VERY IMPORTANT
Below is a brief summary of basic facts. It quickly covers the questions most commonly asked by physicians. For more information, please phone us at (714) 596-2100.
What is the purpose of Functional Tumor Cell Profiling?
To identify the most appropriate chemotherapy
agents for cancer patients on an individual basis.
Why is it called "Functional Tumor Cell Profiling?"
It is true profiling of the tumor cell because it assess the fullest possible range of processes occurring within the cell. It is functional because it measures the net effect of these processes as they occur and, importantly, as they interact in real time in a living cancer cell that is exposed to specific chemotherapy drugs. Compare this with the static profiling method represented by molecular studies which look only for expression of a limited number of genes which, if functional, are believed to be associated with susceptibility to drugs in a broad class. Note also the important distinction that in static molecular profiling studies, dead, fixed cells are used and the cells themselves are never exposed to drugs.
All of the terms above apply to tests that identify drugs having greater or lesser than expected probabilities of helping the cancer patient. However, the different terms are useful in conveying that different technologies and approaches are used by different laboratories. Some assay methodologies clearly are better than others with regard to their ability to accurately identify active drugs versus inactive drugs.
What is the difference
between an "in vitro" assay" and an "ex vivo" assay?
In this context, there is no difference. Some laboratories use "ex vivo" instead of "in vitro" to differentiate their work from others that use similar, or, in some cases, the same technology.
Is it harmful to the patient to stray
from established treatment selection methods?
There are extremely few situations in cancer where one form
of chemotherapy has been identified for all patients. In nearly all
settings, more than one - and often several - different forms of
chemotherapy have demonstrated similar benefit and would be considered
equally acceptable. Functional Tumor Cell Profiling can discriminate
clear differences in drug activity among otherwise acceptable regimens.
Have there been controlled clinical trials of Functional Tumor Cell Profiling?
There have been four prospective, controlled, but non-randomized clinical trials which have been published. In addition, there has been one prospective, controlled, randomized trial presented at a cancer meeting, but not yet published. Finally, there is a large, prospective randomized trial in progress in chronic lymphocytic leukemia, which has not yet been reported even as a meeting abstract, but which has reached its patient accrual goals, so that results should be available at some point in the future. In addition, nearly 50 studies of Functional Tumor Cell Profiling tests, collectively involving over 3,000 patients, have been published in peer reviewed journals. For relevant perspective on the topic of clinical trials for laboratory tests, please click on this link.
There has never been a single published study in which the tests failed to show statistically significant positive correlation between in vitro drug activity and patient response. In every one of nearly 50 studies, response rates were higher among patients treated with in vitro "active" drugs than among patients treated with in vitro "inactive" drugs. In every study, response rates were higher among patients treated with in vitro "active drugs than among the median response rate of all patients in the study. Finally, in every study in which survival data were available, patients who received in vitro "active" drugs lived longer than patients who received in vitro "inactive" drugs and also longer than the median survival rate of all patients in the trials. Please click here for a review article detailing study designs and outcomes, including response rates, survival curves and literature citations.
