Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.

2.50
Hdl Handle:
http://hdl.handle.net/10541/81140
Title:
Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.
Authors:
Howell, Anthony ( 0000-0002-3879-5991 ) ; Robertson, John F R; Quaresma Albano, J; Aschermannova, A; Mauriac, L; Kleeberg, Ulrich R; Vergote, I; Erikstein, B; Webster, A; Morris, C
Abstract:
PURPOSE: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) and anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. PATIENTS AND METHODS: Patients (n = 451) with advanced breast cancer were randomized to receive fulvestrant 250 mg as a once-monthly (one x 5 mL) intramuscular injection or an oral dose of anastrozole 1 mg in this open, parallel-group, multicenter trial. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rates, defined as complete response (CR) or partial response (PR), duration of response (DOR), and tolerability. RESULTS: Patients were followed for a median period of 14.4 months. In terms of TTP, fulvestrant was as effective as anastrozole (hazard ratio, 0.98; confidence interval [CI], 0.80 to 1.21; P =.84). Median TTP was 5.5 months for fulvestrant and 5.1 months for anastrozole. OR rates showed a numerical advantage for fulvestrant (20.7%) over anastrozole (15.7%) (odds ratio, 1.38; CI, 0.84 to 2.29; P =.20). Clinical benefit rates (CR + PR + stable disease > or = 24 weeks) were 44.6% for fulvestrant and 45.0% for anastrozole. Median DOR was 14.3 months for fulvestrant and 14.0 months for anastrozole. Both treatments were well tolerated, with 3.2% and 1.3% of fulvestrant- and anastrozole-treated patients, respectively, withdrawn from treatment because of an adverse event. CONCLUSION: Fulvestrant was as effective as anastrozole. These data confirm that fulvestrant is an additional, effective, and well-tolerated treatment for advanced breast cancer in postmenopausal women whose disease progressed on prior endocrine therapy.
Affiliation:
Department of Medical Oncology, Christie Hospital NHS Trust, Wilmslow Road, Manchester M20 4BX, United Kingdom. maria.parker@christie-tr.nwest.nhs.ukto
Citation:
Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. 2002, 20 (16):3396-403 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
15-Aug-2002
URI:
http://hdl.handle.net/10541/81140
PubMed ID:
12177099
Type:
Article
Language:
en
ISSN:
0732-183X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorHowell, Anthony-
dc.contributor.authorRobertson, John F R-
dc.contributor.authorQuaresma Albano, J-
dc.contributor.authorAschermannova, A-
dc.contributor.authorMauriac, L-
dc.contributor.authorKleeberg, Ulrich R-
dc.contributor.authorVergote, I-
dc.contributor.authorErikstein, B-
dc.contributor.authorWebster, A-
dc.contributor.authorMorris, C-
dc.date.accessioned2009-09-15T15:34:51Z-
dc.date.available2009-09-15T15:34:51Z-
dc.date.issued2002-08-15-
dc.identifier.citationFulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. 2002, 20 (16):3396-403 J. Clin. Oncol.en
dc.identifier.issn0732-183X-
dc.identifier.pmid12177099-
dc.identifier.urihttp://hdl.handle.net/10541/81140-
dc.description.abstractPURPOSE: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) and anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. PATIENTS AND METHODS: Patients (n = 451) with advanced breast cancer were randomized to receive fulvestrant 250 mg as a once-monthly (one x 5 mL) intramuscular injection or an oral dose of anastrozole 1 mg in this open, parallel-group, multicenter trial. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rates, defined as complete response (CR) or partial response (PR), duration of response (DOR), and tolerability. RESULTS: Patients were followed for a median period of 14.4 months. In terms of TTP, fulvestrant was as effective as anastrozole (hazard ratio, 0.98; confidence interval [CI], 0.80 to 1.21; P =.84). Median TTP was 5.5 months for fulvestrant and 5.1 months for anastrozole. OR rates showed a numerical advantage for fulvestrant (20.7%) over anastrozole (15.7%) (odds ratio, 1.38; CI, 0.84 to 2.29; P =.20). Clinical benefit rates (CR + PR + stable disease > or = 24 weeks) were 44.6% for fulvestrant and 45.0% for anastrozole. Median DOR was 14.3 months for fulvestrant and 14.0 months for anastrozole. Both treatments were well tolerated, with 3.2% and 1.3% of fulvestrant- and anastrozole-treated patients, respectively, withdrawn from treatment because of an adverse event. CONCLUSION: Fulvestrant was as effective as anastrozole. These data confirm that fulvestrant is an additional, effective, and well-tolerated treatment for advanced breast cancer in postmenopausal women whose disease progressed on prior endocrine therapy.en
dc.language.isoenen
dc.subjectBreast Canceren
dc.subjectOestrogen Antagonistsen
dc.subjectCancer Metastasisen
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAged, 80 and over-
dc.subject.meshAntineoplastic Agents, Hormonal-
dc.subject.meshBreast Neoplasms-
dc.subject.meshDisease-Free Survival-
dc.subject.meshEstradiol-
dc.subject.meshEstrogen Antagonists-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLogistic Models-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasm Metastasis-
dc.subject.meshNitriles-
dc.subject.meshPostmenopause-
dc.subject.meshQuality of Life-
dc.subject.meshSurvival Rate-
dc.subject.meshTriazoles-
dc.titleFulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.en
dc.typeArticleen
dc.contributor.departmentDepartment of Medical Oncology, Christie Hospital NHS Trust, Wilmslow Road, Manchester M20 4BX, United Kingdom. maria.parker@christie-tr.nwest.nhs.uktoen
dc.identifier.journalJournal of Clinical Oncologyen

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