Abstract
The international CONFIRM study showed that fulvestrant 500 mg improved progression-free survival (PFS) vs fulvestrant 250 mg in postmenopausal women with estrogen receptor (ER)-positive locally advanced/metastatic breast cancer (LA/MBC). In this randomized, double-blind study, postmenopausal Chinese women with ER-positive LA/MBC and progression after endocrine therapy received fulvestrant 500 mg (days 0, 14, 28, and every 28 days thereafter) or fulvestrant 250 mg (every 28 days). Consistency with the international study was assumed if the hazard ratio (HR) for comparison of PFS (primary endpoint) was < 1 (stratified log-rank test). The study was not powered to assess between-group differences.In total, 221 patients were randomized (fulvestrant 500 mg: n = 111; fulvestrant 250 mg: n = 110). Baseline characteristics were balanced. Median PFS was 8.0 months with fulvestrant 500 mg vs 4.0 months with 250 mg (HR = 0.75; 95% confidence interval [CI] 0.54−1.03; P = 0.078). PFS (HR; 95% CI) favored fulvestrant 500 mg in post-antiestrogen (0.86; 0.54−1.37) and post-aromatase inhibitor (0.65; 0.42−1.03) settings. No new safety considerations were observed. These results are consistent with the international CONFIRM study, supporting the superior clinical benefit of fulvestrant 500 mg in women with ER-positive LA/MBC experiencing progression following prior endocrine therapy.
Highlights
Breast cancer is one of the most common female cancers, with approximately 521,900 women dying of breast cancer annually [1]
The international CONFIRM study showed that fulvestrant 500 mg improved progression-free survival (PFS) vs fulvestrant 250 mg in postmenopausal women with estrogen receptor (ER)-positive locally advanced/metastatic breast cancer (LA/ MBC)
The study was not powered to detect significant differences between treatment groups; results met the predefined criterion for consistency with the international CONFIRM study (HR < 1 for the treatment comparison of PFS)
Summary
Breast cancer is one of the most common female cancers, with approximately 521,900 women dying of breast cancer annually [1]. Endocrine therapies are an established treatment for postmenopausal women with hormone receptor-positive advanced breast cancer (estrogen receptor [ER]-positive and/or progesterone receptor [PgR]-positive) [2, 3]. Given that many patients eventually experience disease progression in this setting, non-cross-resistant endocrine therapies are required to provide optimal disease control throughout the treatment cascade [4]. Fulvestrant was originally approved at a dose of 250 mg/month following global registration studies that demonstrated that fulvestrant 250 mg was at least as effective as anastrozole for the treatment of advanced breast cancer in postmenopausal women with disease progression following prior endocrine therapy [6, 7]. Fulvestrant has been shown to induce a response in tumors which have developed resistance to antiestrogen and aromatase inhibitor therapies [4, 8,9,10]
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