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Biomarker testing Substantially Improves Outcomes in Early-Stage Lung Cancer Patients
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A new study reveals how biomarker testing can identify patients who benefit from post-surgery chemotherapy,leading to a 78% reduction in disease recurrence.
CHICAGO – 2025/05/31 21:59:57 By Amelia Smith
A groundbreaking study presented at the American Society of Clinical Oncology (ASCO) demonstrates the power of precision medicine in treating early-stage nonsquamous non-small cell lung cancer (NSCLC). The AIM-HIGH study (NCT01817192) reveals that biomarker testing can pinpoint patients who significantly benefit from chemotherapy after surgery, even when conventional guidelines wouldn’t reccommend it.
The study found that patients who received chemotherapy guided by biomarker testing experienced a remarkable 78% reduction in the likelihood of disease recurrence compared to a similar group that did not receive chemotherapy.
David R. Spigel, MD | Image credit: Sarah Cannon Research Institute
David spigel, MD, chief scientific officer at Sarah Cannon Research Institute, presented the findings, emphasizing the growing importance of precision medicine. The international, multicenter, prospective randomized trial utilized a 14-gene molecular assay to identify high-risk patients with stage IA-IIA NSCLC who were suitable candidates for adjuvant chemotherapy.
According to Dr. Spigel, “Adjuvant therapy, even though used commonly in the treatment of non-small cell lung cancer, is not recommended for stage IA disease, and is frequently enough deferred in stages IB and stage II.”
The molecular testing approach proved highly effective. At 24 months, disease-free survival (DFS) reached 96% (95% CI, 0.92-1.00) in the adjuvant chemotherapy group, compared to 79% (95% CI, 0.70-0.90) in the observation group. Neither group reached median DFS during the study period.
“This is the first prospective, randomized trial to show improvement in DFS with a molecular-risk discriminator in stage IA through stage IIA nonsquamous non-small cell lung cancer,” Dr. Spigel stated. He further noted that using the 14-gene assay to identify patients for adjuvant therapy “may substantially reduce rates of early recurrence and death.”
The Need for Improved Treatment Strategies
Lung cancer remains the leading cause of cancer-related deaths in the United States. The National cancer Institute estimates that approximately 226,650 new cases of lung cancer are diagnosed annually in the US, with about 70,000 cases classified as stage I or stage II NSCLC. Nonsquamous forms of NSCLC, such as adenocarcinoma and large cell carcinoma, account for roughly 70% of these cases.
“This is the first prospective, randomized trial to show improvement in DFS with a molecular-risk discriminator…”
with increased lung cancer screening, more cases are being detected at earlier stages, allowing for surgical intervention. Clinicians consider factors like cancer stage and tumor size to determine the need for pre- or post-operative therapy to prevent recurrence.
Though, the 5-year DFS rate remains at 65%, highlighting the need for better methods to identify patients who would benefit from post-surgery treatment. Molecular testing offers a solution by detecting changes in genes,proteins,and other markers that indicate higher risk.
Dr. Spigel explained that the study utilized RiskReveal, a 14-gene expression profile, to identify stage IA-IIA nonsquamous NSCLC patients who could benefit from adjuvant therapy.The interim analysis included 194 evaluable patients, with 87 randomized to post-surgery therapy and 107 to an observation group. Both groups had 55% of patients with stage IA disease, and demographics and tumor characteristics were well balanced.
After a median follow-up of 19.6 months in the chemotherapy group and 19.0 months in the observation group, the hazard ratio (HR) for disease recurrence or death in the chemotherapy arm was 0.22 (95% CI,0.06-0.76; P = .0087).
Charu Agrawal, MD, MPH | Image credit: Penn medicine
Charu Agrawal, MD, Leslye M. Heisler Professor of Lung Cancer Excellence at Penn medicine, agreed with Dr. Spigel’s view on the necessity of identifying high-risk patients who are not currently receiving adjuvant therapy. Dr.Agrawal stated that there is a need to find patients who aren’t receiving adjuvant therapy, “yet we certainly know that they are high risk.”
“These early interim results from this very promising, prospective randomized study will help us lay the foundation for precision therapy in early-stage non-small cell lung cancer,” she said, adding that clinicians would have help from artificial intelligence solutions to better stratify patients in addition to traditional assays.
“In the future,we may even be able to add personalized vaccines after we identify high-risk disease,” Dr. Agrawal concluded.
