FULVESTRANT COMBINED WITH GOSERELIN FOR PREMENOPAUSAL BREAST CANCER PATIENTS 

Eur J Cancer. 2012 Mar 27. [Epub ahead of print]

Ovarian function suppression and fulvestrant as endocrine therapy in premenopausal women with metastatic breast cancer.

Bartsch R, Bago-Horvath Z, Berghoff A, Devries C, Pluschnig U, Dubsky P, Rudas M, Mader RM, Rottenfusser A, Fitzal F, Gnant M, Zielinski CC, Steger GG.

Source

Comprehensive Cancer Center Vienna, Medical University of Vienna, Austria; Department of Medicine I, Clinical Division of Oncology, Medical University of Vienna, Austria.

Abstract

BACKGROUND:

Endocrine therapy is the preferred treatment for hormone-receptor (HR) positive metastatic breast cancer. In premenopausal patients, ovarian function suppression with goserelin in combination with anastrozole yielded promising results in phase II studies. Fulvestrant, a pure antioestrogen, yields high rates of disease stabilisation in postmenopausal women. Therefore, we investigated the feasibility and safety of fulvestrant plus goserelin in premenopausal women with HR-positive metastatic breast cancer.

METHODS:

Premenopausal patients with metastatic breast cancer eligible for endocrine treatment received fulvestrant 250mg and goserelin 3.6mg every four weeks as first- to fourth-line therapy. Clinical benefit rate (CBR; response rate plus disease stabilisation ⩾6months) was defined as the primary study end-point. Time to progression (TTP) and overall survival (OS) were estimated using the Kaplan-Meier product limit method.

FINDINGS:

Twenty-six patients received treatment as scheduled. 81% were pre-treated with tamoxifen and 69% had received prior aromatase inhibitors in combination with goserelin. The majority of patients (69%) presented with visceral metastases. Complete response was observed in a single patient, partial response in three and disease stabilisation ⩾6months in eleven patients, resulting in a CBR of 58%. Median TTP was 6months (95%confidence interval (CI), 2.4-9.6) and OS 32months (95%CI, 14.28-49.72), respectively.

INTERPRETATION:

Results suggest that the combination of fulvestrant and goserelin offers promising activity in premenopausal patients and further investigation is warranted.