Abstract P2-08-09: Progression-free survival results in postmenopausal Asian women: Subgroup analysis from a phase 3 randomized trial of fulvestrant 500 mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON)
Authors: Shao Z , Ellis MJ , Robertson JFR , Grinsted LM , Fazal M , Noguchi S 
Published: March 2017

Abstract
BACKGROUND
Fulvestrant is a selective estrogen receptor degrader (SERD) with no known agonist effects. In the open-label Phase 2 FIRST study, fulvestrant 500 mg suggested improved efficacy as first-line treatment vs anastrozole in patients with hormone receptor-positive locally advanced or metastatic breast cancer (LA/MBC). The Phase 3, randomized, double-blind, multicenter FALCON trial (NCT01602380) compared fulvestrant 500 mg with anastrozole 1 mg in patients with hormone receptor-positive LA/MBC who had not received prior hormonal therapy. The primary endpoint of the study, progression-free survival (PFS) assessed via RECIST 1.1, surgery/radiotherapy for disease worsening, or death (any cause), was met, as shown by a statistically significant improvement in PFS for fulvestrant 500 mg vs anastrozole. This analysis evaluated PFS in the Asian patient subgroup, which included all randomized patients from centers in China, Japan, and Taiwan.
METHODS
Eligible patients had ER and/or progesterone receptor-positive breast cancer, WHO performance status 0–2, and ≥1 measurable/non-measurable lesion(s). Patients were randomized (1:1) to receive fulvestrant 500 mg (IM on Days 0, 14, 28, and each 28 days thereafter) or anastrozole 1 mg daily, and were stratified according to LA or MBC; prior or no prior treatment with chemotherapy for LA/MBC; and measurable or non-measurable disease. The consistency of effect across patient subgroups was assessed via hazard ratios and 95% confidence intervals using a log-rank test.
RESULTS
In total, 462 patients were randomized (n=230 fulvestrant 500 mg; n=232 anastrozole). The Asian subgroup comprised 67 patients (n=34 fulvestrant 500 mg; n=33 anastrozole). PFS outcomes for the Asian and non-Asian subgroups are presented (Table). The most commonly reported adverse event (AE) was arthralgia (18.2% vs 12.1% of patients with fulvestrant 500 mg and anastrozole, respectively). The rate of AEs leading to discontinuation of treatment was 3.0% and 3.0%, respectively.
CONCLUSIONS
Based on a preliminary assessment of 67 patients, the treatment effect in the Asian patient subgroup from the FALCON trial appears to be broadly consistent with the non-Asian population.
PFS in Asian and non-Asian patient subgroupsGeographic regionNumber of patients (%) with event Hazard ratio (95% CI) Fulvestrant 500 mg n=230Anastrozole n=232 Asia19/34 (55.9%)22/33 (66.7%)0.81 (0.44, 1.50)Non-Asia124/196 (63.3%)144/199 (72.4%)0.79 (0.62, 1.01)
Citation Format: Shao Z, Ellis MJ, Robertson JFR, Grinsted LM, Fazal M, Noguchi S. Progression-free survival results in postmenopausal Asian women: Subgroup analysis from a phase 3 randomized trial of fulvestrant 500 mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-08-09.