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

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...

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Main Authors: Iwata, Hiroji, Masuda, Norikazu, Kim, Sung-Bae, Inoue, Kenichi, Rai, Yoshiaki, Fujita, Takashi, Chiu, Joanne, Ohtani, Shoichiro, Takahashi, Masato, Miyaki, Toshiko, Lu, Yen-Shen, Xu, Binghe, Yap, Yoon Sim, Bustam, Anita Zarina, Yao, Bin, Zhang, Bo, Bryce, Richard, Chan, Arlene
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Published: Future Medicine 2019
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Online Access:http://eprints.um.edu.my/24103/
https://doi.org/10.2217/fon-2019-0143
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spelling my.um.eprints.241032020-03-26T04:50:17Z http://eprints.um.edu.my/24103/ Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer Iwata, Hiroji Masuda, Norikazu Kim, Sung-Bae Inoue, Kenichi Rai, Yoshiaki Fujita, Takashi Chiu, Joanne Ohtani, Shoichiro Takahashi, Masato Miyaki, Toshiko Lu, Yen-Shen Xu, Binghe Yap, Yoon Sim Bustam, Anita Zarina Yao, Bin Zhang, Bo Bryce, Richard Chan, Arlene R Medicine 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. © 2019 Future Medicine Ltd. Future Medicine 2019 Article PeerReviewed Iwata, Hiroji and Masuda, Norikazu and Kim, Sung-Bae and Inoue, Kenichi and Rai, Yoshiaki and Fujita, Takashi and Chiu, Joanne and Ohtani, Shoichiro and Takahashi, Masato and Miyaki, Toshiko and Lu, Yen-Shen and Xu, Binghe and Yap, Yoon Sim and Bustam, Anita Zarina and Yao, Bin and Zhang, Bo and Bryce, Richard and Chan, Arlene (2019) Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer. Future Oncology, 15 (21). pp. 2489-2501. ISSN 1479-6694 https://doi.org/10.2217/fon-2019-0143 doi:10.2217/fon-2019-0143
institution Universiti Malaya
building UM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Malaya
content_source UM Research Repository
url_provider http://eprints.um.edu.my/
topic R Medicine
spellingShingle R Medicine
Iwata, Hiroji
Masuda, Norikazu
Kim, Sung-Bae
Inoue, Kenichi
Rai, Yoshiaki
Fujita, Takashi
Chiu, Joanne
Ohtani, Shoichiro
Takahashi, Masato
Miyaki, Toshiko
Lu, Yen-Shen
Xu, Binghe
Yap, Yoon Sim
Bustam, Anita Zarina
Yao, Bin
Zhang, Bo
Bryce, Richard
Chan, Arlene
Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer
description 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. © 2019 Future Medicine Ltd.
format Article
author Iwata, Hiroji
Masuda, Norikazu
Kim, Sung-Bae
Inoue, Kenichi
Rai, Yoshiaki
Fujita, Takashi
Chiu, Joanne
Ohtani, Shoichiro
Takahashi, Masato
Miyaki, Toshiko
Lu, Yen-Shen
Xu, Binghe
Yap, Yoon Sim
Bustam, Anita Zarina
Yao, Bin
Zhang, Bo
Bryce, Richard
Chan, Arlene
author_facet Iwata, Hiroji
Masuda, Norikazu
Kim, Sung-Bae
Inoue, Kenichi
Rai, Yoshiaki
Fujita, Takashi
Chiu, Joanne
Ohtani, Shoichiro
Takahashi, Masato
Miyaki, Toshiko
Lu, Yen-Shen
Xu, Binghe
Yap, Yoon Sim
Bustam, Anita Zarina
Yao, Bin
Zhang, Bo
Bryce, Richard
Chan, Arlene
author_sort Iwata, Hiroji
title Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer
title_short Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer
title_full Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer
title_fullStr Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer
title_full_unstemmed Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer
title_sort neratinib after trastuzumab-based adjuvant therapy in patients from asia with early stage her2-positive breast cancer
publisher Future Medicine
publishDate 2019
url http://eprints.um.edu.my/24103/
https://doi.org/10.2217/fon-2019-0143
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