Clinical Trial Finds DCISionRT Predicts Radiation Therapy Benefit in Women with DCIS

By News Release


Results of the SweDCIS randomized clinical trial data were published in the Special Issue: Updates on Breast Cancer edition of Cancers, demonstrating that the DCISionRT test from Prelude Corporation (PreludeDx) predicts radiation benefit for reducing 10-year local invasive breast cancer risk.

The study assessed 10-yr outcomes in 504 women treated with breast conserving surgery (BCS) and randomized into RT or no RT arms. Patients in the DCISionRT elevated risk group had a 9%significant reduction in invasive risk from radiation therapy. While women in the low risk group had a 1% non-significant difference after receiving radiation therapy. The results are highly consistent with three prior DCISionRT studies, further validating the predictive value of the assay.

"In this study, DCISionRT demonstrated statistically significant radiation therapy (RT) benefit in patients with higher Decision Scores (DS), and minimal benefit in lower scores," said principal investigator, Fredrik Wärnberg, MD, PhD, Professor in the Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden. "This was a highly valuable use of bio-banked tissue from the landmark SweDCIS patient cohort as no other randomized studies have been able to identify DCIS patients who can omit RT."

"DCISionRT represents a significant advancement in the current standard of care for DCIS patients in deciding who will or who will not benefit from radiation therapy following breast conserving surgery," said study investigator Chirag Shah, MD, Director of Breast Radiation Oncology, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH. "These comprehensive study results will provide the highest level of confidence among physicians to fully adopt and implement DCISionRT to guide their treatment recommendations for patients with 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.

"We are thrilled to publish this latest data on DCISionRT, the only DCIS test validated with peer-reviewed published Level 1b clinical evidence. The results confirm the power of the DCISionRT assay to predict RT benefit and enabling personalized treatment decisions," said Dan Forche, President and CEO of PreludeDx. "The consistency of results with prior validations studies substantiates the robustness and reliable performance of DCISionRT. We believe these much-anticipated results will have a significant impact on clinical practice for DCIS patient management."