Jul 2, 2013

Similar Outcomes with Oral and IUD Hormonal Therapy for Endometrial Neoplasia

For women with endometrial hyperplasia or early cancer who require or prefer a nonsurgical approach, hormone therapy yields similar outcomes whether delivered orally or via an intrauterine device (IUD), a new study shows.

Overall, however, women with early adenocarcinoma had considerably fewer complete responses to primary hormone therapy compared to women with hyperplasia, the researchers found.

In a May 7th online paper in Obstetrics & Gynecology, Dr. Paola A. Gehrig of the University of North Carolina at Chapel Hill and colleagues note that many women with these conditions may not be surgical candidates and alternative treatments are being increasingly considered.

Part of this trend may be due to the increase in obesity. “In addition to being a risk factor for developing disease,” say the researchers “obesity and diabetes predispose patients to many additional comorbidities and surgical complications.”

The investigators recently reviewed data on 153 women who received progestin therapy between 1999 and 2011, without surgery or radiation as part of primary treatment. Ninety-five received oral progesterone; the others used a levonorgestrel-releasing IUD. Medical comorbidities were the main reason for use of hormones (in 46%), followed by fertility concerns (in 21%).

Women with hyperplasia had complete response rates of 66 to 70% and recurrence rates of 11% to 23%. In cancer patients, by comparison, complete response rates were 6 to 13%, and recurrence rates were 19% to 30%.

Because the study was retrospective and patients weren’t monitored with any specific protocol, the researchers grouped them according to how often they returned for follow-up visits: three to six months, six to nine months, nine to 12 months, and more than 12 months.

For women with cancer, there was no demonstrable difference in outcomes (regression, persistence, or progression) at any time point regardless of whether they used the levonorgestrel-releasing device or systemic hormones.

In patients with hyperplasia, outcomes were different only during the nine- to 12-month assessment, where those who received systemic hormones were less likely to have disease persistence or progression.

Six women attempted assisted reproduction and three achieved pregnancy. Given the small numbers, “it is difficult to draw conclusions regarding a woman’s ability to achieve pregnancy in this setting,” the authors wrote.

Overall, they stress that “Close patient monitoring remains paramount given the high recurrence and high percentage of patients who will not respond.”

In light of the findings, Dr. Gehrig told Reuters Health, “Further research with prospective trials is necessary to determine safety and efficacy.”

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Commenting on the broader context in an email to Reuters Health, Dr. John O. Schorge of the Massachusetts General Hospital in Boston, author of a related editorial, observed that in the last 20 years, “the United States has experienced a remarkable 20% decline in total deaths from cancer. All four of the most common diagnoses, including prostate, colorectal, breast, and lung cancer have decreased by at least 30%. In contrast to these successes has been the 30% increase in the number of women dying from uterine cancer over the same time period.”

Dr. Schorge added, “In large measure due to the rampant epidemic of obesity and excessive estrogenic environment, the incidence rates of uterine cancer and its precursor atypical hyperplasia are expected to further escalate for the foreseeable future.”

“Unfortunately,” he concluded, “the larger body size makes a definitive hysterectomy much more technically challenging, resulting in longer operative times, a higher likelihood of complications, and less ability to successfully perform a minimally invasive procedure. In our evolving era of cost-containment, alternative nonsurgical treatment methods as studied in the (current) article, will undoubtedly have a more expansive role in the prevention and treatment of uterine cancer.”

SOURCE: http://bit.ly/14oyEVk

Obstet Gynecol 2013;121:1172-1180.

— David Douglas

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