Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group.

2.50
Hdl Handle:
http://hdl.handle.net/10541/91918
Title:
Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group.
Authors:
Buzdar, Aman; Jonat, Walter; Howell, Anthony ( 0000-0002-3879-5991 ) ; Jones, Stephen E; Blomqvist, Carl P; Vogel, Charles L; Eiermann, Wolfgang; Wolter, Janet M; Steinberg, Mark; Webster, Alan; Lee, David
Abstract:
BACKGROUND: This report presents the results of a survival update based on the combined data from two studies that compared the efficacy and tolerability of anastrozole (1 or 10 mg once daily), a selective, nonsteroidal aromatase inhibitor administered orally, and megestrol acetate (40 mg 4 times daily) in the treatment of postmenopausal women with advanced breast carcinoma whose disease had progressed after treatment with tamoxifen. METHODS: Two randomized, parallel-group, multicenter trials were conducted, involving a total of 764 patients. The two trials were identical in design; both were double blind for anastrozole and open label for megestrol acetate. Overview analyses were conducted with the intent of strengthening the interpretation of results from each trial. The median follow-up duration for this survival update was 31 months. RESULTS: At the clinical dose of 1 mg daily, anastrozole demonstrated a statistically significant survival advantage over megestrol acetate, with a hazard ratio of 0.78 (P < 0.025)(0.60 < 97.5% confidence interval [CI] <1.0). The 1 mg anastrozole group also had a longer median time to death (26.7 months) compared with 22.5 months for the megestrol acetate group. The 10 mg anastrozole group also had a survival benefit over the megestrol acetate group, with a hazard ratio of 0.83 (P=0.09, not significant)(0.64 < 97.5% CI < 1.1). Higher 2-year survival rates were observed for both anastrozole treatment groups than for the megestrol acetate group (56.1%, 54.6%, and 46.3% for the groups given 1 mg anastrozole, 10 mg anastrozole, and megestrol acetate, respectively). CONCLUSIONS: This combined analysis of two trials of postmenopausal patients with advanced breast carcinoma has clearly demonstrated that, after disease progression with tamoxifen, treatment with anastrozole 1 mg once daily results in a statistically and clinically significant advantage over a standard treatment, megestrol acetate. This important benefit, in addition to the good tolerability profile of anastrozole, supports the use of this drug as a valuable new treatment option for this patient population.
Affiliation:
Department of Breast Medical Oncology, the University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
Citation:
Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group. 1998, 83 (6):1142-52 Cancer
Journal:
Cancer
Issue Date:
15-Sep-1998
URI:
http://hdl.handle.net/10541/91918
DOI:
10.1002/(SICI)1097-0142(19980915)83:6<1142::AID-CNCR13>3.0.CO;2-5
PubMed ID:
9740079
Type:
Article
Language:
en
ISSN:
0008-543X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorBuzdar, Amanen
dc.contributor.authorJonat, Walteren
dc.contributor.authorHowell, Anthonyen
dc.contributor.authorJones, Stephen Een
dc.contributor.authorBlomqvist, Carl Pen
dc.contributor.authorVogel, Charles Len
dc.contributor.authorEiermann, Wolfgangen
dc.contributor.authorWolter, Janet Men
dc.contributor.authorSteinberg, Marken
dc.contributor.authorWebster, Alanen
dc.contributor.authorLee, Daviden
dc.date.accessioned2010-02-12T11:22:20Z-
dc.date.available2010-02-12T11:22:20Z-
dc.date.issued1998-09-15-
dc.identifier.citationAnastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group. 1998, 83 (6):1142-52 Canceren
dc.identifier.issn0008-543X-
dc.identifier.pmid9740079-
dc.identifier.doi10.1002/(SICI)1097-0142(19980915)83:6<1142::AID-CNCR13>3.0.CO;2-5-
dc.identifier.urihttp://hdl.handle.net/10541/91918-
dc.description.abstractBACKGROUND: This report presents the results of a survival update based on the combined data from two studies that compared the efficacy and tolerability of anastrozole (1 or 10 mg once daily), a selective, nonsteroidal aromatase inhibitor administered orally, and megestrol acetate (40 mg 4 times daily) in the treatment of postmenopausal women with advanced breast carcinoma whose disease had progressed after treatment with tamoxifen. METHODS: Two randomized, parallel-group, multicenter trials were conducted, involving a total of 764 patients. The two trials were identical in design; both were double blind for anastrozole and open label for megestrol acetate. Overview analyses were conducted with the intent of strengthening the interpretation of results from each trial. The median follow-up duration for this survival update was 31 months. RESULTS: At the clinical dose of 1 mg daily, anastrozole demonstrated a statistically significant survival advantage over megestrol acetate, with a hazard ratio of 0.78 (P < 0.025)(0.60 < 97.5% confidence interval [CI] <1.0). The 1 mg anastrozole group also had a longer median time to death (26.7 months) compared with 22.5 months for the megestrol acetate group. The 10 mg anastrozole group also had a survival benefit over the megestrol acetate group, with a hazard ratio of 0.83 (P=0.09, not significant)(0.64 < 97.5% CI < 1.1). Higher 2-year survival rates were observed for both anastrozole treatment groups than for the megestrol acetate group (56.1%, 54.6%, and 46.3% for the groups given 1 mg anastrozole, 10 mg anastrozole, and megestrol acetate, respectively). CONCLUSIONS: This combined analysis of two trials of postmenopausal patients with advanced breast carcinoma has clearly demonstrated that, after disease progression with tamoxifen, treatment with anastrozole 1 mg once daily results in a statistically and clinically significant advantage over a standard treatment, megestrol acetate. This important benefit, in addition to the good tolerability profile of anastrozole, supports the use of this drug as a valuable new treatment option for this patient population.en
dc.language.isoenen
dc.subjectBreast Canceren
dc.subject.meshAged-
dc.subject.meshAntineoplastic Agents, Hormonal-
dc.subject.meshBreast Neoplasms-
dc.subject.meshDisease Progression-
dc.subject.meshDouble-Blind Method-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshEnzyme Inhibitors-
dc.subject.meshFemale-
dc.subject.meshFollow-Up Studies-
dc.subject.meshHumans-
dc.subject.meshMegestrol-
dc.subject.meshNitriles-
dc.subject.meshPostmenopause-
dc.subject.meshProportional Hazards Models-
dc.subject.meshSurvival Rate-
dc.subject.meshTriazoles-
dc.titleAnastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group.en
dc.typeArticleen
dc.contributor.departmentDepartment of Breast Medical Oncology, the University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.en
dc.identifier.journalCanceren

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