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

To compare efficacy and tolerability of fulvestrant with aromatase inhibitors and tamoxifen that actually represent the standard of care in hormone-sensitive breast cancer. 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. 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. Fulvestrant was similar to other hormonal agents with respect to efficacy measures, with good tolerability profile.