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Annals of Oncology Advance Access originally published online on October 9, 2006
Annals of Oncology 2007 18(1):64-69; doi:10.1093/annonc/mdl341
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© 2006 European Society for Medical Oncology

breast cancer

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)

L Perey1, R Paridaens2, H Hawle1, K Zaman1,*, F Nolé3, H Wildiers2, M Fiche1, D Dietrich1, P Clément2, D Köberle1, A Goldhirsch3 and B Thürlimann1

1 Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland
2 Department of General Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven, Belgium
3 Unit for Medical Care, Department of Medicine, European Institute of Oncology, Milan, Italy

* Correspondence to: Dr K. Zaman, Centre Pluridisciplinaire d'Oncologie, Rue du Bugnon 46, CHUV, 1011 Lausanne, Switzerland. Tel: +41-21-314-46-58; Fax: +41-21-314-02-00; E-mail: Khalil.Zaman{at}chuv.ch

Background: The aim of this study was to evaluate the efficacy and tolerability of fulvestrant, an estrogen receptor antagonist, in postmenopausal women with hormone-responsive tumors progressing after aromatase inhibitor (AI) treatment.

Patients and methods: This is a phase II, open, multicenter, noncomparative study. Two patient groups were prospectively considered: group A (n = 70) with AI-responsive disease and group B (n = 20) with AI-resistant disease. Fulvestrant 250 mg was administered as intramuscular injection every 28 (±3) days.

Results: All patients were pretreated with AI and 84% also with tamoxifen or toremifene; 67% had bone metastases and 45% liver metastases. Fulvestrant administration was well tolerated and yielded a clinical benefit (CB; defined as objective response or stable disease [SD] for ≥24 weeks) in 28% (90% confidence interval [CI] 19% to 39%) of patients in group A and 37% (90% CI 19% to 58%) of patients in group B. Median time to progression (TTP) was 3.6 (95% CI 3.0 to 4.8) months in group A and 3.4 (95% CI 2.5 to 6.7) months in group B.

Conclusions: Overall, 30% of patients who had progressed following prior AI treatment gained CB with fulvestrant, thereby delaying indication to start chemotherapy. Prior response to an AI did not appear to be predictive for benefit with fulvestrant.

Key words: advances breast cancer, aromatase inhibitor, endocrine therapy, fulvestrant, postmenopausal, SAKK Trial 21/00


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