Background: In the management of DCIS clinicians and patients (pts) must choose between the various options for breast conservation treatment based on an assessment of local recurrence (LR) risk. Traditional clinicopathologic (CP) factors such as age, size, grade, margin width or comedo necrosis, provide an average LR risk derived from clinical trials and population studies. The Oncotype DX® 12-gene assay for DCIS gives individual 10-yr LR risk estimates and has now been validated in two studies in a total of 893 pts. We report the 2nd study assessing the impact of the DCIS Score result on XRT recommendations. In addition, surveys assessing pt and physician confidence will provide insight into the overall clinical utility of the DCIS Score result. Baseline characteristics including the pre-assay LR risk and XRT recommendation are described here; final results on change in XRT recommendation from pre- to post-assay and distribution of the score across the CP factors will be presented. Methods: 13 U.S. sites enrolled pts with DCIS from 3/2014-5/2015. Pts with LCIS but no DCIS, invasive BC, or planned mastectomy were excluded. Data were prospectively collected on CP factors, physician estimates of LR risk, DCIS score, and pre/post XRT recommendation. Each pt had a surgeon and radiation oncologist complete study surveys. Pt surveys were also administered pre/post assay for decision conflict and the STAIT anxiety survey. The LR risk estimates and XRT recommendations were analyzed for all physicians as well as by specialty. Descriptive statistics summarized study variables. 95% Clopper-Pearson Exact CIs were calculated for percent change in XRT recommendation. McNemar's test was used to determine if the proportion of pts had a significant change in XRT recommendation post assay. Paired t-tests were used to compare physician estimates of recurrence risk pre/post assay. Results: Of the 121 pts enrolled, median age was 61y (34-83) and 80.2% were postmenopausal. Median size was 8mm and 40% were < 5mm; 22.3% were grade 1, 51.2% grade 2, and 26.4% grade 3. Comedo necrosis was noted in 55.4% and 19% had multiple foci. Median margin width was 3mm and 47.1% had margins 1-3mm. ER and PR by IHC were positive in 88.4% and 75.2% of pts. Among the 242 MD risk assessments, mean 10-yr LR risk was 14.8% (range 4-50%) for any LR; 14.2% for surgeons and 15.3% for radiation oncologists. The pre-assay XRT recommendation was 70.2%; 68.6% for surgeons and 71.9% for radiation oncologists. Conclusions: The role of new molecular tools such as the DCIS Score assay that provide individual risk estimates for LR on treatment decisions is evolving. The DCIS pts enrolled in the study reveal inclusion of baseline features like higher nuclear grade (26%), comedo necrosis (55%) and margin width of 1-3mm (47%) that have historically been associated with XRT use. This represents a continued broadening of the assay use from the predominantly lower risk DCIS cohort in the 1st validation study (E5194). The impact on XRT decisions is critical to establishing the clinical utility of the assay. The decision impact analysis, differences in use of the assay among surgeons and radiation oncologists and the impact on overall confidence with the treatment decision will be presented. Citation Format: Manders JB, Kuerer HM, Smith BD, McCluskey C, Farrar WB, Frazier TG, Li L, Leonard CE, Carter DL, Chawla S, Medeiros LE, Guenther JM, Castellini LE, Buchholz DJ, Mamounas EP, Wapnir IL, Horst KC, Chagpar A, Evans SB, Riker AI, Vali FS, Solin LJ, Jablon L, Recht A, Sharma R, Lu R, Sing AP, Hwang ES, White J. The 12-gene DCIS score assay: Impact on radiation treatment (XRT) recommendations and clinical utility. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-17-03.
Background:Better tools are needed to estimate the risk of local recurrence (LR; DCIS or invasive) after breast-conserving surgery (BCS) for pts with DCIS in order to inform treatment decisions. Traditional clinico-pathologic (CP) factors, e.g., age and tumor size, provide an average LR risk derived from clinical trials and population studies. The Oncotype DX 12-gene DCIS Score assay has been validated to provide individual 10 yr LR risk estimates (Solin JNCI 2013; Rakovitch BCRT 2015). Previously we reported the impact of the DCIS Score result on radiotherapy (RT) recommendations including the pre-assay LR risk and RT recommendation and the change in RT recommendation from pre- to post-assay (Manders Ann Surg Oncol 2016).Recently a patient specific meta-analysis (MA) combined data from E5194 and Ontario DCIS Cohort (ODC) adjusting for pertinent clinico-pathologic factors to provide refined prediction estimates of LR risk after BCS alone (Rakovitch ASCO 2017). Herein we applied these risk estimates integrating DS, tumor size and patient age with adjustment for diagnosis in the year 2000 or later to refine estimates of LR in DCIS patients from the Manders et al study. Methods: 13 U.S. sites enrolled pts with DCIS treated with BCS alone from 3/2014 to 5/2015. Pts with LCIS but no DCIS, invasive BC, or planned mastectomy were excluded. Data were prospectively collected on CP factors, physician estimates of LR risk, and DCIS Score. Refined estimates of 10-yr risk of LR are presented by DCIS Score result category (0-38; 39-54; 55-100), age group (≥50 vs <50 yr) and tumor size (≤1; >1-2.5; >2.5 cm). Results: Of the 127 pts enrolled, median age was 60 yr,79.5% were postmenopausal. Median size was 8mm & 39% were ≤5mm. Median margin width was 3.0mm. ER and PR by IHC were positive in 89% and 78% of pts, respectively. For patients ≥50 yr with tumors ≤1 cm and low risk DS, the 10-yr LR risk ranges from 5.3-10.0%. A high DS result is associated with a higher 10-yr median predicted risk of LR in all subsets (table 1). The DCIS Score integrated with tumor size and patient age and the adjustment for diagnosis in 2000 or later provided risk estimates that are often lower than those provided by the DCIS Score alone without adjustment for diagnostic year. Using DS alone the percentage of patients with risk of LR <8% was 0%; however, incorporating patient age and tumor size with the DS and adjusting for diagnosis in 2000 or later, it increased to 30.9% of patients. Conclusions: Integration of the DCIS Score assay, that provides individual risk estimates of LR, with patient age and DCIS tumor size and adjusting for diagnosis in 2000 or later, provides refined estimates of 10-yr LR risk after BCS alone for DCIS. This integration enhances prognostic LR risk estimates and frequently provides lower risk estimates with which to guide individualized treatment decisions. Distribution of 10-year risk of local recurrence using DCIS Score (DS), tumor size, and age, adjusting for diagnosis in 2000 or later. Low DS (<39)Inter DS (39-54)High DS (≥55)Tumor Size(cm)Age(Yr)NMedian (Min-Max)%NMedian (Min-Max)%NMedian (Min-Max)%≤1≥50457.0 (5.3-10)810.8 (10.2-11.8)1015.1 (12.9-18.6) <50810.3 (7.4-12.1)414.9 (14.1-15.4)0 >1-2.5≥50249.5 (7.3-12.6)914.2 (12.9-15.6)519.6 (16.5-20.4) < 50216.4 (16.1-16.7)220.4 (19.8-21.1)122.2 (22.2-22.2)>2.5≥50515.7 (14.9-23.7)0 138.4 (38.4-38.4) <500 141.2 (41.2-41.2)149.3 (49.3-49.3) Citation Format: Manders JB, Solin LJ, Leonard CE, Mamounas EP, Lu R, Turner M, Baehner FL, White J. Refined estimates of local recurrence risk in a clinical utility study: Integrating the DCIS score, patient age and DCIS tumor size [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-15-09.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.