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Overall survival with neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): A randomised, double-blind, placebo-controlled, phase 3 trial
FA. Holmes, B. Moy, S. Delaloge, SKL. Chia, B. Ejlertsen, J. Mansi, H. Iwata, M. Gnant, M. Buyse, CH. Barrios, T. Silovski, R. Šeparović, A. Bashford, AG. Zotano, N. Denduluri, D. Patt, E. Gokmen, I. Gore, JW. Smith, S. Loibl, N. Masuda, Z....
Language English Country England, Great Britain
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- MeSH
- Double-Blind Method MeSH
- Humans MeSH
- Breast Neoplasms * MeSH
- Disease-Free Survival MeSH
- Antineoplastic Combined Chemotherapy Protocols adverse effects MeSH
- Receptor, ErbB-2 MeSH
- Trastuzumab adverse effects MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: ExteNET showed that neratinib, an irreversible pan-HER tyrosine kinase inhibitor, given for 1 year after trastuzumab-based therapy significantly improved invasive disease-free survival in women with early-stage HER2-positive breast cancer. We report the final analysis of overall survival in ExteNET. METHODS: In this international, randomised, double-blind, placebo-controlled, phase 3 trial, women aged 18 years or older with stage 1-3c (amended to stage 2-3c) HER2-positive breast cancer who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab were eligible. Patients were randomly assigned to oral neratinib 240 mg/day or placebo for 1 year. Randomisation was stratified according to hormone receptor (HR) status (HR-positive vs. HR-negative), nodal status (0, 1-3 or 4+), and trastuzumab regimen (sequentially vs. concurrently with chemotherapy). Overall survival was analysed by intention to treat. ExteNET is registered (Clinicaltrials.gov: NCT00878709) and is complete. RESULTS: Between July 9, 2009, and October 24, 2011, 2840 women received neratinib (n = 1420) or placebo (n = 1420). After a median follow-up of 8.1 (IQR, 7.0-8.8) years, 127 patients (8.9%) in the neratinib group and 137 patients (9.6%) in the placebo group in the intention-to-treat population had died. Eight-year overall survival rates were 90.1% (95% CI 88.3-91.6) with neratinib and 90.2% (95% CI 88.4-91.7) with placebo (stratified hazard ratio 0.95; 95% CI 0.75-1.21; p = 0.6914). CONCLUSIONS: Overall survival in the extended adjuvant setting was comparable for neratinib and placebo after a median follow-up of 8.1 years in women with early-stage HER2-positive breast cancer.
Aichi Cancer Center Chikusa ku Nagoya Japan
Alabama Oncology Birmingham AL USA
Auckland Hospital Auckland New Zealand
BC Cancer Agency Vancouver BC Canada
Breast Cancer Research Centre WA and Curtin University Perth Australia
Comprehensive Cancer Centre Medical University of Vienna Vienna Austria
Daily Chemotherapy Hospital Institute for Oncology and Radiology of Serbia Belgrade Serbia
Department of Oncology UHC Zagreb Zagreb Croatia
Ege University Faculty of Medicine Izmir Turkey
Hospital São Lucas PUCRS Porto Alegre Brazil
Institut Gustave Roussy Villejuif France
Instituto Valenciano de Oncologia València Spain
International Drug Development Institute Louvain la Neuve Belgium
Masaryk Memorial Cancer Institute Brno Czech Republic
Massachusetts General Hospital Cancer Center Boston MA USA
Northwest Cancer Specialists P C US Oncology Research Vancouver VA USA
Puma Biotechnology Inc Los Angeles CA USA
Rigshospitalet Copenhagen Denmark
Texas Oncology P A US Oncology Research Houston TX USA
Texas Oncology Round Rock US Oncology Research Austin TX USA
University Hospital for Tumors University Hospital Center Sestre Milosrdnice Zagreb Croatia
Virginia Cancer Specialists US Oncology Research Arlington VA USA
References provided by Crossref.org
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