The results of the SqeDCIS trial indicated that DCISionRT was predictive of the benefit of radiation therapy in patients with ductal carcinoma in situ of the breast.
Tests with DCISionRT appeared to predict the benefit of radiation in reducing the risk of local invasive breast cancer over 10 years in patients with ductal carcinoma in situ (DCIS) of the breast, according to a press release from the randomized trial SweDCIS.1
The trial recruited a total of 504 patients who had complete data and negative surgical margins. DCISionRT divided patients into high risk (52%) or low risk (48%) groups.2 Patients at high risk had significantly reduced relative rates of ipsilateral total recurrence at 10 years (TotBE; HR: 0.32) and invasive ipsilateral recurrence at 10 years (InvBE; HR, 0.24) after treatment with radiotherapy. This translated into absolute declines of 15.5% and 9.3% in each group, respectively. Notably, no significant risk difference was observed in the low risk group after radiotherapy treatment.
Investigators noted that the trial results are consistent with 3 previous studies evaluating DCISionRT, which served to further validate the test as a potential strategy.
“In this study, DCISionRT demonstrated statistically significant benefit from radiation therapy in patients with higher decision scores (DS) and minimal benefit in lower scores”, principal investigator, Fredrik WÃ¤rnberg, MD, PhD, professor at Department of Surgery at the Institute of Clinical Sciences at Sahlgrenska Academy at Gothenburg University, Sweden, said in a press release: âThis was a very valuable use of the biobank tissues of the cohort. of SweDCIS patients because no other randomized study has been able to identify DCIS patients who may omit RT.
Additional study results indicated that when using an SD cutoff greater than 3.0, the test did not appear to be predictive of benefit from radiation therapy (P = .093). However, the researchers noted that using a cutoff of 2.8 revealed that the benefit of radiation therapy was greater in terms of the InvBE interaction (P = .038). According to DS 5 units, recurrence at 10 years without radiotherapy was found to increase significantly (TotBE: HR, 1.5; InvBE: HR, 1.5). In addition, continuous SD was found to be a prognosis for TotBE risk, but categorical SD did not reach significance.
âWe are delighted to publish this latest data on DCISionRT, the only DCIS test validated with published and peer-reviewed Level 1b clinical evidence. The results confirm the power of the DCISionRT test to predict the benefits of radiation therapy and enable personalized treatment decisions, âsaid Dan Forche, President and CEO of PreludeDx, in a press release. âThe consistency of the results with previous validation studies confirms the robustness and reliability of DCISionRT’s performance. We believe that these eagerly awaited results will have a significant impact on clinical practice for the management of DCIS patients. “
- PreludeDx â¢ DCISionRTÂ® Predicts Radiation Benefits in Historic SweDCIS Randomized Clinical Trial. Press release. PreludeDx. December 7, 2021. Accessed December 9, 2021. https://prn.to/31IVD6f
- WÃ¤rnberg F, Karlsson P, Holmberg E, et al. Assessment of prognostic risk and prediction of benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) of the breast, in a randomized clinical trial (SweDCIS). Cancers. 2021; 13 (23): 6103. doi: 10.3390 / cancers13236103