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FASLODEX (fulvestrant) efficacy

FASLODEX efficacy

FASLODEX 500 mg helps in regaining and maintaining disease control for longer than FASLODEX 250 mg1

To patients with oestrogen receptor-positive advanced breast cancer who recurred or progressed on a prior endocrine anti-oestrogen therapy, FASLODEX 500 mg offers a new level of disease control compared with the 250-mg dose, with a dual mechanism of action resulting in a reduced likelihood of cross-resistance with other endocrine agents.2

FASLODEX 500 mg demonstrated a significantly longer progression free survival compared to FASLODEX 250 mg (HR=0.80; 95% CI, 0.8 to 0.94; P=0.006).1

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Derived from Di Leo A et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28(30): 4594–600.

FASLODEX 500 mg provides sustained disease control over FASLODEX 250 mg (difference is not statistically significant).1

Click on the image to see a larger view

Derived from Di Leo A et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28(30): 4594–600.

  • FASLODEX 500 mg maintained clinical benefit for a median duration of 16.6 months vs 13.9 months for FASLODEX 250 mg1

View details of the CONFIRM trial.

Previously, at the 250-mg dose, FASLODEX was proven to be at least as effective as anastrozole in patients with ER positive advanced breast cancer who recurred/progressed on anti-oestrogen therapy3

FASLODEX 250 mg has previously been shown to:

  • Be non-inferior to anastrozole in prolonging time to progression (5.5 vs 4.1 months, respectively; HR: 0.95 [95.14% CI, 0.82–1.10]; P=0.48)3
  • Have a clinical benefit rate not significantly different than that of anastrozole (43.5% vs 40.9%, respectively)3
  • Provide disease control, with a well understood tolerability profile3

FASLODEX 500 mg offers benefits over and above those seen with the 250-mg dose in:1

  • Significantly improved progression free survival:
    • HR=0.80; 95% CI 0.8 to 0.94; P=0.006
  • Sustained disease control:
    • At 1 year, more than a third of patients are alive and progression-free
  • Non-significant 16% reduction in the risk of death compared to 250 mg dose
    • HR=0.84, 95% CI 069-1.03; P=0.91

FASLODEX 500 mg has shown a new level of disease control without compromising tolerability and quality of life compared to the 250 mg dose1

  • No substantial differences in incidence and severity of adverse events compared to the    250 mg dose
  • No evidence of dose dependence for any adverse event
  • Quality of life similar to that with the 250 mg dose

View trial details.

References

  1. Di Leo A et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28(30): 4594–600.
  2. Howell A. The future of fulvestrant ("Faslodex"). Cancer Treat Rev 2005; 31(suppl 2): S26–S33.
  3. Robertson JF et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer 2003; 98(2): 229–38.