The clinical utility of a 7-gene biosignature on radiation therapy decision making in patients with ductal carcinoma in situ following breast-conserving surgery: An updated analysis of the DCISionRT PREDICT Study

Authors

Chirag Shah, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA. shahc4@ccf.org.
Pat Whitworth, Nashville Breast Center, Nashville, TN, USA.
Frank A. Vicini, Michigan Healthcare Professionals, Farmington Hills, MI, USA.
Steven Narod, Center for Global Health, University of Toronto, Toronto, ON, Canada.
Naamit Gerber, Department of Radiation Oncology, Laura and Isaac Perlmutter Cancer Center, New York, NY, USA.
Sachin R. Jhawar, Department of Radiation Oncology, James Cancer Center, Ohio State University, Columbus, OH, USA.
Tari A. King, Department of Surgery, Dana-Farber Cancer Institute, Boston, MA, USA.
Elizabeth A. Mittendorf, Department of Surgery, Dana-Farber Cancer Institute, Boston, MA, USA.
Shawna C. Willey, Schar Cancer Institute, Inova, Fairfax, VA, USA.
Rachel Rabinovich, Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, CO, USA.
Linsey Gold, Comprehensive Breast Care, Michigan Healthcare Professionals, Troy, MI, USA.
Eric Brown, Comprehensive Breast Care, Michigan Healthcare Professionals, Troy, MI, USA.
Anushka Patel, Arizona Center for Cancer Care, Phoenix, AZ, USA.
John Vargo, Department of Radiation Oncology, University of Pittsburgh, Pittsburgh, PA, USA.
Parul N. Barry, Department of Radiation Oncology, University of Pittsburgh, Pittsburgh, PA, USA.
David Rock, GenesisCare, Fort Myers, FL, USA.
Neil Friedman, Mercy Medical Center, Baltimore, MD, USA.
Gauri Bedi, Mercy Medical Center, Baltimore, MD, USA.
Sandra Templeton, Department of Surgery, Houston Methodist, Sugar Land, TX, USA.
Sheree Brown, Wellstar Radiation Oncology, Hiram, GA, USA.
Robert Gabordi, BayCare Medical Group, Tampa, FL, USA.
Lee Riley, St. Luke's Hospital, Allentown, PA, USA.
Lucy Lee, Northwell Health, New Hyde Park, NY, USA.
Paul Baron, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.
Lonika Majithia, Radiation Oncology Associates, Fairfax, VA, USA.
Kristina L. Mirabeau-Beale, GenesisCare, Fort Myers, FL, USA.
Vincent J. Reid, Hall-Perrine Cancer Center, Cedar Rapids, IA, USA.
Arica Hirsch, Advocate Health - MidwestFollow
Catherine Hwang, AdventHealth, Orlando, FL, USA.
James Pellicane, Bon Secours, Richmond, VA, USA.
et al

Abstract

Background: Breast-conserving surgery (BCS) followed by adjuvant radiotherapy (RT) is a standard treatment for ductal carcinoma in situ (DCIS). A low-risk patient subset that does not benefit from RT has not yet been clearly identified. The DCISionRT test provides a clinically validated decision score (DS), which is prognostic of 10-year in-breast recurrence rates (invasive and non-invasive) and is also predictive of RT benefit. This analysis presents final outcomes from the PREDICT prospective registry trial aiming to determine how often the DCISionRT test changes radiation treatment recommendations.

Methods: Overall, 2496 patients were enrolled from February 2018 to January 2022 at 63 academic and community practice sites and received DCISionRT as part of their care plan. Treating physicians reported their treatment recommendations pre- and post-test as well as the patient's preference. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendation. The impact of the test on RT treatment recommendation was physician specialty, treatment settings, individual clinical/pathological features and RTOG 9804 like criteria. Multivariate logisitc regression analysis was used to estimate the odds ratio (ORs) for factors associated with the post-test RT recommendations.

Results: RT recommendation changed 38% of women, resulting in a 20% decrease in the overall recommendation of RT (p < 0.001). Of those women initially recommended no RT (n = 583), 31% were recommended RT post-test. The recommendation for RT post-test increased with increasing DS, from 29% to 66% to 91% for DS4, respectively. On multivariable analysis, DS had the strongest influence on final RT recommendation (odds ratio 22.2, 95% confidence interval 16.3-30.7), which was eightfold greater than clinicopathologic features. Furthermore, there was an overall change in the recommendation to receive RT in 42% of those patients meeting RTOG 9804-like low-risk criteria.

Conclusions: The test results provided information that changes treatment recommendations both for and against RT use in large population of women with DCIS treated in a variety of clinical settings. Overall, clinicians changed their recommendations to include or omit RT for 38% of women based on the test results. Based on published clinical validations and the results from current study, DCISionRT may aid in preventing the over- and undertreatment of clinicopathological 'low-risk' and 'high-risk' DCIS patients.

Trial registration: ClinicalTrials.gov identifier: NCT03448926 ( https://clinicaltrials.gov/study/NCT03448926 )

Document Type

Article

PubMed ID

38916700


 

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