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).

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It was possible to publish this article open access thanks to a Swiss National Licence with the publisher.
Serval ID
serval:BIB_06370A2C65A1
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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).
Journal
Annals of Oncology
Author(s)
Perey L., Paridaens R., Hawle H., Zaman K., Nolé F., Wildiers H., Fiche M., Dietrich D., Clément P., Köberle D., Goldhirsch A., Thürlimann B.
ISSN
0923-7534
Publication state
Published
Issued date
2007
Peer-reviewed
Oui
Volume
18
Number
1
Pages
64-69
Language
english
Abstract
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 >or=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.
Keywords
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Hormonal, Aromatase Inhibitors, Breast Neoplasms, Disease Progression, Drug Resistance, Neoplasm, Estradiol, Estrogen Receptor Modulators, Female, Humans, Middle Aged, Neoplasms, Hormone-Dependent, Postmenopause, Receptors, Estrogen, Salvage Therapy, Treatment Outcome
Pubmed
Web of science
Open Access
Yes
Create date
28/04/2008 7:26
Last modification date
25/09/2019 6:08
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