Advances in biomarker science are reshaping how patients are diagnosed with and manage early-stage lung cancer. These insights can help connect patients with the treatments most likely to benefit them.
By Anthony Sireci, M.D., senior vice president of clinical biomarkers, laboratories and diagnostics at Eli Lilly and Company
Often, when people hear “biomarker testing” in relation to lung cancer, they associate it with advanced-stage disease. However, the treatment paradigm for non-small cell lung cancer (NSCLC) has evolved significantly in recent years and we see more therapies being introduced in the earliest stages of cancer, including in the neoadjuvant setting. Similar to how we think about biomarker testing in the advanced stages, comprehensive genomic profiling (CGP) is proving to be just as critical in early-stage NSCLC.
CGP is a thorough type of biomarker testing that looks for alterations in the DNA and sometimes RNA of a patient’s tumor cells in a single test to better understand the genomic drivers of their cancer. CGP in early-stage NSCLC can help inform targeted treatment options for patients in whom a potentially actionable genomic target is detected, similar to how it is used in later stage cancer, allowing for a better understanding of one’s cancer and an opportunity to receive care that is tailored to an individual’s unique cancer profile earlier in the treatment journey.
Why Testing in Early-Stage Matters
For patients with early-stage NSCLC, surgery is typically the first step in treatment. But as the treatment landscape continues to shift, people with NSCLC are no longer limited to surgery. Increasingly, alternative options are being used before surgery (neoadjuvant) or after surgery (adjuvant), and healthcare professionals can use CGP results to help guide treatment decisions with their patients as more targeted therapies become available in these early settings.
As the number of lung cancer diagnoses increasingly occur at earlier stages, the role of CGP continues to grow. Early genomic testing is important as the genomic drivers of the disease remain consistent from diagnosis throughout the course of their disease, so CGP results are available to inform every therapy decision, including if a patient progresses to metastatic disease. Early stage CGP can also rule out immunotherapy in certain biomarker-positive patients. Delaying testing can result in losing valuable time on ineffective treatments and interventions, and when it comes to cancer care, time is always of the essence.
What Patients Can Expect from CGP
Once someone is diagnosed with lung cancer, the next essential step is a conversation between the patient and their care team about available treatment options, and this conversation should include plans for CGP.
Here’s what someone might expect from CGP testing, at a high-level:
- Often, the tumor sample, or biopsy, that was collected from a patient for diagnosis, can be used for CGP
- The biopsy sample is sent to a specialized lab
- DNA and/or RNA is extracted from the sample
- The genetic material is sequenced to identify potentially actionable mutations or alterations
- A detailed report is generated and shared with the treating physician to help guide treatment decisions
The Impact of CGP on Treatment Options
Targeted therapies have become increasingly available for early-stage lung cancer, thanks to years of research and innovation. However, these treatments are only a viable option if a patient’s biomarkers are identified. For example, certain genomic alterations may qualify a patient for a specific therapy after surgery, or for a pre-surgical treatment that can shrink the tumor and improve surgical outcomes.
Just a decade ago, targeted therapies for early-stage NSCLC were nonexistent. Today, we’re seeing a rapid shift toward earlier diagnosis and intervention, with more therapies being approved or studied for use in early-stage patients. Over the next few years, this trend will likely only accelerate, making CGP at diagnosis a vital first step in ensuring patients have access to the most effective treatment options available at diagnosis.
Encouraging Uptake and Awareness
Patients and care teams both play a role in making early CGP routine practice. To ensure biomarker testing becomes a standard part of lung cancer care, several elements must work together: streamlined workflows that integrate testing into the diagnosis process, education for both patients and healthcare providers, and open communication between the two to keep testing front of mind.
For patients, a cancer diagnosis can be overwhelming. Amid the whirlwind of emotions, it’s important to remain focused on treatment and feeling empowered to ask a healthcare provider about CGP. Once results are available, understanding how they inform treatment plans can help patients take an active role in their care.
For care teams, staying abreast of the latest advancements in biomarker testing and maintaining efficient workflows are essential. Providers play a key role in making CGP a routine part of the diagnostic process, ensuring results are available as early as possible to guide treatment decisions.
CGP isn’t just for advanced NSCLC, it’s for all stages of lung cancer. The earlier it’s done, the more time patients and HCPs have to understand which options could be most effective.
Guest Author Bio:
Anthony “Nino” Sireci, MD is the senior vice president of clinical biomarkers, laboratories and diagnostics at Eli Lilly and Company.
Dr. Sireci is a board-certified Clinical Pathologist and a practicing molecular pathologist. Prior to joining Lilly, he was an Assistant Professor of Pathology and Cell Biology at Columbia University and a medical director in the Laboratory of Personalized Genomic Medicine at Columbia Medical Center.
He is an active member of the Association for Molecular Pathology (AMP) where he serves on the organization’s Strategy Committee and was the former vice chair for new codes and pricing on the Economic Affairs Committee. He is also a member of the Pathology Coding Caucus in the College of American Pathologists (CAP) and the Molecular Pathology Advisory Group in the American Medical Association (AMA).
Dr. Sireci received a bachelor’s degree in chemistry from New York University, a medical degree from the Johns Hopkins University School of Medicine, and a master’s degree in Biostatistics from the Mailman School of Public Health at Columbia University. He completed his residency training in Clinical Pathology in the New York Presbyterian Hospital-Columbia, where he also served as chief resident.
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