Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer

被引：10

作者：

Iwata, Hiroji ^{[1
]}

Masuda, Norikazu ^{[2
]}

Kim, Sung-Bae ^{[3
]}

Inoue, Kenichi ^{[4
]}

Rai, Yoshiaki ^{[5
]}

Fujita, Takashi ^{[6
]}

Chiu, Joanne ^{[7
]}

Ohtani, Shoichiro ^{[8
]}

Takahashi, Masato ^{[9
]}

Miyaki, Toshiko ^{[10
]}

Lu, Yen-Shen ^{[11
]}

Xu, Binghe ^{[12
,13
]}

Yap, Yoon Sim ^{[14
]}

Bustam, Anita ^{[15
]}

Yao, Bin ^{[16
]}

Zhang, Bo ^{[16
]}

Bryce, Richard ^{[16
]}

Chan, Arlene ^{[17
,18
]}

机构：

[1] Aichi Canc Ctr, Dept Breast Oncol, Chikusa Ku, Nagoya, Aichi 4648681, Japan

[2] Natl Hosp Org Osaka Natl Hosp, Dept Surg, Breast Oncol, Osaka 5400006, Japan

[3] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Oncol, KS013, Seoul, South Korea

[4] Saitama Canc Ctr, Div Breast Oncol, Saitama 3620806, Japan

[5] Hakuaikai Med Corp, Sagara Hosp, Kagoshima 8920845, Japan

[6] Jichi Med Univ Hosp, Dept Breast Oncol, Shimotsuke, Tochigi 3290498, Japan

[7] Queen Mary Hosp, Dept Med, Hong Kong, Peoples R China

[8] Hiroshima City Hosp, Dept Breast Surg, Hiroshima 7308518, Japan

[9] Natl Hosp Org Hokkaido Canc Ctr, Dept Breast Surg, Sapporo, Hokkaido 0630005, Japan

[10] Chiba Canc Ctr, Div Breast Surg, Chiba 2608717, Japan

[11] Natl Taiwan Univ Hosp, Taipei, Taiwan

[12] Chinese Acad Med Sci, Dept Med Oncol, Natl Canc Ctr, Canc Hosp, Beijing 100021, Peoples R China

[13] Peking Union Med Coll, Beijing 100021, Peoples R China

[14] Natl Canc Ctr Singapore, Div Med Oncol, Singapore 169610, Singapore

[15] Univ Malaya, Med Ctr, Clin Oncol Unit, Kuala Lumpur 50603, Malaysia

[16] Puma Biotechnol Inc, Los Angeles, CA 90024 USA

[17] Breast Canc Res Ctr WA, Perth, WA, Australia

[18] Curtin Univ, Perth, WA, Australia

来源：

FUTURE ONCOLOGY | 2019年 / 15卷 / 21期

关键词：

Asia; early stage breast cancer; efficacy; extended adjuvant therapy; HER2; neratinib; safety; tyrosine kinase inhibitor; DOUBLE-BLIND; HKI-272; EXTENET; SAFETY;

D O I：

10.2217/fon-2019-0143

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Aim: To evaluate the efficacy and safety of neratinib as extended adjuvant therapy in patients from Asia based on exploratory analyses of the Phase III ExteNET trial. Patients & methods: A total of 2840 women with early stage HER2-positive breast cancer were randomly assigned to neratinib 240mg/day or placebo for 1year after trastuzumab-based adjuvant therapy. Results: A total of 341 patients were from Asia (neratinib, n=165; placebo, n=176). 2-year invasive disease-free survival rates were 92.8 and 90.8% with neratinib and placebo, respectively (HR: 0.70; 95% CI: 0.31-1.55), and 5-year rates were 91.9 and 87.2%, respectively (HR: 0.57; 95% CI: 0.27-1.13). Diarrhea was the most common adverse event with neratinib. Conclusion: Extended adjuvant therapy with neratinib reduces disease recurrences in Asian women with HER2-positive breast cancer. Trial registration: Clinicaltrials.gov NCT00878709.

引用

页码：2489 / 2501

页数：13

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