by Pat Kramer
A new computer software program in development through the Department of Clinical Cancer Genetics could improve cancer risk prediction for women with breast cancer who carry BRCA1 or BRCA2 gene mutations. The program is called the Individualized Risk Information System, or IRIS.
By showing these patients their risks for subsequent cancers and how different treatments could improve their odds, the team hopes to make the treatment decision-making process easier.
IRIS resulted from an international collaboration among investigators at the University of Toronto, George Washington University and City of Hope. Jeffrey Weitzel, M.D, director of the Department of Clinical Cancer Genetics, leads the project to develop and test the new software.
The program predicts a woman’s risk of a new primary breast cancer and cancer death at five and 10 years, based on her gene-mutation status, age, cancer treatments and possible prevention choices such as mastectomy and oophorectomy, or removal of the ovaries.
“IRIS is an innovative prototype that was designed as a computerized risk prediction model and decision aid,” said IRIS project coordinator Julie Culver, M.S., cancer risk counselor in the Department of Clinical Cancer Genetics. “IRIS offers the ability to determine specific risks for BRCA-positive patients to help them decide on the best course of treatment for them.”
The software relies on data from historical studies of BRCA-positive survivors. A University of Toronto study tracked 491 breast cancer survivors known to have BRCA1 or BRCA2 mutations. Based on treatments the women received, researchers calculated rates of survival and new primary breast cancers over a five and ten year period. The resulting information provides the parameters that indicate cancer risk, translating human experience into predictive results.
“We often see these women in our clinics,” said Culver. “They have difficult choices to make regarding whether they should undergo a bilateral mastectomy, consider breast MRI screening, have a salpingo-oophorectomy [removal of ovaries and fallopian tubes] or whether they should take tamoxifen.
“What IRIS provides is an accurate assessment of cancer risk with and without preventive surgery. By giving this information to women who are at risk, we can help them make more informed decisions about future treatment.”
The study’s first phase will validate the predictive model. In the second phase, researchers will develop IRIS as a decision aid and, lastly, the team will test the software’s effectiveness through focus groups with patients and providers, beginning in mid 2007. The group eventually plans to test IRIS through a randomized trial. If IRIS is shown to help women make treatment decisions, genetic counselors may use it in clinical settings.
Collaborators with City of Hope on the IRIS study include Steven Narod, M.D., and Kelly Metcalfe, R.N., Ph.D., at the University of Toronto, and Harry B. Burke, M.D., Ph.D., at George Washington University. Additional partners include Mark Robson, M.D., at Memorial Sloan-Kettering Cancer Center, and several investigators working with Lori Pierce, M.D., at University of Michigan. The Susan G. Komen Breast Cancer Foundation funded the project through a two-year, $250,000 grant.
For more information on IRIS, please contact Culver through e-mail at jculver@coh.org or at 626-256-4673, ext. 64346.
