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Breast Cancer Res Treat (2008) 109:5965 DOI 10.1007/s10549-007-9628-2
CLINICAL TRIAL
Patrick Neven Robert Paridaens Gino Pelgrims Marc Martens Alain Bols Jean Charles Goeminne Anita Vindevoghel Jan Demol Barbara Stragier Jacques De Greve Christel Fontaine Danielle Van Den Weyngaert Dominique Becquart Marleen Borms Veronique Cocquyt Rudy Van Den Broecke Jean Selleslags Ahmad Awada Luc Dirix Peter Van Dam Marie Agnes Azerad Guy Vandenhoven Marie Rose Christiaens Ignace Vergote
Received: 2 February 2007 / Accepted: 22 May 2007 / Published online: 26 June 2007 Springer Science+Business Media B.V. 2007
Abstract Fulvestrant (FaslodexTM) 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. TheFaslodexTM 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 forABC. Two patients experienced partial responses and 118 experienced stable disease lasting 6 months, resulting in an overall clinical benet 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 ndings 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.
Keywords Advanced or metastatic breast cancer
Compassionate use Endocrine Fulvestrant Postmenopausal
Introduction
Fulvestrant (FaslodexTM) is a novel estrogen receptor (ER) antagonist with no known agonist effects that binds, blocks and increases degradation of the ERRobertson et al. [1]. It is the rst endocrine agent of this type to be licensed for the treatment of postmenopausal women with hormone-sensitive advanced breast cancer
Fulvestrant (FaslodexTM) in advanced breast cancer: clinical experience from a Belgian cooperative study
P. Neven (&) R. Paridaens M. R. Christiaens I. Vergote
Multidisciplinary Breast Centre & Gynaecological Oncology, UZ KULeuven, Leuven, Belgiume-mail: [email protected]
G. Pelgrims M. Martens
St. Elisabeth, Turnhout, Belgium