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Old 11-14-2020, 09:05 PM   #1
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Final Efficacy Results of Neratinib in HER2+ER+ early bc

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Clin Breast Cancer

. 2020 Oct 6;S1526-8209(20)30258-5.

doi: 10.1016/j.clbc.2020.09.014.Online ahead of print.
Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial

Arlene Chan 1, Beverly Moy 2, Janine Mansi 3, Bent Ejlertsen 4, Frankie Ann Holmes 5, Stephen Chia 6, Hiroji Iwata 7, Michael Gnant 8, Sibylle Loibl 9, Carlos H Barrios 10, Isil Somali 11, Snezhana Smichkoska 12, Noelia Martinez 13, Mirta Garcia Alonso 14, John S Link 15, Ingrid A Mayer 16, Søren Cold 17, Serafin Morales Murillo 18, Francis Senecal 19, Kenichi Inoue 20, Manuel Ruiz-Borrego 21, Rina Hui 22, Neelima Denduluri 23, Debra Patt 24, Hope S Rugo 25, Stephen R D Johnston 26, Richard Bryce 27, Bo Zhang 27, Feng Xu 27, Alvin Wong 27, Miguel Martin 28, ExteNET Study Group

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Background: The ExteNET trial demonstrated improved invasive disease-free survival (iDFS) with neratinib, an irreversible pan-HER tyrosine kinase inhibitor, versus placebo in patients with human epidermal growth factor receptor 2-positive (HER2+)/hormone receptor-positive (HR+) early-stage breast cancer (eBC).
Patients and methods: ExteNET was a multicenter, randomized, double-blind, phase III trial of 2840 patients with HER2+ eBC after neoadjuvant/adjuvant trastuzumab-based therapy. Patients were stratified by HR status and randomly assigned 1-year oral neratinib 240 mg/day or placebo. The primary endpoint was iDFS. Descriptive analyses were performed in patients with HR+ eBC who initiated treatment ≤ 1 year (HR+/≤ 1-year) and > 1 year (HR+/> 1-year) post-trastuzumab.
Results: HR+/≤ 1-year and HR+/> 1-year populations comprised 1334 (neratinib, n = 670; placebo, n = 664) and 297 (neratinib, n = 146; placebo, n = 151) patients, respectively. Absolute iDFS benefits at 5 years were 5.1% in HR+/≤ 1-year (hazard ratio, 0.58; 95% confidence interval [CI], 0.41-0.82) and 1.3% in HR+/>1-year (hazard ratio, 0.74; 95% CI, 0.29-1.84). In HR+/≤ 1-year, neratinib was associated with a numerical improvement in overall survival (OS) at 8 years (absolute benefit, 2.1%; hazard ratio, 0.79; 95% CI, 0.55-1.13). Of 354 patients in the HR+/≤ 1-year group who received neoadjuvant therapy, 295 had residual disease, and results showed absolute benefits of 7.4% at 5-year iDFS (hazard ratio, 0.60; 95% CI, 0.33-1.07) and 9.1% at 8-year OS (hazard ratio, 0.47; 95% CI, 0.23-0.92). There were fewer central nervous system events with neratinib. Adverse events were similar to those previously reported.
Conclusion: Neratinib significantly improved iDFS in the HER2+/HR+/≤ 1-year population, and a similar trend was observed in patients with residual disease following neoadjuvant treatment. Numerical improvements in central nervous system events and OS were consistent with iDFS benefits and suggest long-term benefit for neratinib in this population.

Keywords: Adjuvant therapy; Disease-free survival; Distant disease-free survival; Neoadjuvant therapy; Overall survival.

Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.
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