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Shah, C et al. SABCS 2020; Abstract: Clinical utility of a biologic signature to assess DCIS recurrence risk in patients meeting good-risk criteria (RTOG 9804, ECOG E5194): interim analysis of the DCISionRT PREDICT study

PURPOSE

Validation

Investigate the change in adjuvant RT recommendation by physicians based on DCISionRT.

STUDY

513 patients from 32 sites in U.S. with DCISionRT testing completed after treatment with breast conserving surgery, but prior to radiation therapy decision.

SUMMARY

  • DCISionRT demonstrates high clinical utility by impacting radiation therapy recommendations in 45% of women overall
  • Recommendations for RT increased 37% in patients initially recommended to omit RT in clinicopathologic low risk groups
  • DCISionRT may help precent over- and under- treatment of DCIS
2020-11-20T14:32:30-06:00November 20th, 2020|

Vicini, F et al. SABCS 2020; Abstract: DCIS biosignature reclassified patients who met RTOG 9804 or ECOG-ACRIN E5194 low-risk clinicopathologic criteria into an elevated invasive risk group who benefited significantly from radiation therapy

PURPOSE

Validation

Determine the utility of DCISionRT in reclassifying patients who met RTOG 9804 or ECOG-ACRIN E5194 ‘low-risk’ clinicopathologic criteria but remained at elevated invasive risk after BCS and benefited from RT.

STUDY

Complete biomarker and clinical data for 535 women meeting ‘good risk’ clinicopathologic criteria (negative margins vs wide margins) and 660 women meeting ECOG E5194 grade 1 or 2 criteria

SUMMARY

Outcomes in clinicopathological low-risk DCIS women after breast cancer surgery (BCS):

  • DCISionRT Elevated Risk patients had substantial risk of 10-year invasive occurrence
  • DS Elevated Risk patients (>3) had significant RT benefit (8-15% absolute difference)
  • DS Low RIsk patients (≤3) had minimal RT benefit (1-2% absolute difference)
2020-11-20T14:33:25-06:00November 20th, 2020|

Bremer, TM et al. ASTRO 2020; Poster: A Novel Biosignature to Assess Residual Risk in Early Stage Invasive Breast Cancer after Standard Breast Conserving Surgery

PURPOSE

Development

Assessment of a poor response-type (RSt) signature with breast conserving surgery to potentially identify women at elevated risk after surgery and radiation.

STUDY

284 eligible patients with biomarker data and 102 received hormone therapy and 233 received radiation therapy. The RSt biosignature was calculated using specific biomarkers scored by board certified pathologists in a CLIA certified laboratory.

SUMMARY

  • A new biosignature identified a Poor Response Type in women with early stage invasive breast cancer
  • Women with a Poor Response Type had high risk for ispilateral breast events after BCS + RT
  • Women with a Good Response Type had an excellent outcome after BCS + RT
2020-11-19T13:53:50-06:00November 6th, 2020|

Bremer, TM et al. ASTRO 2020; Poster: Age and Grade as a Function of Decision Score in Women Diagnosed with DCIS

PURPOSE

Validation

Assessed discordance of Decision Score (DS) with a variety of clinical factors used to make treatment decisions

STUDY

De-identified datasets totaling 1,797 women grouped by age, tumor size, nuclear grade and RTOG 9804-like criteria

SUMMARY

  • Clinicopathologic factors have limited utility to true low risk group
  • 48% of women under the age of 50 are Low Risk by DCISionRT
  • 48% of women with low to intermediate grade are Elevated Risk by DCISionRT
2020-11-06T17:05:45-06:00November 6th, 2020|

Weinmann, S et al. Validation of a ductal carcinoma in situ biomarker profile for risk of recurrence after breast-conserving surgery with and without radiation therapy, Clinical Cancer Research 2020, Published Online 4/27/2020

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
2020-07-07T01:47:25-05:00April 27th, 2020|

Raldow, AC et al. JNCI Cancer Spectrum; Abstract: Cost Effectiveness of DCISionRT for Guiding Treatment of Ductal Carcinoma in Situ

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.
2020-06-26T13:50:29-05:00April 10th, 2020|

Bremer, TM et al. MBCC 2020; Poster: A Novel Biosignature Identifies DCIS Patients with Elevated Residual Risk After Breast Conserving Surgery and Radiation Therapy

PURPOSE

Development

A radiation-response type (RRT) biosignature for elevated risk lesions was developed with a first cohort and validated in a second cohort for differential response to RT.

STUDY

Two observational cohorts of patients treated with and without whole breast RT after Breast Conserving Surgery (BCS) were consecutively collected in Sweden (1986-2004) and the USA (1999-2008).

SUMMARY

  • A new biosignature identified a subset of women with DCIS at high risk for ipsilateral breast events after BCS + RT.
  • A subset of women with grade 3 tumors and HER2+ had a poor response type.
  • Women with a good response type had a substantial apparent benefit from RT.
2020-06-26T13:57:17-05:00March 5th, 2020|

Shivers, SC et al. MBCC 2020; Poster: Interim Analysis of the PREDICT Registry: Clinical Utility of a Biologic Signature Predictive of Radiation Therapy (RT) Benefit in Patients with DCIS

PURPOSE

Validation

A post-market decision impact registry study is being conducted to assess the impact of DCISionRT score (DS) in changing treatment recommendations for women diagnosed with pure DCIS.

STUDY

This is a planned interim analysis of the study with the first 532 patients with complete data from 32 sites.

SUMMARY

  • This second PREDICT interim analysis demonstrates a significant net change in RT recommendation based on DCISionRT.
  • Treatment recommendations were changed post-assay in 45% of women for RT and 15% of women for HT.
  • The integration of DCISionRT into clinical-decision processes will enable clinicians and patients to identify optimal treatments while preventing over- or under-treatment.
2020-06-26T14:01:19-05:00March 5th, 2020|

Shivers, SC et al. MBCC 2020; Poster: The PREDICT Registry: A prospective registry study to evaluate the effect of a Biologic Signature Predictive of Radiation Therapy (RT) Benefit on treatment decisions in patients with DCIS following breast conserving therapy

PURPOSE

Validation

The PREDICT Registry is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast.

STUDY

The primary objective of the study is to create a deidentified database of patients, test results, treatment decisions and outcomes that can be queried to determine the utility of the DCISionRT test in the diagnosis and treatment of ductal carcinoma in situ of the breast.

SUMMARY

  • The PREDICT Study has consented 747 women with 458 consented in 2019. There are 42 sites enrolled and an additional 25 sites pending activation.
  • The aim of PREDICT is to activate up to 100 sites and consent 2,500 patients diagnosed with DCIS.
2020-06-26T14:00:27-05:00March 5th, 2020|

Shivers, SC et al. SABCS; Poster: The PREDICT Registry: A prospective registry study to evaluate the effect of the DCISionRT test on treatment decisions in patients with DCIS following breast conserving therapy

PURPOSE

Validation

The PREDICT Registry is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast.

STUDY

The primary objective of the study is to create a deidentified database of patients, test results, treatment decisions and outcomes that can be queried to determine the utility of the DCISionRT test in the diagnosis and treatment of ductal carcinoma in situ of the breast.

SUMMARY

  • The PREDICT Study has consented 747 women with 458 consented in 2019. There are 42 sites enrolled and an additional 25 sites pending activation.
  • The aim of PREDICT is to activate up to 100 sites and consent 2,500 patients diagnosed with DCIS.
2020-07-02T10:28:54-05:00December 14th, 2019|