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Future Oncol. 2019 May 29. doi: 10.2217/fon-2019-0143. [Epub ahead of print]

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

Author information

1
Department of Breast Oncology, Aichi Cancer Center, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
2
Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, 540-0006, Japan.
3
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KS013, Korea.
4
Division of Breast Oncology, Saitama Cancer Center, Saitama, 362-0806, Japan.
5
Hakuaikai Medical Corporation Sagara Hospital, Kagoshima City, 892-0845, Japan.
6
Department of Breast Oncology, Jichi Medical University Hospital, Tochigi, 329-0498, Japan.
7
Department of Medicine, Queen Mary Hospital, Hong Kong Island, Hong Kong.
8
Department of Breast Surgery, Hiroshima City Hospital, Hiroshima, 730-8518, Japan.
9
Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, 063-0005, Japan.
10
Division of Breast Surgery, Chiba Cancer Center, Chiba, 260-8717, Japan.
11
National Taiwan University Hospital, Taipei City, Taiwan.
12
Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, China.
13
Division of Medical Oncology, National Cancer Centre Singapore, 169610, Singapore.
14
Clinical Oncology Unit, University Malaya Medical Centre, Kuala Lumpur, 50603, Malaysia.
15
Puma Biotechnology, Inc., Los Angeles, CA 90024, USA.
16
Breast Cancer Research Centre-WA & Curtin University, Perth, Australia.

Abstract

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 240 mg/day or placebo for 1 year 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.

KEYWORDS:

Asia; HER2; early stage breast cancer; efficacy; extended adjuvant therapy; neratinib; safety; tyrosine kinase inhibitor

PMID:
31140297
DOI:
10.2217/fon-2019-0143

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