can decide which treatment regimens to include on a clinical pathway based on the efficacy of the treatment, assessment of the value of that treatment regimen ultimately lies with the patient. Patient definitions of value will be an important component to enhancing current value-based oncology care models and incorporating new, high-quality, value-based therapeutics into oncology clinical pathways.

The effect of radiation therapy in the treatment of adult soft tissue sarcomas of the extremities: a long-term community-based cancer center experience.

The aim of the study was to determine the effect of external beam radiotherapy (RT) in the treatment of extremity soft tissue sarcoma (STS) before or after limb-sparing surgery (LSS) in a community-based setting. Patients presenting to our institution from 1992 to 2010 and meeting eligibility criteria were stratified into low (G1) or high (G2, G3) pathologic grade and evaluated. Major complication events, including amputation, radiation-induced sarcoma, and pathologic fracture, were assessed. Kaplan-Meier techniques and Cox proportional hazards regression models were used. One hundred and sixty-two eligible patients underwent LSS for extremity STS (120 high grade, 42 low grade). Median time of follow-up was 5.1 years (0.8-20.3 years). RT was administered to 111 patients. In unadjusted models, RT significantly decreased the risk of local recurrence (LR) in high-grade STS patients (P = 0.005) and had a trend for improved recurrence-free survival (RFS) (P = 0.069). In multivariable-adjusted models, RT significantly improved time to LR (P = 0.001), RFS (P = 0.003), and overall survival (OS) (P = 0.003). Analysis of all patients showed those who underwent RT had a major complication rate (MCR) of 16.2%, compared to 3.9% in the no RT group (P = 0.037); however, the difference in MCR did not differ significantly when the analysis was restricted to high-grade sarcomas. In our large experience of patients with extremity STS undergoing limb sparing surgery (LSS), RT significantly improved local recurrence (LR), RFS, and OS, in patients with high-grade tumors. Efficacy benefits of RT should be weighed against potential complications. External beam RT should be considered in patients with resected high-grade sarcomas.

Knowledge of, attitudes toward, and use of low-dose computed tomography for lung cancer screening among family physicians.

BACKGROUND: The results of the National Lung Screening Trial showed a 20% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality when high-risk patients were screened with low-dose computed tomography (LDCT) versus chest x-ray (CXR). The US Preventive Services Task Force has issued a grade B recommendation for LDCT screening, and the Centers for Medicare and Medicaid Services and private insurers now cover the screening cost under certain conditions. The purpose of this study was to assess the knowledge of, attitudes toward, and use of LDCT screening for lung cancer among family physicians. METHODS: A 32-item questionnaire was distributed to members of the South Carolina Academy of Family Physicians in 2015. Descriptive statistics were calculated. RESULTS: There were 101 respondents, and most had incorrect knowledge about which organizations recommended screening. Many physicians continued to recommend CXR for lung cancer screening. Most felt that LDCT screening increased the odds of detecting disease at earlier stages (98%) and that the benefits outweighed the harms (75%). Concerns included unnecessary procedures (88%), stress/anxiety (52%), and radiation exposure (50%). Most physicians discussed the risks/benefits of screening with their patients in some capacity (76%); however, more than 50% reported making 1 or no screening recommendations in the past year. CONCLUSIONS: Most family physicians report discussing LDCT with patients at high risk for lung cancer; however, referrals remain low. There are gaps in physician knowledge about screening guidelines and reimbursement, and this indicates a need for further educational outreach. The development of decision aids may facilitate shared decision-making discussions about screening, and targeted interventions may improve knowledge gaps. Cancer 2016;122:2324-2331. © 2016 American Cancer Society.

Transforming Clinical Trial Eligibility Criteria to Reflect Practical Clinical Application.

Historically, oncology clinical trials have focused on comparing a new drug's efficacy to the standard of care. However, as our understanding of molecular pathways in oncology has evolved, so has our ability to predict how patients will respond to a particular drug, and thus comparison with a standard therapy has become less important. Biomarkers and corresponding diagnostic testing are becoming more and more important to drug development but also limit the type of patient who may benefit from the therapy. Newer clinical trial designs have been developed to assess clinically meaningful endpoints in biomarker-enriched populations, and the number of modern, molecularly driven clinical trials are steadily increasing. At the same time, barriers to clinical trial enrollment have also grown. Many barriers contribute to nonenrollment in clinical trials, including patient, physician, institution, protocol, and regulatory barriers. At the protocol level, eligibility criteria have become a large roadblock to clinical trial accrual. Over time, eligibility criteria have become more and more restrictive. To accrue an adequate number of patients to molecularly driven trials, we should consider eligibility criteria carefully and attempt to reduce restrictive criteria. Reducing restrictive eligibility criteria will allow more patients to be eligible for clinical trial participation, will likely increase the speed of drug approvals, and will result in clinical trial results that more accurately reflect treatment of the population in the clinical setting.

Lung cancer biomarkers, targeted therapies and clinical assays.

Until recently, the majority of genomic cancer research has been in discovery and validation; however, as our knowledge of tumor molecular profiling improves, the idea of genomic application in the clinic becomes increasingly tangible, paralleled with the drug development of newer targeted therapies. A number of profiling methodologies exist to identify biomarkers found within the patient (germ-line DNA) and tumor (somatic DNA). Subsequently, commercially available clinical assays to test for both germ-line and somatic alterations that are prognostic and/or predictive of disease outcome, toxicity or treatment response have significantly increased. This review aims to summarize clinically relevant cancer biomarkers that serve as targets for therapy and their potential relationship to lung cancer. In order to realize the full potential of genomic cancer medicine, it is imperative that clinicians understand these intricate molecular pathways, the therapeutic implication of mutations within these pathways, and the availability of clinical assays to identify such biomarkers.

Management of hyperglycemia from epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) targeting T790M-mediated resistance.

Epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC) patients are associated with sensitivity to small molecule tyrosine kinase inhibitors (TKIs) such as erlotinib, gefitinib, and afatinib. Although studies show an increased progression free survival (PFS) with use of EGFR TKIs in the first-line setting, most patients will develop resistance to therapy after the first 8-16 months. T790M is an acquired resistance mutation reported in 60-70% of patients who initially responded to a prior EGFR TKI. Recently, EGFR TKIs targeting T790M have been developed to overcome resistance with positive results in PFS and objective response rate in patients who have had disease progression on at least one TKI. Two EGFR TKIs targeting T790M, AZD9291 and rociletinib, are new active treatment options for NSCLC but differ in adverse effect profiles. Dose-limiting hyperglycemia has been reported with rociletinib and has required dose reduction, an oral antihyperglycemic, or both, without discontinuation of therapy. This suggests that patients may be effectively treated chronically for hyperglycemia associated with EGFR TKIs targeting T790M, however, guidelines for treatment of hyperglycemia in this setting have not been published. We discuss mechanisms of hyperglycemia associated with TKIs and initial management of hyperglycemia, including benefits and limitations of oral antihyperglycemic options, adjustment of therapy based on grade of hyperglycemia, and recommendations for follow-up glucose monitoring.

Modernizing Eligibility Criteria for Molecularly Driven Trials.

As more clinical trials of molecularly targeted agents evolve, the number of eligibility criteria seems to be increasing. The importance and utility of eligibility criteria must be considered in the context of the fundamental goal of a clinical trial: to understand the risks and benefits of a treatment in the intended-use patient population. Although eligibility criteria are necessary to define the population under study and conduct trials safely, excessive requirements may severely restrict the population available for study, and often, this population is not reflective of the general population for which the drug would be prescribed. The American Society of Clinical Oncology Cancer Research Committee, which comprises academic faculty, industry representatives, and patient advocates, evaluated this issue. Evaluation results were mixed. Most physicians agreed that excessive eligibility criterias slow study enrollment rates and prolong the duration of enrollment; however, this hypothesis was difficult to validate with the data examined. We propose the organization of a public workshop, with input from regulatory bodies and key stakeholders, with the goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols, which may help guide future investigators and companies in streamlining eligibility criteria in the era of molecularly driven therapy.

Geographic Access to Mammography and Its Relationship to Breast Cancer Screening and Stage at Diagnosis: A Systematic Review.

INTRODUCTION: A review was conducted to summarize the current evidence and gaps in the literature on geographic access to mammography and its relationship to breast cancer-related outcomes. METHODS: Ovid, Medline, and PubMed were searched for articles published between January 1, 2000, and April 1, 2013, using Medical Subject Headings and key terms representing geographic accessibility and breast cancer-related outcomes. Owing to a paucity of breast cancer treatment and mortality outcomes meeting the criteria (N = 6), outcomes were restricted to breast cancer screening and stage at diagnosis. Studies included one or more of the following types of geographic accessibility measures: capacity, density, distance, and travel time. Study findings were grouped by outcome and type of geographic measure. RESULTS: Twenty-one articles met the inclusion criteria. Fourteen articles included stage at diagnosis as an outcome, five included mammography use, and two included both. Geographic measures of mammography accessibility varied widely across studies. Findings also varied, but most articles found either increased geographic access to mammography associated with increased use and decreased late-stage at diagnosis or no association. CONCLUSION: The gaps and methodologic heterogeneity in the literature to date limit definitive conclusions about an underlying association between geographic mammography access and breast cancer-related outcomes. Future studies should focus on the development and application of more precise and consistent measures of geographic access to mammography.