Daniel F. Hayes, MD, FASCO, the Stuart B. Padnos Professor of Breast Cancer Research at the University of Michigan, Ann Arbor, wrote an accompanying editorial on the value of these newly developed omics-related criteria.1
Dr. Hayes pointed out that since the cloning of the human genome, there has been great interest in the development of multiparameter signatures that correlate with biologic or clinical phenotypes and outcomes. Few diagnostics, however, have been successfully integrated into clinical care, largely because of challenges that must be addressed. These include the need for analytical validity (accuracy, reproducibility, and reliability) and clinical utility (based on high levels of evidence).
The publications offer a “comprehensive yet concise set of criteria about which any investigator considering a clinical trial to generate high levels of evidence for clinical utility of a tumor biomarker test must be aware.… Taken together with several other initiatives to increase the rigor of tumor biomarker research, these criteria will increase the perception of value for tumor biomarker test research and application in the clinic,” Dr. Hayes maintained.
The checklist is needed, he emphasized, because “a bad tumor marker is as bad as a bad drug,” and because “tumor biomarker investigations have, too often, been studies of convenience, in which the investigators have applied an assay (which may or may not have analytical validity) to some available patient specimens, observed separation in some outcome of the population at hand with a P value < .05, and declared victory,” he wrote in his editorial.
Such studies, he pointed out, may suggest clinical utility but do not prove it. Few biomarker tests have gained a high enough level of evidence to warrant use in direct patient care, he said.
Without addressing these problems—and the checklist is a good roadmap, he said—the promise of personalized oncology will never materialize. ■
Disclosure: Dr. Hayes has three patents pending regarding clinical use of circulating tumor cells. He serves on the advisory boards of Oncimmune LLC and Inbiomotion, LLC, and has stock options in both of these companies.
1. Hayes DF: Omics-based personalized oncology: If it is worth doing, it is worth doing well! BMC Medicine 11:221, 2013.
High-throughput “omics” technologies that generate molecular profiles on tumor specimens are increasingly being incorporated into clinical trials, but some of these assays have not been well validated, leading many in the research community to question their fitness for use in patient-care...