University of Chicago Comprehensive Cancer Center
For nearly 40 years, the University of Chicago (UChicago) Comprehensive Cancer Center (UCCCC) has enjoyed a reputation for excellence and innovation, with more than 200 basic and physician scientists collaborating on research aimed at transforming cancer prevention, screening, and treatment. UCCCC researchers have pioneered studies in a broad range of areas, including the molecular genetics of cancer, cancer immunology, bone marrow transplantation, hormone therapy, and advanced imaging techniques.
As one of only two National Cancer Institute– designated comprehensive cancer centers in Illinois, the UCCCC is committed not only to conducting the highest-quality research and providing the best possible patient care, but also to increasing public awareness, encouraging participation in clinical trials, and eliminating health disparities among ethnic and social groups. Two prime examples of such endeavors are the 1200 Patients Project and the UCCCC breast program.
Genomic Prescribing: The 1200 Patients Project
Initiated at UChicago, and the flagship project of the newly created Center for Personalized Therapeutics directed by Mark J. Ratain, MD, the 1200 Patients Project is examining the feasibility and potential benefits of using a patient’s genetic information to guide pharmacologic treatment decisions and develop personalized therapeutics throughout his or her lifetime. The study was initiated in January 2011 and by April 2012 had enrolled more than 700 of an anticipated 1200 UChicago outpatients.
“We’re hoping that being able to predict up front how a patient will respond to a particular drug will allow physicians to prescribe more precisely and individually, rather than by the usual trial-anderror approach,” said 1200 Patients Project principal investigator and recently named assistant professor of Medicine Peter H. O’Donnell, MD.
Peter H. O’Donnell, MD
Upon enrollment in this first-of-its-kind, 3-year study, each patient submits a single blood sample that is tested for all published genetic markers that might predict response to hundreds of drugs, as well as the likelihood of adverse effects. Patient-specific results will then be made available to study-participating physicians, who will be monitored to determine whether they use the information in decisions about medicine selection or dosing, O’Donnell explained.
O’Donnell collaborated with UChicago’s informatics team to create a prescribing system that integrates patient data with published pharmacogenomic information and generates an easyto- read clinical summary for the 12 UChicago physicians, including three oncologists, participating in the study. One challenge is that new data about genetic markers will need to be incorporated into the system as they’re published, said O’Donnell, noting that stored samples from enrolled patients can be retested when that happens, if necessary.
While the study is not cancer-specific, the database includes chemotherapy agents and other drugs prescribed to cancer patients. To date, a significant amount of research has been performed to examine the interplay between patient DNA and cancer drugs such as irinotecan, tamoxifen, methotrexate, and cisplatin, O’Donnell said.
The potential benefits of such information notwithstanding, consulting genomic prescribing data will necessitate an extra step for treating physicians, which, in turn, could make prescribing decisions more complicated and require an attitudinal adjustment. But O’Donnell doesn’t see that challenge as a downside. Determining how the genomic prescribing system can be integrated into routine care, he said, is one of the most exciting aspects of the study.
The 1200 Patients Project is still in the genetic testing phase, but pharmacogenomic information is expected to be available to the study’s physicians this summer. Already, O’Donnell and his colleagues are looking ahead to additional studies that will help determine how this new model of care could affect patient outcomes, and how well it will be accepted by a larger physician population.
Patient interest has already been robust. “Patients want their physicians to think of them as individuals, not as a disease that’s being treated,” O’Donnell said. “Patients have been exceptionally enthusiastic, and current enrollment has exceeded our expectations.”