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Adjuvant Tamoxifen Treatment of Elderly Women with Stage II Breast Cancer: A Double-Blind Comparison with Placebo

FRANK J. CUMMINGS, M.D.; ROBERT GRAY, Ph.D.; THOMAS E. DAVIS, M.D.; DOUGLASS C. TORMEY, M.D., Ph.D.; JULES E. HARRIS, M.D.; GEOFFREY FALKSON, M.D.; and JAMES ARSENEAU, M.D.
[+] Article and Author Information

This study was conducted by the Eastern Cooperative Oncology Group, Paul P. Carbone, M.D., Chairman (CA 21115), and was supported by Public Health Service grants from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services. Institutions participating in this study were Brown University and Roger Williams General Hospital, Providence, Rhode Island (CA 15947); Dana-Farber Cancer Institute, Boston, Massachusetts (CA 23318); Wisconsin Clinical Cancer Center, Madison, Wisconsin (CA 21076); Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois (CA 10948); University of Pretoria, Pretoria, South Africa (CA 21692); University of Rochester Cancer Center, Rochester, New York (CA 11083). Other institutions participating in the ECOG include Albany Medical College, Albany, New York (CA 06594); Albert Einstein College of Medicine, Bronx, New York (CA 14958); American Oncologic Hospital, Philadelphia, Pennsylvania (CA 18281); Case Western Reserve University, Cleveland, Ohio (CA 14548); Chicago Medical School, Chicago, Illinois (CA 14144); Johns Hopkins Oncology Center, Baltimore, Maryland (CA 16116); University of Genoa, Genoa, Italy; Medical College of Ohio, Toledo, Ohio; University of Minnesota, Minneapolis, Minnesota (CA 20365); New York University Medical Center, New York, New York (CA 16395); Northwestern University Medical Center, Chicago, Illinois (CA 17145); Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania (CA 15488); Tufts University, Walpole, Massachusetts (CA 07190); Yale School of Medicine, New Haven, Connecticut (CA 15485).

▸Requests for reprints should be addressed to Frank J. Cummings, M.D., Roger Williams General Hospital, 825 Chalkstone Avenue, Providence, RI 02908.


Providence, Rhode Island; Boston, Massachusetts; Madison, Wisconsin; Chicago, Illinois; Rochester, New York; and Pretoria, South Africa


© 1985 American College of PhysiciansAmerican College of Physicians


Ann Intern Med. 1985;103(3):324-329. doi:10.7326/0003-4819-103-3-324
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One hundred seventy elderly women with stage II breast cancer, stratified on the basis of the number of positive axillary nodes and estrogen receptor status, were randomly assigned to receive tamoxifen or placebo for 24 months in a prospective, double-blind, adjuvant trial. The median age was 71 years with a range from 65 to 84 years. The overall percentage of patients disease-free at 4 years was 76% for those given tamoxifen and 52% for those given placebo (p = 0.0004). Benefit was seen in all subgroups of patients treated with tamoxifen. Two years of tamoxifen therapy represents an effective postoperative adjuvant treatment for elderly women with stage II breast cancer, resulting in improved time to relapse, statistically fewer distant first recurrences, and minimal toxicity. No improvement in overall survival has been seen yet.

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