title: Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection.
abstract: OBJECTIVE
  The 21-gene Recurrence Score (RS) assay has been validated to quantify the risk of distant recurrence in tamoxifen-treated patients with lymph node-negative, estrogen receptor-positive breast cancer and predict magnitude of chemotherapy benefit. This multicenter study was designed to prospectively examine whether RS affects physician and patient adjuvant treatment selection and satisfaction.
  
  
  METHODS
  Before and after obtaining the 21-gene RS assay, medical oncologists stated their adjuvant treatment recommendation and confidence in it. Patients also indicated their treatment choice pre- and post-RS assay. Patients completed measures for decisional conflict, anxiety, and quality of life.
  
  
  RESULTS
  Seventeen medical oncologists at one community and three academic practices consecutively enrolled 89 assessable patients. The medical oncologist treatment recommendation changed for 28 patients (31.%). Twenty-four patients (27%) changed their treatment decision. The largest change after the RS results was conversion from the medical oncologist's pretest recommendation for chemotherapy plus hormonal therapy (CHT) to post-test recommendation for hormone therapy (HT) in 20 cases (22.5%). Nine patients (10.1%) changed their treatment decision from CHT to HT. RS results increased medical oncologist confidence in their treatment recommendation in 68 cases (76%). Patient anxiety and decisional conflict were significantly lower after RS results.
  
  
  CONCLUSIONS
  The results of this study indicate that the RS assay impacts medical oncologist adjuvant treatment recommendations, patient treatment choice, and patient anxiety.
authors.affiliation: Loyola University Medical Center, Cardinal Bernardin Cancer Center, 2160 S First Ave, Maywood, IL 60153, USA. shlo@lumc.edu
authors.forename: Shelly S
authors.initials: SS
authors.lastname: Lo
authors.forename: Patricia B
authors.initials: PB
authors.lastname: Mumby
authors.forename: John
authors.initials: J
authors.lastname: Norton
authors.forename: Karen
authors.initials: K
authors.lastname: Rychlik
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Smerage
authors.forename: Joseph
authors.initials: J
authors.lastname: Kash
authors.forename: Helen K
authors.initials: HK
authors.lastname: Chew
authors.forename: Ellen R
authors.initials: ER
authors.lastname: Gaynor
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Hayes
authors.forename: Andrew
authors.initials: A
authors.lastname: Epstein
authors.forename: Kathy S
authors.initials: KS
authors.lastname: Albain
mesh_terms: D000328:Adult; D000368:Aged; D001007:Anxiety / Q000209:etiology; D001943:Breast Neoplasms / Q000235:genetics* / Q000523:psychology / Q000628:therapy*; D003657:Decision Making; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D008495:Medical Oncology; D008875:Middle Aged; D057240:Patient Preference; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life