2016年6月23日，美國(guó)《腫瘤標(biāo)靶》在線發(fā)表哈爾濱醫(yī)科大學(xué)附屬腫瘤醫(yī)院、復(fù)旦大學(xué)附屬腫瘤醫(yī)院、上海交通大學(xué)醫(yī)學(xué)院附屬瑞金醫(yī)院、大連醫(yī)科大學(xué)第一附屬醫(yī)院、江蘇省腫瘤醫(yī)院、天津市腫瘤醫(yī)院、安徽醫(yī)科大學(xué)第一附屬醫(yī)院、浙江省腫瘤醫(yī)院、中國(guó)醫(yī)學(xué)科學(xué)院北京協(xié)和醫(yī)學(xué)院附屬腫瘤醫(yī)院、阿斯利康中國(guó)、阿斯利康英國(guó)、軍事醫(yī)學(xué)科學(xué)院附屬醫(yī)院的中國(guó)隨機(jī)雙盲注冊(cè)研究報(bào)告，比較了氟維司群500mg與250mg用于雌激素受體陽(yáng)性進(jìn)展期乳腺癌絕經(jīng)后女性的有效性與安全性。

　　該研究于2011年3月9日至2013年12月30日將221例雌激素受體陽(yáng)性、局部進(jìn)展期或轉(zhuǎn)移性乳腺癌絕經(jīng)后女性隨機(jī)分為氟維司群500mg組（111例，每14天）和250mg組（105例，每28天）。

　　結(jié)果發(fā)現(xiàn)，氟維司群500mg組和250mg組的中位無(wú)進(jìn)展生存分別為8.0個(gè)月和4.0個(gè)月（風(fēng)險(xiǎn)比：0.75，95%置信區(qū)間：0.54～1.03，P=0.078）。亞組分析顯示，氟維司群500mg組與250mg組相比，抗雌激素后與芳香酶抑制劑后的無(wú)進(jìn)展生存風(fēng)險(xiǎn)比分別為0.86（95%置信區(qū)間：0.54～1.37）和0.65（95%置信區(qū)間：0.42～1.03）。安全性無(wú)意外發(fā)現(xiàn)。

　　2010年發(fā)表的國(guó)際Ⅲ期CONFIRM研究（NCT00099437）中期結(jié)果顯示，氟維司群500mg組和250mg組的中位無(wú)進(jìn)展生存分別為6.5個(gè)月和5.5個(gè)月（風(fēng)險(xiǎn)比：0.80，95%置信區(qū)間：0.68～0.94，P=0.006）；2014年發(fā)表的CONFIRM研究最終結(jié)果顯示，總生存分別為26.4個(gè)月和22.3個(gè)月（風(fēng)險(xiǎn)比：0.81，95%置信區(qū)間：0.69～0.96，P=0.02）。

Oncotarget. 2016 Jun 23. [Epub ahead of print]

Fulvestrant 500 mg vs 250 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer: a randomized, double-blind registrational trial in China.

Zhang Q, Shao Z, Shen K, Li L, Feng J, Tong Z, Gu K, Wang X, Xu B, Sun G, Chen H, Rukazenkov Y, Jiang Z.

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China; Fudan University Shanghai Cancer Center, Shanghai, China; Shanghai Ruijin Hospital, Shanghai, China; The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China; Jiangsu Cancer Hospital, Nanjing, Jiangsu, China; Tianjin Cancer Hospital, Tianjin, China; The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China; Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China; Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; AstraZeneca, Shanghai, China; AstraZeneca, Macclesfield, UK; Hospital of Chinese People's Liberation Army, Beijing, China.

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.

KEYWORDS: advanced breast cancer; endocrine therapy; fulvestrant; hormone receptor-positive breast cancer

PMID: 27359058

DOI: 10.18632/oncotarget.10254