Kimizuka Kei, Inoue Kenichi, E Nagai Shigenori, Saito Tsuyoshi, Nakano Satoko, Futsuhara Kazushige, Yamada Hirofumi, Kaneko Shiori, Sakurai Takashi, Hata Satoshi, Kurosumi Masafumi
Department of Breast Surgery, Kasukabe Medical Center.
Division of Breast Oncology, Saitama Cancer Center.
J Nippon Med Sch. 2019;86(3):165-171. doi: 10.1272/jnms.JNMS.2019_86-305.
Fulvestrant 500 mg has been an option for endocrine therapy for advanced or recurrent breast cancer after prior endocrine treatment since November 2011 in Japan. This study aimed to clarify the effectiveness and safety of fulvestrant 500 mg in clinical settings.
This was a multicenter, both prospective and retrospective, observational study of 132 postmenopausal women (median age 66) with locally advanced or metastatic breast cancer, who had been treated with fulvestrant. Information from medical records was retrospectively obtained from 9 hospitals (Saitama Breast Cancer Clinical Study Group: SBCCSG) in Saitama prefecture, Japan, from October 2012 to April 2014. The primary end point was time to treatment failure (TTF). The secondary end points were overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), and adverse events (AE) (CTCAE ver. 4). The choice of subsequent therapy after fulvestrant was also evaluated.
The median TTF was 6.1 months. Median OS was 28.5 months (the starting date was the first day of fulvestrant). ORR was 12.9% and CBR was 45.5%. The most common AEs were injection site reactions (9.1%). The rate of grade 3 AE was only 2.3% (3/132). The number of patients who underwent subsequent therapy after fulvestrant were 54 (55.7%) receiving chemotherapy, 42 (43.3%) receiving non-fulvestrant endocrine therapy, and 1 (1%) receiving mammalian target of rapamycin inhibitor (mTORi) + endocrine therapy (ET).
Fulvestrant 500 mg is an effective and safe treatment for patients with advanced or recurrent breast cancer after prior endocrine treatment.
自2011年11月起，500mg氟维司群在日本成为既往内分泌治疗后晚期或复发性乳腺癌内分泌治疗的一种选择。本研究旨在明确500mg氟维司群在临床环境中的有效性和安全性。
这是一项多中心、前瞻性和回顾性的观察性研究，纳入了132例接受氟维司群治疗的绝经后局部晚期或转移性乳腺癌女性患者（中位年龄66岁）。2012年10月至2014年4月期间，从日本埼玉县的9家医院（埼玉乳腺癌临床研究组：SBCCSG）回顾性获取病历信息。主要终点是至治疗失败时间（TTF）。次要终点是总生存期（OS）、客观缓解率（ORR）、临床获益率（CBR）和不良事件（AE）（CTCAE第4版）。还评估了氟维司群治疗后后续治疗的选择。
中位TTF为6.1个月。中位OS为28.5个月（起始日期为氟维司群治疗的第一天）。ORR为12.9%，CBR为45.5%。最常见的AE是注射部位反应（9.1%）。3级AE的发生率仅为2.3%（3/132）。氟维司群治疗后接受后续治疗的患者中，54例（55.7%）接受化疗，42例（43.3%）接受非氟维司群内分泌治疗，1例（1%）接受雷帕霉素靶蛋白抑制剂（mTORi）+内分泌治疗（ET）。
500mg氟维司群对既往内分泌治疗后的晚期或复发性乳腺癌患者是一种有效且安全的治疗方法。
