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0020/0021 trials

FASLODEX 250 mg is at least as effective for advanced breast cancer as anastrozole 1 mg1,2

  • Studies 0020 and 0021 randomised a total of 851 postmenopausal patients with advanced breast cancer that progressed after adjuvant endocrine therapy (primarily with tamoxifen) or after first-line endocrine therapy for advanced breast cancer
  • The efficacy and tolerability of FASLODEX 250 mg monthly were compared to that of anastrozole 1 mg daily p.o.

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Derived from 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.

Primary endpoint of both trials

  • Time to progression (TTP)

Secondary endpoints included:

  • Objective response rate (OR)
  • Clinical benefit rate (CBR)
  • Duration of response (DoR)
  • Time to treatment failure
  • Time to death (TTD)/overall survival
  • Tolerability

Key efficacy results

Time to progression (TTP)1

FASLODEX 250 mg was non-inferior to anastrozole for TTP.

  • Median TTP for FASLODEX 250 mg was 5.5 months vs 4.1 months for anastrozole (hazard ratio: 0.95 [0.82–1.10]; P=0.48 [not significant])

Objective response (OR) and clinical benefit rate (CBR)

  • OR: 19.2% for FASLODEX 250 mg vs 16.5% for anastrozole (95.14% CI, -2.27–9.05%; P=0.31) [not significant])1,2
  • CBR*: 43.5% for FASLODEX 250 mg vs 40.9% for anastrozole (P=not significant)2

*Clinical benefit = complete response (CR) + partial response (PR) + stable disease (SD) ≥24 weeks.

Duration of response (DoR)1

FASLODEX 250 mg offers proven control

Median DoR was 16.7 months for FASLODEX 250 mg vs 13.7 months for anastrozole (in responding patients from randomisation to progression).1

  • DoR in all randomised patients (defined from the onset of response to disease progression for responders and as 0 for non-responders) was significantly longer for FASLODEX 250 mg vs anastrozole
    • Ratio of average response durations was 1.30 (95% CI, 1.13– 1.50; P <0.01).1

Time to death (TTD)/overall survival

  • At a median follow-up of 27 months, 74.5% of patients treated with FASLODEX 250 mg had died compared to 76.1% of patients treated with anastrozole2
  • At the same period of follow-up, the median overall survival was 27.4 months and 27.7 months for FASLODEX 250 mg and anastrozole, respectively (hazard ratio: 0.98 [95% CI 0.84–1.15]; P=0.809)2

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References

  1. 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.
  2. Howell A et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials. Cancer 2005; 104(2): 236–9