title: Prospective study of the effect of the 21-gene assay on adjuvant clinical decision-making in Japanese women with estrogen receptor-positive, node-negative, and node-positive breast cancer.
abstract: BACKGROUND
  In this study we investigated if the 21-gene assay result affects adjuvant decision-making in Japanese women with ER+ invasive EBC.
  
  
  METHODS
  A total of 124 consecutive eligible patients with ER+, HER2-negative EBC and 0 to 3 positive lymph nodes were enrolled. Treatment recommendations, physicians' confidence and patients' decisional conflict before and after knowledge of the Recurrence Score results of the 21-gene assay were recorded.
  
  
  RESULTS
  One-hundred four patients (84%) had N0 disease, including micrometastases, and 20 (16%) had N+ disease. Overall, recommendations changed in 33% (95% CI, 24%-43%) of N0 and 65% (95% CI, 41%-85%) of N+ patients. In 27 of 48 (56%) of N0 and 13 of 15 (87%) of N+ patients an initial recommendation for chemohormonal therapy was revised to only hormonal therapy after assay results, and in 7 of 56 (13%) of N0 and 0 of 5 N+ patients from only hormonal to combined chemohormonal therapy. Decisions appeared to follow the Recurrence Score results for low and high values. For patients with intermediate Recurrence Score values, overall recommendations for chemohormonal treatment tended to decrease after assay results. Physicians' confidence increased in 106 of 124 (85.5%; 95% CI, 78%-91%) cases. Patients' decisional conflict significantly improved as indicated by changes in the total score and the 5 defined subscores (P = .014 for Informed Subscore; P < .001 for all others).
  
  
  CONCLUSIONS
  Results from this prospective study in a Japanese population confirm an effect of the 21-gene assay results on adjuvant treatment decision-making, consistent with reported experiences from the United States and Europe.
authors: St Luke's International Hospital, Department of Breast Surgery, Tokyo, Japan. Electronic address: hideyama@luke.or.jp.
authors: Hideko
authors: H
authors: Yamauchi
authors: St Luke's International Hospital, Department of Breast Surgery, Tokyo, Japan.
authors: Chizuko
authors: C
authors: Nakagawa
authors: Saitama Cancer Center, Division of Breast Surgery, Saitama, Japan.
authors: Hiroyuki
authors: H
authors: Takei
authors: Genomic Health, Inc, Redwood City, CA.
authors: Calvin
authors: C
authors: Chao
authors: Genomic Health, Inc, Redwood City, CA.
authors: Carl
authors: C
authors: Yoshizawa
authors: St Luke's International Hospital, Department of Breast Surgery, Tokyo, Japan.
authors: Hiroshi
authors: H
authors: Yagata
authors: St Luke's International Hospital, Department of Breast Surgery, Tokyo, Japan.
authors: Atsushi
authors: A
authors: Yoshida
authors: St Luke's International Hospital, Department of Breast Surgery, Tokyo, Japan.
authors: Naoki
authors: N
authors: Hayashi
authors: Medical Affairs Consulting, Speyer, Germany.
authors: Susanne
authors: S
authors: Hell
authors: St Luke's International Hospital, Department of Breast Surgery, Tokyo, Japan; Department of Breast Surgery, Showa University, Tokyo, Japan.
authors: Seigo
authors: S
authors: Nakamura
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology*; D017024:Chemotherapy, Adjuvant; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D011960:Receptors, Estrogen / Q000235:genetics
chemical_list: D011960:Receptors, Estrogen
keywords: Adjuvant; Chemotherapy; Early breast cancer; Multi-gene assay; Recurrence Score