1097-0142/asset/cover.gif?v=1&s=a7299bc18f075294c232ade468773cd0672bd470 "Cancer")
Additional members of the Arimidex Study Group who participated in this trial were Harvey B. Sher, University Professional Center, Jacksonville, FL; David B. Myers, BIOP, Billings, MT; Carol J. Fabian, University of Kansas Medical Center, Kansas City, KS; Rayna Kneuper-Hall, Medical University of South Carolina, Charleston, SC; Andrew G. Glass, Kaiser Foundation Hospital, Portland, OR; Nicholas James Robert, Fairfax Hospital, Annandale, VA; Irving M. Berkowitz, Medical Center of Delaware, Newark, DE; Stuart J. Tipping, Marshfield Clinic, Marshfield, WI; Gershon Y. Locker, The Evanston Hospital, Evanston, IL; Michael Meshad, Providence Cancer Center, Mobile, AL; Peter D. Eisenberg, Marin Oncology Associates Incorportated, Greenbrae, CA; Harold A. Harvey, Milton Hershey Medical Center, Hershey, PA; James W. Lynch, Univeristy of Florida, Gainesville, FL; Barbara A. Parker, University of California at San Diego Cancer Center, San Diego, CA; Debu Tripathy, Mount Zion Medical Center, San Francisco, CA; Reginald P. Pugh, Allegheny General Hospital, Pittsburgh, PA; Hernan I. Vargas and Stanley R. Klein, Harbor-UCLA Medical Center, Torrance, CA; Lucille A. Leong, City of Hope Medical Center, Duarte, CA; Gregory B. Smith, Hematology and Oncology Group, Santa Rosa, CA; John K. Erban and Susan A. Sajer, New England Medical Center, Boston, MA; Leo L. Stolbach, Saint Vincent's Hospital, Worcester, MA; Steven Perkins, Dallas, TX; Kathleen I. Pritchard, Toronto-Bayview Regional Cancer Centre, North York, Ontario, Canada; Nikolay V. Dimitrov, Michigan State University, East Lansing, MI; Karl K. Boatman, Baptist Medical Center of Oklahoma, Oklahoma City, OK; Jacob Amir, Little Rock Diagnostic Clinic PA, Little Rock, AR; Aroop Mangalik, University of New Mexico Cancer Center, Albuquerque, NM; Francis J. Cummings, Roger Williams General Hospital, Providence, RI; Joseph Aisner, University of Maryland Cancer Center, Baltimore, MD; Joseph A. Sparano, Montefiore Medical Center, Bronx, NY; Gary B. Fleishman, Research for Health Incorporated, Houston, TX; David N. Krag, University of Vermont Cancer Center, Burlington, VT; Fredric C. Kass, Cancer Foundation of Santa Barbara, Santa Barbara, CA; Mary A. Simmonds, Cowley Associates, Camp Hill, PA; James A. Mailliard, Creighton Cancer Center, Omaha, NE; Lori J. Goldstein, Fox Chase Cancer Center, Philadelphia, PA; Ellis G. Levine, Roswell Park Cancer Center, Buffalo, NY; Harvey J. Lerner, Oncology Associates, Philadelphia, PA; Thomas G. Frazier, Bryn Mawr, PA; Kenneth E. Gale, Syracuse, NY; Ishmael A. Jaiyesimi, Cancer Care Associates, PC, Royal Oak, MI; Sanford Jay Kempin, and Gary A. Palmer, Cooperative Cancer Center, Palm Springs, CA; Gregory P. Sarna, Comprehensive Cancer Center, Cedars Sinai, Los Angeles, CA; Martin Wiesenfeld, Cedar Rapids Oncology Project, Cedar Rapids, IA; Dala J. R. Jarolim, International Medical Technical Consultants, Inc., Tulsa, OK; Rebecca L. Moroose, Altamonte Springs, FL; Susan N. Rosenthal, Rochester General Hospital, Rochester, NY; Joseph M. Koenig, Akron City Hospital, Akron, OH; David Prager, Allentown, PA; John Showel, West Suburban Hospital, Oak Park, IL; Elizabeth C. Reed, University of Nebraska Medical Center, Omaha, NE; John R. Feagler, Immanuel Cancer Center, Omaha, NE; Gamini S. Soori, Maryland Plaza, Omaha, NE; Robert W. Warner, Heartland Oncology and Hematology, PC, Council Bluffs, IA; James A. Stewart, University of Wisconsin, Hospital and Clinics, Madison, WI; Robert A. Johnson, The Memphis Cancer Center, Inc., Memphis, TN; Silvana Martino, Westlake Comprehensive Cancer Center, Westlake Village, CA; James R. Borst, Butterworth Hospital, Grand Rapids, MI; Howard L. Ritter, The Toledo Clinic, Toledo, OH; Robert C. Hermann, Marrietta, GA; Barry S. Berman, and Michael S. Robert, Regional Oncology and Hematology Associates, Kissimmee, FL; Peter Todd Silberstein, Mercy Cancer Center, Mason City, IA; John M. Bennett, University of Rochester Cancer Center, Rochester, NY; and Daniel Booser, Gabriel Hortobagyi, Richard Therault, and Frankie Holmes, M. D. Anderson Cancer Center, Houston, TX.
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Original Article
A Phase III trial comparing anastrozole (1 and 10 milligrams), a potent and selective aromatase inhibitor, with megestrol acetate in postmenopausal women with advanced breast carcinoma
Article first published online: 27 SEP 2000
DOI: 10.1002/(SICI)1097-0142(19970215)79:4<730::AID-CNCR10>3.0.CO;2-0
Copyright © 1997 American Cancer Society
Additional Information
How to Cite
Buzdar, A. U., Jones, S. E., Vogel, C. L., Wolter, J., Plourde, P., Webster, A. and for the Arimidex Study Group (1997), A Phase III trial comparing anastrozole (1 and 10 milligrams), a potent and selective aromatase inhibitor, with megestrol acetate in postmenopausal women with advanced breast carcinoma. Cancer, 79: 730–739. doi: 10.1002/(SICI)1097-0142(19970215)79:4<730::AID-CNCR10>3.0.CO;2-0
Publication History
- Issue published online: 27 SEP 2000
- Article first published online: 27 SEP 2000
- Manuscript Accepted: 28 OCT 1996
- Manuscript Received: 19 SEP 1996
- Abstract
- Article
- References
- Cited By
Keywords:
- anastrozole;
- megestrol acetate;
- aromatase inhibition;
- progestin;
- breast carcinoma;
- postmenopausal
The new aromatase inhibitor anastrozole, given in doses of 1 and 10 mg once daily, is well tolerated and represents an effective therapeutic option for the treatment of advanced breast carcinoma in postmenopausal women who progress after tamoxifen treatment.
Abstract
BACKGROUND
Anastrozole is a new oral aromatase inhibitor with highly potent and selective activity for the aromatase enzyme. In a Phase III trial, the efficacy and tolerability of anastrozole, given in doses of 1 and 10 mg orally once daily, and megestrol acetate, given in doses of 40 mg orally 4 times daily, were compared in 386 postmenopausal women with advanced breast carcinoma who progressed after tamoxifen therapy.
METHODS
The trial was randomized, double blind for anastrozole, open label for megestrol acetate, parallel group, and multicenter. Patients were randomly assigned to receive anastrozole, 1 mg (n = 128); anastrozole, 10 mg (n = 130); or megestrol acetate (n = 128). The primary efficacy measures were time to progression and tumor response; secondary measures were time to treatment failure, duration of response, quality of life, and time to death.
RESULTS
With a median duration of follow-up of 6 months, there was no statistical evidence of a difference between either 1 or 10 mg doses of anastrozole and megestrol acetate for any efficacy endpoint. According to rigid response criteria, 10%, 6%, and 6% of patients in the anastrozole 1 mg, anastrozole 10 mg, and megestrol acetate groups, respectively, had an objective response (complete response or partial response) and 27%, 24%, and 30% of patients in the respective groups had stable disease for a duration of 24 weeks or longer. Quality-of-life assessments revealed that anastrozole in a 1-mg dose was associated with better physical scores and anastrozole in a 10-mg dose with better psychologic scores than megestrol acetate. Both anastrozole and megestrol acetate were generally well tolerated. Among anticipated adverse events, gastrointestinal disturbance was more common among patients in the anastrozole groups, whereas weight gain occurred more frequently among patients in the megestrol acetate groups. Weight increases of 5% or more and 10% or more were more common among megestrol acetate-treated patients; moreover, patients in this group continued to gain weight over time.
CONCLUSIONS
Anastrozole, given in doses of 1 and 10 mg once daily, represents a well tolerated and effective therapeutic option for the treatment of postmenopausal women with advanced breast carcinoma who progress after tamoxifen treatment. Cancer 1997; 79:730-9. © 1997 American Cancer Society.