title: Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ.
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.
authors.affiliation: The Christ Hospital Health Network, Cincinnati, OH, USA. Jennifer.Manders@thechristhospital.com.
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: Manders
authors.affiliation: University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Henry M
authors.initials: HM
authors.lastname: Kuerer
authors.affiliation: University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Benjamin D
authors.initials: BD
authors.lastname: Smith
authors.affiliation: The Christ Hospital Health Network, Cincinnati, OH, USA.
authors.forename: Cornelia
authors.initials: C
authors.lastname: McCluskey
authors.affiliation: Ohio State University James Cancer Hospital, Columbus, OH, USA.
authors.forename: William B
authors.initials: WB
authors.lastname: Farrar
authors.affiliation: Bryn Mawr Hospital, Bryn Mawr, PA, USA.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Frazier
authors.affiliation: Bryn Mawr Hospital, Bryn Mawr, PA, USA.
authors.forename: Linna
authors.initials: L
authors.lastname: Li
authors.affiliation: Rocky Mountain Cancer Centers, Denver, CO, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Leonard
authors.affiliation: Rocky Mountain Cancer Centers, Denver, CO, USA.
authors.forename: Dennis L
authors.initials: DL
authors.lastname: Carter
authors.affiliation: Rochester Regional Health System, Rochester, NY, USA.
authors.forename: Sheema
authors.initials: S
authors.lastname: Chawla
authors.affiliation: Rochester Regional Health System, Rochester, NY, USA.
authors.forename: Lori E
authors.initials: LE
authors.lastname: Medeiros
authors.affiliation: Saint Elizabeth Medical Center, Inc., Edgewood, KY, USA.
authors.forename: J Michael
authors.initials: JM
authors.lastname: Guenther
authors.affiliation: Saint Elizabeth Medical Center, Inc., Edgewood, KY, USA.
authors.forename: Lauren E
authors.initials: LE
authors.lastname: Castellini
authors.affiliation: UF Health Cancer Center at Orlando Health, Orlando, FL, USA.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Buchholz
authors.affiliation: UF Health Cancer Center at Orlando Health, Orlando, FL, USA.
authors.forename: Eleftherios P
authors.initials: EP
authors.lastname: Mamounas
authors.affiliation: Stanford Cancer Institute, Stanford University, Palo Alto, CA, USA.
authors.forename: Irene L
authors.initials: IL
authors.lastname: Wapnir
authors.affiliation: Stanford Cancer Institute, Stanford University, Palo Alto, CA, USA.
authors.forename: Kathleen C
authors.initials: KC
authors.lastname: Horst
authors.affiliation: Yale University, New Haven, CT, USA.
authors.forename: Anees
authors.initials: A
authors.lastname: Chagpar
authors.affiliation: Yale University, New Haven, CT, USA.
authors.forename: Suzanne B
authors.initials: SB
authors.lastname: Evans
authors.affiliation: Advocate Christ Medical Center, Oak Lawn, IL, USA.|Louisiana State University Health New Orleans, New Orleans, LA, USA.
authors.forename: Adam I
authors.initials: AI
authors.lastname: Riker
authors.affiliation: Advocate Christ Medical Center, Oak Lawn, IL, USA.
authors.forename: Faisal S
authors.initials: FS
authors.lastname: Vali
authors.affiliation: Albert Einstein Healthcare Network, Philadelphia, PA, USA.
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Solin
authors.affiliation: Albert Einstein Healthcare Network, Philadelphia, PA, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Jablon
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Abram
authors.initials: A
authors.lastname: Recht
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Ranjna
authors.initials: R
authors.lastname: Sharma
authors.affiliation: Genomic Health, Inc., Redwood City, CA, USA.
authors.forename: Ruixiao
authors.initials: R
authors.lastname: Lu
authors.affiliation: Genomic Health, Inc., Redwood City, CA, USA.
authors.forename: Amy P
authors.initials: AP
authors.lastname: Sing
authors.affiliation: Duke University Medical Center, Durham, NC, USA.
authors.forename: E Shelley
authors.initials: ES
authors.lastname: Hwang
authors.affiliation: Ohio State University James Cancer Hospital, Columbus, OH, USA.
authors.forename: Julia
authors.initials: J
authors.lastname: White
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000209:etiology; D001943:Breast Neoplasms / Q000235:genetics* / Q000532:radiotherapy* / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000235:genetics* / Q000532:radiotherapy* / Q000601:surgery; D000066491:Clinical Decision-Making; D003220:Conflict, Psychological; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D000072378:Radiation Oncologists; D018714:Radiotherapy, Adjuvant; D018570:Risk Assessment / Q000379:methods; D066231:Surgeons; D011795:Surveys and Questionnaires