Miami Breast Cancer Conference 2021: Neratinib-Based Regimens for CNS Metastases
Posted: Friday, March 19, 2021
Frankie Ann Holmes, MD, of Texas Oncology Houston, and colleagues conducted the phase III ExteNET trial to evaluate the outcomes of patients with HER2-positive breast cancer who were treated with the small-molecule irreversible pan-HER tyrosine kinase inhibitor neratinib. Additionally, a subgroup analysis of the NALA trial was conducted by Cristina Saura, MD, PhD, of Vall d’Hebron University Hospital, Barcelona, and colleagues to assess the safety and efficacy of neratinib plus capecitabine in a similar population of patients with central nervous system (CNS) metastases at baseline. The results of both phase III trials, which were presented during the virtual edition of the 2021 PER’s Miami Breast Cancer Conference (Abstracts 19 and 10, respectively), showed improvements in the prevention and treatment of CNS metastases with neratinib-based regimens.
In the ExteNET trial, a total of 2,840 patients with early-stage disease were randomly assigned in a 1:1 ratio to receive neratinib or a placebo. The death rates were 8.9% and 9.6% with neratinib and the placebo, respectively, in the intention-to-treat population; the estimated 8-year overall survival rates did not seem to significantly differ between the arms (90.1% vs. 90.2%, respectively; P = .6916). In all study groups, fewer CNS events were observed with neratinib compared with the placebo.
In the NALA trial, a total of 621 patients were randomly assigned in a 1:1 ratio to receive capecitabine in combination with neratinib or lapatinib. Of them, 101 had asymptomatic CNS metastases at baseline. The median duration of overall (16.4 vs. 15.4 months; P = .6352), progression-free (7.8 vs. 5.5 months; P = .0741), and CNS progression-free (12.4 vs. 8.3 months; P = .143) survival were longer with neratinib than lapatinib. The duration of time for CNS disease intervention was 25.5 and 36.0 months, respectively (P = .430). Overall, the safety profile in this subgroup was similar to that in the overall population.
Disclosure: No information regarding conflicts of interest was provided.