Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study

被引：15

作者：

Watanabe, Junichiro ^{[1
]}

Ito, Yoshinori ^{[2
]}

Ohsumi, Shozo ^{[3
]}

Mizutani, Mitsuhiro ^{[4
]}

Tashiro, Hideya ^{[5
]}

Sakurai, Kenichi ^{[6
]}

Takahashi, Masato ^{[7
]}

Saito, Tsuyoshi ^{[8
]}

Tsurutani, Junji ^{[9
]}

Mukai, Hirofumi ^{[10
]}

Yoshinami, Tetsuhiro ^{[11
]}

Takao, Shintaro ^{[12
]}

Yamamoto, Yasuhisa ^{[13
]}

Matsuoka, Toshiyuki ^{[14
]}

Iwase, Hirotaka ^{[15
]}

Iwata, Hiroji ^{[16
]}

Nakamura, Seigo ^{[17
]}

Saeki, Toshiaki ^{[18
]}

机构：

[1] Shizuoka Canc Ctr, Div Breast Oncol, 1007 Shimonagakubo, Nagaizumi, Shizuoka 4118777, Japan

[2] Japanese Fdn Canc Res, Dept Breast Med Oncol, Canc Inst Hosp, Koto Ku, 3-8-31 Ariake, Tokyo 1358550, Japan

[3] Natl Hosp Org, Dept Breast Oncol, Shikoku Canc Ctr, 160 Minamiumemotomachikou, Matsuyamashi, Ehime 7910280, Japan

[4] Mikawa Breast Canc Clin, 39-6 Koita,Sasame Cho, Anjo, Aichi 4460073, Japan

[5] Oita Prefectural Hosp, Dept Surg, 476 Bunyou, Oita, Oita 8708511, Japan

[6] Nihon Univ, Dept Breast Surg, Sch Med, Itabashi Ku, 30-1 Ohyaguchi Kami Cho, Tokyo 1738610, Japan

[7] Natl Hosp Org, Dept Breast Surg, Hokkaido Canc Ctr, Shiroishi Ku, 2-3-54 Kikusuishijo, Sapporo, Hokkaido 0030804, Japan

[8] Japanese Red Cross Saitama Hosp, Breast Surg Unit, Chuo Ku, 1-5 Shintoshin, Saitama, Saitama 3308553, Japan

[9] Kinki Univ, Dept Med Oncol, Fac Med, 377-2 Onohigashi, Osaka, Osaka 5898511, Japan

[10] Natl Canc Ctr Hosp East, Div Breast & Med Oncol, 6-5-1 Kashiwanoha, Kashiwa, Chiba 2778577, Japan

[11] Osaka Med Ctr Canc & Cardiovasc Dis, Dept Clin Oncol, Higashinari Ku, 1-3-3 Nakamichi, Osaka, Osaka 5378511, Japan

[12] Hyogo Canc Ctr, Dept Breast Surg, 13-70 Kitaojicho, Akashi, Hyogo 6738558, Japan

[13] Oomoto Hosp, Dept Surg, Kita Ku, 1-1-5 Oomoto, Okayama, Okayama 7000924, Japan

[14] Eisai & Co Ltd, Oncol PMS Sect, Dept Med Oncol, Med Div,Bunkyo Ku, 4-6-10 Koishikawa, Tokyo 1128088, Japan

[15] Kumamoto Univ, Grad Sch Med Sci, Dept Breast & Endocrine Surg, Chuo Ku, 1-1-1 Honjo, Kumamoto, Kumamoto 8608556, Japan

[16] Aichi Canc Ctr, Div Immunol, Res Inst, Chikusa Ku, 1-1 Kanokoden, Nagoya, Aichi 4648681, Japan

[17] Showa Univ, Div Breast Surg Oncol, Dept Surg, Shinagawa Ku, 1-5-8 Hatanodai, Tokyo 1428555, Japan

[18] Saitama Med Univ, Dept Breast Oncol, Int Med Ctr, 1397-1 Yamane, Hidaka, Saitama 3501298, Japan

来源：

INVESTIGATIONAL NEW DRUGS | 2017年 / 35卷 / 06期

关键词：

Breast cancer; Eribulin; Japan; Post-marketing surveillance; Real world; HALICHONDRIN B ANALOG; PHASE-II; MESYLATE; TAXANE; ANTHRACYCLINE; CAPECITABINE; MONOTHERAPY; WOMEN;

D O I：

10.1007/s10637-017-0486-4

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background This large-scale study was conducted to evaluate the safety and effectiveness of eribulin for the treatment of inoperable or recurrent breast cancer in real-world settings in Japan. Methods Between July and December 2011, eligible patients with inoperable or recurrent breast cancer receiving eribulin for the first time were centrally registered and observed for 1 year. Eribulin was administered intravenously (1.4 mg/m(2)) on days 1 and 8 of every 3-week cycle. The primary endpoint was the frequency and intensity of adverse drug reactions (ADRs). Secondary endpoints included overall response rate (ORR) and time to treatment failure (TTF). Results Of 968 patients registered at 325 institutions, 951 and 671 were included in the safety and effectiveness analyses, respectively. In the safety population, ADRs were observed in 841 patients (88.4%). The most common (ae15% incidence) were neutropenia (66.6%), leukopenia (62.4%), lymphopenia (18.4%), and peripheral neuropathy (16.8%). The most common grade ae 3 ADRs (> 5% incidence) were neutropenia (59.8%), leukopenia (50.5%), lymphopenia (16.1%), and febrile neutropenia (7.7%). In the effectiveness population, ORR was 16.5% (95% confidence interval: 13.7, 19.4). The median TTF was 127 days (95% confidence interval: 120, 134). Conclusions The safety and effectiveness profile of eribulin was consistent with prior studies. Eribulin had a favorable risk-benefit balance when used in real-world clinical settings.

引用

页码：791 / 799

页数：9

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