Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: results of overview analysis of two phase III trials. Arimidex Study Group.

Buzdar, A; Jonat, W; Howell, A; Jones, S E; Blomqvist, C; Vogel, C L; Eiermann, W; Wolter, J M; Azab, M; Webster, A; Plourde, P V

doi:10.1200/jco.1996.14.7.2000

Cited by 406Breast Cancer Treatment StudiesAdvanced Breast Cancer TherapiesEstrogen and related hormone effects

Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: results of overview analysis of two phase III trials. Arimidex Study Group.

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Buzdar, A, Jonat, W, Howell, A, Jones, S E, Blomqvist, C, Vogel, C L, Eiermann, W, Wolter, J M +3 more·1996·Journal of Clinical Oncology

DOI 10.1200/jco.1996.14.7.2000

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Abstract

PURPOSE: To compare the efficacy and tolerability of anastrozole (1 and 10 mg once daily), a selective, oral, nonsteroidal aromatase inhibitor, and megestrol acetate (40 mg four times daily), in postmenopausal women who progressed following tamoxifen treatment. PATIENTS AND METHODS: Two randomized, double-blind for anastrozole, open-label for megestrol acetate, parallel-group, multicenter trials were conducted in 764 patients. Because both trials were identical in design, an analysis of the combined results was performed to strengthen interpretation of results from each trial. RESULTS: The median follow-up duration was approximately 6 months. The estimated progression hazards ratios were 0.97 (97.5% confidence interval [CI], 0.75 to 1.24) for anastrozole 1 mg versus megestrol acetate and 0.92 (97.5% CI, 0.71 to 1.19) for anastrozole 10 mg versus megestrol acetate. The overall median time to progression was approximately 21 weeks. Approximately one third of patients in each group benefited from treatment. Twenty-seven patients (10.3%) in the anastrozole 1-mg group, 22 (8.9%) in the anastrozole 10-mg group, and 20 (7.9%) in the megestrol acetate group had a complete or partial response, and 66 (25.1%), 56 (22.6%), and 66 (26.1%) patients, respectively, had stable disease for > or = 24 weeks. For all end points, individual trial results were similar to the results of the combined analysis. Anastrozole and megestrol acetate were well tolerated. Gastrointestinal disturbance was more common among patients in the anastrozole groups than the megestrol acetate group; the difference between the anastrozole 10 mg and megestrol acetate groups was significant (P = .005). Significantly fewer patients in the anastrozole 1-mg (P < .0001) and 10-mg (P < .002) groups had weight gain than in the megestrol acetate group. More than 30% of megestrol acetate-treated patients had weight gain > or = 5%, and 10% of patients had weight gain > or = 10%. Patients who received megestrol acetate continued to gain weight over time. CONCLUSION: Anastrozole, 1 and 10 mg once daily, is well tolerated and as effective as megestrol acetate in the treatment of postmenopausal women with advanced breast cancer who progressed following tamoxifen treatment. Moreover, anastrozole therapy avoids the weight gain associated with megestrol acetate treatment.

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Untitled work
(1998) · doi:10.1002/(sici)1097-0142(19980915)83:6
Clinical Overview of Anastrozole A New Selective Oral Aromatase Inhibitor
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Authors: Buzdar, A., Jonat, W., Howell, A., Jones, S. E., Blomqvist, C., Vogel, C. L., Eiermann, W., Wolter, J. M., Azab, M., Webster, A., & Plourde, P. V.
Affiliations: The University of Texas MD Anderson Cancer Center (US)
ORCID: Buzdar, A
Howell, A
Jones, S E
Blomqvist, C
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 1996-07
Volume: 14
Issue: 7
Pages: 2000-2011
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.1996.14.7.2000
OpenAlex: W1909697168
Cited by: 406
References: 24
Citations by year: 2025: 2 · 2024: 3 · 2022: 2 · 2021: 2 · 2020: 4 · 2019: 8 · 2018: 2 · 2017: 5 · 2016: 11 · 2015: 7 · 2014: 4 · 2013: 18 · 2012: 10
FWCI: 12.96
Type: journal article
Language: en
Open access: green
research.manchester.ac.uk
Licence: other-oa
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Research Explorer (The University of Manchester) (publishedVersion, other-oa)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
Keywords: anastrozole, megestrol acetate, aromatase inhibitors, advanced breast cancer, postmenopausal women, progression-free survival, time to progression, complete response, stable disease, gastrointestinal adverse effects, weight gain, drug tolerability, dose comparison, combination chemotherapy, combined radiotherapy, combination endocrine therapy
MeSH terms: Anastrozole, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Breast Neoplasms, Double-Blind Method, Female, Humans, Megestrol, Middle Aged, Nitriles, Prognosis, Tamoxifen, Triazoles, Survival Rate, Postmenopause, Disease Progression, Antineoplastic Agents, Hormonal, Megestrol Acetate, Aromatase Inhibitors

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Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: results of overview analysis of two phase III trials. Arimidex Study Group.

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