ERT Not Harmful in Women With Localized, Treated Breast Cancer

Laurie Barclay, MD

October 21, 2002

Oct. 21, 2002 — Estrogen-replacement therapy (ERT) may be given two years after women are disease-free from estrogen receptor (ER)-negative early-stage breast carcinoma, or after 10 years if ER status was unknown. Results of a five-year prospective trial reported in the Nov. 1 issue of Cancer showed that women meeting these criteria were not harmed by starting ERT, but the investigators suggest that larger randomized trials are needed to confirm these findings.

This study "provides prospective data with much longer follow-up than previous series and reinforced the notion that ERT does not compromise disease-free states in patients with curatively treated breast cancer," write Rena Vassilopoulou-Sellin, MD, and colleagues from the M.D. Anderson Cancer Center in Houston, Texas.

This randomized, prospective clinical trial followed women with a history of treated stage I or II localized breast cancer who were disease-free for at least two years if ER was negative and for at least 10 years if ER status was unknown. Women with a history of known ER-positive tumors were specifically excluded. Of 77 women in the randomized arm of the study, 34 received ERT and 43 did not. An additional 222 women participated in the nonrandomized arm of the study, including 22 who received ERT and 200 who did not. Clinical and other prognostic characteristics were similar in all groups at baseline.

Follow-up evaluations every three months for two years and every six months for an additional three years included clinical and laboratory assessments, lipid profile, FH, FHS, and estradiol levels at each visit. Bone mineral density (BMD) was measured at baseline and annually for five years.

Five-year survival and disease-free survival were not significantly different in women who received ERT compared with those who did not, based on analyses of both the randomized arm and the entire study population. Patients receiving ERT had a higher probability of breast cancer-free survival (P=.04; hazard ratio, 4.08). New or recurrent breast cancer developed in 33 women (13.5%) not receiving ERT and in 2 women (3.6%) who did receive ERT. There was no difference in disease-free survival among women with ER-negative tumors, and no difference in the development of other cancers between groups receiving or not receiving ERT.

Women treated with ERT had modest improvement in bone density and lipid profiles, and significant improvement in hip BMD (P=.0001) and in high-density lipoprotein cholesterol after five years.

"Larger prospective, randomized trials with appropriate statistical power are clearly very important to define the safety of ERT in this setting and, perhaps, modify current standards of care for women with a history of treated primary breast cancer," the authors write.

Cancer. 2002;95:1817-1826

Reviewed by Gary D. Vogin, MD

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