We are seeing an elegant interplay of careful clinical investigation with hypothesis-driven molecular science. Efforts such as this one will lead to a new era in prediction of outcomes that will refine our approaches to treatment.
—Derek Raghavan, MD, PhD
In a study reported in The Lancet Oncology and reviewed in this issue of The ASCO Post, Brian Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues showed that a 16-gene assay recurrence score could predict postoperative outcome in patients with stage I to III clear cell renal cell carcinoma.1 The work reported by Dr. Rini and colleagues represents a forecast of the future.
The team at the Taussig Cancer Institute was an early adopter of the services offered from Genomic Health, during my watch as Head of the Institute, and I was delighted at the productive collaboration that emerged. Several hallmark studies have been published on gene expression in colorectal cancer, prostate cancer, and now renal carcinoma by the Genomic Health and Taussig Cancer Institute teams. In each case, important signatures that allow molecular prediction and prognostication with a pretty strong degree of reliability have been identified.
Algorithm Stands the Test of Time
The Cleveland Clinic genitourinary oncology team, formerly headed by Ron Bukowski, MD, Eric Klein, MD, and Rob Dreicer, MD, took leadership roles in identifying important clinical prognosticators for the management of advanced renal cell carcinoma and created an important algorithm that has stood the test of time. Now Rini et al have extended these clinical observations to the molecular level, leveraging the Cleveland Clinic tissue resources, augmented by an international collaboration.
There are two aspects that particularly appeal to me about this work. First, this is intelligent, hypothesis-driven translational science, as one would expect from Dr. Rini and his partners—focused on known gene expression, mechanisms of invasion, metastasis, tumor vascularization, inflammatory response, and tumor growth. This is so much better than the soft science that we constantly encounter focused on molecular fishing expeditions in which “investigators” perform batteries of random gene tests and hope to find “something.”
Second, as I recall it, Genomic Health actually funded these studies, rather than simply charging the system for unproven technology. I have always been puzzled by the tendency of molecular diagnostic groups to provide unproven and sometimes unvalidated services to the oncology community while happily charging somebody (health funds, Medicare, patients) for their services. By contrast, most of the ethical pharmaceutical industry tends to bankroll its early-phase studies, choosing to make profits once specific efficacy has been identified.
Perhaps the most important issue here is that we are seeing an elegant interplay of careful clinical investigation with hypothesis-driven molecular science. Efforts such as this one will lead to a new era in prediction of outcomes that will refine our approaches to treatment. ■
Disclosure: Dr. Raghavan reported no potential conflicts of interest.
1. Rini B, Goddard A, Knezevic D, et al: A 16-gene assay to predict recurrence after surgery in localised renal cell carcinoma. Lancet Oncol 16:676-685, 2015.
Dr. Raghavan is President, Levine Cancer Institute, Carolinas HealthCare System, and Professor, University of North Carolina School of Medicine, Chapel Hill.