Clinical Research Papers:
Fulvestrant 500 mg vs 250 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer: a randomized, double-blind registrational trial in China
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Qingyuan Zhang1, Zhimin Shao2, Kunwei Shen3, Li Li4, Jifeng Feng5, Zhongsheng Tong6, Kangsheng Gu7, Xiaojia Wang8, Binghe Xu9, Guofang Sun10, Huifang Chen10, Yuri Rukazenkov11, Zefei Jiang12
1Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
2Fudan University Shanghai Cancer Center, Shanghai, China
3Shanghai Ruijin Hospital, Shanghai, China
4The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
5Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
6Tianjin Cancer Hospital, Tianjin, China
7The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
8Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
9Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
10AstraZeneca, Shanghai, China
11AstraZeneca, Macclesfield, UK
12307 Hospital of Chinese People’s Liberation Army, Beijing, China
Zefei Jiang, email: email@example.com
Keywords: advanced breast cancer, fulvestrant, endocrine therapy, hormone receptor-positive breast cancer
Received: February 15, 2016 Accepted: May 28, 2016 Published: June 23, 2016
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.
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