Originally published as JCO Early Release 10.1200/JCO.2007.11.6061 on December 17 2007

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Survival After Adjuvant Oophorectomy and Tamoxifen in Operable Breast Cancer in Premenopausal Women

Richard R. Love, Nguyen Van Dinh, Tran Tu Quy, Nguyen Dieu Linh, Nguyen Dinh Tung, Tien-zhen Shen, Erinn M. Hade, Gregory S. Young, David Jarjoura

From the Comprehensive Cancer Center and The Center for Biostatistics, The Ohio State University, Columbus, OH; Hospital K, National Cancer Institute, Hanoi; Danang General Hospital, Danang; and Hue Central Hospital, Hue, Socialist Republic of Vietnam; People's Hospital of Haimen City, Haimen, Jiangsu, People's Republic of China

Corresponding author: Richard R. Love, MD, The Ohio State University, B402 Starling Loving Hall, 320 W 10th Ave, Columbus, OH 43210; e-mail: Richard.Love{at}osumc.edu

Purpose: Worldwide, approximately 750,000 new cases of breast cancer are diagnosed annually in premenopausal women with limited economic resources. Longer-term survival benefits from adjuvant therapies in such women with operable breast cancer are unknown.

Patients and Methods: From 1993 to 1999, we recruited 709 premenopausal women with operable breast cancer to a multisite randomized clinical trial of adjuvant oophorectomy and tamoxifen for 5 years or observation and this combined hormonal therapy on recurrence.

Results: With a median follow-up of 7.0 years, disease-free and overall survival were significantly improved with the adjuvant treatment (log-rank P = .0003 and .0002, respectively). Five year disease-free survival (DFS) probabilities of 74% and 61% (95% CI for difference, 7% to 21%) and overall survival (OS) rates of 78% and 71% (95% CI for difference, 1% to 21%) were observed in the adjuvant and observation groups. Ten-year DFS probabilities of 62% and 51% (95% CI for difference, 4% to 22%) and OS probabilities of 70% and 52% (95% CI for difference, 6% to 34%) between adjuvant and observation groups, respectively, were observed. In the subset of estrogen receptor–positive patients, 5-year DFS probabilities were 83% and 61%, and 10-year DFS probabilities were 66% and 47%, while 5-year OS probabilities were 88% and 74%, and 10-year OS probabilities were 82% and 49% in the adjuvant and observation groups, respectively.

Conclusion: In premenopausal women with operable breast cancer not selected for estrogen receptor status or with estrogen receptor–positive tumors, 5- and 10-year DFS and OS rates are significantly improved following adjuvant oophorectomy and tamoxifen.

Supported by Grant No. CA64339 from the National Institutes of Health, Bethesda, MD, and by the International Breast Cancer Research Foundation, Madison, WI.

The tamoxifen (Nolvadex) for this study was provided at cost by AstraZeneca Pharmaceuticals.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.