Life Technologies Corporation announced publication in the Journal of the American Medical Association1 (JAMA) of a study that underscores the clinical utility of the company's early stage lung cancer test, Pervenio™ Lung RS. Launched in September 2012, the genetic test has now been demonstrated to reliably identify patients who are at high risk for mortality following surgery even for the earliest stage of lung cancer.
The test was initially validated through two independent, blinded retrospective studies involving approximately 1,500 patients, which were published in the March 2012 issue of The Lancet.2 The new study reports data from a subset of patients included in the larger validation studies. Specifically, it looks at those patients with "T1a, node-negative" tumors, cancers that are smaller than two centimeters in diameter and that have no detectable spread of the disease.
"We know that roughly a quarter of patients with T1a, node negative tumors will die within five years, most often with recurrent lung cancer," said Michael Mann, M.D., senior author of the study. "And yet these patients do not receive any chemotherapy following surgery because there are no guidelines for identifying which T1a patients are at high risk for mortality."
Dr. Mann is associate professor of cardiothoracic surgery at the University of California, San Francisco and was involved in the development of the PervenioTM Lung RS test along with co-author David Jablons, M.D., chief of general thoracic surgery at the University of California, San Francisco.
"By the time the disease recurrence can be detected, it is too late for therapies to be curative," said Dr. Jablons. "We know from previous clinical trials that chemotherapy can cure metastatic lung cancer when it is treated even before it can be detected. Therefore, we need to identify the high-risk patients earlier, immediately after surgery if possible. Current published guidelines already recommend consideration of chemotherapy at that time even for stage I patients who are believed to be at the highest risk."
Pervenio™ Lung RS is a genetic test that examines activity of 14 genes in tumor tissue. The current JAMA study demonstrates that the test accurately predicted mortality risk among 269 T1a, node-negative patients. The test categorized 92 patients as high risk; survival among these patients was just over 50 percent. In contrast, survival among patients classified by the test as low risk was nearly 85 percent. Further, when patients with tumors smaller than one centimeter were examined, 100 percent of the low-risk patients survived, as compared to just over 30 percent of the patients determined to be at high risk by the test.
"Physicians don't need to send these early stage patients home for 'watchful waiting' anymore, knowing that a good percentage of them will see their cancer recur and many of those will die," said Ronnie Andrews, president of Medical Sciences at Life Technologies. "We haven't seen survival rates for early stage lung cancer improve significantly during the past 30 years, but now we have a tool that can help enable more patients to receive a treatment that may increase their survival closer to what we see in diseases in which we have made progress, such as breast and colon cancer."
Five-year survival rates for stage I lung cancer are approximately 60 percent. By comparison, patients with stage I colon or breast cancer can expect surgical cure rates of greater than 90 percent. In addition, genetic testing of tumors may play a role in extending early screening efforts.
"Currently, the issue of screening for lung cancer is somewhat controversial," said Dr. Mann. "One challenge of screening is how to maximize the chances of survival for a dramatically increased number of patients who would be diagnosed at the very earliest stages. Right now, a quarter or more of those patients would still die, despite early detection. The Pervenio™ test could add a layer of sophistication and personalization to the care of that growing population that could improve survival rates even further."
"There is also a movement toward limiting the loss of healthy lung tissue to lung cancer operations," Dr. Jablons added, "but there is concern that important prognostic information currently used in conventional staging might be lost with less radical surgery. Pervenio™ has been shown to provide even more accurate information about prognosis and would therefore enable equal or even better clinical management decisions with lung-sparing operations."
Pervenio™ Lung RS is available through the Life Technologies' Clinical Services Lab, which is licensed in all 50 U.S. states. Life Technologies also plans to make Pervenio™ Lung RS available outside of the United States, so the test can be broadly deployed on Life Technologies' regulated platforms, including the 7500 Fast Dx for qPCR.
The study, titled "Ability of a Prognostic Assay to Identify Patients at High Risk of Mortality Despite Small, Node-Negative Lung Tumors," was supported by private endowments to the UCSF Thoracic Oncology Laboratory and by Pinpoint Genomics, which Life Technologies acquired in July 2012.