Dr. Nagourney's Blog

Harvard Investigators Endorse Functional Profiling

By Robert A. Nagourney, MD

In the December 2015 issue of Nature Reviews: Cancer, investigators from Harvard University published an editorial in support of functional profiling that uses a patient’s living tumor cells exposed to potential therapies to match each patient to the right drug.

The article references our published studies to support arguments in favor of their “next generation” of functional technologies. 

The editorial entitled “Precision medicine for cancer with next-generation functional diagnostics” starts with an overview of the field that reads as if it was from one of my prior papers.

It defines the importance of functional analyses, the failure of genotypic studies to provide clarity, as well as the importance of dynamic (cellular) over static (genomic) platforms. To quote Yogi Berra, “It’s déjà vu all over again”. 

The authors do a nice job of reviewing the data and examining the techniques that are both in use and in development. They then go on to suggest that “older technologies” can now be replaced with “next-generation” techniques. As one examines the data, however, this premise seems less and less supported.

Their predictive validities from their small pilot clinical studies, using a statistical tool of accuracy known as the receiver-operator-curve (ROC) of 0.7, doesn’t approach our own ROC of 0.89 from over 2500 peer reviewed published patient outcomes which we reported in 2013.  

As we consider their focus on increasingly complicated tumor manipulations like “conditional reprogramming” and “target engagement” or “BH3 loading", I am reminded of William of Occam (of Occam’s Razor fame) who said “if you have two likely solutions for a problem, choose the simplest” and that “entities should not be multiplied unnecessarily”. The modern distillation of this being “Keep It Simple, Stupid (KISS principle).

The beauty of our EVA-PCD® functional platform lies in its simplicity, efficiency and close proximity to human biology, unadorned by manipulations that risk adding complexity and cost without benefit. Not unlike the sport of baseball, one cannot enter the field today and claim an entirely new game of your own invention by simply offering to hit the ball “left-handed”.

I applaud the fact that investigators at Harvard have familiarized themselves with and become supporters of our approach to cancer patient care.

The theoretical principles to which they allude have been well outlined in many of my and my colleagues' prior papers.

I am gratified that investigators from so august an institution are now calling for a renewed emphasis on approaches that we have successfully employed for two decades.

As these authors review the data, they will find that the receiver-operator curves (ROC) and other measures of predictive validity that we have reported in large meta-analyses are superior to their results and that ours have the added benefit of multi-year follow ups. 

It is comforting to know that patients who confront resistance from their oncologists when they seek to use EVA-PCD® assays can now bolster their arguments with endorsements from one of the leading institutions in the world. This is a turning point for cancer medicine as we recognize the importance of human tumor biology at the level of cellular function over genomics. 

We are pleased to have yet another arrow in our quiver, as we confront occasional resistance. After all, if Harvard University investigators support our work, it shouldn’t be long before other major institutions will too.

I welcome your thoughts and comments.

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