Details

Autor(en) / Beteiligte

• Holmes, Frankie A.
• Moy, Beverly
• Delaloge, Suzette
• Chia, Stephen K.L.
• Ejlertsen, Bent
• Mansi, Janine
• Iwata, Hiroji
• Gnant, Michael
• Buyse, Marc
• Barrios, Carlos H.
• Silovski, Tajana
• Šeparović, Robert
• Bashford, Anna
• Zotano, Angel Guerrero
• Denduluri, Neelima
• Patt, Debra
• Gokmen, Erhan
• Gore, Ira
• Smith, John W.
• Loibl, Sibylle
• Masuda, Norikazu
• Tomašević, Zorica
• Petráková, Katarina
• DiPrimeo, Daniel
• Wong, Alvin
• Martin, Miguel
• Chan, Arlene

Titel

Overall survival with neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): A randomised, double-blind, placebo-controlled, phase 3 trial

Ist Teil von

• European journal of cancer (1990), 2023-05, Vol.184, p.48-59

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2023

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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. 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). 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. •Neratinib improves iDFS after trastuzumab in early HER2+ breast cancer.•We report the final analysis of overall survival from the phase 3 ExteNET trial.•At 8 years' follow-up, OS in the ITT population was similar with neratinib vs placebo.