Fulvestrant (Faslodex™) in advanced breast cancer: clinical experience from a Belgian cooperative study
- 228 Downloads
Fulvestrant (Faslodex™) is a new estrogen receptor (ER) antagonist with no agonist effects that is licensed for the treatment of postmenopausal women with hormone-sensitive advanced breast cancer (ABC) who have progressed/recurred on prior antiestrogen therapy. The Faslodex™ Compassionate Use Program (CUP) provides expanded access to fulvestrant in countries where it is not yet available for patients who are not eligible to enter clinical trials. This analysis pools data from 402 patients who received fulvestrant as part of the CUP in Belgium, predominantly as 3rd- to 5th-line endocrine therapy for ABC. Two patients experienced partial responses and 118 experienced stable disease lasting ≥6 months, resulting in an overall clinical benefit rate of 29.9%. Fulvestrant was active in patients with multiple sites of metastases, visceral metastases, human epidermal growth factor receptor 2-positive disease and after heavy endocrine pre-treatment. Fulvestrant was well tolerated, with only six patients (1.5%) discontinuing treatment following adverse events. These data support the findings of previous CUP analyses and Phase II and III trials, suggesting that fulvestrant is a valuable addition to the treatment sequence for postmenopausal women with ABC who have progressed/recurred on prior endocrine therapy.
KeywordsAdvanced or metastatic breast cancer Compassionate use Endocrine Fulvestrant Postmenopausal
We thank Miss Katleen Pappaert and Mrs Heidi Camps, both secretaries in the Department of Gynaecological Oncology, for secretarial assistance and Dr Martin Quinn of Complete Medical Communications, who provided medical writing support funded by AstraZeneca.
- 1.Robertson JF, Nicholson RI, Bundred NJ et al (2001) Comparison of the short-term biological effects of 7alpha-[9-(4,4,5,5,5- pentafluoropentylsulfinyl)-nonyl]estra-1,3,5, (10)-triene-3,17beta-diol (Faslodex) versus tamoxifen in postmenopausal women with primary breast cancer. Cancer Res 61:6739–6746PubMedGoogle Scholar
- 6.Osborne CK, Pippen J, Jones SE et al (2002) Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol 20:3386–3395PubMedCrossRefGoogle Scholar
- 8.Howell A, Robertson JFR, Abram P et al (2004) Comparison of fulvestrant versus tamoxifen for the treatment of advanced breast cancer in postmenopausal women previously untreated with endocrine therapy: a multinational, double-blind, randomized trial. J Clin Oncol 22:1605–1613PubMedCrossRefGoogle Scholar
- 10.Cardoso AA, Mendes GQ, Froimtchuk MJ et al (2004) Fulvestrant after aromatase inhibitor failure: results from the expanded access program in Rio de Janeiro, Brazil. Breast Cancer Res Treat 88:S237Google Scholar
- 12.Mauriac L, Debled M, Jourand A et al (2005) Compassionate use of fulvestrant: experience from the institut bergonie. J Clin Oncol (Meeting Abstracts) 23:64sGoogle Scholar
- 14.Perey L, Paridaens R, Hawle H et al (2007) Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer and primary or acquired resistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical Cancer Research Trial (SAKK 21/00). Ann Oncol 18:64–69PubMedCrossRefGoogle Scholar
- 17.Gradishar W, Chia S, Piccart M et al (2006) Fulvestrant versus exemestane following prior non-steroidal aromatase inhibitor therapy: first results from EFECT, a randomized, phase III trial in postmenopausal women with advanced breast cancer. Breast Cancer Res Treat 100 (Suppl 1):S8 (Late-breaking abstract, including data, from 2006 San Antonio Breast Cancer Symposium available on-line at: http://www.abstracts2view.com/sabcs06/view.php?nu=SABCS06L_1152. Date accessed: 08/01/07)Google Scholar