Predicts radiation benefit.
DCISionRT is the only test capable of predicting an individual patient’s benefit from radiation therapy. Using DCISionRT provides you with 10-year Total and Invasive Recurrence Risk after breast conserving surgery as well as surgery with radiation therapy. No other test can do this.
Enables precision medicine.
DCISionRT provides you the information to deliver precision medicine to your patients. Unlike grade, tumor size or patient age, DCISionRT quantifies a woman’s risk based on her DCIS biology. Studies have shown that DCISionRT reclassifies over 50% of patients compared to grade and size[REF CCR]. The future of DCIS management is here with DCISionRT.
Unmatched clinical evidence.
DCISionRT has undergone multiple independent validations, including the landmark SweDCIS randomized clinical trial. The test has the highest dynamic range and most consistent results study to study. Evidence includes over 2000 patients from development through validation. No other DCIS test is supported by published Level 1b clinical evidence.
DCISionRT provides physicians with the first radio-genomics tool to predict radiation therapy benefit.
In an independent clinical validation of DCISionRT in the landmark SweDCIS randomized clinical trial, patients with low Decision Scores no significant invasive risk reduction from radiation therapy after surgery whereas patients with elevated Decision Scores had a 9% reduction in invasive risk (HR 0.24, p=0.012). This study, for the first time, demonstrates a DCIS test that predicts the extent to which patients benefit from radiation therapy.
DCISionRT enables physicians to deliver precision medicine to DCIS patients
Results are shown are for the 196 patients treated with conserving surgery treated patients with clear margins in a multisite study. Total recurrence risks shown are adjusted for year of diagnosis. This was demonstrated in a multisite study of 474 patients1.
1 Bremer T, Whitworth P, Patel R, et al. . A biologic signature for breast ductal carcinoma in situ to predict radiation therapy (RT) benefit and assess recurrence risk. Clin Cancer Res . 2018; doi:10.1158/1078-0432.CCR-18-0842.
Unmatched Clinical Evidence
Purpose
Validation
Evaluate DCISionRT with Residual Risk Subtype (RRt) to help identify patients with elevated IBR risk after BCS+RT.
Study
926 women with DCIS treated with BCS +/- RT were classified into three biosignature groups by DCISionRT with RRt. Total and invasive IBR rates were assessed by risk group and treatment.
Summary
DCISionRT with RRt identified 3 distinct patient risk profiles and corresponding 10-yr IBR rates:
- Low Risk – low recurrence risk after BCS +/- RT
- Total 5.1%; Invasive 2.7%
- Elevated Risk – low recurrence risk decreased after BCS + RT
- Total 20.6% vs. 4.9%; Invasive 10.9% vs. 3.1%
- Residual Risk – elevated recurrence risk even with BCS + RT
- Total 42.1% vs. 14.7%; Invasive 18.3% vs. 6.5%
Residual Risk patients may warrant intensified or alternative treatment approaches.
Purpose
To validate DCISionRT® in a large, randomized cohort (SweDCIS) with long term follow-up.
Study
A prospective-retrospective randomized clinical trial conducted on 504 women with randomized treatment of BCS or BCS+RT
Summary
- Level 1b evidence
- Predictive for radiation therapy
- Prognostic for 10-year risk
- Elevated Risk group experienced significant RT benefit
- Absolute decreases in TotBE and InvBE rates of 16% and 9%
- Low Risk group experienced minimal RT benefit
- Absolute differences in TotBe and InvBE rates of 6% and 1%
- 40% of patients meeting RTOG-9804 ‘good risk’ criteria were classified as DS Elevated risk
Purpose
Validation
Independent clinical validation of DCISionRT after breast conserving surgery in a Kaiser Permanente NW population
Study
455 health plan members of Kaiser Permanente Northwest diagnosed with DCIS and treated with BCS or BCS+RT from 1990-2007
Summary
- The continuous and categorical DS was prognostic for both TotBE and InvBE risk after adjusting for RT
- Further reinforces DCISionRT’s ability to correctly reclassify patients into Low (42%) and Elevated risk (58%) groups
- Low Risk Group had a minimal (2%) benefit from RT (10-yr invasive risk BCS: 5%, BCS+RT: 3%)
- DCISionRT reclassifies 49% of RTOG 9804 “good risk” patients as Elevated Risk patients
- >70% risk reduction from RT in Elevated Group for invasive breast events
Purpose
Validation
A biological signature that calculates an individualized Decision Score (DS) was developed and cross-validated in 526 DCIS patients treated with BCS ± RT. The relationship was assessed between DS and 10-year risk of invasive breast cancer (IBC) or any ipsilateral breast event (IBE), including IBC or DCIS. RT benefit was evaluated by risk group and as a function of DS.
Study
The study was conducted on archived tissue samples in collaboration with Uppsala University Hospital and Västmanland County Hospital, Sweden (UUH), the University of Massachusetts, Worcester (UMass). Patients were included consecutively between 1986 and 2004 at UUH and between 1999 and 2008 at UMass. Treatment decisions were neither randomized nor strictly rules-based.
Summary
- The DS was significantly associated with IBC and IBE risk, HR (per 5 units) of 4.2 and 3.1, respectively.
- For patients treated without RT, DS identified a Low Group with 10-year IBC risk of 4% (7% IBE) and an Elevated Risk Group with IBC risk of 15% (23% IBE).
- In analysis of DS and RT by group, the Elevated Risk Group received significant RT benefit, HR of 0.3 for IBC and IBE.
- In a clinicopathologically low-risk subset, DS reclassified 42% of patients into the Elevated Risk Group.
- In an interaction analysis of DS and RT, patients with elevated DS had significant RT benefit over baseline.
Purpose
Validation
Present results from analytical validity, performance assessment, and clinical performance validation and clinical utility for DCISionRT.
Study
Performed analytical validation of DCISionRT assay based on the CLSI guidelines and CAP/ASCO recommendations.
Summary
- Analytical Validation (AV) and prior Clinical Validation (CV) studies further supports adoption of DCISionRT
- AV:
- ≥95% sensitivity, specificity and accuracy/reproducibility
- CV:
- 99% NPV for RT benefit
- NNT: Treat 100 patients to prevent one invasive breast cancer recurrence.
- AV:
Purpose
Validation
Decision Impact Study: Evaluate impact of DCISionRT on clinicians’ recommendations for adjuvant radiation therapy (RT).
Study
Within cohort of 539 women diagnosed with DCIS, physicians’ treatment recommendations were captured pre- and post- DCISionRT testing.
Summary
- Post-testing, a change in radiation therapy recommendations were made in 42% of the patients
- When compared with traditional clinicopathologic features used to determine RT recommendations, the DCISionRT result was the factor most strongly associated with radiation therapy recommendations.
Purpose
Validation
External analysis of the cost-effectiveness of the DCISionRT test to guide treatment of DCIS
Study
Used a Markov model simulating 10-year outcomes for 60-year old women with DCIS based on non-randomized data.
Summary
When compared to giving RT to all women with DCIS, the use of DCISionRT to guide the decision for RT was cost-effective and minimized the number of women undergoing RT per future ipsilateral breast event.
What information does DCISionRT give me?
Based on the biology of your DCIS, the DCISionRT test provides you and your physician the information needed to make a decision whether surgery alone or surgery with radiation therapy is appropriate.
Case Studies
The DCISionRT® test indicates your individual risk of recurrence and expected benefit from radiation therapy.
Example 1
Age: 51 years | DCIS Grade: Intermediate (Grade 2) | DCIS size: 30mm
Before DCISionRT
Risk Assessment
Traditional Clinpath Features
TREATMENT PLAN:
Surgery with radiation therapy
TREATMENT RATIONALE:
Radiation therapy after breast conserving surgery is recommended based on age, grade and size.
After DCISionRT
Risk Assessment
TREATMENT PLAN:
Breast conserving surgery
TREATMENT RATIONALE:
Because the patient has a Low DCISionRT score, the Physician and patient decide to defer radiation therapy and elect breast conserving surgery.
Example 2
Age: 45 years | DCIS Grade: Low (Grade 1) | DCIS size: 10mm
Before DCISionRT
Risk Assessment
Traditional Clinpath Features
TREATMENT PLAN:
Breast conserving surgery
TREATMENT RATIONALE:
Traditional risk assessment using clinicopathologic features indicates patient could be considered “low risk” and therefore, the patient and physician elect to forego radiation therapy.
After DCISionRT
Risk Assessment
TREATMENT PLAN:
Surgery with radiation therapy
TREATMENT RATIONALE:
New information from DCISionRT indicates the patient is at Elevated Risk if treated with surgery alone. The patient and physician decide to use radiation therapy-–despite traditionally low risk clinicopathalogic features—due to the large risk reduction from radiation therapy.
Ordering Information
Contact Customer Care
Phone: 1.888.211.3247 or Email: customercare@preludedx.com