Skip to main content

Advertisement

SpringerLink
Log in

The Austrian fulvestrant registry: results from a prospective observation of fulvestrant in postmenopausal patients with metastatic breast cancer

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

Abstract

Background Endocrine therapy is the preferred treatment in oestrogen- and/or progesterone-receptor (ER/PgR) positive breast cancer. Fulvestrant is a pure ER-antagonist. We present results from the Austrian Fulvestrant Registry. Methods Three-hundred and fifty patients were included. Time to progression (TTP) was defined as primary endpoint. A multivariate analysis was performed to identify factors significantly associated with TTP. Results Fulvestrant was administered as first-line therapy in 26%, second-line in 49%, and third-line or beyond in 25%. TTP was median 7 months. We observed a response in 15% of patients and 41% had SD ≥ 6 months. First-line treatment and non-visceral metastases were associated with longer TTP. One case of pulmonary embolism was reported. Grade 3 toxicities consisted of joint pain (1.4%), nausea (1.4%) and hot flashes (0.3%). Conclusions Fulvestrant was effective and well tolerated. TTP was superior to other trials, due to the large proportion of first-line patients. Activity is apparently independent of Her2-status.

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

Similar content being viewed by others

References

  1. O’Shaughnessy J (2005) Extending survival with chemotherapy in metastatic breast cancer. Oncologist 10(3):20–29. doi:10.1634/theoncologist.10-90003-20

    Article  PubMed  Google Scholar 

  2. Osborne CK (1998) Tamoxifen in the treatment of breast cancer. N Engl J Med 339:1609–1618. doi:10.1056/NEJM199811263392207

    Article  PubMed  CAS  Google Scholar 

  3. Early Breast Cancer Trialists’ Collaborative Group (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of randomised trials. Lancet 365:1687–1717. doi:10.1016/S0140-6736(05)66544-0

    Article  CAS  Google Scholar 

  4. Paridaens R, Dirix L, Lohrisch C et al (2003) Mature results of a randomized phase II multicenter study of exemestane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer. Ann Oncol 14:1391–1398. doi:10.1093/annonc/mdg362

    Article  PubMed  CAS  Google Scholar 

  5. Bajetta E, Procopio G, Ferrari L et al (2002) A randomized, multicenter prospective trial assessing long-acting release octreotide pamoate plus tamoxifen as a first line therapy for advanced breast carcinoma. Cancer 94:299–304. doi:10.1002/cncr.10239

    Article  PubMed  CAS  Google Scholar 

  6. Bonneterre J, Buzdar A, Nabholtz JM et al (2001) Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced beast carcinoma. Cancer 92:2247–2258. doi:10.1002/1097-0142(20011101)92:9<2247::AID-CNCR1570>3.0.CO;2-Y

    Article  PubMed  CAS  Google Scholar 

  7. Dutertre M, Smith CL (2000) Molecular mechanisms of selective estrogen receptor modulator (SERM) action. J Pharmacol Exp Ther 295:431–437

    PubMed  CAS  Google Scholar 

  8. Schiff R, Massarweh SA, Shou J et al (2004) Cross-talk between estrogen receptor and growth factor pathways as a molecular target for overcoming endocrine resistance. Clin Cancer Res 10(1 Pt 2):331–336. doi:10.1158/1078-0432.CCR-031212

    Article  Google Scholar 

  9. Sun M, Paciga JE, Feldman RI et al (2001) Phosphatidylinostol-3-OH kinase (PI3K)/AKT2, activated in breast cancer, regulates and is induced by estrogen receptor α (Erα) via interaction between Erα and PI3K. Cancer Res 61:5985–5991

    PubMed  CAS  Google Scholar 

  10. Smith IE, Dowsett M (2003) Aromatase inhibitors in breast cancer. N Engl J Med 348:2431–2442. doi:10.1056/NEJMra023246

    Article  PubMed  CAS  Google Scholar 

  11. Miller WR, Bartlett JM, Canney P et al (2007) Hormonal therapy for postmenopausal breast cancer: the science of sequencing. Breast Cancer Res Treat 103:149–160. doi:10.1007/s10549-006-9369-7

    Article  PubMed  CAS  Google Scholar 

  12. Macedo LF, Sabnis G, Brodie A (2008) Preclinical modeling of endocrine response and resistance. Cancer 112(Suppl 3):679S–688S. doi:10.1002/cncr.23191

    Article  CAS  Google Scholar 

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

    PubMed  CAS  Google Scholar 

  14. Fawell SE, White R, Hoare S et al (1990) Inhibition of estrogen receptor-DNA binding by the “pure” anti-estrogen ICI 164, 384 appears to be mediated by impaired receptor dimerization. Proc Natl Acad Sci USA 87:6883–6888. doi:10.1073/pnas.87.17.6883

    Article  PubMed  CAS  Google Scholar 

  15. Wakeling AE (2000) Similarities and distinctions in the mode of action of different classes of antioestrogens. Endocr Relat Cancer 7:17–28. doi:10.1677/erc.0.0070017

    Article  PubMed  CAS  Google Scholar 

  16. Howell A (2006) Is fulvestrant (“faslodex”) just another selective estrogen receptor modulator? Int J Gynecol Cancer 16(Suppl 2):521S–523S. doi:10.1111/j.1525-1438.2006.00686.x

    Article  Google Scholar 

  17. Osborne CK, Shou J, Massarweh S et al (2005) Crosstalk between estrogen receptor and growth factor receptor pathways is a cause for endocrine resistance in breast cancer. Clin Cancer Res 11(2 Pt 2):865–870

    Google Scholar 

  18. Normanno N, Di Maio M, De Maio E et al (2005) Mechanisms of endocrine resistance and novel therapeutic strategies in breast cancer. Endocr Relat Cancer 12:721–747. doi:10.1677/erc.1.00857

    Article  PubMed  CAS  Google Scholar 

  19. Bartsch R, Wenzel C, Altorjai G et al (2007) Her2 and progesterone receptor status are not predictive of response to fulvestrant treatment. Clin Cancer Res 13:4435–4439. doi:10.1158/1078-0432.CCR-06-3050

    Article  PubMed  CAS  Google Scholar 

  20. Robertson JF, Steger GG, Neven P et al (2007) Fulvestrant in the treatment of Her2-positive advanced breast cancer (ABC). J Clin Oncol 25(Suppl 18):47S. doi:10.1200/JCO.2006.09.3146

    Google Scholar 

  21. 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. doi:10.1200/JCO.2002.10.057

    Article  PubMed  CAS  Google Scholar 

  22. 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 20:386–3395. doi:10.1200/JCO.2002.10.058

    Article  CAS  Google Scholar 

  23. 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. doi:10.1002/cncr.11468

    Article  PubMed  CAS  Google Scholar 

  24. Steger GG, Bartsch R, Wenzel C et al (2005) Fulvestrant (“Faslodex”) in pre-treated patients with advanced breast cancer: a single-centre experience. Eur J Cancer 41:2655–2661

    Article  PubMed  CAS  Google Scholar 

  25. Steger GG, Gips M, Simon SD et al (2005) Fulvestrant (“Faslodex”): clinical experience from the Compassionate Use Programme. Cancer Treat Rev 31(Suppl 2):10S–16S. doi:10.1016/j.ctrv.2005.08.009

    Article  CAS  Google Scholar 

  26. Mlineritsch B, Psenak O, Mayer P et al (2007) Fulvestrant („faslodex”) in heavily pretreated postmenopausal patients with advanced breast cancer: single centre clinical experience from the Compassionate Use Programme. Breast Cancer Res Treat 106:105–112. doi:10.1007/s10549-006-9482-7

    Article  PubMed  CAS  Google Scholar 

  27. Chia S, Gradisher W, Mauriac L et al (2008) Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromtase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT. J Clin Oncol 26:1664–1670. doi:10.1200/JCO.2007.13.5822

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  Google Scholar 

  29. Vergote I, Robertson JFR, Kleeberg U et al (2003) Postmenopausal women who progress on fulvestrant (‘Faslodex’) remain sensitive to further endocrine therapy. Breast Cancer Res Treat 79:207–211. doi:10.1023/A:1023983032625

    Article  PubMed  CAS  Google Scholar 

  30. Howell A (2002) Postmenopausal women with advanced breast cancer who progress on fulvestrant or tamoxifen retain sensitivity to further endocrine therapies. Breast Cancer Res Treat 76(Suppl 1):72S

    Google Scholar 

  31. 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. doi:10.1093/annonc/mdl341

    Article  PubMed  CAS  Google Scholar 

  32. Beslija S, Bonneterre J, Burstein H et al (2007) Second consenus on medical treatment of metastatic breast cancer. Ann Oncol 18:215–225. doi:10.1093/annonc/mdl155

    Article  PubMed  CAS  Google Scholar 

  33. Arpino G, Weiss H, Lee AV et al (2005) Estrogen receptor-positive, progesterone receptor-negative breast cancer: association with growth factor receptor expression and tamoxifen resistance. J Natl Cancer Inst 97:1254–1261

    Article  PubMed  CAS  Google Scholar 

  34. Stendhal M, Ryden L, Nordenskjold B et al (2006) High progesterone receptor expression correlates to the effect of adjuvant tamoxifen in premenopausal breast cancer patients. Clin Cancer Res 12:4614–4618. doi:10.1158/1078-0432.CCR-06-0248

    Article  Google Scholar 

  35. Ellis MJ, Coop A, Singh B et al (2003) Letrozole inhibits tumor proliferation more effectively than tamoxifen independent of HER1/2 expression status. Cancer Res 63:6523–6531

    PubMed  CAS  Google Scholar 

  36. Nicholson RI, McClelland RA, Robertson JF et al (1999) Involvement of steroid hormone and growth factor cross-talk in endocrine response in breast cancer. Endocr Relat Cancer 6:373–387. doi:10.1677/erc.0.0060373

    Article  PubMed  CAS  Google Scholar 

  37. Osborne CK, Schiff R, Fuqua SA et al (2001) Estrogen receptor: current understandings of its activation and modulation. Clin Cancer Res 7(Suppl 12):4338S–4342S

    PubMed  CAS  Google Scholar 

  38. 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. doi:10.1200/JCO.2004.02.112

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgements

Apart from the authors of this manuscript, individuals contributing to the Austrian Fulvestrant Registry included the following: Aiginger P, Andel J, Artner S, Fiegl M, Fortelny A, Gunegger D, Gomar-Hoess C, Halbritter W, Haslbauer F, Hehenwarter W, Hellan J, Hojas S, Horvath W, Kier P, Kis A, Kopetzky G, Kretschmar A, Kührer I, Labuda B, Lass H, Lobmaier G, Loncsar G, Luschin-Ebengreuth G, Magg P, Manfreda D, Medl M, Niedermayer A, Papala T, Paurits T, Rainer G, Reimer D, Renner K, Riedl M, Schenk T, Schmid G, Stangl W, Tichatschek R, Thiel I, Trapl H, Ulsperger E, Urbania A, Walla B, Wette V, Wilthoner K. The Austrian Fulvestrant Registry was supported by a grant from AstraZeneca Pharmaceuticals.

Author information

Authors and Affiliations

  1. First Department of Medicine and Cancer Centre, Clinical Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria

    Rupert Bartsch, Ursula Pluschnig, Catharina Wenzel, Christoph C. Zielinski & Guenther G. Steger

  2. Paracelsus Private Medical University, Salzburg, Austria

    Brigitte Mlineritsch & Richard Greil

  3. Department of Surgery, Medical University of Vienna, Vienna, Austria

    Michael Gnant

  4. Department of Surgery, LKH Leoben, Leoben, Austria

    Thomas Niernberger

  5. Department of Gynaecology, KH Hietzing, Vienna, Austria

    Paul Sevelda

  6. Department of Medicine 4, KH Wels and Grieskirchen, Wels, Austria

    Josef Thaler

  7. Department of Pathology, Medical University of Vienna, Vienna, Austria

    Margaretha Rudas

  8. Department of Medicine, KH St. Poelten, St. Poelten, Austria

    Michael Pober

Authors
  1. Rupert Bartsch
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Brigitte Mlineritsch
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Michael Gnant
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Thomas Niernberger
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Ursula Pluschnig
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Richard Greil
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Catharina Wenzel
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Paul Sevelda
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Josef Thaler
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Margaretha Rudas
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Michael Pober
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Christoph C. Zielinski
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Guenther G. Steger
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

on behalf of the Austrian Fulvestrant Registry

Corresponding authors

Correspondence to Rupert Bartsch or Guenther G. Steger.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Bartsch, R., Mlineritsch, B., Gnant, M. et al. The Austrian fulvestrant registry: results from a prospective observation of fulvestrant in postmenopausal patients with metastatic breast cancer. Breast Cancer Res Treat 115, 373–380 (2009). https://doi.org/10.1007/s10549-008-0132-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10549-008-0132-0

Keywords

Search

Navigation