Study Demonstrates Clinical Utility of DCISionRT for DCIS Breast Cancer Patients

Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early stage breast cancer, announced results for a prospective study in 44 US academic and community cancer centers that evaluated the impact of DCISionRT on clinicians’ recommendations to administer or omit adjuvant radiotherapy (RT) in patients with DCIS (ductal carcinoma in situ) following breast conserving surgery (BCS). Data published today in the Annals of Surgical Oncology demonstrates that utilization of DCISionRT led to a change in recommendation for adjuvant RT in 42% of patients with DCIS, also known as stage 0 breast cancer.

“In the PREDICT Registry Study, utilization of DCISionRT demonstrated a substantial overall change in the recommendation for RT for DCIS patients undergoing breast conserving surgery,” said study investigator Chirag Shah, MD, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH. “Of particular interest, compared to traditional clinical and pathological features such as tumor grade, tumor size and margin status, the DCISionRT result was viewed as the most impactful factor in making adjuvant RT recommendations following surgery. Surgeons and radiation oncologists now have a biologically driven tool to make individualized radiation treatment recommendations for DCIS patients.”

The primary endpoint of the study was to identify the percent of all women for whom DCISionRT led to a change in physician treatment recommendations regarding adjuvant RT. The study included 539 patients at 44 study sites. DCISionRT changed recommendations both to add or omit radiation treatment, demonstrating the benefits of precision medicine across all clinical and pathology factors.

“The uncertainty associated with subsequent breast cancer has historically complicated DCIS treatment decisions, leading to the broad utilization of RT following BCS. This collective data will be instrumental in providing more informed treatment decisions to help prevent over and under treatment of our patients,” said co-lead investigator Pat Whitworth, MD, Breast, Surgical Oncologist, Director, Nashville Breast Center.

“We are delighted to present this data that clearly demonstrates DCISionRT is differentiating and compelling for doctors to change their treatment recommendations for their DCIS patients following breast surgery,” said Dan Forche, President and CEO of PreludeDx. “Women and their physicians contemplating the next treatment steps now can now have greater peace of mind when making a personalized decision to add or omit radiation therapy after breast conserving surgery that includes their individual tumor biology.”

The PREDICT study is an observational, ongoing prospective cohort study for patients diagnosed with DCIS of the breast. The primary objective of the study is to determine the utility of the DCISionRT test in 2,500 women diagnosed with DCIS, and then to assess prospective 10-year outcomes.