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

Autor: 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
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Popis: 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.
Databáze: OpenAIRE