Lung cancer odds better with gene test
ONCOLOGY In early stages, doctors can detect which patients are at highest risk of recurring disease after surgery
Published 4:49 pm, Tuesday, November 13, 2012
When Stephen Heinrichs nearly choked to death four years ago, it probably saved his life.
In follow-up tests and scans to see that no particle of the food he choked on had entered his lungs, doctors discovered what they first thought was a scar or other anomaly. It turned out that Heinrichs, who has never smoked, had very early-stage lung cancer.
Through that chance encounter, Heinrichs, a Hillsborough resident, became one of the first patients to benefit from a new molecular test developed by UCSF researchers that can predict whether a tumor - even at the earliest stage - is likely to turn deadly, requiring chemotherapy or other treatment after surgery to remove it.
The 14-gene test, which in September became available through a Southern California company under the brand-name Pervenio, has been validated through a number of studies, including one published late last month in the Journal of the American Medical Association.
"What they seem to be able to do with this test is make a high-risk versus low-risk determination. In my case it was a low risk of recurrence based upon the test," said Heinrichs, 65, whose tumor was tested after he underwent surgery to remove it along with about a third of his upper lobe. Regular monitoring has shown that he has remained cancer-free.
Lung cancer, the most common cause of cancer death in the United States as well as worldwide, is particularly deadly because fewer than a third of cases are caught in the early stages. And there are no guarantees that those early-stage patients will survive.
At least one quarter of patients who undergo seemingly successful surgery - complete removal of the tumor with no evidence of metastases - harbor tiny traces of cancer cells that have already spread outside their lungs.
"Even with early detection, the patients with the absolute earliest tumors have a 25 percent death rate," said Dr. Michael Mann, a thoracic surgeon at UCSF Medical Center and co-developer of the test. "It's such a poor prognosis, even with the best we can throw at it."
The 14-gene test gives doctors a way of telling which lung cancers are at high risk of recurring and whether certain patients in the early stages of disease would benefit from chemotherapy after surgery. By analyzing the biological makeup of the tumor, the test has been shown to reliably predict which patients are at high risk of harboring undetected disease.
Its effectiveness was validated in the largest clinical trials ever conducted on the molecular genetics of lung cancer - nearly 1,500 patients from Northern California Kaiser hospitals as well as from China. The results were published earlier this year in the medical journal the Lancet.
A new study published Oct. 23 in the Journal of the American Medical Association focused on a smaller subset of those same patients - those with the earliest stage of the disease, known as "T1a." This is the earliest stage of non-squamous, non-small-cell lung cancer, in which the tumor is less than 2 centimeters and has no lymph node involvement.
The study showed that the test can successfully identify patients even in this group.
These patients have a 50 percent chance of death, but UCSF's Mann, an author of the study, said early chemotherapy has shown promise toward improving their chances.
"It's a principle now emerging that cancer is more likely to be cured by chemotherapy if you're treating very tiny deposits of the disease," he said.
Based on developments out of UCSF, Pervenio, the 14-gene test, was created by Pinpoint Genomics in Mountain View, a company that was acquired this summer by Life Technologies Corp. in Carlsbad (San Diego County).
Life Technologies can offer Pervenio - even though it has not yet been approved by the U.S. Food and Drug Administration - on a proprietary basis through the company's federally certified laboratory. The test costs $3,995, and company officials said insurers have generally not had time to determine whether to cover it.
"It is Life Lab's intent, however, to work with patients, payers and physicians to make sure that this important tool is available to any patient for whom their physician believes it to be medically necessary," said Ronnie Andrews, president of medical sciences at Life Technologies.
Bonnie Addario, a lung cancer survivor and founder of the Bonnie Addario Lung Cancer Foundation in San Carlos, said the test will improve the survival rate of tens of thousands of patients in this country with early-stage but high-risk disease.
"Basically what this assay says is surgery is not enough," she said. "They need to throw everything at them."
For Heinrichs, a retired accountant, the test showed that he was at low enough risk to avoid chemotherapy or radiation with confidence.
"What the hope here is (is that) more physicians and more hospitals will adopt this kind of next step in testing procedures so they can then really focus on the people who need the chemotherapy the most," he said.