Functional profiling using ex-vivo analysis of programmed cell death (EVA/PCD
®) doubles the response rate and improves time-to-progression and survival in patients with advanced
lung cancer, according to a Phase II clinical trial conducted by investigators at Rational Therapeutics (
http://www.rational-t.com) and the MemorialCare Todd
Cancer Institute (Long Beach, CA) and published in the October issue of
Anticancer Research.
"Medical oncologists have long pursued methods that can match patients to available therapies," said Dr. Robert Nagourney, lead investigator. "This study confirms the ability of a laboratory test to accurately predict drug activity for individual patients."
Functional profiling provides a window into the dynamic process by which human tumor cells respond to therapy. By capturing cells within their natural microenvironment, human biology is recreated in the laboratory.
The article, titled "Functional Profiling to Select
Chemotherapy in Untreated, Advanced or Metastatic Non-Small Cell Lung Cancer," describes results achieved in patients who received first-line chemotherapy based on their individual ex-vivo analysis.
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Using only FDA-approved, standard
lung cancer drugs available to all oncologists, this process of laboratory selection provided a 64.5 percent response rate - more than double the national average of 30 percent (p = 0.00015), well established in the literature. More importantly, the median overall survival of 21.3 months was nearly two-fold longer than the best results of 13.5 months reported for non-assay based standard treatments. Strikingly, among the Stage IV (metastatic) patients, there are several who remain alive approaching eight years since diagnosis.
"These results suggest that laboratory selection of
chemotherapy can change the natural history of this lethal disease," said Dr. Nagourney. "What makes the EVA/PCD approach unique is its capacity to capture human tissues in their native state, recreating conditions found in the human body."
Attempts to use
gene profiling in this disease resulted in failure and controversy ("How Bright Promise In
Cancer Testing Fell Apart." - Gina Kolata, New York Times, July 7, 2011). Contrary to gene-based methods, functional platforms capture the systems biology of human tumors in real-time providing therapeutic insights that translate directly into improved clinical outcomes.
Source: Rational Therapeutics