title: Use of the neo-adjuvant exemestane in post-menopausal estrogen receptor-positive breast cancer: a randomized phase II trial (PTEX46) to investigate the optimal duration of preoperative endocrine therapy.
abstract: OBJECTIVE
  The optimal treatment duration time and the causal relationship between neoadjuvant endocrine therapy and clinical response are not clear. Therefore, we conducted the present study to investigate the potential benefits of neoadjuvant exemestane therapy with the goal of identifying the optimal treatment duration.
  
  
  METHODS
  This study was conducted at three hospitals, as a multicenter, randomized phase II trial(UMIN000005668) of pre-operative exemestane treatment in post-menopausal women with untreated primary breast cancer. Fifty-one post-menopausal women with ER-positive and/or PgR-positive invasive breast cancer were randomly assigned to exemestane for 4 months or 6 months. Clinical response, pathological response, and decisions regarding breast-conserving surgery were the main outcome measures.
  
  
  RESULTS
  Of the 52 patients that enrolled, 51 patients underwent surgery. Of those, 26 and 25 patients had been treated with exemestane for 4 and 6 months, respectively. Treatments were performed at 3 hospitals in Japan between April 2008 and August 2010. The response rates as assessed by clinical examination were 42.3% and 48.0% for 4 and 6 months of treatment, respectively. Pathological responses (minimal response or better) were observed in 19.2% and 32.0% of patients, and breast-conserving surgery was performed on 50.0% and 48.0% of patients from the 4 and 6 month treatment groups, respectively.
  
  
  CONCLUSIONS
  The results of this study demonstrate that responses were equal to 4 or 6 months of exemestane treatment. Therefore, we propose that the rates of breast-conserving surgery could be maximized by 4 months of treatment. Furthermore, in addition to using exemestane as a preoperative treatment in post-menopausal women with ER-positive breast cancer, we envision administering the drug over the long term under careful clinical supervision.
authors.affiliation: Department of Breast Surgery, National Cancer Center Hospital, 1-1 Tsukiji 5-chome, Chuo-ku, Tokyo, Japan. tahojo@ncc.go.jp
authors.forename: Takashi
authors.initials: T
authors.lastname: Hojo
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Shigeru
authors.initials: S
authors.lastname: Imoto
authors.forename: Chikako
authors.initials: C
authors.lastname: Shimizu
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Isaka
authors.forename: Hiroki
authors.initials: H
authors.lastname: Ito
authors.forename: Kentaro
authors.initials: K
authors.lastname: Imi
authors.forename: Noriaki
authors.initials: N
authors.lastname: Wada
authors.forename: Masashi
authors.initials: M
authors.lastname: Ando
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000601:surgery; D002277:Carcinoma / Q000737:chemistry / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017698:Postmenopause; D011960:Receptors, Estrogen / Q000032:analysis; D013997:Time Factors
chemical_list: D000730:Androstadienes; D000970:Antineoplastic Agents; D011960:Receptors, Estrogen; C056516:exemestane