Summary: Several diagnostic associations announced the open comment period for the revised 2018 guideline on molecular testing for lung cancer, emphasizing the importance of updated recommendations for optimal patient care.
Takeaways:
- Guideline Revision Focus: The updated guideline addresses advancements in adjuvant and neoadjuvant therapies for non-small cell lung carcinoma (NSCLC), ensuring recommendations align with the latest clinical research.
- Public Input Opportunity: The open comment period, ending on Sept. 12, 2024, allows stakeholders to review and provide feedback on new and reaffirmed recommendations, crucial for refining the final guidelines.
- Comprehensive Evidence Review: The revised recommendations are based on an unbiased review of recent experimental literature, with input from a global panel of experts, to guide molecular testing practices for NSCLC patients.
The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced the open comment period for the revised 2018 evidence-based guideline, “Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors.”
“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,” says guideline update co-chair Sinchita Roy-Chowdhuri, MD, PhD, FCAP, Professor of Pathology at The University of Texas MD Anderson Cancer Center. “This revised guideline provides a clear framework based on evidence from recently published clinical literature.”
Open Comment for Lung Cancer Molecular Testing Guideline
The open comment period is now open and will close on Sept. 12, 2024. The online format provides an opportunity for public review of new draft recommendations for several key topics, as well as recommendation statements that have been reaffirmed since the initial guideline was jointly published in 2013 and updated in 2018 online by Archives of Pathology & Laboratory Medicine, The Journal of Thoracic Oncology, and The Journal of Molecular Diagnostics. For more information and to provide comments, visit https://www.amp.org/opencomment/.
State-of-the-art Molecular Testing Recommendations for Lung Cancer
The guideline revisions are designed to provide state-of-the-art molecular testing of lung cancer recommendations for pathologists, oncologists, patient advocacy groups, and cancer and molecular diagnostic laboratory professionals. The revisions are all based on evidence from an unbiased review of published experimental literature since 2018 and include the recommendations from an expert panel of renowned worldwide leaders in the field. The final recommendations will be approved and jointly published after consideration of the public comments, further panel discussion, and a complete evidence analysis.
“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,” says guideline update co-chair Sanja Dacic, MD, PhD, FCAP, Professor of Pathology at Yale School of Medicine. “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.”
“The final manuscript will serve as both an update and extension of the 2013 and 2018 practice guidelines that established evidence-based best practices for molecular biomarker testing for patients diagnosed with lung adenocarcinoma,” says Neal I. Lindeman, MD, guideline update co-chair, the Faculty Distinguished Professor of Pathology and Laboratory Medicine II at Weill Cornell Medicine. “We will continue to update this guideline as appropriate, and we will add guidelines for other biomarkers associated with lung cancer as medical knowledge and clinical practice continue to advance.”
Further reading: AMP Files Lawsuit Against FDA to Challenge LDT Final Rule
Key Questions to Help Guide Testing Recommendations
Together with a multi-disciplinary expert panel, co-chairs Roy-Chowdhuri, Dacic, and Lindeman formulated new draft recommendations addressing the following key questions:
- In patients with 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?
In conjunction with updating the guideline, CAP, IASLC, and AMP will develop clinical tools and resources for pathologists and oncologists that summarize the findings and recommendations. The organizations expect to develop a patient guide for further understanding, including questions for patients to ask their physicians.
