Adjuvant endocrine therapy with letrozole was not superior to anastrazole with respect to efficacy or safety in postmenopausal patients with hormone receptor (HR)-positive and node-positive early breast cancer, according to final results of the FACE trial published in the Journal of Clinical Oncology.1
For the open-label, phase 3 study (ClinicalTrials.gov Identifier: NCT00248170), investigators enrolled 4136 postmenopausal women with HR-positive, node-positive early breast cancer and randomly assigned them to receive adjuvant therapy with either letrozole or anastrazole daily for 5 years or until disease recurrence.
At final analysis, results showed no significant difference in the recurrence rate at 5 years between the 2 arms (hazard ratio [HR], 0.93; 95% CI, 0.80-1.07; P = .3150). The 5-year estimated disease-free survival rates were 84.9% and 82.9% with letrozole and anastrazole, respectively.
Investigators observed similar results across all evaluated subgroups, including those stratified by the number of lymph nodes and HER2 status.
In addition, there was no statistically significant difference in overall survival between the 2 groups (HR, 0.98; 95% CI, 0.82-1.17; P = .7916). Investigators estimated that 89.9% of letrozole-treated patients would be alive at 5 years vs 89.2% of those given anastrazole.
The most frequently reported grade 3 to 4 adverse events in the letrozole arm were arthralgia (3.9%), hypertension (1.2%), hot flushes (0.8%), myalgia (0.8%), dyspnea (0.8%), and depression (0.8%). The incidence of those adverse events was similar in the anastrazole group.
Given the findings that show no difference in disease-free or overall survival between the 2 treatments and no safety benefit with letrozole, the authors concluded that letrozole is not superior to anastrazole as adjuvant endocrine therapy in this population.
1. Smith I, Yardley D, Burris H, et al. Comparative efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor–positive, node-positive early breast cancer: final results of the randomized phase III Femara Versus Anastrozole Clinical Evaluation (FACE) Trial. J Clin Oncol. 2017 Jan 23. doi: 10.1200/JCO.2016.69.2871 [Epub ahead of print]