Australian-first study reveals 45% change in breast cancer treatment recommendations

MedTech News: An Australian partnership has unveiled the significant potential of precision medicine to optimise care for Australian women diagnosed with breast cancer.

GenesisCare and PreludeDxTM, a leader in molecular diagnostics and precision medicine, announced interim results from the AUS-PREDICT registry. Data presented at the Australasian International Breast Congress demonstrates a significant (45%) change in radiation therapy treatment recommendations when using the DCISionRT test, optimising management to prevent over and under treatment of Australian women with Ductal Carcinoma In Situ (DCIS).

DCIS is a pre-invasive disease of the breast that may lead to invasive breast cancer if untreated. After breast conserving surgery (BCS) for DCIS, radiation therapy is often used to minimise the risk of recurrence. DCISionRT is a novel molecular test that assesses the 10-year risk of recurrence after BCS and if there would be a benefit to treating with radiation therapy.

GenesisCare and PreludeDx formed a strategic partnership in 2021 to bring DCISionRT to Australia for the first time and establish the AUS-PREDICT registry to collect real-world data to further the development of precision medicine and decision tools globally.

The study results of 232 Australian patients who had received the DCISionRT test following breast-conserving surgery revealed that radiation therapy recommendation decreased by 70% in patients with a low risk DCISionRT score and increased 29% in patients with elevated risk scores.

Leading Specialist Breast Surgeon and Director of Breast Cancer Services for Royal Melbourne and Royal Women’s Hospital, Melbourne, Professor Bruce Mann, said “Historically, we have relied on clinical pathology, such as tumour grade and size, to determine treatment plans for patients with DCIS. This data demonstrates the integration of DCISionRT into clinical decision making has a substantial impact on RT recommendations and has the ability to prevent over and under treatment of DCIS patients.”

Principal Investigator and GenesisCare Radiation Oncologist, Dr Yvonne Zissiadis, said the interim results “demonstrate the critical role of DCISionRT in the clinical treatment pathway for DCIS patients, ensuring women receive the right treatment at the right time. “Our study highlights that DCISionRT is a promising predictive tool, arming clinicians and patients with the information to make informed decisions about treatment options based on a patient’s individual biological risk profile.”

“GenesisCare, in partnership with PreludeDx, is thrilled to present the interim findings from our Australian-first study,” continued Dr Zissiadis.

“The first interim analysis of AUS-PREDICT is highly consistent with the US-PREDICT registry3 that has completed enrollment of 2,500 patients,” said Troy Bremer, PhD, Chief Scientific Officer of PreludeDx.
“In the registry studies in both countries, DCISionRT was the most impactful single factor for changing treatment recommendations regarding radiation therapy following breast conserving surgery,” continued Dr. Bremer.

“We are delighted to bring precision medicine to Australian women diagnosed with DCIS and further enrolment in the AUS-PREDICT registry. We look forward to the continued expansion of our global data network and clinical evidence for DCISionRT,” said Dan Forche, CEO of PreludeDx.