氟维司群是一种选择性雌激素受体降解剂，被批准用于激素受体阳性晚期乳腺癌绝经后女性的一线和二线治疗，既往标准用量为每次一支（250毫克）。近年来，FALCON、FIRST、CONFIRM、FINDER1、FINDER2、中国CONFIRM等随机对照研究相继证实了氟维司群每次两支（500毫克）安全有效。
2019年5月11日，日本乳腺癌学会《乳腺癌》在线发表英国诺丁汉大学约翰·罗伯逊、中国人民解放军总医院第五医学中心江泽飞、意大利托斯卡纳中心医院、日本东京癌症研究会有明医院、加拿大多伦多大学森尼布鲁克奥德特癌症中心、美国贝勒医学院马修·埃利斯、英国前沿科学基金会的研究报告，荟萃分析了氟维司群500毫克与其他内分泌疗法相比，对于激素受体阳性晚期乳腺癌的临床获益率。
英国诺丁汉大学约翰·罗伯逊教授（2106年SIBCS）
美国贝勒医学院马修·埃利斯教授（2017年SIBCS）
该研究对评估氟维司群500毫克用于绝经后激素受体阳性晚期乳腺癌的随机对照研究进行荟萃分析，以评估氟维司群500毫克与其他内分泌疗法的临床获益率（完全缓解、部分缓解或疾病稳定至少24周的患者比例），计算临床获益率的比值比和95%置信区间，并且通过固定效应模型对一线或二线、单药或联合进行分析。
结果，共有六项随机对照研究（FALCON、FIRST、CONFIRM、FINDER1、FINDER2、中国CONFIRM）符合分析条件，其中两项二线治疗II期研究（FINDER1、FINDER2）和两项一二线治疗III期研究（CONFIRM、中国CONFIRM）比较了氟维司群500毫克与氟维司群250毫克、一项一线治疗II期研究（FIRST）和一项一线治疗III期研究（FALCON）比较了氟维司群500毫克与阿那曲唑1毫克。一线、二线治疗患者分别为1054例、534例。按一线、二线治疗对临床获益率的比值比和95%置信区间进行分析，氟维司群500毫克均优于其他内分泌疗法。根据固定效应模型，氟维司群500毫克与其他内分泌疗法相比：
所有治疗：临床获益率高33%（比值比：1.33，95%置信区间：1.13～1.57，P=0.001）
一线治疗：临床获益率高33%（比值比：1.33，95%置信区间：1.02～1.73，P=0.035）
二线治疗：临床获益率高27%（比值比：1.27，95%置信区间：0.90～1.79，P=0.174）
因此，该荟萃分析结果表明，对于激素受体阳性晚期乳腺癌绝经后患者，氟维司群500毫克与其他内分泌疗法相比，一线治疗的临床获益率显著高于二线治疗。
相关阅读
Breast Cancer. 2019 May 11. [Epub ahead of print]
A meta-analysis of clinical benefit rates for fulvestrant 500 mg vs. alternative endocrine therapies for hormone receptor-positive advanced breast cancer.
John F. R. Robertson, Zefei Jiang, Angelo Di Leo, Shinji Ohno, Kathleen I. Pritchard, Matthew Ellis, Ian Bradbury, Christine Campbell.
The University of Nottingham, Nottingham City Hospital, Nottingham, UK; Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China; Hospital of Prato, Azienda USL Toscana Centro, Prato, Italy; Cancer Institute Hospital, Tokyo, Japan; Sunnybrook Odette Cancer Centre and the University of Toronto, Toronto, Canada; Baylor College of Medicine, Houston, USA; Frontier Science, Grampian View, Kingussie, UK.
BACKGROUND: Fulvestrant, a selective estrogen receptor degrader, is approved for first- and second-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer (ABC).
METHODS: Meta-analysis of randomized controlled trials (RCTs) evaluating fulvestrant 500 mg in postmenopausal hormone receptor-positive ABC, to evaluate differences in clinical benefit rate (CBR; proportion of patients experiencing best overall response of complete response, partial response, or stable disease for≥24 weeks) between fulvestrant 500 mg and comparator endocrine therapies. Odds ratios (OR) and 95% confidence intervals (CI) for CBR were calculated; fixed effects (FE) models were constructed (first- and second-line data, alone and combined).
RESULTS: Six RCTs were included. Four studies evaluated fulvestrant 500 mg vs. fulvestrant 250 mg; two evaluated fulvestrant 500 mg vs. anastrozole 1 mg. In total, 1054 and 534 patients were included (first- and second-line treatment, respectively). Analysis of OR and 95% CI of CBR by therapy line favored fulvestrant 500 mg vs. comparator therapy. Assessing all results combined in the FE model indicated significant improvement in CBR with fulvestrant 500 mg vs. comparator treatments (OR 1.33; 95% CI 1.13-1.57; p=0.001). Restricting the FE model to therapy line demonstrated significant improvement in CBR vs. comparator treatments (OR 1.33; 95% CI 1.02-1.73; p=0.035) for first-line, and a trend to improvement vs. comparator treatments (OR 1.27; 95% CI 0.90-1.79; p=0.174) for second-line.
CONCLUSIONS: In postmenopausal patients with hormone receptor-positive ABC, fulvestrant 500 mg first-line was associated with significantly greater CBR (more patients benefiting from treatment) vs. comparator endocrine therapy.
KEYWORDS: Advanced breast cancer Clinical benefit rate Fulvestrant Hormone receptor-positive Meta-analysis
DOI: 10.1007/s12282-019-00973-4
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