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

Autor: Manders JB; The Christ Hospital Health Network, Cincinnati, OH, USA. Jennifer.Manders@thechristhospital.com., Kuerer HM; University of Texas MD Anderson Cancer Center, Houston, TX, USA., Smith BD; University of Texas MD Anderson Cancer Center, Houston, TX, USA., McCluskey C; The Christ Hospital Health Network, Cincinnati, OH, USA., Farrar WB; Ohio State University James Cancer Hospital, Columbus, OH, USA., Frazier TG; Bryn Mawr Hospital, Bryn Mawr, PA, USA., Li L; Bryn Mawr Hospital, Bryn Mawr, PA, USA., Leonard CE; Rocky Mountain Cancer Centers, Denver, CO, USA., Carter DL; Rocky Mountain Cancer Centers, Denver, CO, USA., Chawla S; Rochester Regional Health System, Rochester, NY, USA., Medeiros LE; Rochester Regional Health System, Rochester, NY, USA., Guenther JM; Saint Elizabeth Medical Center, Inc., Edgewood, KY, USA., Castellini LE; Saint Elizabeth Medical Center, Inc., Edgewood, KY, USA., Buchholz DJ; UF Health Cancer Center at Orlando Health, Orlando, FL, USA., Mamounas EP; UF Health Cancer Center at Orlando Health, Orlando, FL, USA., Wapnir IL; Stanford Cancer Institute, Stanford University, Palo Alto, CA, USA., Horst KC; Stanford Cancer Institute, Stanford University, Palo Alto, CA, USA., Chagpar A; Yale University, New Haven, CT, USA., Evans SB; Yale University, New Haven, CT, USA., Riker AI; Advocate Christ Medical Center, Oak Lawn, IL, USA.; Louisiana State University Health New Orleans, New Orleans, LA, USA., Vali FS; Advocate Christ Medical Center, Oak Lawn, IL, USA., Solin LJ; Albert Einstein Healthcare Network, Philadelphia, PA, USA., Jablon L; Albert Einstein Healthcare Network, Philadelphia, PA, USA., Recht A; Beth Israel Deaconess Medical Center, Boston, MA, USA., Sharma R; Beth Israel Deaconess Medical Center, Boston, MA, USA., Lu R; Genomic Health, Inc., Redwood City, CA, USA., Sing AP; Genomic Health, Inc., Redwood City, CA, USA., Hwang ES; Duke University Medical Center, Durham, NC, USA., White J; Ohio State University James Cancer Hospital, Columbus, OH, USA.
Jazyk: angličtina
Zdroj: Annals of surgical oncology [Ann Surg Oncol] 2017 Mar; Vol. 24 (3), pp. 660-668. Date of Electronic Publication: 2016 Oct 04.
DOI: 10.1245/s10434-016-5583-7
Abstrakt: 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.
Databáze: MEDLINE