Experts publish revised guidelines for lung cancer testing

The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) today announced the open comment period for the revised 2018 evidence-based guideline, “Updated Guideline for Molecular Testing for Selection of Lung Cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors.”

Due to rapid advances in adjuvant and neoadjuvant therapy for patients with early-stage non-small cell lung cancer, this revision is essential to ensure optimal patient care. This revised guideline provides a clear framework based on evidence from recently published clinical literature.”

Sinchita Roy-Chowdhuri, MD, PhD, FCAP, guideline update co-chair and professor of pathology, The University of Texas MD Anderson Cancer Center

The open comment period begins today and ends September 12, 2024. The online format provides an opportunity for public review of new draft recommendations on several important topics, as well as recommendation statements that have been reaffirmed online since the joint publication of the first guideline in 2013 and the update in 2018. Archives of Pathology and Laboratory Medicine, The Journal of Thoracic Oncology, And The Journal of Molecular Diagnostics.

The revised guidelines are intended to provide pathologists, oncologists, patient advocacy groups, and cancer and molecular diagnostic laboratory professionals with state-of-the-art recommendations for the molecular testing of lung cancer. The revised guidelines are all based on evidence from an unbiased review of the published experimental literature since 2018 and include recommendations from an expert panel of renowned world-leading experts in the field. The final recommendations will be approved and published jointly after consideration of public comments, further panel discussions, and a full evidence analysis.

“The revised guideline addresses next-generation sequencing and expanded biomarker testing for patients with nonsquamous non-small cell lung cancer enrolled in other clinical trials,” said Sanja Dacic, MD, PhD, FCAP, professor of pathology at Yale School of Medicine, co-chair of the guideline. “We strongly encourage our colleagues to provide feedback to ensure that our draft recommendations are sound, practical, actionable, and support best clinical practices and optimal patient care.”

“The final manuscript serves as both an update and an extension of the 2013 and 2018 practice guidelines that established evidence-based best practices for molecular biomarker testing in patients diagnosed with lung adenocarcinoma,” said Neal I. Lindeman, MD, co-chair of the guideline update and Distinguished Professor of Pathology and Laboratory Medicine II at Weill Cornell Medicine. “We will continue to update this guideline as needed and add guidance for other biomarkers associated with lung cancer as medical knowledge and clinical practice evolve.”

Together with an interdisciplinary panel of experts, co-chairs Dr. Roy-Chowdhuri, Dr. Dacic and Dr. Lindeman formulated new draft recommendations that address the following key questions:

• Do biomarker testing improve treatment response and survival rates in patients with NSCLC being considered for molecularly targeted therapy?
• In patients with NSCLC being considered for molecular targeted therapy, what histopathological and clinical features should be used to select patients for molecular testing?
• Do biomarker testing improve treatment response rates, survival rates, or diagnostic accuracy in patients diagnosed with lung cancer without adenocarcinoma component or NSCLC NOS who are being considered for molecularly targeted therapy?
• What diagnostic test characteristics do the available tests for examining lung biomarkers have?
• Should biomarker testing be used to guide the next line of therapy in patients with NSCLC whose disease has progressed during treatment with molecularly targeted therapies?
• Which tests to detect resistance mutations are preferable in patients with NSCLC whose disease has progressed during treatment with molecularly targeted therapies?

• Should molecular testing be used to monitor progression in patients with NSCLC treated with molecularly targeted therapies?

As part of the guideline update, CAP, IASLC and AMP will develop clinical tools and resources for pathologists and oncologists that summarize the findings and recommendations. The organizations intend to develop a patient guide to aid understanding, including questions patients can ask their physicians.