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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|

Wadsten, C et al. ASCO; Abstract: Risk stratification in early stage luminal breast cancer patients treated with and without RT

PURPOSE

Development

To develop a biologic signature for 10-year ipsilateral invasive breast events in luminal stage 1 breast cancer patients treated with BCS with or without adjuvant RT.

STUDY

Studied a cohort of 423 patients from Sweden diagnosed with Stage 1 breast cancer between 1987 and 2004. Treatment was neither randomized nor strictly rules based.

SUMMARY

  • The biologic risk signature identified subgroups of patients with early-stage breast cancer who will benefit from RT.
  • For patients with luminal breast cancer, the biologic signature provided both prognostic and predictive value for benefit from adjuvant RT.
2020-06-26T14:20:44-05:00June 28th, 2019|

Wadsten, C et al. ASCO; Poster: Risk stratification in early stage luminal breast cancer patients treated with and without RT

PURPOSE

Development

To develop a biologic signature for 10-year ipsilateral invasive breast events in luminal stage 1 breast cancer patients treated with BCS with or without adjuvant RT.

STUDY

Studied a cohort of 423 patients from Sweden diagnosed with Stage 1 breast cancer between 1987 and 2004. Treatment was neither randomized nor strictly rules based.

SUMMARY

  •  The biologic risk signature identified subgroups of patients with early-stage breast cancer who will benefit from RT.
  • For patients with luminal breast cancer, the biologic signature provided both prognostic and predictive value for benefit from adjuvant RT.
2020-06-26T14:21:15-05:00June 28th, 2019|

Whitworth, PW et al. ASBS; Abstract: Interim Analysis of the DCISionRT PREDICT Study: Clinical Utility of a Biologic Signature Predictive of Radiation Therapy Benefit in Patients with DCIS

PURPOSE

Validation

A planned early interim analysis of the DCISionRT PREDICT Study, a registry designed to assess the impact of the DCISionRT score (DS) in changing treatment recommendations for women diagnosed with pure DCIS.

STUDY

Analyzed the first 197 patients with complete data from 18 sites across the US.

SUMMARY

  • Demonstrated a significant absolute overall change in RT recommendation based on DCISionRT.
  • Treatment recommendations were changed post-assay for 51% of women for RT and 13% of women for HT.
  • Integration of DCISionRT impacts the clinical decision process as clinicians and patients consider strategies aimed at reducing overtreatment and minimizing undertreatment.
2020-06-26T14:22:22-05:00May 1st, 2019|

Whitworth, PW et al. ASBS; Poster: Interim Analysis of the DCISionRT PREDICT Study: Clinical Utility of a Biologic Signature Predictive of Radiation Therapy Benefit in Patients with DCIS

PURPOSE

Validation

A planned early interim analysis of the DCISionRT PREDICT Study, a registry designed to assess the impact of the DCISionRT score (DS) in changing treatment recommendations for women diagnosed with pure DCIS.

STUDY

Analyzed the first 197 patients with complete data from 18 sites across the US.

SUMMARY

  • Demonstrated a significant absolute overall change in RT recommendation based on DCISionRT.
  • Treatment recommendations were changed post-assay for 51% of women for RT and 13% of women for HT.
  • Integration of DCISionRT impacts the clinical decision process as clinicians and patients consider strategies aimed at reducing overtreatment and minimizing undertreatment.
2020-06-26T14:25:00-05:00May 1st, 2019|