The Ruesch Center for the Cure of Gastrointestinal Cancers has been hosting topical symposia for the last 4 years. We have focused on: biomarker use in cancer medicine (2010); defining value in cancer care (2011); how to engage more patients in clinical trial enrollment (2012); and then, on December 6 and 7, 2013, “Molecular Profiling in Cancer: Research or Practice”. This topic was selected for the 2013 symposium because of the explosion of molecular profiling assays that are now available to practicing oncologists, and these assays are believed, by most, to be a significant advancement in cancer care innovation.
Molecular profiling is a broad term encompassing genetic or protein testing done on patients’ tumors or other tissues, with the aim of characterizing their individual gene or protein profiles. Following such testing, the ideal scenario is that drug selection or drug dosing can be optimized for individually improved clinical outcomes (otherwise known as personalized medicine).
The purpose of our 2013 symposium was to bring together a multidisciplinary group of cancer care stakeholders and experts to debate the merits of molecular profiling, the different tests that are available, and how molecular profiling impacts patients in their current day-to-day care. In essence, is this technology still research or has it already moved into the realm of current oncologic practice?
In early December 2013, the FDA actually cleared DNA testing (a form of molecular profiling) as part of routine medical care. This decision represents a landmark moment for the world of personalized medicine. Medical insurance companies should now cover the cost of this testing and we like to anticipate that in the not too distant future, molecular profiling will predict the right treatment for the right patient, and patient outcomes will improve. We also foresee changes in our regulatory systems that will support drug approvals for novel gene targets instead of for diseases and lines of therapy. The theory is that targeted therapy leads to less toxicity, is more likely to be efficacious in carefully selected patients (via molecular profiling), and is more likely to cost much less money before being granted approval by the FDA. The rest of the world applies the additional standard of “value” to new drug approvals. It is of utmost importance that US payers recognize the value of molecular testing and targeted therapies, and that hopefully, over time, costs will fall and we will have significantly less trial and error and more cancer treatment success stories.
How far we are from this new world is uncertain but we are certainly in a stage of metamorphosis, waiting for the day that we can blossom into the world of molecular profiling.
John L. Marshall, MD
Otto J. Ruesch Center for the Cure of Gastrointestinal Cancers
Georgetown Lombardi Comprehensive Cancer Center