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| Clinical breast cancer. 2020 Oct 6. pii: S1526-8209(20)30258-5. doi: 10.1016/j.clbc.2020.09.014 |
| Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial. |
| Chan A1, Moy B2, Mansi J3, Ejlertsen B4, Holmes FA5, Chia S6, Iwata H7, Gnant M8, Loibl S9, Barrios CH10, Somali I11, Smichkoska S12, Martinez N13, Alonso MG14, Link JS15, Mayer IA16, Cold S17, Murillo SM18, Senecal F19, Inoue K20, Ruiz-Borrego M21, Hui R22, Denduluri N23, Patt D24, Rugo HS25, Johnston SRD26, Bryce R27, Zhang B28, Xu F29, Wong A30, Martin M31 |
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Abstract 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. |
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Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved. |
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KEYWORDS: Adjuvant therapy, Disease-free survival, Distant disease-free survival, Neoadjuvant therapy, Overall survival |
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Publikations ID: 33183970 Quelle: öffnen |
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