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Welcome to a New Paradigm for DCIS Management

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 test is backed by this level of 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

Cross-validation
A Biologic Signature for Breast DCIS to Predict RT Benefit & Assess Recurrence Risk

Study

2018 Multisite Study
526 patients from UMass and UUH treated with BCS & BCS+RT

Summary

  • DCISionRT stratifies invasive risk from 3% to 40%
  • Clinically relevant Low Risk Group
    • 10-yr invasive risk: BCS: 4% | BCS+RT: 3%
  • >70% risk reduction from RT in Elevated Group
  • No/minimal RT benefit in Low Group
  • 42% RTOG 9804 “good risk” patients upstaged (23% IBC risk)

Purpose

Predictive Validation
Validation of predictive biologic profile

Study

2017 SweDCIS, NCI
584 patients. Randomized to BCS or BCS+RT. Prospective-retrospective randomized clinical trial.

Summary

  • Predicted RT benefit
  • Absolute invasive risk reduction:
  • Low group =1% (HR 0.8, p=NS)
  • Elevated group = 9% (HR 0.2, p=0.01)

Purpose

Comparison to Clin/path
Comparison of biologic risk profile to MSKCC

Study

2017 UUH/ UMass/ KPNW
999 patients. Biologic risk profile vs. MSKCC weighted clin/path risk.

Summary

  • DCISionRT provides information beyond clin/path features:
    • 59% of clin/path low risk upstaged by DCISionRT
    • 27% of clin/path high risk downstaged by DCISionRT

Purpose

Prognostic Validation
Validation of biologic profile

Study

2016 Kaiser Perm. NW, NCI
455 patients. BCS & BCS+RT patients. Prospective- restrospective clinical validation.

Summary

  • 10-yr total risk after BCS:
    • Low group = 10% Elevated group = 30%
  • 10-yr total risk after BCS+RT:
    • Low group = 5% Elevated group = 10%

Purpose

Development
Development of biologic profile

Study

2010 UCSF, NCI
329 patients. BCS & BCS+RT.

Summary

  • Algorithm identified a low risk group with 8% total recurrence risk at 8 years. Phase I of risk algorithm development identifies patients at increased risk of invasive breast cancer.

Purpose

Discovery
Discovery of biologic profile

Study

2007 UCSF, NCI
70 patients.

Summary

  • Assessment of Rb & cellular stress response pathways allow early prediction of recurrence. Cell line investigation of DCIS progression/ recurrence mechanisms.

Hear what physicians are saying about DCISionRT

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: 54 years  |  DCIS Grade: High (Grade 3)  |  DCIS size: 12mm

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 presence of high grade (grade 3) DCIS.

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 in order to preserve the option for radiation therapy should the patient have a recurrence in the future.

Example 2

Age: 65 years  |  DCIS Grade: Low (Grade 1)  |  DCIS size: 6mm

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.

dcisionrt example 2 graph

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.

How to Order

  1. Fill out a DCISionRT test requisition form
  2. Fax the following information to PreludeDx Customer Care at 1.888.909.3247
    • Completed test requisition form
    • Pathology report
    • Insurance card (front and back)
  3. Customer Care will request the tissue specimen as indicated on the test requisition
  4. DCISionRT results are typically available within 3-5 days from receiving the tissue specimen

Insurance

  • PreludeDx accepts all insurance plans
  • Financial assistance may be available for patients meeting certain requirements (contact Customer Care for details)