The Ongoing Journey: Improving Molecular Biomarker Testing in NSCLC

The treatment of non-small cell lung cancer (NSCLC) has rapidly evolved over the last several years as new molecularly targeted therapies have been approved by the U.S. Food and Drug Administration (FDA).  Among these therapies are novel drugs that target EGFR, ALK, and ROS1 mutations in patients with NSCLC. Anticipating that advances in lung cancer care will be driven by molecularly-targeted therapies, in 2014, eight ACCC member programs participated in Learning Labs for Process Improvement, an ACCC initiative focused on improving molecular biomarker testing in patients with NSCLC.

Participating programs’ improvement plans were based on the 2013 College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) “Molecular Testing Guideline for Selection of Lung Cancer Patients for Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitors.” These guidelines addressed key questions including:

• When should molecular testing NSCLC be performed?
• How should EGFR and ALK testing be performed?
• Should other genes be routinely tested in lung adenocarcinoma?
• How should molecular testing of lung adenocarcinomas be implemented and operationalized?

These cancer programs have been on an ongoing journey to improve their molecular biomarker testing processes and to ensure that patients are receiving the most precise care based on actionable test results.

Earlier this year, ACCC had an opportunity to follow up with three of the cancer programs that participated in the 2014 Learning Labs process improvement program. Each program reviewed their current molecular testing processes for patients with advanced NSCLC. They also reviewed their biomarker testing rates from 2016 and found that they had sustained their process improvements by embracing a culture of continuous improvement that is led by clinical champions, administrative support, and refined processes. Their clinical goals have focused on ensuring that a consistent and timely process for biomarker testing and interpretation will guide the use of targeted therapies for appropriate patients. Their programmatic goals have focused on improving the quality and quantity of lung biopsy tissue samples sent for testing, standardizing their biomarker testing process for NSCLC, and tracking biomarker testing as a quality measure. Read the case studies from the following programs:

• Goshen Center for Cancer Care
• Sarah Cannon Cancer Institute at Johnston-Willis Hospital
• Southside Regional Medical Center

As cancer programs continue their journey to improve how they provide precision medicine for patients with advanced NSCLC, pathologists are becoming more involved to ensure that the right tests are being ordered for appropriate patients. Radiologists, pulmonologists, and surgeons are collaborating and sharing best practices for obtaining better biopsy samples for molecular testing. Medical oncologists are leading complex discussions around the role of expanded molecular testing as newer targeted therapies emerge on the horizon. Cancer teams are also actively discussing the role of broader next-generation sequencing (NGS) and liquid biopsy (circulating tumor DNA tests) as they manage patients with NSCLC. New targeted therapies are constantly emerging and clinicians must also be aware of when to look for treatment resistance and switch therapies to maximize clinical efficacy.

ACCC encourages member programs to utilize the resources that have been developed that can help them integrate, optimize, and track biomarker testing processes for patients with NSCLC. ACCC, LUNGevity, CHEST, and CAP have partnered on a NSCLC process improvement toolkit for molecular testing. Access the toolkit on the ACCC eLearning Portal.

Stay tuned for more actionable strategies for process and quality improvement from the upcoming ACCC 34 National Oncology Conference, Oct. 18-20, in Nashville, TN.