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Jump to Key Points The 14-gene RiskReveal assay (RazorGenomics) may predict whether patients will benefit from chemotherapy after resection of early-stage non-small cell lung cancer (NSCLC).
Among 194 patients with stage IA-IIA NSCLC deemed high risk for recurrence by the assay, 2-year disease-free survival was 96% vs 79% in patients randomly assigned to adjuvant chemotherapy vs observation alone in the AIM-HIGH trial.
In a separate cohort of 101 patients deemed high risk by the test, 5-year overall survival was 97% vs 80% in patients who received chemotherapy after surgery vs those who did not receive chemotherapy.
Anne-Marie Dingemans, MD, PhD, thoracic oncologist at Erasmus MC in Rotterdam, Netherlands, said the new research “showed very impressive outcome data and very impressive overall survival data, so probably this can be implemented in guidelines.”
- 14-gene RiskReveal assay stratifies resected early-stage NSCLC recurrence risk.
- High-risk stage IA-IIA patients had 2-year DFS 96% vs 79% with adjuvant chemo vs observation.
- In separate cohort, 5-year OS 97% vs 80% with postop platinum doublets vs no chemo.
- Benefit appeared independent of age, sex, and tumor size; margins were negative.
- Adjuvant regimens included platinum-based chemo ± immunotherapy or TKI.
Johannes Kratz, MD, thoracic surgeon at the University of California, San Francisco, presented the findings of the two studies at the World Congress on Lung Cancer (WCLC) 2026 in Seoul, South Korea. Kratz is part of the group that developed the new assay. RiskReveal uses polymerase chain reaction to categorize patients as low, intermediate, or high risk for recurrence based on the expression of 11 cancer genes and three reference genes in resected tumor tissue.
Currently, most patients with early-stage NSCLC don’t get additional treatment after surgery, but cancer comes back in up to half. The problem has led to a search for ways to identify patients who will benefit from adjuvant treatment, but tumor size and other standard markers haven’t worked out in clinical trials. Because of that, guidelines leave it up to clinicians to decide whether patients need treatment after surgery, but given the high recurrence rates, something better is needed, Kratz explained.
The multicenter AIM-HIGH trial randomly assigned 236 patients identified as high risk by the assay to either adjuvant treatment or observation after resection. At the time of the interim analysis, there were 87 vs 107 patients in the adjuvant group vs the observation arm.
Adjuvant treatment included four cycles of platinum-based chemotherapy plus or minus immunotherapy or TKI at the investigator’s discretion.
In this study, those randomly assigned to adjuvant chemotherapy had a 78% reduction in the risk for recurrence or death vs the control individuals. Resections had negative margins, and the 2-year disease-free survival benefit with the test was independent of age, sex, and tumor size.
Kratz and his team turned to the 101-person cohort — which they have followed since 2012 — for overall survival data because AIM-HIGH hasn’t been going on long enough to assess that outcome. In this cohort of resected patients with stage IA-IIA NSCLC, 33 vs 68 patients opted for platinum doublets vs observation. The overall survival benefit seen in this study represented an 87% decrease in the risk for death and was also independent of age, sex, or tumor size.
Dingemans, who was not involved in the new research, noted that in early-stage breast cancer, gene expression assays are already used “to guide whether you give adjuvant treatment or not.” She added that with many similar tests in development, including artificial intelligence, it’s unclear how many of them are needed.
The funding source wasn’t disclosed. Kratz reported being a consultant and patent holder on RiskReveal. Dingemans didn’t report disclosures.
M. Alexander Otto is a physician assistant and award-winning journalist. He is also an MIT science journalism fellow. Email: aotto@medscape.net
