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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 3/2017

Open Access 01-03-2017 | Breast Oncology

Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ

Authors: Jennifer B. Manders, MD, Henry M. Kuerer, MD, PhD, Benjamin D. Smith, MD, Cornelia McCluskey, MD, William B. Farrar, MD, Thomas G. Frazier, MD, Linna Li, MD, Charles E. Leonard, MD, Dennis L. Carter, MD, Sheema Chawla, MD, Lori E. Medeiros, MD, J. Michael Guenther, MD, Lauren E. Castellini, MD, Daniel J. Buchholz, MD, Eleftherios P. Mamounas, MD, Irene L. Wapnir, MD, Kathleen C. Horst, MD, Anees Chagpar, MD, Suzanne B. Evans, MD, Adam I. Riker, MD, Faisal S. Vali, MD, Lawrence J. Solin, MD, Lisa Jablon, MD, Abram Recht, MD, Ranjna Sharma, MD, Ruixiao Lu, PhD, Amy P. Sing, MD, E. Shelley Hwang, MD, Julia White, MD, Study investigators and study participants

Published in: Annals of Surgical Oncology | Issue 3/2017

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Abstract

Objective

The aim of this study was to determine the impact of the results of the 12-gene DCIS Score assay on (i) radiotherapy recommendations for patients with pure ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS), and (ii) patient decisional conflict and state anxiety.

Methods

Thirteen sites across the US enrolled patients (March 2014–August 2015) with pure DCIS undergoing BCS. Prospectively collected data included clinicopathologic factors, physician estimates of local recurrence risk, DCIS Score results, and pre-/post-assay radiotherapy recommendations for each patient made by a surgeon and a radiation oncologist. Patients completed pre-/post-assay decisional conflict scale and state-trait anxiety inventory instruments.

Results

The analysis cohort included 127 patients: median age 60 years, 80 % postmenopausal, median size 8 mm (39 % ≤5 mm), 70 % grade 1/2, 88 % estrogen receptor-positive, 75 % progesterone receptor-positive, 54 % with comedo necrosis, and 18 % multifocal. Sixty-six percent of patients had low DCIS Score results, 20 % had intermediate DCIS Score results, and 14 % had high DCIS Score results; the median result was 21 (range 0–84). Pre-assay, surgeons and radiation oncologists recommended radiotherapy for 70.9 and 72.4 % of patients, respectively. Post-assay, 26.4 % of overall recommendations changed, including 30.7 and 22.0 % of recommendations by surgeons and radiation oncologists, respectively. Among patients with confirmed completed questionnaires (n = 32), decision conflict (p = 0.004) and state anxiety (p = 0.042) decreased significantly from pre- to post-assay.

Conclusions

Individualized risk estimates from the DCIS Score assay provide valuable information to physicians and patients. Post-assay, in response to DCIS Score results, surgeons changed treatment recommendations more often than radiation oncologists. Further investigation is needed to better understand how such treatment changes may affect clinical outcomes.
Appendix
Available only for authorised users
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Metadata
Title
Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ
Authors
Jennifer B. Manders, MD
Henry M. Kuerer, MD, PhD
Benjamin D. Smith, MD
Cornelia McCluskey, MD
William B. Farrar, MD
Thomas G. Frazier, MD
Linna Li, MD
Charles E. Leonard, MD
Dennis L. Carter, MD
Sheema Chawla, MD
Lori E. Medeiros, MD
J. Michael Guenther, MD
Lauren E. Castellini, MD
Daniel J. Buchholz, MD
Eleftherios P. Mamounas, MD
Irene L. Wapnir, MD
Kathleen C. Horst, MD
Anees Chagpar, MD
Suzanne B. Evans, MD
Adam I. Riker, MD
Faisal S. Vali, MD
Lawrence J. Solin, MD
Lisa Jablon, MD
Abram Recht, MD
Ranjna Sharma, MD
Ruixiao Lu, PhD
Amy P. Sing, MD
E. Shelley Hwang, MD
Julia White, MD
Study investigators and study participants
Publication date
01-03-2017
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 3/2017
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-016-5583-7

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