Experts plan to update and extend the 2013 and 2018 practice guidelines that established evidence-based best practices for molecular biomarker testing for patients diagnosed with lung adenocarcinoma, according to the three organizations sponsoring the project.
The College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) will take comments from key stakeholders until September 12, 2024. The feedback will be considered toward updating the 2018 evidence-based guideline, “Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors."
Included in the draft published for review August 14 are recommendations around EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS, and ERBB2 (HER2) biomarker testing, as well as cell-free DNA biomarker testing.
“Rapid advancements in adjuvant and neoadjuvant therapy for patients with early-stage non-small cell lung carcinoma make this revision essential to guide optimal patient care,” said guideline update co-chair Dr. Sinchita Roy-Chowdhuri in an AMP statement. Roy-Chowdhuri is a professor of pathology at University of Texas MD Anderson Cancer Center.
Dr. Sanja Dacic, vice chair and director of anatomic pathology at Yale School of Medicine, and Dr. Neal Lindeman, vice chair of laboratory medicine and molecular pathology at Weill Cornell Medicine/New York Presbyterian Hospital, also lead the project with input from a multidisciplinary panel drawn from at least 15 other institutions.
“The revised guideline addresses next-generation sequencing and expanded biomarker testing for patients with non-squamous non-small cell lung carcinoma participating in other clinical trials,” Dacic said. “We strongly encourage our peers to provide feedback to ensure our draft recommendations are sound, practical, and implementable, supporting best clinical practices and optimal patient care.”
Lindeman added that the guideline will be updated as appropriate, and guidelines for other biomarkers associated with lung cancer will be added as medical knowledge and clinical practice continue to advance.
In formulating the new draft recommendations, the authors addressed seven key questions, according to the CAP.
- In patients with non-small cell lung cancer (NSCLC) being considered for molecularly targeted therapies, does biomarker testing improve treatment response rates and survival rates?
- In patients with NSCLC being considered for molecularly targeted therapies, what histopathologic and clinical characteristics should be used to select patients for molecular testing?
- In patients diagnosed with lung cancer without an adenocarcinoma component or NSCLC NOS and being considered for molecularly targeted therapies, does biomarker testing improve treatment response rates, survival rates, or diagnostic accuracy?
- When conducting lung biomarkers testing, what are the diagnostic test characteristics of the available assays?
- In patients with NSCLC who have progressed while undergoing treatment with molecularly targeted therapies, should biomarker testing be utilized to guide the next line of therapy?
- In patients with NSCLC who have progressed while undergoing treatment with molecularly targeted therapies, what are the preferred resistance mutation detection assays?
- In patients with NSCLC undergoing treatment with molecularly targeted therapies, should molecular testing be used to monitor for progression?
The authors also used clinical literature published since the 2018 guideline was finalized.
Individuals and organizations can review the draft lung cancer molecular testing guideline and participate in the comment process via AMP's website here. Final recommendations will be approved and jointly published after consideration of the public comments, further panel discussion, and a complete evidence analysis. Details from the draft should not be distributed, used, or considered as an accurate representation of the CAP/IASLC/AMP Lung Guideline Expert Panel work product(s) after September 12, 2024, organizers noted.
More information is available via the CAP, here.
Review the 2018 guideline here.
