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Randomized Double-Blind Trial of Estrogen Replacement Therapy Versus Placebo in Stage I or II Endometrial Cancer: A Gynecologic Oncology Group Study

From the Gynecology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; Division of Gynecologic Oncology, Women's Cancer Center, University of Nevada School of Medicine, Las Vegas, NV; Department of Gynecologic Oncology, Riverside Methodist Hospital; Department of Obstetrics and Gynecology, Ohio State University, Columbus, OH; Section of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK

Address reprint requests to Denise Mackey, Gynecologic Oncology Group Administrative Office, Four Penn Center, Ste 1020, 1600 John F. Kennedy Blvd, Philadelphia, PA 19103; e-mail: gynbreast{at}mskcc.org

PURPOSE: To determine the effect of estrogen replacement therapy (ERT) on recurrence rate and survival in women who have undergone surgery for stage I or II endometrial cancer.

PATIENTS AND METHODS: After surgery, eligible patients were allocated to therapy with ERT or placebo after undergoing hysterectomy with or without pelvic and aortic nodal sampling. Planned duration of hormonal versus placebo treatment was 3 years, with an additional 2 years of follow-up.

RESULTS: The median follow-up time for all 1,236 eligible and assessable patients was 35.7 months. Stage, grade, histologic subtype, and percentage of patients receiving adjuvant therapy were similarly distributed between the groups. The median age at diagnosis for the 618 patients randomly assigned to ERT was 57 years (range, 26 to 91 years). Two hundred fifty-one patients (41.1%) were compliant with ERT for the entire treatment period. Disease recurrence was experienced in 14 patients (2.3%). Eight patients (1.3%) developed a new malignancy. There were 26 deaths (4.2%), and five deaths (0.8%) were a result of endometrial cancer. The median age at diagnosis for the 618 patients in the placebo group was 57 years (range, 30 to 88 years). Twelve patients (1.9%) experienced disease recurrence. Ten patients (1.6%) developed a new malignancy. There were 9 deaths (3.1%) in the placebo group, and four deaths (0.6%) were a result of endometrial cancer.

CONCLUSION: Although this incomplete study cannot conclusively refute or support the safety of exogenous estrogen with regard to risk of endometrial recurrence, it is noteworthy that the absolute recurrence rate (2.1%) and the incidence of new malignancy were low.

Supported by National Cancer Institute Grant No. CA 27469 to the Gynecologic Oncology Group Administrative Office and Grant No. CA 37517 to the Gynecologic Oncology Group Statistical and Data Center.

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

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