April 26, 2012

Personalized cancer care highlighted at IOM meeting

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Taking part in Monday’s regional meeting of the Institute of Medicine (IOM) were, from left, Jeff Balser, M.D., Ph.D., Harvey Fineberg, M.D., Ph.D., Harold (Hal) Moses, M.D., and William Pao, M.D., Ph.D. (photo by Anne Rayner)

Personalized cancer care highlighted at IOM meeting

A recent explosion in technological advances has created a new field known as translational “omics” that allows the measurement of molecules within a tissue or cell — genomics investigates DNA and proteomics examines proteins. These new omics-based tests may be used to guide patient therapy in the future.

Such omics-based tests are much more complex than in the past, because they are composed or derived from multiple molecular measurements and interpreted by a fully specified computational model to produce a result which can be used for patients in the clinic.

The future of omics and personalized cancer medicine was in the spotlight as Vanderbilt University School of Medicine hosted a regional meeting of the Institute of Medicine (IOM) of the National Academies. Jeff Balser, M.D., Ph.D., vice chancellor for Health Affairs and dean of the School of Medicine, and Harvey Fineberg, M.D., Ph.D., president of the IOM, led the open forum.

Fineberg discussed the importance of “proceeding sensibly, safely and effectively in translating genomic knowledge into clinical trials.”

“What is likely going to be the case for all of us in clinical and investigational medicine is that our concept of disease at diagnosis will be profoundly altered as genomic information and omic knowledge becomes more prevalent and more established in differentiating patients,” said Fineberg.

However, translating omics-based tests for patient care has turned out to be far more demanding than anticipated and has already led to invalidation of a set of tests used to match patients to clinical trials at one academic medical center.

Two Vanderbilt cancer researchers served on a specially appointed national IOM committee to develop guidelines for future omics-based testing. Harold (Hal) Moses, M.D., director emeritus of Vanderbilt-Ingram Cancer Center and Hortense B. Ingram Professor of Molecular Oncology, and William Pao, M.D., Ph.D., director of the Division of Hematology and Oncology and director of Personalized Cancer Medicine, reported on the lessons learned from the committee’s investigation and the different approach Vanderbilt is taking to enable a personalized cancer medicine approach.

Moses pointed out that omics-based tests are not straightforward.

“These are complex data sets and there is a high risk that the computational model will “overfit” the data,” explained Moses.

He said the resulting tests must be accurate and reproducible, so the use of rigorous methods in statistics, bioinformatics and data management are essential.

As part of the best practices recommended by the IOM committee for the creation and evaluation of future omics-based tests, test investigators need to disclose their methods and provide detailed information about each step in the process. The computational procedures should be “locked down” and then confirmed with a new set of samples.

The committee also stressed the importance of institutional awareness and oversight of the development of tests for clinical trials.

Pao pointed out that non-omics based tests can already be used to match the right therapy to patients with certain cancers. Existing technology can identify gene mutations that predict tumor sensitivity to specific therapies, and Vanderbilt has been on the leading edge of such efforts to match lung cancer and melanoma patients to the best treatments based on the genetic makeup of individual tumors.

“These new personalized treatment options are leading to increased overall survival in lung cancer and melanoma, and we are hopeful that this approach will provide better outcomes for patients,” Pao said.

To help patients, physicians and researchers quickly find information about the importance of specific mutations, as well as the availability of clinical research trials, Pao and Mia Levy, M.D., Ph.D., assistant professor of Biomedical Informatics and Medicine and Cancer Clinical Informatics Officer, have developed My Cancer Genome, an online medical decision support tool.

The award-winning My Cancer Genome has already been viewed more than 60,000 times by individuals in 120 countries.
Fineberg praised these new Vanderbilt initiatives.

“This program is pushing ahead at the frontiers and contributing greatly not only to patient welfare but also providing the kind of patient information, patient insights and the strategies that will help guide all investigations in this very critical field,” Fineberg said.