title: [Assessment of goserelin treatment in adjuvant therapy for premenopausal patients with breast cancer in Japan-zoladex breast cancer study group trial-B].
abstract: OBJECTIVE
  Goserelin (GOS) therapy in an adjuvant setting for estrogen receptor(ER)-positive premenopausal patients with breast cancer was assessed in a randomised comparative study.
  
  
  METHODS
  ER positive premenopausal patients with n + or n 0 and T > or = 3 cm received tamoxifen (TAM) 20 mg/day, GOS 3.6 mg/4 weeks or GOS + TAM for 2 years, and the clinical efficacy and safety of these regimens were assessed.
  
  
  RESULTS
  In the data analysis of total 207 patients, hazard ratios of disease free survival (DFS) and overall survival (OS) in the GOS group compared to the TAM group were 0.87 and 2.10,respectively. The incidence of adverse drug reactions was similar (42-55%) in all three groups. Since the number of patients in this study did not reach the target number, the efficacy could not be assessed from a statistical aspect. Therefore,meta-analysis with similar foreign studies(ZIPP) was implemented. The results of meta-analysis showed that the hazard ratios of DFS and OS in the GOS group compared to the non-GOS group were 0.83 and 0.85, respectively.
  
  
  CONCLUSIONS
  Although the analysis of 207 patients did not show any statistically significant difference between each of the treatment groups, the results of meta-analysis showed a significant prolongation of DFS in the GOS group. Also high tolerability of GOS was suggested. From these results, GOS was considered highly useful in adjuvant therapy for ER-positive premenopausal patients with breast cancer.
authors.affiliation: Dept. of Surgery, Kitakyushu Municipal Medical Center.
authors.forename: Shosyu
authors.initials: S
authors.lastname: Mitsuyama
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Nomura
authors.forename: Shinji
authors.initials: S
authors.lastname: Ohno
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Miyauchi
authors.forename: Naoto
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Tsunehito
authors.initials: T
authors.lastname: Kimura
authors.forename: Motonori
authors.initials: M
authors.lastname: Saku
authors.forename: Shigeto
authors.initials: S
authors.lastname: Miura
authors.forename: Nobuteru
authors.initials: N
authors.lastname: Yoshikawa
authors.forename: Toshimasa
authors.initials: T
authors.lastname: Tsujinaka
authors.forename: Junichi
authors.initials: J
authors.lastname: Koh
authors.forename: Tsunehiro
authors.initials: T
authors.lastname: Ishida
authors.forename: Osahiko
authors.initials: O
authors.lastname: Abe
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D017273:Goserelin / Q000008:administration & dosage* / Q000009:adverse effects; D006160:Guanosine Triphosphate / Q000097:blood; D019584:Hot Flashes / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D017697:Premenopause; D016016:Proportional Hazards Models; D011788:Quality of Life; D011960:Receptors, Estrogen / Q000032:analysis; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D018931:Antineoplastic Agents, Hormonal; D011960:Receptors, Estrogen; D013629:Tamoxifen; D017273:Goserelin; D006160:Guanosine Triphosphate