ABSTRACT
Advances in biomarker-driven therapies for patients with nonsmall cell lung cancer (NSCLC) both provide opportunities to improve the treatment (and thus outcomes) for patients and pose new challenges for equitable care delivery. Over the last decade, the continuing development of new biomarker-driven therapies and evolving indications for their use have intensified the importance of interdisciplinary communication and coordination for patients with or suspected to have lung cancer. Multidisciplinary teams are challenged with completing comprehensive and timely biomarker testing and navigating the constantly evolving evidence base for a complex and time-sensitive disease. This guide provides context for the current state of comprehensive biomarker testing for NSCLC, reviews how biomarker testing integrates within the diagnostic continuum for patients, and illustrates best practices and common pitfalls that influence the success and timeliness of biomarker testing using a series of case scenarios.
Subject(s)
Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Humans , Lung Neoplasms/diagnosis , Lung Neoplasms/therapy , Carcinoma, Non-Small-Cell Lung/diagnosis , Carcinoma, Non-Small-Cell Lung/therapy , Biomarkers, TumorABSTRACT
Comprehensive biomarker testing is a crucial requirement for the optimal treatment of advanced-stage non-small cell lung cancer (NSCLC), with emerging relevance in the adjuvant treatment setting. To advance its goal of ensuring optimal therapy for persons diagnosed with lung cancer, the American Cancer Society National Lung Cancer Roundtable (ACS NLCRT) held The Summit on Optimizing Lung Cancer Biomarkers in Practice in September 2020 to align its partners toward the goal of ensuring comprehensive biomarker testing for all eligible patients with NSCLC. The ACS NLCRT's Strategic Plan for Advancing Comprehensive Biomarker Testing in NSCLC, a product of the summit, comprises actions to promote comprehensive biomarker testing for all eligible patients. The approach is multifaceted, including policy-level advocacy and the development and dissemination of targeted educational materials, clinical decision tools, and guides to patients, physicians, and payers aimed at ameliorating barriers to testing experienced by each of these groups. PLAIN LANGUAGE SUMMARY: The ACS NLCRT works to improve care for patients with lung cancer. The ACS NLCRT supports comprehensive biomarker testing as essential to determine treatment options for all eligible patients with non-small cell lung cancer. Many factors lead to some patients not receiving optimal biomarker testing. The ACS NLCRT held a collaborative summit and developed a strategic plan to achieve and promote comprehensive biomarker testing for all patients. These plans include developing educational materials and physician tools and advocating for national policies in support of biomarker testing.
ABSTRACT
Comprehensive biomarker testing for patients with non-small cell lung cancer is critical for selecting appropriate targeted therapy or immunotherapy. Ensuring timely ordering, processing, and reporting is key to optimizing patient outcomes. However, various factors can prevent or delay patients from being offered the option of treatment selection based on comprehensive biomarker testing. These factors include problems with access to testing, tissue adequacy, turnaround time, and health insurance coverage and billing practices. Turnaround time depends on several logistical and tissue handling factors, which involve institutional policies, processes, resources, testing methodology, and testing algorithms that vary across different practices. In this article, the authors identify key factors that prolong biomarker testing turnaround time, propose strategies to reduce it, and present a process map to aid physicians and key organizational stakeholders in improving testing efficiency.
ABSTRACT
BACKGROUND: Despite advances in precision medicine for non-small cell lung cancer (NSCLC), biomarker testing for these therapies remain frequently underused, delayed, and inequitable. Pulmonologists often play a critical role in the initial diagnostic steps for patients with lung cancer, and previous data show variability in their knowledge and practices regarding biomarker testing. The purpose of this study is to better understand how pulmonologists view their role in lung cancer care. RESEARCH QUESTION: With the increasing importance of biomarker testing and precision medicine, how do pulmonologists view their role in lung cancer care? STUDY DESIGN: An electronic survey consisting of 31 items focused on attitudes and practices regarding diagnostic steps for NSCLC was randomly distributed to a sample of practicing pulmonologists in the American College of Chest Physicians (CHEST) analytics database. Inferential statistics were performed using χ2 tests and multivariable logistic regression models. RESULTS: A total of 401 pulmonologists responded to the survey. Most (92%) were general pulmonologists, and more than half (62%) indicate they order biomarker testing. Longer practice tenure, higher case volumes, and participation in a multidisciplinary tumor board were associated with ordering biomarkers (P < .05). Pulmonology was identified to have the leading responsibility for the initial diagnostic biopsy by most respondents (83%) and less often for staging (45%), leading discussions about biomarker testing with patients (28%), and for ordering biomarkers (22%). The most common reasons for not ordering biomarkers included the following: oncology was responsible (84%), it was not within their scope of practice (46%), or lack of the necessary knowledge (51%). INTERPRETATION: Pulmonologists vary in their practices for ordering biomarkers, and many defer this responsibility to oncology. Despite the role of bronchoscopy and pulmonology societal guidelines for staging, many defer leadership of this process. Many pulmonologists lack the necessary resources and multidisciplinary infrastructure likely required to efficiently accomplish biomarker testing.
ABSTRACT
The initial management of patients with lung cancer is growing more complex in the context of an expanding number of precision medicine treatments. These challenges are accompanied by opportunities to deliver more efficacious and less toxic treatments to patients. Indications for these treatments are also expanding, and patients with lung cancer across multiple stages now require biomarker testing. Given their role in the initial management of patients being diagnosed with lung cancer, pulmonologists must have fundamental knowledge regarding the importance, indications, and implications of biomarker testing across the spectrum of histology and stage. The purpose of this review is to provide fundamental knowledge regarding biomarker testing, its incorporation into the initial diagnostic and staging evaluation, and guidance for working within a multidisciplinary team to achieve timely and comprehensive biomarker testing to direct the use of precision medicine treatments.
ABSTRACT
BACKGROUND: Targeted therapies for advanced non-small cell lung cancer (NSCLC) with oncogenic drivers have caused a paradigm shift in care. Biomarker testing is needed to assess eligibility for these therapies. Pulmonologists often perform bronchoscopy, providing tissue for both pathologic diagnosis and biomarker analysis. We performed this survey to define the existing knowledge and practices regarding the pulmonologists' role in biomarker testing for advanced NSCLC. RESEARCH QUESTION: What is the current knowledge and practice of pulmonologists regarding biomarker testing and targeted therapies in advanced NSCLC? STUDY DESIGN AND METHODS: This cross-sectional study was performed using an electronic survey of a random sample of 7,238 pulmonologists. Questions focused on diagnostic steps and biomarker analyses for NSCLC. RESULTS: A total of 453 pulmonologists responded. Respondents vary by reported lung cancer patient volume, ranging from 51% evaluating one to four new cases per month to 19% evaluating > 10 cases per month. Interventional training, academic practice setting, and higher volume of endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) were associated with increased knowledge of practice guidelines for the number of recommended passes during EBUS-TBNA (P < .05). Academic pulmonologists more commonly performed or referred for EBUS-TBNA than community pulmonologists (96% and 83%, respectively; P < .0005). Higher testing rates were associated with interventional training, academic setting, and the presence of an institutional policy, whereas lower testing rates were associated with general pulmonologists, practice in community settings, and lack of a guiding institutional policy (P < .05). INTERPRETATION: Substantial differences among pulmonologists' evaluation of advanced NSCLC, variation in knowledge of available biomarkers and the importance of targeted therapies, and differences in institutional coordination likely lead to underutilization of biomarker testing. Interventional training appears to drive improved knowledge and practice for biomarker testing more than practice setting. Improvements are needed in tissue acquisition and interdisciplinary coordination to ensure universal and comprehensive testing for eligible patients.
Subject(s)
Biomarkers, Tumor/analysis , Carcinoma, Non-Small-Cell Lung/diagnosis , Health Knowledge, Attitudes, Practice , Lung Neoplasms/diagnosis , Pulmonologists , Adult , Aged , Aged, 80 and over , Carcinoma, Non-Small-Cell Lung/pathology , Cross-Sectional Studies , Endoscopic Ultrasound-Guided Fine Needle Aspiration , Female , Humans , Lung Neoplasms/pathology , Male , Middle AgedABSTRACT
Pulmonary nodules are increasingly identified on imaging exams performed for a number of clinical presentations and can pose a diagnostic problem for clinicians. Guideline-directed management algorithms are structured on nodule pre-test probability of malignancy. The risk of malignancy can be clinician-assigned or calculated utilizing validated risk prediction calculators. Once pre-test probability of cancer is estimated, nodule management options range from a conservative approach with serial imaging to more invasive measures including biopsy procedures or surgical resection. Here we review pulmonary nodule management with a focus on methods for assigning malignancy risk and highlight novel ways currently under active research to improve nodule risk assessment and management.