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Complete pathological response following levonorgestrel intrauterine device in clinically stage I endometrial adenocarcinoma: results of a randomized clinical trial

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Mar 21, 2021

Hormonal IUD shows promise as nonsurgical treatment for early endometrial cancer or precancer

CHICAGO (March 21, 2021)—An intrauterine device, or IUD, that releases the hormone levonorgestrel appears to be an effective treatment for endometrial (uterine) precancer and early-stage endometrial cancer, according to new study results. The study is being presented at the Society of Gynecologic Oncology 2021 Virtual Annual Meeting on Women’s Cancer.

Six months after insertion of the hormonal IUD, biopsy results showed no signs of cancer or precancer in two-thirds of 165 women with stage I endometrial cancer or atypical endometrial hyperplasia, the investigators reported. Atypical endometrial hyperplasia is a precancerous condition of the lining of the uterus (endometrium).

“Our results are encouraging, and further research is warranted using a longer treatment duration,” said lead study author Andreas Obermair, MD, professor, University of Queensland Faculty of Medicine, Brisbane, Australia.

The biopsy-proven treatment response, called complete pathological response, varied by disease. While 82 percent of women with precancer (79 of 96) had a complete response, only 43 percent of women with cancer (30 of 69) responded completely.

“This difference in response rates is what previous studies with much smaller case numbers reported, and it is not surprising,” Dr. Obermair said. “As cells move from healthy to cancer, they lose capability to respond to levonorgestrel.”

The investigators also studied response rates for women who received treatment in addition to the IUD. Forty-seven patients received IUD plus metformin, a diabetes drug with potential anti-cancer activity, and 47 IUD recipients also participated in a weight loss program. All study participants had obesity, a known risk factor for endometrial cancer.

At six months, the complete pathological response ranged from 57 percent for metformin treatment to 67 percent for weight loss, Dr. Obermair reported. He cautioned that a complete pathological response at six months does not always translate to a cure because recurrences are possible.

Although the levonorgestrel IUD is available as a contraceptive, Dr. Obermair said its use as an endometrial cancer treatment is still experimental. If approved, this IUD would be an option for women who wish to preserve fertility or cannot have an operation because of a high risk for complications.

The most common first treatment of endometrial cancer is a total hysterectomy (surgical removal of the uterus, cervix and fallopian tubes) and removal of both ovaries. Endometrial is the most common gynecologic cancer. According to the American Cancer Society, an estimated 60,000 new cases will be diagnosed in 2021 in the United States.