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A new molecular test can predict which patients with early-stage nonsquamous non-small cell lung cancer (NSCLC) are at high risk for death after surgical resection more accurately than conventional methods. This knowledge could help at-risk patients receive additional therapy immediately after surgery, before any residual cancer has the opportunity to metastasize.

The frequent recurrence of early-stage NSCLC is attributed to undetected metastatic disease, according to a team of investigators co-led by David M. Jablons, MD, head of the thoracic oncology program at the Helen Diller Family Comprehensive Cancer Center at University of California-San Francisco (UCSF). As the researchers explained in The Lancet, treatment is based on prognostic staging of the cancer. Jablons and colleagues sought to develop and validate a practical, reliable assay that improves risk stratification compared with conventional staging. 

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Working with a cohort of 361 patients with nonsquamous NSCLC at UCSF, the investigators developed an assay that measures the activity of 14 genes in the cancerous tissue. The assay, which uses quantitative polymerase chain reaction (PCR), was then independently validated in 433 patients with stage 1 nonsquamous NSCLC at the Kaiser Permanente hospitals in California and in 1,006 patients with stage 1-3 nonsquamous NSCLC at several cancer centers in China. 

Five-year overall survival was predicted to be 71.4% in low-risk, 58.3% in intermediate-risk, and 49.2% in high-risk patients in the northern California group. Corresponding 5-year survival rates for the Chinese patients were 74.1%, 57.4%, and 44.6%. The assay improved prognostic accuracy beyond National Comprehensive Cancer Network (NCCN) criteria for stage 1 high-risk tumors and differentiated low-risk, intermediate-risk, and high-risk patients within all disease stages.

These and related findings underscore the need for a practical assay that reliably identifies subsets of patients who have different statistical outcomes despite similar staging by conventional criteria—a need answered by this new molecular test.

The investigators are now planning a prospective study in which patients with stage 1 disease who have been identified as high risk by the 14-gene assay will be randomized to observation vs chemotherapy. ONA