Molecular Assay Accurately Identifies Patients With Non-Small Cell Lung Cancer Who Could Benefit From Adjuvant Chemotherapy
Results from an international clinical trial show that a 14-gene molecular assay, RiskReveal, can accurately identify patients with high-risk, early-stage non-squamous non-small cell lung cancer (NSCLC) who derived benefit from adjuvant chemotherapy.
These data were first presented by David Spigel, MD, Sarah Cannon Research Institute, Nashville, Tennessee, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
In this multicenter study, researchers identified 421 patients with low-, intermediate-, or high-risk stage Ia-IIa NSCLC who underwent surgical resection. Patients with intermediate- or high-risk disease (n = 194) were randomized to undergo either 4 cycles of platinum-based adjuvant chemotherapy (n = 87) or observation (n = 107). The primary end point was disease-free survival (DFS).
At analysis, median DFS was not achieved in either treatment arm. The 24-month DFS rate was 96% in the adjuvant chemotherapy arm and 79% in the observation arm (hazard ratio [HR] 0.22; 95% confidence interval [CI], 0.06 to 0.76; P = .0087).
“Identification of patients who benefit from adjuvant chemotherapy using this predictive test could result in a dramatic improvement in survival for the growing percentage of patients diagnosed in stages I-IIa,” concluded Dr Spigel et al. “Although the study DSMB recommended a halt to enrollment, follow up continues and may provide further confirmation of this benefit.”
Source:
Spigel D, Westeel V, Anderson I, et al. An international, multicenter, prospective randomized trial of adjuvant chemotherapy for stage Ia-IIa non-small cell lung cancer identified as high-risk by a 14-gene molecular assay. Presented at 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract LBA8027
