Test Predicts Lung-Cancer Recurrence Risk

A genomic test predicts which patients with early-stage lung cancer will need chemotherapy and which patients can avoid the toxic regimen of drugs.

The new test, called the Lung Metagene Predictor, scans thousands of genes to identify patterns of gene activity in individual tumors that indicate which patients are likely to suffer a recurrence of disease. Recurrent tumors are typically fatal, so identifying at-risk patients is critical to properly treating them.

The test was developed by scientists at Duke University Medical Center (Durham, NC, USA), who analyzed the activity of genes from early-stage lung cancer patients whose disease outcomes were known. The Duke scientists validated the genomic test in 129 patients by comparing the test's predictions with the patients' actual outcomes. The test predicted the risk of recurrence with 90% accuracy. The findings were published in the August 2006 issue of the New England Journal of Medicine.

A sample of the tumor is taken for the test as it is removed during surgery. Messenger RNA is extracted and labeled with fluorescent tags and placed on a gene chip where it binds to its complementary DNA sequence. When scanned with special light, the fluorescent RNA emits a luminescence that demonstrates how much RNA is bound to the chip--and therefore which genes are most active in a given tumor. The relative risk of large grouping of genes, or metagenes, is assessed.

The test has the potential to save thousands of lives each year according to the test's developers. Patients with lung cancer can be recommended for chemotherapy who are currently advised against it. A multi-center clinical trial will be led by Duke investigators next year. Patients with early-stage non-small cell lung cancer, the most common and fatal form of cancer, will receive the genomic test, and its results will determine their treatment.

"This new genomic test is a clear example of personalized medicine, where we use the unique molecular characteristics of each patient's tumor to guide treatment decisions,” said Geoffrey Ginsburg, M.D., Ph.D., a professor of medicine and co-author of the study.



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