A Cochrane review [Abstract] 1 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) T1. 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 progressionfollow-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 |
| Mortalityfollow-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 toxicityfollow-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 |
| Arthralgiafollow-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 toxicityfollow-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 |
See also the breast cancer guideline of American society of oncology 2.
A phase III trial 3 assessed fulvestrant vs anastrozole in endocrine therapy-naive women with hormone receptor-positive advanced breast cancer. After the primary progress free survival analysis, data were collected on survival, serious adverse events, and health-related quality of life. At the data cutoff, 314 (68.0%) of 462 patients had died (fulvestrant, 157/230 [68.3%], anastrozole, 157/232 [67.7%]). The final overalla survival (OS) analysis demonstrated no significant difference between fulvestrant and anastrozole (medians, 44.8 and 42.7 months, respectively; HR 0.97 [95% CI 0.77 to 1.21]).
Date of latest search:2025-08-31
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