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Estrogen therapy does not cause new cancer in menopausal women with treated localized breast cancer

Estrogen replacement therapy does not cause new or recurrent breast cancer in menopausal women with a history of treated, localized breast cancer, according to an article currently available online and to be published in the November 1st print issue of CANCER.

After five years, estrogen replacement therapy had no adverse effect on survival or compromise of disease-free states among women with a history of treated localized breast cancer. These results, which come from one of the longest follow-up trials to date, provide additional evidence of the safety of such therapy in menopausal women with treated primary breast cancer --- a group that has previously largely been denied the health benefits of replacement therapy.

The researchers conducted a randomized, prospective clinical trial to evaluate the safety and efficacy of estrogen replacement therapy in patients with a history of treated stage I or II localized breast cancer. Women with a history of known estrogen receptor-positive tumors were specifically excluded from the study. A total of 77 women participated in the randomized arm (34 received therapy, whereas 43 did not). An additional 222 women participated in the non-randomized arm of the study (22 received therapy, whereas 200 did not).

No statistically significant differences between the clinical prognostic characteristics of randomized and nonrandomized patients were observed. Participants were evaluated every three months for two years, and then every six months for an additional three years, with clinical and laboratory assessments including lipid profile, follicular stimulating hormone level, and estradiol levels. Bone Mineral Density was measured at baseline and annually for five years.

There was no significant difference in survival after five years between women who received replacement therapy and those who did not. Analysis of the randomized group showed no differences in disease-free survival among women receiving therapy and those who did not or among women with estrogen receptor-negative tumors.

Analysis of all 299 participants showed similar findings. In fact, patients who received replacement therapy were more likely to enjoy breast cancer-free survival (P=0.04, hazard ratio=4.08). New or recurrent breast cancer developed in 33 (13.5 percent) women in the no-therapy arm; contralateral new breast cancer developed in 2 (3.6 percent) women who received replacement therapy. No difference in disease-free survival was observed among participants with receptor-negative tumors. There were no deaths and no difference between therapy and no-therapy groups in the development of other cancers.

There was modest improvement in bone density and lipid profiles among women treated with estrogen replacement therapy. After five years there was significant beneficial effect on bone mineral density of the hip (P=0.0001) and in high-density lipoprotein cholesterol in the group treated with replacement therapy.

The authors concluded that this study "provides prospective data with much longer follow-up than previous series and reinforced the notion that estrogen replacement therapy does not compromise disease-free states in patients with curatively treated breast cancer."

The authors added, "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."




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