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.

2.50
Hdl Handle:
http://hdl.handle.net/10541/77934
Title:
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.
Authors:
Howell, Anthony ( 0000-0002-3879-5991 ) ; Robertson, John F R; Abram, Paul; Lichinitser, Mikhail R; Elledge, Richard M; Bajetta, Emilio; Watanabe, Toru; Morris, Charles; Webster, Alan; Dimery, Isaiah; Osborne, C Kent
Abstract:
PURPOSE: To evaluate the efficacy and tolerability of fulvestrant (Faslodex; AstraZeneca Pharmaceuticals LP, Wilmington, DE), a new estrogen receptor (ER) antagonist that downregulates ER and has no agonist effects, versus tamoxifen, an antiestrogen with agonist and antagonist effects, for the treatment of advanced breast cancer in postmenopausal women. PATIENTS AND METHODS: In this multicenter, double-blind, randomized trial, patients with metastatic/locally advanced breast cancer previously untreated for advanced disease were randomly assigned to receive either fulvestrant (250 mg, via intramuscular injection, once monthly; n = 313) or tamoxifen (20 mg, orally, once daily; n = 274). Patients' tumors were positive for ER (ER+) and/or progesterone receptor (PgR+), or had an unknown receptor status. RESULTS: At a median follow-up of 14.5 months, there was no significant difference between fulvestrant and tamoxifen for the primary end point of time to progression (TTP; median TTP, 6.8 months and 8.3 months, respectively; hazard ratio, 1.18; 95% CI, 0.98 to 1.44; P =.088). In a prospectively planned subset analysis of patients with known ER+ and/or PgR+ tumors ( approximately 78%), median TTP was 8.2 months for fulvestrant and 8.3 months for tamoxifen (hazard ratio, 1.10; 95% CI, 0.89 to 1.36; P =.39). The objective response rate for the overall population was 31.6% with fulvestrant and 33.9% with tamoxifen, and 33.2% and 31.1%, respectively, in the known hormone receptor-positive subgroup. Both treatments were well tolerated. CONCLUSION: In the overall population, between-group differences in efficacy end points favored tamoxifen, and statistical noninferiority of fulvestrant could not be demonstrated. However, in patients with hormone receptor-positive tumors, fulvestrant had similar efficacy to tamoxifen and was well tolerated.
Affiliation:
Christie Hospital and Holt Radium Institute, Manchester, UK. maria.parker@christie-tr.nwest.nhs.uk
Citation:
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. 2004, 22 (9):1605-13 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
1-May-2004
URI:
http://hdl.handle.net/10541/77934
DOI:
10.1200/JCO.2004.02.112
PubMed ID:
15117982
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.authorAbram, Paul-
dc.contributor.authorLichinitser, Mikhail R-
dc.contributor.authorElledge, Richard M-
dc.contributor.authorBajetta, Emilio-
dc.contributor.authorWatanabe, Toru-
dc.contributor.authorMorris, Charles-
dc.contributor.authorWebster, Alan-
dc.contributor.authorDimery, Isaiah-
dc.contributor.authorOsborne, C Kent-
dc.date.accessioned2009-08-19T15:54:39Z-
dc.date.available2009-08-19T15:54:39Z-
dc.date.issued2004-05-01-
dc.identifier.citationComparison 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. 2004, 22 (9):1605-13 J. Clin. Oncol.en
dc.identifier.issn0732-183X-
dc.identifier.pmid15117982-
dc.identifier.doi10.1200/JCO.2004.02.112-
dc.identifier.urihttp://hdl.handle.net/10541/77934-
dc.description.abstractPURPOSE: To evaluate the efficacy and tolerability of fulvestrant (Faslodex; AstraZeneca Pharmaceuticals LP, Wilmington, DE), a new estrogen receptor (ER) antagonist that downregulates ER and has no agonist effects, versus tamoxifen, an antiestrogen with agonist and antagonist effects, for the treatment of advanced breast cancer in postmenopausal women. PATIENTS AND METHODS: In this multicenter, double-blind, randomized trial, patients with metastatic/locally advanced breast cancer previously untreated for advanced disease were randomly assigned to receive either fulvestrant (250 mg, via intramuscular injection, once monthly; n = 313) or tamoxifen (20 mg, orally, once daily; n = 274). Patients' tumors were positive for ER (ER+) and/or progesterone receptor (PgR+), or had an unknown receptor status. RESULTS: At a median follow-up of 14.5 months, there was no significant difference between fulvestrant and tamoxifen for the primary end point of time to progression (TTP; median TTP, 6.8 months and 8.3 months, respectively; hazard ratio, 1.18; 95% CI, 0.98 to 1.44; P =.088). In a prospectively planned subset analysis of patients with known ER+ and/or PgR+ tumors ( approximately 78%), median TTP was 8.2 months for fulvestrant and 8.3 months for tamoxifen (hazard ratio, 1.10; 95% CI, 0.89 to 1.36; P =.39). The objective response rate for the overall population was 31.6% with fulvestrant and 33.9% with tamoxifen, and 33.2% and 31.1%, respectively, in the known hormone receptor-positive subgroup. Both treatments were well tolerated. CONCLUSION: In the overall population, between-group differences in efficacy end points favored tamoxifen, and statistical noninferiority of fulvestrant could not be demonstrated. However, in patients with hormone receptor-positive tumors, fulvestrant had similar efficacy to tamoxifen and was well tolerated.en
dc.language.isoenen
dc.subjectBreast Canceren
dc.subject.meshAdministration, Oral-
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAged, 80 and over-
dc.subject.meshAntineoplastic Agents, Hormonal-
dc.subject.meshBreast Neoplasms-
dc.subject.meshDisease Progression-
dc.subject.meshDisease-Free Survival-
dc.subject.meshDouble-Blind Method-
dc.subject.meshEstradiol-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshInjections, Intramuscular-
dc.subject.meshMiddle Aged-
dc.subject.meshReceptors, Estrogen-
dc.subject.meshReceptors, Progesterone-
dc.subject.meshTamoxifen-
dc.titleComparison 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.en
dc.typeArticleen
dc.contributor.departmentChristie Hospital and Holt Radium Institute, Manchester, UK. maria.parker@christie-tr.nwest.nhs.uken
dc.identifier.journalJournal of Clinical Oncologyen

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