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Similar articles (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#similar)
Title & authors Abstract Similar articles
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 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Chan+A&cauthor_id=33183970) 1 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-1), Beverly Moy (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Moy+B&cauthor_id=33183970) 2 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-2), Janine Mansi (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Mansi+J&cauthor_id=33183970) 3 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-3), Bent Ejlertsen (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Ejlertsen+B&cauthor_id=33183970) 4 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-4), Frankie Ann Holmes (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Holmes+FA&cauthor_id=33183970) 5 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-5), Stephen Chia (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Chia+S&cauthor_id=33183970) 6 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-6), Hiroji Iwata (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Iwata+H&cauthor_id=33183970) 7 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-7), Michael Gnant (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Gnant+M&cauthor_id=33183970) 8 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-8), Sibylle Loibl (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Loibl+S&cauthor_id=33183970) 9 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-9), Carlos H Barrios (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Barrios+CH&cauthor_id=33183970) 10 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-10), Isil Somali (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Somali+I&cauthor_id=33183970) 11 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-11), Snezhana Smichkoska (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Smichkoska+S&cauthor_id=33183970) 12 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-12), Noelia Martinez (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Martinez+N&cauthor_id=33183970) 13 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-13), Mirta Garcia Alonso (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Alonso+MG&cauthor_id=33183970) 14 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-14), John S Link (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Link+JS&cauthor_id=33183970) 15 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-15), Ingrid A Mayer (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Mayer+IA&cauthor_id=33183970) 16 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-16), Søren Cold (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Cold+S&cauthor_id=33183970) 17 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-17), Serafin Morales Murillo (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Murillo+SM&cauthor_id=33183970) 18 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-18), Francis Senecal (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Senecal+F&cauthor_id=33183970) 19 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-19), Kenichi Inoue (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Inoue+K&cauthor_id=33183970) 20 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-20), Manuel Ruiz-Borrego (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Ruiz-Borrego+M&cauthor_id=33183970) 21 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-21), Rina Hui (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Hui+R&cauthor_id=33183970) 22 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-22), Neelima Denduluri (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Denduluri+N&cauthor_id=33183970) 23 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-23), Debra Patt (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Patt+D&cauthor_id=33183970) 24 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-24), Hope S Rugo (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Rugo+HS&cauthor_id=33183970) 25 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-25), Stephen R D Johnston (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Johnston+SRD&cauthor_id=33183970) 26 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-26), Richard Bryce (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Bryce+R&cauthor_id=33183970) 27 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-27), Bo Zhang (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Zhang+B&cauthor_id=33183970) 27 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-27), Feng Xu (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Xu+F&cauthor_id=33183970) 27 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-27), Alvin Wong (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Wong+A&cauthor_id=33183970) 27 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-27), Miguel Martin (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Martin+M&cauthor_id=33183970) 28 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-28), ExteNET Study Group (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=ExteNET+Study+Group%5BCorporate+Author%5D)
Affiliations expand
PMID: 33183970
DOI: 10.1016/j.clbc.2020.09.014 (https://doi-org.laneproxy.stanford.edu/10.1016/j.clbc.2020.09.014)
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.
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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Title & authors (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#heading)
Abstract (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#abstract)
Similar articles (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#similar)
Title & authors Abstract Similar articles
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 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Chan+A&cauthor_id=33183970) 1 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-1), Beverly Moy (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Moy+B&cauthor_id=33183970) 2 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-2), Janine Mansi (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Mansi+J&cauthor_id=33183970) 3 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-3), Bent Ejlertsen (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Ejlertsen+B&cauthor_id=33183970) 4 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-4), Frankie Ann Holmes (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Holmes+FA&cauthor_id=33183970) 5 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-5), Stephen Chia (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Chia+S&cauthor_id=33183970) 6 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-6), Hiroji Iwata (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Iwata+H&cauthor_id=33183970) 7 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-7), Michael Gnant (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Gnant+M&cauthor_id=33183970) 8 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-8), Sibylle Loibl (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Loibl+S&cauthor_id=33183970) 9 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-9), Carlos H Barrios (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Barrios+CH&cauthor_id=33183970) 10 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-10), Isil Somali (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Somali+I&cauthor_id=33183970) 11 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-11), Snezhana Smichkoska (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Smichkoska+S&cauthor_id=33183970) 12 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-12), Noelia Martinez (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Martinez+N&cauthor_id=33183970) 13 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-13), Mirta Garcia Alonso (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Alonso+MG&cauthor_id=33183970) 14 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-14), John S Link (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Link+JS&cauthor_id=33183970) 15 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-15), Ingrid A Mayer (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Mayer+IA&cauthor_id=33183970) 16 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-16), Søren Cold (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Cold+S&cauthor_id=33183970) 17 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-17), Serafin Morales Murillo (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Murillo+SM&cauthor_id=33183970) 18 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-18), Francis Senecal (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Senecal+F&cauthor_id=33183970) 19 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-19), Kenichi Inoue (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Inoue+K&cauthor_id=33183970) 20 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-20), Manuel Ruiz-Borrego (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Ruiz-Borrego+M&cauthor_id=33183970) 21 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-21), Rina Hui (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Hui+R&cauthor_id=33183970) 22 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-22), Neelima Denduluri (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Denduluri+N&cauthor_id=33183970) 23 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-23), Debra Patt (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Patt+D&cauthor_id=33183970) 24 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-24), Hope S Rugo (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Rugo+HS&cauthor_id=33183970) 25 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-25), Stephen R D Johnston (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Johnston+SRD&cauthor_id=33183970) 26 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-26), Richard Bryce (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Bryce+R&cauthor_id=33183970) 27 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-27), Bo Zhang (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Zhang+B&cauthor_id=33183970) 27 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-27), Feng Xu (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Xu+F&cauthor_id=33183970) 27 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-27), Alvin Wong (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Wong+A&cauthor_id=33183970) 27 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-27), Miguel Martin (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=Martin+M&cauthor_id=33183970) 28 (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/33183970/#affiliation-28), ExteNET Study Group (https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/?sort=date&size=100&term=ExteNET+Study+Group%5BCorporate+Author%5D)
Affiliations expand
PMID: 33183970
DOI: 10.1016/j.clbc.2020.09.014 (https://doi-org.laneproxy.stanford.edu/10.1016/j.clbc.2020.09.014)
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.
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.