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Breast Cancer. 2016 Sep;23(5):771-9. doi: 10.1007/s12282-015-0637-4. Epub 2015 Sep 9.

Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer.

Author information

1
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita City, Osaka, 565-0871, Japan. noguchi@onsurg.med.osaka-u.ac.jp.
2
Department of Surgery, Asan Medical Center, Seoul, Korea.
3
Cancer Clinic, Iloilo, Philippines.
4
Breast Disease Management Group, Tata Memorial Hospital, Mumbai, India.
5
Department of Breast Oncology, Niigata Cancer Center Hospital, Niigata, Japan.
6
Department of Surgery, China Medical University Hospital, Taichung, Taiwan.
7
Division of General Surgery, Rajavithi Hospital, Bangkok, Thailand.
8
Great Saviour International Hospital, Iloilo, Philippines.
9
Department of Breast and Thyroid Surgery, Ulsan City Hospital, Ulsan, Korea.
10
AstraZeneca K.K., Osaka, Japan.

Abstract

BACKGROUND:

Monthly goserelin 3.6 mg dosing suppresses estradiol (E2) production and has proven efficacy in pre-menopausal women with estrogen receptor (ER)-positive breast cancer. This non-inferiority study evaluated the efficacy and safety of 3-monthly goserelin 10.8 mg compared with monthly goserelin 3.6 mg.

METHODS:

This was a Phase 3, open-label, multicenter trial. Pre-menopausal women with ER-positive advanced breast cancer were randomized to 3-monthly goserelin 10.8 mg or monthly goserelin 3.6 mg; all patients received concomitant tamoxifen (20 mg daily). The primary endpoint was progression-free survival (PFS) rate at 24 weeks; non-inferiority was to be confirmed if the entire 95 % confidence interval (CI) for the treatment difference was above -17.5 %. Secondary endpoints included objective response rate (ORR), serum E2 levels, safety, and tolerability.

RESULTS:

In total, 222 patients were randomized (goserelin 10.8 mg, n = 109; goserelin 3.6 mg, n = 113). PFS rate at week 24 was 61.5 % (goserelin 10.8 mg) and 60.2 % (goserelin 3.6 mg); treatment difference (95 % CI) was 1.3 % (-11.4, 13.9), confirming non-inferiority of goserelin 10.8 mg compared with goserelin 3.6 mg. ORR was 23.9 % (goserelin 10.8 mg) and 26.9 % (goserelin 3.6 mg); treatment difference (95 % CI) was -3.0 % (-15.5, 9.7). At week 24, mean serum E2 concentrations were similar in the goserelin 10.8 mg and goserelin 3.6 mg groups (20.3 pg/mL and 24.8 pg/mL, respectively).

CONCLUSION:

A regimen of 3-monthly goserelin 10.8 mg demonstrated non-inferiority compared with monthly goserelin 3.6 mg for PFS rate at 24 weeks, with similar pharmacodynamic and safety profiles, in pre-menopausal women with ER-positive breast cancer.

KEYWORDS:

Advanced breast cancer; Estrogen receptor; Goserelin; Pre-menopausal; Progression-free survival

PMID:
26350351
PMCID:
PMC4999470
DOI:
10.1007/s12282-015-0637-4
[Indexed for MEDLINE]
Free PMC Article

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