Health-related quality of life from a phase 3 randomized trial of fulvestrant 500 mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON).

Abstract

1048 Background: The Phase 3 randomized FALCON trial (NCT01602380) demonstrated improved progression-free survival with fulvestrant 500 mg (F) vs anastrozole 1 mg (A) in postmenopausal women with hormone receptor-positive (HR+) locally advanced or metastatic breast cancer (BC) without prior endocrine therapy (hazard ratio [HR] 0.797, 95% confidence interval [CI] 0.637-0.999; p = 0.0486; Robertson et al. Lancet 2016). Overall health-related quality of life (HRQoL) was maintained and similar for F and A. There was no evidence of a detriment with F vs A in time to deterioration for both Trial Outcome Index (TOI; HR 0.90, 95% CI 0.70-1.15; p = 0.4008) and Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) total score (HR 0.84, 95% CI 0.66-1.07; p = 0.1594). We present additional analyses of patient (pt)-reported HRQoL outcomes from FALCON. Methods: Women with HR+ BC were randomized 1:1 to F (Days 0, 14, 28, then every 28 days) or A (daily) until disease progression or discontinuation. HRQoL was assessed by FACT-B questionnaire (TOI [summary of physical and functional well-being and breast cancer subscale scores] and FACT-B total score) at randomization and every 12 weeks during treatment. HRQoL data post-treatment (with or without progression) were also collected. Results: 462 pts were randomized (F, n = 230; A, n = 232). Compliance to FACT-B during treatment ranged from 84.6-100.0%. Mean change from baseline in TOI (scale range 0-92) and FACT-B total score (scale range 0-144) remained broadly stable (approximately ±3 points to Week 132) and similar between arms during treatment. HRQoL was also maintained in FACT-B subscales. Approximately one third of pts had improved TOI (≥ +6 points) and FACT-B (≥ +8 points) total scores from baseline up to Week 144 of treatment with F (ranges 26.4-45.0%, and 20.0-35.8%, respectively) and A (ranges 18.6-32.9%, and 22.7-37.9%, respectively). Conclusions: Compliance to the FACT-B questionnaire on treatment with F and A for HR+ BC in the FALCON trial was good; mean change from baseline in TOI and FACT-B total score was maintained, and similar proportions of pts had improved TOI and FACT-B total score in both arms. Clinical trial information: NCT01602380.