Naslov
Continued efficacy of neratinib in patients with HER2-positive early-stage breast cancer: Final overall survival analysis from the randomized phase 3 ExteNET trial

Autori
Holmes, Frankie Ann ; Moy, Beverly ; Delaloge, Suzette ; Chia, Stephen ; Ejlertsen, Bent ; Mansi, Janine ; Iwata, Hiroji ; Gnant, Michael ; Buyse, Mark ; Barrios, Carlos ; Silovski, Tajana ; Separovic, Robert ; Bashford, Anna ; Guerrero-Zotano, Angel ; Denduluri, Neelima ; Patt, Debra ; Gokmen, Erhan ; Gore, Ira ; Smith, John ; Bryce, Richard ; Xu, Feng ; Wong, Alvin ; Martin, Miguel ; Chan, Arlene

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, stručni

Skup
2020 San Antonio Breast Cancer Virtual Symposium

Mjesto i datum
San Antonio (TX), Sjedinjene Američke Države, 08.12.2020. - 11.12.2020

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
breast cancer, HER2-positive, adjuvant therapy, survival

Sažetak
Neratinib (NERLYNX®) is an irreversible pan-HER inhibitor that significantly improves invasive disease-free survival (iDFS) compared with placebo when given as extended adjuvant therapy in patients with HER2-positive (HER2+) early breast cancer after trastuzumab-based adjuvant therapy. In the phase 3 ExteNET trial, an absolute iDFS benefit of 2.5% and distant disease-free survival (DDFS) benefit of 1.7% were observed with neratinib after 5 years’ follow-up. In this final OS analysis of ExteNET, there were fewer deaths with neratinib than placebo in the ITT population, but the results did not reach statistical significance. Analyses showed greater OS improvements with neratinib in subgroups including HR+/≤1 year, and HR+/≤1 year with residual disease after neoadjuvant therapy. These findings are consistent with the results based on the primary endpoint of iDFS, and support the use of neratinib in clinical practice in these patients.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA