But toxic chemotherapy drugs are prescribed only to patients with relatively large and aggressive tumors.
Early-stage patients – those with small, stationary tumors – are considered at low risk of recurrence. Hence, they only receive surgery but not chemotherapy. The dilemma, said Potti, is that a third or more of early-stage patients who appear to be at low risk will experience a recurrent tumor.
"Until now, there simply has been no way to identify the 30 percent to 40 percent of early-stage lung cancer patients who would experience a recurrence," Potti said. "Now, with our test, we can say with confidence that we can identify this group of patients so they can be treated accordingly."
The upcoming trial is the first to use a genomic test to select treatment options for individual lung cancer patients, said David Harpole, M.D., a professor of thoracic surgery at Duke and principal investigator of the upcoming clinical trial. The trial, to begin within six months, will enroll more than 1,000 patients at multiple centers in the United States and Canada.
"If we can use the test to increase patient survival by even 5 percent, we would save 10,000 lives a year," Harpole said.
The Duke researchers developed the test by analyzing the activity of genes from early-stage lung cancer patients whose disease outcomes were known. The Duke scientists then validated the genomic test in 129 patients by comparing the test's predictions with the patient's actual outcomes. The test predicted their risk of recurrence with 90 percent accuracy, the study showed.
If proven to be effective in the clinical trial, the test will replace the current method of assessing risk, which is imprecise and provides only a broad estimate of a patient's risk, said Joseph Nevins, Ph.D., a professor of molecular genetics at Duke and senior author of the study being reported.
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