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500毫克氟维司群治疗转移性乳腺癌的患者数据库分析:欧洲视角

Patient database analysis of fulvestrant 500 mg in the treatment of metastatic breast cancer: A European perspective.

作者信息

Marchetti Paolo, Maass Nicolai, Gligorov Joseph, Berger Karin, MacDougall Finlay, Montonen Jukka, Lewis Jan

机构信息

Department of Clinical and Molecular Medicine, Sapienza University of Rome and IDI-IRCCS, Rome, Italy.

Department of Gynecology and Obstetrics, University Medical Center Schleswig-Holstein, Kiel, Germany.

出版信息

Breast. 2017 Apr;32:247-255. doi: 10.1016/j.breast.2016.12.002. Epub 2016 Dec 20.

DOI:10.1016/j.breast.2016.12.002
PMID:28011074
Abstract

INTRODUCTION

Clinical guidelines recommend that patients with hormone receptor (HR)-positive metastatic breast cancer (MBC) should be preferentially treated with endocrine therapy. Fulvestrant (a selective estrogen receptor degrader) is approved for use in these patients following relapse after, or relapse or progression during, antiestrogen therapy. This descriptive study analyzed European treatment patterns for HR-positive MBC in real-world clinical practice.

METHODS

The IMS Oncology Analyzer (OA), a retrospective cancer treatment database reporting physician-entered patient case histories, was used to identify records for postmenopausal women with HR-positive MBC from April 1, 2004 to June 30, 2013 in France, Germany, Italy, and Spain. Treatments were allocated to mutually exclusive categories (fulvestrant-containing, aromatase inhibitor [AI]-containing, tamoxifen-containing, or chemotherapy-containing regimens) and assessed by line of therapy for MBC. Fulvestrant use was also assessed pre- and post-2010 (when fulvestrant 500 mg dosing was approved).

RESULTS

In total, 27,214 eligible patients were included (France: 6801; Germany: 6852; Italy: 7061; Spain: 6500). Chemotherapy-based regimens were the most common first-line treatments for MBC across all countries. Across countries, the proportion of patients initiating on each treatment category ranged from: chemotherapy, 57.5-70.4%; AI, 23.5-30.1%; tamoxifen, 2.7-9.8%; fulvestrant 0.8-2.6%. When administered, fulvestrant was usually given as first- or second-line treatment. Post-2010, more patients received fulvestrant 500 mg than fulvestrant 250 mg in France, Germany, and Spain; in Italy, more patients continued to receive fulvestrant 250 mg.

CONCLUSION

Most patients with HR-positive MBC receive chemotherapy over endocrine therapy; fulvestrant constitutes a small proportion of treatments for such patients.

摘要

引言

临床指南建议,激素受体(HR)阳性转移性乳腺癌(MBC)患者应优先接受内分泌治疗。氟维司群(一种选择性雌激素受体降解剂)被批准用于抗雌激素治疗后复发、或在抗雌激素治疗期间复发或进展的此类患者。这项描述性研究分析了欧洲在实际临床实践中HR阳性MBC的治疗模式。

方法

使用IMS肿瘤分析器(OA),这是一个回顾性癌症治疗数据库,报告医生录入的患者病史,以识别2004年4月1日至2013年6月30日期间法国、德国、意大利和西班牙绝经后HR阳性MBC患者的记录。治疗方案被分为相互排斥的类别(含氟维司群、含芳香化酶抑制剂[AI]、含他莫昔芬或含化疗方案),并按MBC的治疗线数进行评估。还评估了2010年前后氟维司群的使用情况(氟维司群500mg剂量获批时)。

结果

总共纳入了27214例符合条件的患者(法国:6801例;德国:6852例;意大利:7061例;西班牙:6500例)。基于化疗的方案是所有国家MBC最常见的一线治疗方法。在各个国家,开始接受每种治疗类别的患者比例范围为:化疗,57.5 - 70.4%;AI,23.5 - 30.1%;他莫昔芬,2.7 - 9.8%;氟维司群,0.8 - 2.6%。使用氟维司群时,通常作为一线或二线治疗给药。2010年后,在法国、德国和西班牙,接受500mg氟维司群的患者比接受250mg氟维司群的患者更多;在意大利,更多患者继续接受250mg氟维司群。

结论

大多数HR阳性MBC患者接受化疗而非内分泌治疗;氟维司群在此类患者的治疗中占比很小。

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