2016年6月23日，美国《肿瘤标靶》在线发表哈尔滨医科大学附属肿瘤医院、复旦大学附属肿瘤医院、上海交通大学医学院附属瑞金医院、大连医科大学第一附属医院、江苏省肿瘤医院、天津市肿瘤医院、安徽医科大学第一附属医院、浙江省肿瘤医院、中国医学科学院北京协和医学院附属肿瘤医院、阿斯利康中国、阿斯利康英国、军事医学科学院附属医院的中国随机双盲注册研究报告，比较了氟维司群500mg与250mg用于雌激素受体阳性进展期乳腺癌绝经后女性的有效性与安全性。
该研究于2011年3月9日至2013年12月30日将221例雌激素受体阳性、局部进展期或转移性乳腺癌绝经后女性随机分为氟维司群500mg组（111例，每14天）和250mg组（105例，每28天）。
结果发现，氟维司群500mg组和250mg组的中位无进展生存分别为8.0个月和4.0个月（风险比：0.75，95%置信区间：0.54～1.03，P=0.078）。亚组分析显示，氟维司群500mg组与250mg组相比，抗雌激素后与芳香酶抑制剂后的无进展生存风险比分别为0.86（95%置信区间：0.54～1.37）和0.65（95%置信区间：0.42～1.03）。安全性无意外发现。
2010年发表的国际Ⅲ期CONFIRM研究（NCT00099437）中期结果显示，氟维司群500mg组和250mg组的中位无进展生存分别为6.5个月和5.5个月（风险比：0.80，95%置信区间：0.68～0.94，P=0.006）；2014年发表的CONFIRM研究最终结果显示，总生存分别为26.4个月和22.3个月（风险比：0.81，95%置信区间：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
