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

Qingyuan Zhang, Zhimin Shao, Kunwei Shen, Li Li, Jifeng Feng, Zhongsheng Tong, Kangsheng Gu, Xiaojia Wang, Binghe Xu, Guofang Sun, Huifang Chen, Yuri Rukazenkov and Zefei Jiang _

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Oncotarget. 2016; 7:57301-57309. https://doi.org/10.18632/oncotarget.10254

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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

Correspondence to:

Zefei Jiang, email: jiangzf@hotmail.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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