A Cochrane review included 9 studies with a total of 4514 subjects. Fulvestrant is a selective oestrogen receptor down-regulator (SERD) used in hormone-sensitive locally advanced or metastatic breast cancer in postmenopausal women. Overall results for the primary endpoint of progression-free survival (PFS), mortality, or toxicity indicated that women receiving fulvestrant did at least as well as the control groups (other endocrine therapy) . In the one high-quality study that tested fulvestrant at the currently approved and now standard dose of 500 mg against anastrozole, women treated with fulvestrant 500 mg did better, with a hazard ratio (HR) for time to progressio of 0.66 (95% CI 0.47 to 0.93; n=205) and a HR for overall survival of 0.70 (95% CI 0.50 to 0.98; n=205). There was no difference in PFS whether fulvestrant was used in combination with another endocrine therapy or in the first- or second-line setting, when compared to control treatments: for monotherapy HR 0.97 (95% CI 0.90 to 1.04) versus HR 0.87 (95% CI 0.77 to 0.99) for combination therapy when compared to control, and HR 0.93 (95% CI 0.84 to 1.03) in the first-line setting and HR 0.96 (95% CI 0.88 to 1.04) in the second-line setting.
| Outcome | Relative effect (95% CI) | Risk with control - Any other standard endocrine therapy | Risk with intervention - Fulvestrant (95% CI) | No of women (studies) Quality of evidence |
|---|---|---|---|---|
| Time to progression follow-up: 8.9 months (mo) to 38 mo | HR 0.95 (0.89 to 1.02) | 600 per 1000 | 581 per 1000 (558 to 607) | 4258 (9) Moderate |
| Mortality follow-up for overall survival: 8.9 mo to 38 mo | HR 0.97 (0.87 to 1.09) | 400 per 1000 | 391 per 1000 (359 to 427) | 2480 (5) High |
| Vasomotor toxicity follow-up: 8.9 mo to 38 mo | RR 1.02 (0.89 to 1.18) | 2170 per 1000 | 174 per 1000 (151 to 201) | 3544 (8) High |
| Arthralgia follow-up: 8.9 mo to 38 mo | RR 0.96 (0.86 to 1.09) | 2225 per 1000 | 216 per 1000 (193 to 245) | 3244 (7) High |
| Gynaecological toxicity follow-up: 8.9 mo to 38 mo | RR 1.22 (0.94 to 1.57) | 68 per 1000 | 83 per 1000 (64 to 107) | 2848 (6) High |
Date of latest search: 7 July 2015