Skip to main content

Advertisement

SpringerLink
Log in

Fulvestrant (Faslodex™) in advanced breast cancer: clinical experience from a Belgian cooperative study

  • Clinical Trial
  • Published:
Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  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 61:6739–6746

    PubMed  CAS  Google Scholar 

  2. Wakeling AE (1995) Use of pure antioestrogens to elucidate the mode of action of oestrogens. Biochem Pharmacol 49:1545–1549

    Article  PubMed  CAS  Google Scholar 

  3. Wakeling AE (2000) Similarities and distinctions in the mode of action of different classes of antioestrogens. Endocr Relat Cancer 7:17–28

    Article  PubMed  CAS  Google Scholar 

  4. Wakeling AE, Dukes M, Bowler J (1991) A potent specific pure antiestrogen with clinical potential. Cancer Res 51:3867–3873

    PubMed  CAS  Google Scholar 

  5. Howell A, Robertson JFR, Quaresma Albano J et al (2002) Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol 20:3396–3403

    Article  PubMed  CAS  Google 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 20:3386–3395

    Article  PubMed  CAS  Google Scholar 

  7. Robertson JF, Osborne CK, Howell A et al (2003) Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women—a prospective combined analysis of two multicenter trials. Cancer 98:229–238

    Article  PubMed  CAS  Google 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 22:1605–1613

    Article  PubMed  CAS  Google Scholar 

  9. Steger GG, Gips M, Simon SD et al (2005) Fulvestrant (‘Faslodex’): Clinical experience from the compassionate use programme. Cancer Treat Rev 31(Suppl 2):S10–S16

    Article  PubMed  CAS  Google 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:S237

    Google Scholar 

  11. Petruzelka L, Konopasek B, Pribylova O et al (2006) Fulvestrant in postmenopausal women with metastatic breast cancer progressing on prior endocrine therapy – updated results from an expanded access programme. Eur J Cancer Suppl 4:171

    Article  Google 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) 23:64s

    Google Scholar 

  13. Ingle JN, Suman VJ, Rowland KM et al (2006) Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: north central cancer treatment group trial n0032. J Clin Oncol 24:1052–1056

    Article  PubMed  CAS  Google 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 18:64–69

    Article  PubMed  CAS  Google Scholar 

  15. Lønning PE, Bajetta E, Murray R et al (2000) Activity of exemestane in metastatic breast cancer after failure of nonsteroidal aromatase inhibitors: a phase II trial. J Clin Oncol 18:2234–2244

    PubMed  Google Scholar 

  16. Gennatas C, Michalaki V, Carvounis E et al (2006) Third-line hormonal treatment with exemestane in postmenopausal patients with advanced breast cancer progressing on letrozole or anastrozole. A phase II trial conducted by the Hellenic Group of Oncology (HELGO). Tumori 92:13–17

    PubMed  CAS  Google 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)

  18. Robertson JF, Erikstein B, Osborne KC et al (2004) Pharmacokinetic profile of intramuscular fulvestrant in advanced breast cancer. Clin Pharmacokinet 43:529–538

    Article  PubMed  CAS  Google Scholar 

  19. Nabholtz JM, Buzdar A, Pollak M et al (2000) Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol 18:3758–3767

    PubMed  CAS  Google Scholar 

Download references

Acknowledgement

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.

Author information

Authors and Affiliations

  1. Multidisciplinary Breast Centre & Gynaecological Oncology, UZ KULeuven, Leuven, Belgium

    Patrick Neven, Robert Paridaens, Marie Rose Christiaens & Ignace Vergote

  2. St. Elisabeth, Turnhout, Belgium

    Gino Pelgrims & Marc Martens

  3. AZ St. Jan, Brugge, Belgium

    Alain Bols

  4. Clinique St. Elisabeth, Namur, Belgium

    Jean Charles Goeminne & Anita Vindevoghel

  5. Heilig Hartkliniek, Roeselare, Belgium

    Jan Demol & Barbara Stragier

  6. AZ VUB, Brussels, Belgium

    Jacques De Greve & Christel Fontaine

  7. AZ Middelheim, Antwerpen, Belgium

    Danielle Van Den Weyngaert & Dominique Becquart

  8. AZ Groeninge, Kortrijk, Belgium

    Marleen Borms

  9. UZ Gent, Gent, Belgium

    Veronique Cocquyt & Rudy Van Den Broecke

  10. Institut Bordet, Brussels, Belgium

    Jean Selleslags & Ahmad Awada

  11. AZ St. Augustinus, Antwerpen, Belgium

    Luc Dirix & Peter Van Dam

  12. AstraZeneca, Brussels, Belgium

    Marie Agnes Azerad & Guy Vandenhoven

Authors
  1. Patrick Neven
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Robert Paridaens
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Gino Pelgrims
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Marc Martens
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Alain Bols
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Jean Charles Goeminne
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Anita Vindevoghel
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Jan Demol
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Barbara Stragier
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Jacques De Greve
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Christel Fontaine
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Danielle Van Den Weyngaert
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Dominique Becquart
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Marleen Borms
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Veronique Cocquyt
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Rudy Van Den Broecke
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Jean Selleslags
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. Ahmad Awada
    View author publications

    You can also search for this author in PubMed Google Scholar

  19. Luc Dirix
    View author publications

    You can also search for this author in PubMed Google Scholar

  20. Peter Van Dam
    View author publications

    You can also search for this author in PubMed Google Scholar

  21. Marie Agnes Azerad
    View author publications

    You can also search for this author in PubMed Google Scholar

  22. Guy Vandenhoven
    View author publications

    You can also search for this author in PubMed Google Scholar

  23. Marie Rose Christiaens
    View author publications

    You can also search for this author in PubMed Google Scholar

  24. Ignace Vergote
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Patrick Neven.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Neven, P., Paridaens, R., Pelgrims, G. et al. Fulvestrant (Faslodex™) in advanced breast cancer: clinical experience from a Belgian cooperative study. Breast Cancer Res Treat 109, 59–65 (2008). https://doi.org/10.1007/s10549-007-9628-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10549-007-9628-2

Keywords

Search

Navigation