Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.,The Lancet

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Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.
The Lancet ( IF 98.4 ) Pub Date : 2017-12-01 , DOI: 10.1016/s1470-2045(17)30717-9
Miguel Martin ₁ , Frankie A Holmes ₂ , Bent Ejlertsen ₃ , Suzette Delaloge ₄ , Beverly Moy ₅ , Hiroji Iwata ₆ , Gunter von Minckwitz ₇ , Stephen K L Chia ₈ , Janine Mansi ₉ , Carlos H Barrios ₁₀ , Michael Gnant ₁₁ , Zorica Tomašević ₁₂ , Neelima Denduluri ₁₃ , Robert Šeparović ₁₄ , Erhan Gokmen ₁₅ , Anna Bashford ₁₆ , Manuel Ruiz Borrego ₁₇ , Sung-Bae Kim ₁₈ , Erik Hugger Jakobsen ₁₉ , Audrone Ciceniene ₂₀ , Kenichi Inoue ₂₁ , Friedrich Overkamp ₂₂ , Joan B Heijns ₂₃ , Anne C Armstrong ₂₄ , John S Link ₂₅ , Anil Abraham Joy ₂₆ , Richard Bryce ₂₇ , Alvin Wong ₂₇ , Susan Moran ₂₇ , Bin Yao ₂₇ , Feng Xu ₂₇ , Alan Auerbach ₂₇ , Marc Buyse ₂₈ , Arlene Chan ₂₉ ,

Affiliation

Instituto de Investigación Sanitaria Gregorio Marañón, Grupo Español de Investigación en Cáncer de Mama (GEICAM), Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Universidad Complutense, Madrid, Spain.
Texas Oncology, Houston, TX, USA.
Rigshospitalet, Copenhagen, Denmark.
Institut Gustave Roussy, Villejuif, France.
Massachusetts General Hospital Cancer Center, Boston, MA, USA.
Aichi Cancer Center, Chikusa-ku, Nagoya, Japan.
Luisenkrankenhaus, German Breast Group Forschungs GmbH, Düsseldorf, Neulsenburg, Germany.
BC Cancer Agency, Vancouver, BC, Canada.
Guy's and St Thomas' Hospital National Health Service Foundation Trust and Biomedical Research Centre, King's College, London, UK.
Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre, Brazil.
Department of Surgery and Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.
Daily Chemotherapy Hospital, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.
Virginia Cancer Specialists, Arlington, VA, USA.
University Hospital for Tumors, University Hospital Center "Sestre milosrdnice", Zagreb, Croatia.
Ege University Faculty of Medicine, Izmir, Turkey.
Auckland Hospital, Auckland, New Zealand.
Oncology Department, Hospital Universitario Virgen del Rocio, Seville, Spain.
Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Department of Oncology, Lillebaelt Hospital, Vejle, Denmark.
Oncology Institute of Vilnius University, Vilnius, Lithuania.
Breast Oncology, Saitama Cancer Center, Kita-Adachi, Japan.
Oncologianova GmbH, Recklinghausen, Germany.
Department of Medical Oncology, Amphia Hospital, Breda, Netherlands.
Department of Oncology, Christie Hospital Manchester, Manchester, UK.
Breastlink Medical Group Inc, Santa Ana, CA, USA.
University of Alberta, Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada.
Puma Biotechnology Inc, Los Angeles, CA, USA.
International Drug Development Institute, Louvain-la-Neuve, Belgium.
Breast Cancer Research Centre-Western Australia, Perth, WA, Australia; Curtin University, Perth, WA, Australia.

ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings.

中文翻译：

HER2 阳性乳腺癌 (ExteNET) 中基于曲妥珠单抗的辅助治疗后来那替尼：随机、双盲、安慰剂对照、3 期试验的 5 年分析。

ExteNET 表明，对于 HER2 阳性乳腺癌女性，在基于曲妥珠单抗的辅助治疗后，1 年的来那替尼（一种不可逆的泛 HER 酪氨酸激酶抑制剂）显着提高了 2 年无侵袭性生存率。我们报告了根据协议定义的 5 年随访敏感性分析和长期毒性发现的更新疗效结果。

更新日期：2017-11-30

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