Produção Nacional
Revisado por pares
Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial
2020; Elsevier BV; Volume: 21; Issue: 1 Linguagem: Inglês
10.1016/j.clbc.2020.09.014
ISSN1938-0666
AutoresArlene Chan, Beverly Moy, Janine Mansi, Bent Ejlertsen, Frankie A. Holmes, Stephen Chia, Hiroji Iwata, Michael Gnant, Sibylle Loibl, Carlos H. Barrios, Işıl Somali, Snezhana Smichkoska, Noelia Martínez-Jáñez, Mirta Garcia Alonso, John S. Link, Ingrid A. Mayer, Søren Cold, Serafín Morales, Francis M. Senecal, Kenichi Inoue, Manuel Ruíz‐Borrego, Rina Hui, Neelima Denduluri, Debra A. Patt, Hope S. Rugo, Stephen Johnston, Richard Bryce, Bo Zhang, Feng Xu, Alvin Wong, Miguel Martín,
Tópico(s)Advanced Breast Cancer Therapies
ResumoBackgroundThe 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 MethodsExteNET 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.ResultsHR+/≤ 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.ConclusionNeratinib 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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