title: Phase III randomized trial of toremifene versus tamoxifen for Japanese postmenopausal patients with early breast cancer.
abstract: BACKGROUND
  Toremifene, a selective estrogen receptor modulator, is used as adjuvant therapy for postmenopausal patients with breast cancer in Japan. For Japanese patients, however, only limited data are available on the efficacy and safety profile of toremifene. To establish the long term efficacy and safety of toremifene for Japanese patients, we conducted a prospective, multicenter, randomized phase III trial comparing toremifene and tamoxifen.
  
  
  METHODS
  The subjects were postmenopausal Japanese patients who had undergone surgery for node-negative breast cancer. Toremifene or tamoxifen was administered for 2 years. The primary endpoint was demonstration of the non-inferiority of toremifene compared with tamoxifen in respect of 5-year survival. Secondary endpoints were cumulative overall survival, cumulative disease-free survival, effects on lipid profiles, and adverse events.
  
  
  RESULTS
  A total of 253 patients were enrolled. The baseline characteristics of the two treatment groups were well-balanced. Median follow-up was 66.5 months. Five-year survival was similar for toremifene and tamoxifen (97.0 vs. 96.9 %; 90 % confidence interval -3.9 to 4.1), indicating that toremifene is not inferior to tamoxifen for postmenopausal Japanese patients with early breast cancer. Cumulative overall survival and cumulative disease-free survival were also very similar for toremifene and tamoxifen (97.5 vs. 97.3 %, log-rank test P = 0.9458; 88.4 vs. 90.6 %, log-rank test P = 0.3359, respectively). Adverse events in both groups were similar and mostly mild or moderate. Thus, both are equally effective and well tolerated.
  
  
  CONCLUSIONS
  Our results suggest that the efficacy and safety of toremifene and tamoxifen are equivalent for postmenopausal Japanese patients with early breast cancer.
authors.affiliation: Department of Surgery, Gunma Cancer Center, Ota, Japan, mkimura@qk9.so-net.ne.jp.
authors.forename: Morihiko
authors.initials: M
authors.lastname: Kimura
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tominaga
authors.forename: Izo
authors.initials: I
authors.lastname: Kimijima
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takatsuka
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Nomura
authors.forename: Fujio
authors.initials: F
authors.lastname: Kasumi
authors.forename: Akihiro
authors.initials: A
authors.lastname: Yamaguchi
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Shinzaburo
authors.initials: S
authors.lastname: Noguchi
authors.forename: Nobuoki
authors.initials: N
authors.lastname: Eshima
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use; D044466:Asian People; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects / Q000627:therapeutic use; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*; D017312:Toremifene / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; D017312:Toremifene