麻豆传媒

NEW YORK -- An FDA warning on the use of power morcellators, which were linked to the spread of cancerous tissue, may have led to a drop in the incidence of distant leiomyosarcoma, according to a population analysis.

From 2001 to 2014 -- before the FDA put out a warning against the use of power morcellators -- the incidence of distant leiomyosarcoma rose by an average of 4% per year, reported Deanna Wong, MD, of the University of California Los Angeles.

But after the FDA's 2014 warning, the incidence of distant leiomyosarcoma decreased by 4.67% per year through 2018.

The "correlation of these findings to the FDA warning on power morcellators warrants further investigation," she said at the International Gynecologic Cancer Society (IGCS) annual meeting.

Incidence of local and regional leiomyosarcoma did not change after the warning, and 5-year survival rates remained stable over the study time period, at roughly 40%, according to the presentation.

Leiomyosarcoma accounts for 1% to 2% of all uterine malignancies, and around half are diagnosed during surgeries for presumed benign leiomyomas. Power morcellation has been associated with undetected spreading of cancer, linked to upstaging in between 21% to 42% of cases, and a threefold increased risk of recurrence and death, Wong said.

The FDA placed a warning on the use power morcellators for hysterectomies and myomectomies in 2014, stating that the device carried a risk of spreading cancerous tissue. After the agency published the warning, the use of power morcellators dropped dramatically.

IGCS discussant Jubilee Brown, MD, of the Levine Cancer Institute in Charlotte, North Carolina, emphasized that the medical community should "absolutely not" go back to the use of power morcellation.

Brown said the stable survival rates highlight "the need for better systemic therapy and overall therapy for leiomyosarcoma."

In this study, Wong's group investigated the incidence of advanced stage leiomyosarcoma, describing survival outcomes over time. The researchers obtained 2001-2018 leiomyosarcoma incidence data from the U.S. Cancer Statistics database, and 2004-2016 survival data from the National Cancer Database.

The study included nearly 850,000 patients with uterine cancer, with 16,808 cases of leiomyosarcoma.

From 2001-2018, uterine cancer incidence increased by an average of 0.71% per year, and leiomyosarcoma rose at an average of 0.48% per year. Approximately a quarter of patients with leiomyosarcoma were Black women, with incidence of the illness rising by a mean of nearly 2% per year. Among white women, who made up 61% of patients with leiomyosarcoma, the incidence decreased by 0.5% during the study time period.

Wong noted that the researchers did not have a central pathology review, which limits these findings. Additionally, the researchers did not have access to survival data for patients who underwent power morcellation.

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