Morcellation Foe Presses On Despite Return of Cancer

March 10, 2015

During a telephone interview, her voice at times sounded weak.

Granted, a tired tone might be expected of a woman who had undergone surgery just 2 weeks earlier to remove metastatic cancer. And who, with her husband, is raising six children — four boys and two girls, ages 13 to 2.

Amy Reed, MD, PhD, nevertheless comes across as nothing but resilient. The anesthesiologist whose occult uterine cancer was upstaged as a result of laparoscopic power morcellation during a hysterectomy remains a staunch patient-safety advocate despite the recent return of her disease. Her high-profile case already has spurred a retreat from the use of the tissue-shredding devices, abetted by strong warnings from the US Food and Drug Administration (FDA) about the risk of dispersing occult cancer in abdominal cavities. However, she and her husband, Hooman Noorchashm, MD, PhD, hope to persuade gynecologic surgeons to abandon the technology entirely.

In addition, Dr Reed plans to conduct bench research on how to curb her particular cancer's growth. Dr Noorchashm, a cardiothoracic surgeon, will join her in the laboratory. Both are experienced researchers with doctorates in immunology and have joint publication credits.

But first comes the matter of recovery.

"Right now, I'm focusing on my health," the 41-year-old Dr Reed told Medscape Medical News.

Leg Numbness, Then Discovery of a New Tumor

A power morcellator shreds the uterus and fibroids into pieces that can be easily removed through the vagina or a laparoscopic incision, averting the need for a larger incision to remove the tissue intact.

Dr Reed underwent a laparoscopic hysterectomy with morcellation in October 2013 to remove uterine fibroids thought to be benign. After discovering that the procedure had resulted in the upstaging of a previously undiagnosed uterine leiomyosarcoma to stage 4, Dr Reed underwent cytoreduction and hyperthermic intraperitoneal chemotherapy, followed by six rounds of systemic chemotherapy. Subsequent MRI and CT scans indicated that she was cancer free.

Then, back on the job at the Hospital of the University of Pennsylvania in February, she noticed numbness in her upper left leg. Dr Reed initially chalked it up to long work hours on her feet, but a routine MRI pelvic screening revealed a tumor behind her left kidney that impinged on her spine and the second lumbar nerve. On February 20, a neurosurgeon excised the tumor and performed a laminectomy and lumbar fusion.

The tumor turned out to be cancerous, similar to the one in her uterus.

Now Dr Reed faces several rounds of radiation treatment ASAP. "This is a really aggressive cancer," she said. "We would be deluding ourselves if we think we can sit back and wait."

The medical couple recognizes that the cancer, now having metastasized, may be a lifetime foe.

"We're in for a big fight," said Dr Noorchashm in a separate interview with Medscape Medical News. "We're assuming that this disease is present in microscopic form elsewhere, and we're going after it. It's hard to predict where it will return."

"I'm hoping it takes more of a chronic-type route (in which) it comes up occasionally and we...deal with it," said Dr Reed.

The couple has assembled a team of medical colleagues to help chart a path forward after the end of radiation treatment. One option under consideration is treating Dr Reed with mammalian target of rapamycin (mTOR) inhibitors, which curb runaway cell growth and proliferation. Another possibility is T-cell therapy to goad these bloodstream guard dogs into attacking the cancer cells. Both treatments are largely experimental.

"We're going with extreme, outside-of-the-box thinking," said Dr Noorchashm, an assistant professor of surgery at the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia. "Amy and I intend to cure this thing. It's not outside the range of our capacity. It's a clump of dividing cells. We should be able to get this."

The couple also intends to play a direct role in this battle by eventually working in the laboratory together to find a therapy or regimen "to keep the cancer at bay," said Dr Reed. "We will pour all our resources into looking at these tumors and things that inhibit their growth. mTOR inhibition is definitely one of the things we're going to look at."

A String of Victories

Dr Reed and Dr Noorchashm can point to a string of victories since they went public with their criticism of power morcellators as too dangerous for gynecologic surgery. In April 2014, the FDA recommended that surgeons stop using the devices for hysterectomy or myomectomy in most women with uterine fibroids because of the risk of dispersing occult cancer. One in 350 women who undergo morcellation to remove fibroids have an unsuspected uterine sarcoma such as leiomyosarcoma, the FDA reported. The agency added an even tougher boxed warning 7 months later.

The healthcare industry last year quickly responded to the FDA alarm bells. Johnson & Johnson voluntarily withdrew its morcellators from the market because of cancer "uncertainty." Giant hospital chain HCA Holdings banned the use of power morcellators for removing uterine fibroids at its facilities. Highmark, a health insurer in the eastern United States, stopped paying for laparoscopic power morcellation in gynecologic procedures.

Still another insurer joined the backlash in February. UnitedHealthcare said that it would require preauthorization for all hysterectomies other than vaginal procedures performed on an outpatient basis. The company said that the FDA's warnings about the risk for morcellation dispersing occult cancer contributed to its decision.

These trends bode well for fewer procedures performed with power morcellation, said Dr Reed. However, she and her husband would like to bring that number down to zero. Otherwise, the number of women who have died from upstaged occult cancer such as Dr Reed's will only increase, they argue.

"We want the gynecologic community to collectively say, ‘This is something we should not be doing,' " she said.

The couple has not been able to convince the FDA to ban power morcellators outright, but they hope at least to reform the FDA's process for approving medical devices. Power morcellators were cleared through the agency's 510(k) process, which requires that a manufacturer need only prove that its product is substantially the same as a device already approved by the agency. Dr Reed and Dr Noorchashm contend that patients are ill served by a process that does not require premarket safety testing and lacks a mechanism for monitoring adverse outcomes. They are trying to persuade members of Congress to hold hearings on the deficiencies of the 510(k) approval pathway.

Dr Noorchashm, who has been a far more vocal advocate of eliminating gynecologic morcellation than his ailing wife, is eager to testify. "All I need is 5 minutes," he said.

"Look at What's in Front of You Today"

In taking their stand against laparoscopic morcellators, the couple has clashed with several medical societies that believe the devices still have a place in the surgeon's toolbox. The AAGL, formerly known as the American Association of Gynecologic Laparoscopists, holds that "appropriately performed" power morcellation outweighs the risk for open surgery in low-risk patients, provided there is informed consent and careful patient selection. Capturing and removing shredded tissue in an endobag appears to minimize the risk for dispersal, the AAGL states. The Society of Gynecologic Oncology takes a similar position, as does the American College of Obstetricians and Gynecologists, which expects preoperative screening for uterine cancer to improve.

The controversy has gotten personal at times. Several Medscape Medical News readers have commented that although they wish the best for Dr Reed, they think that Dr Noorchashm's understandably emotional response to her plight gets the best of his reasoning on clinical issues. He begs to differ.

"We have four doctorates between us and a record that says we're not just crazy people," said Dr Noorchashm. "The results of what we've done (such as the FDA warnings and product withdrawals} speak for themselves."

People who are harmed by something, he added, "have the most clarity on what's wrong."

Family conversations about her cancer have produced another kind of clarity, said Dr Reed. She and her husband have learned to be very honest with their children as well as with themselves. And to keep it simple.

"In the beginning, it was hard," she said. "We didn't know what to say. When you're talking to a kid, it forces you to state things very bare-bones. It's even somewhat comforting because you strip away a lot of the fear and the what-if's.

"They ask you questions like, 'Are you going to die?' I say, 'Well, everybody dies. I feel okay today.'

"They say, 'Is the cancer going to come back?' I say, 'I hope not. If it does, we'll deal with it.' "

"You don't go down all those horrible, what-if pathways with the kids. And I don't think we should do that as adults.

"Look at what's in front of you today."

Such as the 2-year-old boy who woke up from a nap and interrupted the phone interview. What Dr Reed's son said was hard to make out, except for the word "Mommy."

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