Four RCTs (eight reports) were included in the review (n=2,125 patients, table 1; range 400 to 693). Trial quality was varied: only one trial described the method of randomisation and allocation concealment; three trials were double-blinded; three trials described withdrawals; and none of the trials were stopped early.
No statistically significant differences were found between fulvestrant and other hormonal agents for overall survival, time to progression, clinical benefit, objective response rate or adverse events (three RCTs each).
The incidence of joint disorders was significantly higher in patients receiving hormonal agents other than fulvestrant (pooled OR 0.621, 95% CI 0.424 to 0.909; three RCTs; n=1,544 patients).