The Clinical Utility of DCISionRT <sup>®</sup> on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery

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Abstract

Background

The role of radiation therapy (RT) following breast-conserving surgery (BCS) in ductal carcinoma in situ (DCIS) remains controversial. Trials have not identified a low-risk cohort, based on clinicopathologic features, who do not benefit from RT. A biosignature (DCISionRT ^®) that evaluates recurrence risk has been developed and validated. We evaluated the impact of DCISionRT on clinicians’ recommendations for adjuvant RT.

Methods

The PREDICT study is a prospective, multi-institutional, observational registry in which patients underwent DCISionRT testing. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendations.

Results

Overall, 539 women were included in this study. Pre DCISionRT testing, RT was recommended to 69% of patients; however, post-testing, a change in the RT recommendation was made for 42% of patients compared with the pre-testing recommendation; the percentage of women who were recommended RT decreased by 20%. For women initially recommended not to receive an RT pre-test, 35% had their recommendation changed to add RT following testing, while post-test, 46% of patients had their recommendation changed to omit RT after an initial recommendation for RT. When considered in conjunction with other clinicopathologic factors, the elevated DCISionRT score risk group (DS > 3) had the strongest association with an RT recommendation (odds ratio 43.4) compared with age, grade, size, margin status, and other factors.

Conclusions

DCISionRT provided information that significantly changed the recommendations to add or omit RT. Compared with traditional clinicopathologic features used to determine recommendations for or against RT, the factor most strongly associated with RT recommendations was the DCISionRT result, with other factors of importance being patient preference, tumor size, and grade.

Supplementary Information

The online version contains supplementary material available at 10.1245/s10434-021-09903-1.

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Most cited references 15

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Long-term outcomes of invasive ipsilateral breast tumor recurrences after lumpectomy in NSABP B-17 and B-24 randomized clinical trials for DCIS.

J Dignam, Richard G Margolese, Bernard Fisher … (2011)

Ipsilateral breast tumor recurrence (IBTR) is the most common failure event after lumpectomy for ductal carcinoma in situ (DCIS). We evaluated invasive IBTR (I-IBTR) and its influence on survival among participants in two National Surgical Adjuvant Breast and Bowel Project (NSABP) randomized trials for DCIS. In the NSABP B-17 trial (accrual period: October 1, 1985, to December 31, 1990), patients with localized DCIS were randomly assigned to the lumpectomy only (LO, n = 403) group or to the lumpectomy followed by radiotherapy (LRT, n = 410) group. In the NSABP B-24 double-blinded, placebo-controlled trial (accrual period: May 9, 1991, to April 13, 1994), all accrued patients were randomly assigned to LRT+ placebo, (n=900) or LRT + tamoxifen (LRT + TAM, n = 899). Endpoints included I-IBTR, DCIS-IBTR, contralateral breast cancers (CBC), overall and breast cancer-specific survival, and survival after I-IBTR. Median follow-up was 207 months for the B-17 trial (N = 813 patients) and 163 months for the B-24 trial (N = 1799 patients). Of 490 IBTR events, 263 (53.7%) were invasive. Radiation reduced I-IBTR by 52% in the LRT group compared with LO (B-17, hazard ratio [HR] of risk of I-IBTR = 0.48, 95% confidence interval [CI] = 0.33 to 0.69, P < .001). LRT + TAM reduced I-IBTR by 32% compared with LRT + placebo (B-24, HR of risk of I-IBTR = 0.68, 95% CI = 0.49 to 0.95, P = .025). The 15-year cumulative incidence of I-IBTR was 19.4% for LO, 8.9% for LRT (B-17), 10.0% for LRT + placebo (B-24), and 8.5% for LRT + TAM. The 15-year cumulative incidence of all contralateral breast cancers was 10.3% for LO, 10.2% for LRT (B-17), 10.8% for LRT + placebo (B-24), and 7.3% for LRT + TAM. I-IBTR was associated with increased mortality risk (HR of death = 1.75, 95% CI = 1.45 to 2.96, P < .001), whereas recurrence of DCIS was not. Twenty-two of 39 deaths after I-IBTR were attributed to breast cancer. Among all patients (with or without I-IBTR), the 15-year cumulative incidence of breast cancer death was 3.1% for LO, 4.7% for LRT (B-17), 2.7% for LRT + placebo (B-24), and 2.3% for LRT + TAM. Although I-IBTR increased the risk for breast cancer-related death, radiation therapy and tamoxifen reduced I-IBTR, and long-term prognosis remained excellent after breast-conserving surgery for DCIS.

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Overview of the randomized trials of radiotherapy in ductal carcinoma in situ of the breast.

Michael Gnant (2010)

Individual patient data were available for all four of the randomized trials that began before 1995, and that compared adjuvant radiotherapy vs no radiotherapy following breast-conserving surgery for ductal carcinoma in situ (DCIS). A total of 3729 women were eligible for analysis. Radiotherapy reduced the absolute 10-year risk of any ipsilateral breast event (ie, either recurrent DCIS or invasive cancer) by 15.2% (SE 1.6%, 12.9% vs 28.1% 2 P <.00001), and it was effective regardless of the age at diagnosis, extent of breast-conserving surgery, use of tamoxifen, method of DCIS detection, margin status, focality, grade, comedonecrosis, architecture, or tumor size. The proportional reduction in ipsilateral breast events was greater in older than in younger women (2P < .0004 for difference between proportional reductions; 10-year absolute risks: 18.5% vs 29.1% at ages <50 years, 10.8% vs 27.8% at ages ≥ 50 years) but did not differ significantly according to any other available factor. Even for women with negative margins and small low-grade tumors, the absolute reduction in the 10-year risk of ipsilateral breast events was 18.0% (SE 5.5, 12.1% vs 30.1%, 2P = .002). After 10 years of follow-up, there was, however, no significant effect on breast cancer mortality, mortality from causes other than breast cancer, or all-cause mortality.

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A Multigene Expression Assay to Predict Local Recurrence Risk for Ductal Carcinoma In Situ of the Breast

Lawrence Solin, Robert D.M. Gray, Frederick Baehner … (2013)

Background For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. Methods The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. Results There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P = .02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P = .01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤ .006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤ .02). Conclusions The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria.

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Author and article information

Contributors

Frank A. Vicini: Frank.Vicini@21co.com , Frank.Vicini2@usa.genesiscare.com

Journal

Journal ID (nlm-ta): Ann Surg Oncol

Journal ID (iso-abbrev): Ann Surg Oncol

Title: Annals of Surgical Oncology

Publisher: Springer International Publishing (Cham )

ISSN (Print): 1068-9265

ISSN (Electronic): 1534-4681

Publication date (Electronic): 5 April 2021

Publication date PMC-release: 5 April 2021

Publication date (Print): 2021

Volume: 28

Issue: 11

Pages: 5974-5984

Affiliations

[1 ]GRID grid.239578.2, ISNI 0000 0001 0675 4725, Department of Radiation Oncology, Taussig Cancer Institute, , Cleveland Clinic, ; Cleveland, OH USA

[2 ]GRID grid.505075.2, PreludeDx, ; Laguna Hills, CA USA

[3 ]GRID grid.170693.a, ISNI 0000 0001 2353 285X, University of South Florida, ; Tampa, FL USA

[4 ]GRID grid.496763.9, ISNI 0000 0004 0460 8910, Nashville Breast Center, ; Nashville, TN USA

[5 ]GRID grid.416759.8, ISNI 0000 0004 0460 3124, Sutter Health, ; Castro Valley, CA USA

[6 ]Arizona Center for Cancer Care, Phoenix, AZ USA

[7 ]GRID grid.489185.9, ISNI 0000 0004 0554 7339, Comprehensive Breast Care, , Michigan Healthcare Professionals, ; Troy, MI USA

[8 ]GenesisCare, Fort Myers, FL USA

[9 ]GRID grid.416480.f, ISNI 0000 0004 0376 0953, St. Luke’s Hospital, ; Allentown, PA USA

[10 ]GRID grid.490348.2, ISNI 0000000446839645, Radiation Oncology Department, , Northwestern Medicine, ; Warrenville, IL USA

[11 ]Wellstar Radiation Oncology, Hiram, GA USA

[12 ]BayCare Medical Group, Tampa, FL USA

[13 ]Bon Secours, Richmond, VA USA

[14 ]GRID grid.430503.1, ISNI 0000 0001 0703 675X, Department of Radiation Oncology, , University of Colorado School of Medicine, ; Aurora, CO USA

[15 ]Hoag Breast Center, Irvine, CA USA

[16 ]GRID grid.63368.38, ISNI 0000 0004 0445 0041, Department of Surgery, , Houston Methodist, ; Sugar Land, TX USA

[17 ]GRID grid.492885.a, Radiation Oncology Associates, ; Fairfax, VA USA

[18 ]GRID grid.48336.3a, ISNI 0000 0004 1936 8075, Schar Cancer Institute, ; Inova, Fairfax, VA USA

[19 ]GRID grid.1649.a, ISNI 000000009445082X, Department of Surgery, , Sahlgrenska University Hospital, ; Gothenburg, Sweden

[20 ]GRID grid.240324.3, ISNI 0000 0001 2109 4251, Department of Radiation Oncology, , Laura and Isaac Perlmutter Cancer Center, ; New York, NY USA

[21 ]GRID grid.489185.9, ISNI 0000 0004 0554 7339, GenesisCare, Michigan Healthcare Professionals, ; Farmington Hills, MI USA

Article

Publisher ID: 9903

DOI: 10.1245/s10434-021-09903-1

PMC ID: 8526470

PubMed ID: 33821346

SO-VID: 71d13d89-effd-4ad1-9dbb-174c7224528f

License:

The article is forthwith distributed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/

History

Date received : 4 December 2020

Date accepted : 8 March 2021

Funding

Funded by: PreludeDX

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ScienceOpen disciplines: Oncology & Radiotherapy

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ScienceOpen disciplines: Oncology & Radiotherapy

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