On December 9, 2022 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported study results demonstrating that DCISionRT provides patients with ductal carcinoma in situ (DCIS) superior recurrence risk stratification and radiation therapy (RT) benefit prediction compared to commonly used clinicopathologic (CP) features (Press release, PreludeDx, DEC 9, 2022, View Source [SID1234625000]). The data was presented in a spotlight presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS).
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Until now, clinicians have relied upon clinicopathologic features alone, such as nuclear grade (NG), tumor size and age to determine which patients may not need radiation therapy.
This study, titled ‘7-gene Predictive Biosignature Improves Risk Stratification for Breast Ductal Carcinoma in Situ Patients Compared to Clinicopathologic Criteria, Identifying a Low-Risk Group Not Clinically Benefiting from Adjuvant Radiotherapy’, revealed in 926 women from four cohorts, that DCISionRT was a superior predictor of 10-year IBR rates and RT benefit compared to clinicopathologic criteria. DCISionRT identified that approximately half of CP-Low Risk patients were classified as elevated risk by the test and significantly benefited from RT with an absolute 17.7% reduction in 10-year ipsilateral breast recurrence. Whereas DCISionRT Low Risk patients, which included about one-third of CP High-Risk patients, had no significant RT benefit, representing a true low risk group.
"In the DCISionRT Low Risk group, I would have to treat approximately 100 patients to benefit just one patient. In contrast, in the DCISionRT High Risk group, I would have to treat approximately 6 patients to benefit one. This study further validates that the biosignature is far more accurate than using grade or other factors for determining DCIS outcomes," said Rachel Rabinovitch, MD, FASTRO, Professor of Radiation Oncology at University of Colorado. "Traditional methods result in the over-and-under treatment of DCIS. It is a very significant advancement to have a patient specific biosignature tool which predicts RT benefit."
"We are grateful for our prestigious physician-researchers around the world who are working tirelessly to further integrate and share the immense data and clinical value of DCISionRT in shared treatment decision making with DCIS patients," said Dan Forche, President and CEO of PreludeDx. "We are inspired by their enthusiasm and dedicated to continued innovation in the fight against early-stage breast cancer."
About DCISionRT for Breast DCIS
DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.