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Evidence summaries

Fulvestrant for Hormone-Sensitive Metastatic Breast Cancer

For postmenopausal women with advanced hormone-sensitive breast cancer, fulvestrant is at least as effective and safe as the comparator endocrine therapies. However, fulvestrant may be potentially more effective than current therapies when given at a dose of 500 mg. Level of evidence: "A"

Summary

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.

Fulvestrant versus any other endocrine therapy for hormone-sensitive advanced breast cancer

OutcomeRelative effect(95% CI)Risk with control - Any other standard endocrine therapyRisk with intervention - Fulvestrant (95% CI)No of women (studies) Quality of evidence
Time to progressionfollow-up: 8.9 months (mo) to 38 moHR 0.95(0.89 to 1.02)600 per 1000581 per 1000(558 to 607)4258(9) Moderate
Mortalityfollow-up for overall survival: 8.9 mo to 38 moHR 0.97(0.87 to 1.09)400 per 1000391 per 1000(359 to 427)2480 (5) High
Vasomotor toxicityfollow-up: 8.9 mo to 38 moRR 1.02(0.89 to 1.18)2170 per 1000174 per 1000(151 to 201)3544(8) High
Arthralgiafollow-up: 8.9 mo to 38 moRR 0.96(0.86 to 1.09)2225 per 1000216 per 1000(193 to 245)3244 (7) High
Gynaecological toxicityfollow-up: 8.9 mo to 38 moRR 1.22(0.94 to 1.57)68 per 100083 per 1000(64 to 107)2848 (6) High

See also the breast cancer guideline of American society of oncology 2.

Clinical comments

Note

Date of latest search:2022-01-11

    References

    • Lee CI, Goodwin A, Wilcken N. Fulvestrant for hormone-sensitive metastatic breast cancer. Cochrane Database Syst Rev 2017;(1):CD011093. [PubMed]
    • Burstein HJ, Somerfield MR, Barton DL et al. Endocrine Treatment and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: ASCO Guideline Update. J Clin Oncol 2021;39(35):3959-3977. [PubMed]

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