publication date: May. 25, 2018

CDC announces review of pre-op diagnosis of uterine cancers by gynecologists

By Matthew Bin Han Ong

Robert Redfield, director of the Centers for Disease Control and Prevention, said the agency is reviewing the methods gynecologists use to identify women at risk of uterine cancers.

In a May 22 letter to Rep. Brian Fitzpatrick (R-PA), Redfield wrote that “CDC is committed to working to prevent cancer and its consequences wherever possible.”

The agency is reviewing medical literature on the number of women who go into gynecologic surgery with their physicians not knowing that their patients have cancer.

Redfield specifically cited a paper that sheds new light on the prevalence of undetected uterine cancers: “Occult Gynecologic Cancer in Women Undergoing Hysterectomy or Myomectomy for Benign Indications.” The paper was recently published in Obstetrics & Gynecology.

With all surgical routes considered, up to one in 70 women overall had undetected cancers in the main body of the uterus when they were subjected to hysterectomies. For women over age 55 who underwent total abdominal hysterectomies, the prevalence of corpus uteri cancer was nearly one in 10 (The Cancer Letter, May 18).

The study, which analyzed data from 26,444 women, was conducted by researchers from Yale University—Vrunda Desai, Jason Wright, Peter Schwartz, Elisa Jorgensen, Linda Fan, Babak Litkouhi, Haiqun Lin, Cary Gross, and Xiao Xu.

Redfield’s letter was a response to the April 24 inquiry from Fitzpatrick  (The Cancer Letter, May 4).

More than 600,000 women undergo hysterectomy every year in the United States.

These new estimates could mean that about 8,640 women annually are at risk of having their undetected uterine cancers upstaged—especially if their gynecologists fail to preoperatively diagnose the malignancies and proceed to use surgical procedures that fragment the tissue or that do not otherwise follow oncologically safe principles.

Many women who had their hidden cancers disseminated by power morcellation or manual morcellation die from metastatic disease. Patients who present with no evidence of disease after follow-up surgery to remove malignant implants experience anxiety about potential recurrence and adverse effects from drugs taken to prevent or delay the onset of recurrence (The Cancer Letter, May 18).

“CDC is reviewing available information, including data in the journal article,” Redfield wrote to Fitzpatrick. “It’s important to understand how to improve women’s health outcomes related to these surgeries, including how gynecologists might better identify women at risk of uterine cancers.”

The CDC letter was publicly released on May 24, exactly one year after Amy Reed, the anesthesiologist who launched an aggressive campaign against power morcellation, died from complications stemming from disseminated uterine disease. She was 44 (The Cancer Letter, May 26, 2017).

A Letter to the Editor by her husband Hooman Noorchashm, a cardiothoracic surgeon, appears on page <?>.

Another study, published May 18 in the Journal of Minimally Invasive Gynecology, concluded that “morcellation of non-malignant tissue is not without consequence,” after reviewing data from 5,154 women.

“Pathology confirmed endometriosis was documented for the first time in 20.4 percent of patients who underwent a second surgery,” the authors,  who practice at Kaiser Permanente Los Angeles Medical Center, wrote. “This finding raises the suspicion that morcellation and dispersion of the uterine specimen may be associated in the development of endometriosis.”

Peter Lurie, the former associate commissioner for public health strategy and analysis at FDA who was involved in the agency’s efforts against power morcellators, said that CDC should move quickly to establish guidelines for preoperative workup by gynecologists.

“The CDC is to be commended for ensuring that this reevaluation takes place in an evidence-based manner that will ultimately promote the health of women considering these procedures,” said Lurie, who is now director and president of the Center for Science in the Public Interest.

“As an associate commissioner at the FDA, my office was responsible for estimating the prevalence of unsuspected sarcoma (a specific form of cancer),” Lurie said in a statement. “This ultimately led to warnings from the FDA in 2014 that sharply limited the practice of power morcellation, since the process runs the risk of spreading any undetected cancer cells from a growth thought to be a fibroid throughout the patient’s abdomen, significantly worsening her prognosis.

“This warning was recently reviewed and reiterated by FDA Commissioner [Scott] Gottlieb.

“While our focus at FDA was on sarcoma, the new paper [by Yale researchers] expands the analysis to other forms of malignancy and finds prevalences of undiagnosed cancer that raise even greater public health concerns.

“The FDA warnings against morcellation were a necessary step, but the new research and the magnitude of risk it reveals suggest that more must be done: a complete reevaluation of preoperative screening for these patients.

“It is our hope that the CDC leadership will move quickly to establish the necessary guidelines to ensure that all gynecologists utilize adequate risk stratification methods, including robust tissue biopsy methods, to identify women with gynecological cancer preoperatively.”

 

The text of Redfield’s letter follows:

Dear Representative Fitzpatrick:

Thank you for congratulating me on my new position as the Director of the Centers for Disease Control and Prevention (CDC). I am honored to lead the world’s premier public health agency.

I appreciate your bringing to our attention the potential risk of laparoscopic power morcellators and your curiosity as to whether uterine tissue biopsy may protect against any procedure that may lead to spread or upstaging of occult cancer.

The journal article your constituent provided, Occult Gynecologic Cancer in Women Undergoing Hysterectomy or Myomectomy for Benign Indications, adds to the body of evidence estimating the number of women undergoing gynecologic surgery with unsuspected cancers.

CDC is reviewing available information, including data in the journal article. It’s important to understand how to improve women’s health outcomes related to these surgeries, including how gynecologists might better identify women at risk of uterine cancers.

CDC leads nationwide efforts to ease the burden of cancer, working with national cancer organizations, state health agencies, and other key groups to develop, implement, and promote effective strategies for preventing and controlling cancer. More specifically, CDC conducts surveillance and education and awareness activities related to gynecologic cancers, including uterine cancer.

The U.S. Food and Drug Administration (FDA) has taken important steps to raise awareness of laparoscopic power morcellators’ potential dangers to women with unsuspected uterine cancer. FDA issued a safety warning for the devices in 2014, later reaffirmed in 2017, discouraging the use of laparoscopic power morcellators during hysterectomy or myomectomy for treatment of women with uterine fibroids.

The warning also recommends against the use of power morcellators among women with suspected or known uterine cancer. FDA continues to review adverse event reports, peer-reviewed scientific literature, and information from patients, health care providers, gynecologic and surgical professional societies, and medical device manufacturers to assure patient safety.

CDC is committed to working to prevent cancer and its consequences wherever possible. We will continue to work with federal partners and medical professional organizations to improve the health of women. Thank you, again, for your letter and your interest in CDC’s public health efforts.

Sincerely,

Robert R. Redfield, MD

Director, CDC

Copyright (c) 2018 The Cancer Letter Inc.