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Presence of unexpected uterine sarcoma during myomectomy increases with age
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The risk for unexpected uterine sarcoma in women undergoing myomectomy for presumed benign leiomyoma varied greatly across age groups, according to study results.
These data may help inform researchers of the risk for using morcellators to remove masses that are presumed to be benign.
“Our study represents an advancement in the understanding of the risk of unexpected uterine sarcoma in the setting of surgery for presumed benign leiomyoma,” Andrew S. Brohl, MD, of the department of hematology and medical oncology at Icahn School of Medicine at Mount Sinai, said in a press release. “Importantly, our risk model is the first to take into account how much a patient’s age affects her risk and shows that some age groups are at a much higher risk for unexpected uterine sarcoma than previous estimates imply.”
The FDA recently issued guidance recommending manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge the risk that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during power morcellation, increasing risks for morbidity and mortality.
The guidance also recommends laparoscopic power morcellators be contraindicated for women who are peri- or postmenopausal, as well as those who are candidates for en bloc tissue removal through the vagina or mini-laparotomy incision.
Brohl and colleagues conducted a retrospective cohort study to determine the incidence of unexpected uterine sarcoma in women who underwent surgery for presumed benign leiomyoma. They also stratified risk by age.
The researchers evaluated data from 2,075 patients (mean age, 38.3 years) who underwent myomectomy at Mount Sinai between 2005 and 2014. The analysis also included data from eight additional studies, resulting in an aggregate population of 10,120 women.
Eighteen women were diagnosed with leiomyosarcoma following surgery, equating to an aggregate risk of 1.78 per 1,000 women (95% CI, 1.1-2.8). Eight additional women were diagnosed with endometrial stromal sarcoma, equating to an aggregate risk of 1.16 per 1,000 women (95% CI, 0.5-4.9). These diagnoses combined translated to a total risk estimate of uterine sarcoma of 2.94 per 1,000 women (95% CI, 1.8-4.1).
The analysis also included data from 8,365 women with uterine sarcoma identified using the SEER 18 database. Researchers compared the age of women in the SEER cohort at the time of diagnosis of uterine sarcoma with the ages of women in the retrospective cohort at the time of myomectomy surgery. The analysis assumed age-stratified risk following myomectomy would parallel the age-stratified ratio of incidence of uterine sarcoma to incidence of uterine leiomyoma requiring surgery.
Results of these analyses indicated the highest estimated risk for uterine sarcoma occurred in women aged 75 to 79 years (10.1 cases per 1,000 surgical procedures, or 1 in 98). The lowest risk occurred in women aged younger than 30 years (˂1 in 500). The risks increased from approximately 1 in 400 among women aged 35 to 44 years, to 1 in 304 among women aged 45 to 49 years, to 1 in 216 among women aged 50 to 54 years.
“Clinicians and expert groups can use this risk-prediction model to inform practice guidelines and to provide more accurate and more individualized counseling to patients who require surgical intervention for uterine fibroids or myomas,” Brohl said. – by Cameron Kelsall
Disclosure: One researcher reports a consultant/advisory role with, honoraria and research funding from and equity ownership in AstraZeneca, Ayasdi, GlaxoSmithKline, Janssen Pharmaceuticals, NuMedii and Roche.
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