[Assessment of goserelin treatment in adjuvant therapy for premenopausal patients with breast cancer in Japan-zoladex breast cancer study group trial-B].
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.
Mitsuyama
Shosyu
S
Dept. of Surgery, Kitakyushu Municipal Medical Center.
Nomura
Yasuo
Y
Ohno
Shinji
S
Miyauchi
Mitsuru
M
Yamamoto
Naoto
N
Kimura
Tsunehito
T
Saku
Motonori
M
Miura
Shigeto
S
Yoshikawa
Nobuteru
N
Tsujinaka
Toshimasa
T
Koh
Junichi
J
Ishida
Tsunehiro
T
Abe
Osahiko
O
Ohashi
Yasuo
Y
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
D018931:Antineoplastic Agents, Hormonal; D011960:Receptors, Estrogen; D013629:Tamoxifen; D017273:Goserelin; D006160:Guanosine Triphosphate