title: Fulvestrant 500 mg vs 250 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer: a randomized, double-blind registrational trial in China.
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.
authors.affiliation: Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.
authors.forename: Qingyuan
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: Fudan University Shanghai Cancer Center, Shanghai, China.
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Shao
authors.affiliation: Shanghai Ruijin Hospital, Shanghai, China.
authors.forename: Kunwei
authors.initials: K
authors.lastname: Shen
authors.affiliation: The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.affiliation: Jiangsu Cancer Hospital, Nanjing, Jiangsu, China.
authors.forename: Jifeng
authors.initials: J
authors.lastname: Feng
authors.affiliation: Tianjin Cancer Hospital, Tianjin, China.
authors.forename: Zhongsheng
authors.initials: Z
authors.lastname: Tong
authors.affiliation: The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
authors.forename: Kangsheng
authors.initials: K
authors.lastname: Gu
authors.affiliation: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China.
authors.forename: Xiaojia
authors.initials: X
authors.lastname: Wang
authors.affiliation: Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Binghe
authors.initials: B
authors.lastname: Xu
authors.affiliation: AstraZeneca, Shanghai, China.
authors.forename: Guofang
authors.initials: G
authors.lastname: Sun
authors.affiliation: AstraZeneca, Shanghai, China.
authors.forename: Huifang
authors.initials: H
authors.lastname: Chen
authors.affiliation: AstraZeneca, Macclesfield, UK.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Rukazenkov
authors.affiliation: Hospital of Chinese People's Liberation Army, Beijing, China.
authors.forename: Zefei
authors.initials: Z
authors.lastname: Jiang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D047072:Aromatase Inhibitors / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D002681:China; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004965:Estrogen Antagonists / Q000008:administration & dosage; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage; D047628:Estrogen Receptor alpha / Q000378:metabolism*; D005260:Female; D000077267:Fulvestrant; D006801:Humans; D008875:Middle Aged; D061214:Patient Safety; D017698:Postmenopause; D016016:Proportional Hazards Models
chemical_list: D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; C506487:ESR1 protein, human; D004965:Estrogen Antagonists; D020847:Estrogen Receptor Modulators; D047628:Estrogen Receptor alpha; D000077267:Fulvestrant; D004958:Estradiol
keywords: advanced breast cancer; endocrine therapy; fulvestrant; hormone receptor-positive breast cancer