Low Uterine Sarcoma Rates Among Women Undergoing Leiomyomata Surgery

By Will Boggs MD

February 12, 2015

NEW YORK (Reuters Health) - Uterine sarcoma rates are quite low among women undergoing surgery for uterine leiomyomata, especially women younger than 50 years, researchers report.

Uterine leiomyomata are often treated by electric morcellation as a less invasive alternative to open surgery, but concerns have been raised that unsuspected sarcoma tissue could be spread through morcellation. In April 2014, the U.S. Food and Drug Administration (FDA) discouraged the use of morcellation in this setting as a result of these concerns.

"We need to have a large-scale observational comparative analysis of safety and effectiveness of morcellation compared to more invasive alternatives," Dr. Art Sedrakyan, from Weill Medical College of Cornell University in New York, told Reuters Health by email. "More evidence will help us understand the benefits and harms."

Dr. Sedrakyan and colleagues used data from the Surveillance, Epidemiology, and End Results (SEER) database, the California State Inpatient Database, and the State Ambulatory Surgery Database, and all California cancer registries to calculate two estimates of the prevalence of uterine sarcoma.

The first estimate used as the population denominator women who received a diagnosis of leiomyomata and underwent a hysterectomy or a myomectomy, which overestimates the prevalence of uterine sarcoma, and the second estimate used as the denominator all women who underwent a hysterectomy or a myomectomy for any diagnosis, which could underestimate its prevalence.

For women younger than 50 years, the sarcoma prevalence ranged from 0.08% to 0.13%, whereas women older than 60 years had sarcoma prevalence between 0.36% and 1.53%.

Based on conservative estimates of surgical treatment of leiomyomata (0.13% to 1.53%), this translates into 1 in 769 women younger than 50 years and 1 in 65 women older than 60 years having sarcomas, according to the February 4 JAMA Surgery online report.

Depending on age group, open surgery was associated with in-hospital mortality ranging from 0.01% to 0.33% and with an acute myocardial infarction risk ranging from 0.32% to 0.92%.

"Sarcoma spread is a serious safety issue and might well be the deciding factor," Dr. Sedrakyan said, "but we do not have the complete picture yet? Can morcellation reduce mortality and serious morbidity? The mortality and serous morbidity are rare after surgery, but can we further reduce their occurrence? This evidence is needed before a strong message can be communicated to physicians."

"In general, from a policy perspective, we need to make sure availability of less invasive surgery does not lead to inappropriate surgery," Dr. Sedrakyan concluded.

Dr. Togas Tulandi from McGill University Health Center, Montreal, told Reuters Health, "Today, there has been no reliable test to diagnose sarcoma in women with uterine myoma. It does not mean that all women with myoma should undergo surgery. In fact, nonsurgical treatment of uterine myoma, including uterine artery embolization, magnetic resonance focused ultrasound, has been shown to be safe."

In any recommendation for leiomyomata treatment, Dr. Tulandi said, "Regardless of the use of morcellation, the prevalence of sarcoma in different age of women should be stated. It should state that most uterine fibroids are benign and do not require any treatment."

"FDA discussed power-morcellation but not the use of other types of morcellator," he explained. "Safer morcellators are being developed."

"Most laparoscopic myomectomies or hysterectomies do not lead to spreading of undiagnosed cancer," Dr. Tulandi concluded. "The use of morcellation has allowed surgery with minimally invasive technique, avoiding laparotomy."

Dr. Sedrakyan reports being the founder of the Medical Device Epidemiology Network's Science and Infrastructure Center at Cornell University, with FDA and institutional funding. No other authors report any disclosures.

SOURCE: http://bit.ly/1FyptEc

JAMA Surg 2015.


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