Fulvestrant in the treatment of advanced breast cancer : a systematic review and meta-analysis of randomized controlled trials

Purpose: To compare efficacy and tolerability of fulvestrant with aromatase inhibitors and tamoxifen that actually represent the standard of care in hormone-sensitive breast cancer. Methods: Systematic review and meta-analysis of available trials. Primary outcomes were overall survival, time to progression, clinical outcome and objective response. Secondary outcome was the tolerability profile of the drugs. Results: Four trials were identified with 2125 eligible patients. There was no statistically significant difference between fulvestrant and other hormonal agents in terms of overall survival (pooled HR: 1.047, 95% CI: 0.688-1.592), time to progression (pooled HR: 0.994, 95% CI: 0.691-1.431), clinical benefit (pooled OR: 1.044, 95% CI: 0.828-1.315) or objective response rate (pooled OR: 0.949, 95% CI: 0.736-1.224). A higher incidence of joint disorders (pooled OR: 0.621, 95% CI: 0.424-0.909; P=0.014) was noted in patients receiving hormonal agents other than fulvestrant. Conclusion: Fulvestrant was similar to other hormonal agents with respect to efficacy measures, with good tolerability profile.