In women with early breast cancer, goserelin 10.8 mg was non-inferior to 3.6 mg for estradiol AUC (ratio 0.974; 95% CI 0.80, 1.19).
In plain wordsIn women with breast cancer, three-monthly goserelin 10.8 mg met the non-inferiority criterion versus monthly 3.6 mg for estradiol suppression.
- Peptide
- Goserelin
- Outcome
- Direction not reportedEstradiol AUC over 24 weeks
- Study
n = 170
- Comparator
- Goserelin 3.6 mg monthly
- Analysis
- Primary
- Outcome group
- Sex hormones and fertility · Endocrine and hormones
- Studied dose
- 10.8 mg every 3 months · 24 weeksAs given in this study (human).
Measurements
- Estradiol AUC
- 18.32 pg/ml·week
- Goserelin 10.8 mg
- Estradiol AUC
- 18.95 pg/ml·week
- Goserelin 3.6 mg
- AUC ratio
- 0.974
- 95% confidence interval 0.80, 1.19
Source sentences
Mean AUCs for E(2) were similar between treatment groups (18.32 and 18.95 pg/ml·week for goserelin 10.8 and 3.6 mg, respectively).
4 context sentences(design, population, supporting numbers)
AUC ratio was 0.974 (95% confidence interval, 0.80, 1.19), indicating non-inferiority for goserelin 10.8 mg.
This study compared the efficacy and safety of a 3-monthly 10.8-mg depot goserelin (Zoladex(TM)) injection with the current 3.6 mg monthly dose in pre-menopausal Japanese women with estrogen receptor-positive (ER+) early breast cancer.
This was a multicenter, open-label, randomized study.
In total, 170 patients were randomized to receive goserelin 10.8 mg every 3 months (n = 86) or 3.6 mg every month (n = 84).