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David Spigel, MD, discusses the potential clinical effect of a 14-gene molecular assay for identifying candidates for adjuvant chemotherapy in NSCLC.
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“Our field is [quickly] moving beyond traditional ways of assessing risk. We still look at tumor size, grade, and histology, but we now have such great molecular tools to better assess risk, [which allows us] to have good conversations with patients and their families.”
David Spigel, MD, chief scientific officer at Sarah Cannon Research Institute, discussed the clinical utility of a 14-gene molecular assay for identifying patients with stage IA to IIA non–small cell lung cancer (NSCLC) who could be candidates for adjuvant chemotherapy.
In the prospective AIM-HIGH study (NCT01817192), data from which were presented during the 2025 ASCO Annual Meeting, investigators evaluated adjuvant chemotherapy vs observation in patients with NSCLC who were identified as being high risk by the assay.
Data from the study revealed that the 24-month disease-free survival (DFS) rate was in the chemotherapy arm (n = 107) was 96% (95% CI, 92%-100%) compared with 79% (95% CI, 70%-90%) in the observation arm (n = 87; HR, 0.22; 95% CI, 0.06-0.76; P = .0087). Additionally, patients with stage IA disease in the chemotherapy (n = 48) and observation (n = 58) groups achieved 24-month DFS rates of 98% (95% CI, 94%-100%) and 78% (95% CI, 65%-93%), respectively. Patients in the chemotherapy arm experienced an 85% reduction in the risk of disease recurrence or death compared with those who underwent observation (HR, 0.15; 95% CI, 0.02-1.16).
Spigel noted that the field of lung cancer is moving past traditional risk-assessment measures like tumor size, aggressiveness, grade, and histology toward molecular measures, including the 14-gene molecular assay. Molecular tools have been widely used in other disease areas, such as breast, prostate, and colorectal cancers, but they have not been previously widely adopted in lung cancer, he added. With the validation of the 14-gene molecular assay, investigators in the field of lung cancer now have a tool that can help them have more complete conversations with patients, he concluded.
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