AACR: Estrogen Replacement/Tamoxifen Combo Poses No Additional Threat For Breast Cancer In Women With Hysterectomies
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AACR: Estrogen Replacement/Tamoxifen Combo Poses No Additional Threat For Breast Cancer In Women With Hysterectomies

By Cameron Johnston
Special to DG News

NEW ORLEANS, LA -- March 29, 2001 -- Tamoxifen use combined with estrogen replacement therapy in low- and moderate risk women previously treated for gynecologic cancers might reduce the number of new breast cancers that develop, say researchers. The results of a large Italian trial were reported yesterday at the annual meeting of the American Association for Cancer Research (AACR).

In presenting the results of the Italian Trial in Hysterectomized Women, Dr. Bernardo Bonanni, of the department of chemotherapeutics at the European Institute of Oncology, in Milan, stressed that the trial involved only low- and moderate-risk women who had been treated for benign genecological conditions, not women who had been treated for other forms of cancer, and were using tamoxifen.

The main trial involved a total of 5408 women who had had complete or partial hysterectomies and/or oopherectomies and were receiving 20mg of tamoxifen per day, or placebo.

A sub-group of 1350 women who were taking tamoxifen had also taken some form of estrogen replacement therapy for at least some period during the five-year trial. These were compared with a matched group of women who used only placebo. The most common form of ERT used was a transdermal estrogen patch.

Overall the larger trial showed a non-significant reduction of approximately 25 percent in the number of cancers that developed: 45 in the placebo group versus 34 in the tamoxifen group. There were no deaths attributed to breast cancer. Among those who had taken, or were taking tamoxifen and ERT, the results were more striking.

There were 17 cases of breast cancer in the group taking placebo, and six in the group taking ERT and tamoxifen. Among those who were taking ERT at baseline, the results were even more favorable, with 11 in the placebo group developing breast cancer, and three in the ERT/tamoxifen group developing breast cancer.

These results appeared early in the study, and became even more evident as the follow-up progressed, Dr. Bonanni said in a scientific presentation at the meeting.

As for non-malignant events that occurred, almost half of the women using tamoxifen developed hypertension, and 60 percent developed some form of cerebrovascular event. There was a significant difference in the numbers developing phlebitis: 73 percent versus 29 percent.

It is unclear whether combining ERT with tamoxifen would help ameliorate the symptoms of menopause such as hot flashes, Dr. Bonanni said. Side effects reported were an excess of vaginal discharge, fluid retention and hot flashes.

"On the basis of these encouraging results, we think it's very important to further investigate the role and potential beneficial effects of this combination," Dr. Bonanni said.

Potential benefits may include a reduced risk of breast cancer, and better compliance with the recommended tamoxifen regimen because of fewer menopausal symptoms among those women.

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