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Tuesday, Sep 30, 2014

Siegel: Questioning the campaign against power morcellation

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Uterine cancer has been in the news because of a technique called power morcellation, in which doctors use an electric tool to cut up what they think are benign fibroids so that the pieces can be extracted through small incisions in the abdomen.

Doctors have ways to determine endometrial carcinoma (the common form of uterine cancer). But biopsies and imaging studies like ultrasounds and MRIs don’t do a good job of detecting uterine sarcomas (rare forms of cancer). Some sarcomas can be quite aggressive, and no one doubts that cutting them up and leaving pieces behind is a bad idea.

The Food and Drug Administration will hold hearings Thursday and Friday in Silver Spring, Maryland, on whether to ban power morcellators in laparoscopic procedures.

Meanwhile, doctors in Tampa and elsewhere are working on safer tools and better bags to collect the cut-up pieces. For fear of lawsuits, we can expect to see informed consent improved and fewer morcellations. Research continues on ways to identify sarcomas before surgery.

As a longtime patient advocate, I was horrified by research presented at an international sarcoma conference last October, and I helped other advocates concerned with the issue. Hooman Noorchashm, M.D., Ph.D, a Harvard cardiothoracic surgeon, has become the leading proponent of a ban. His wife, an anesthesiologist, underwent the procedure only to discover that she had leiomyosarcoma, the same sarcoma as mine.

But I disagree with him going public with personal attacks. Cooperation among doctors in different fields will help women more than conflict. Some patient advocates fear challenging him.

Dr. Noorchashm thinks informed consent is not enough. But cutting up cancer by accident is not the only risk in surgery, and laparoscopy appears to have advantages over open abdominal hysterectomies (laparotomies). Should the FDA let women choose power morcellation if they are properly informed and they are given other options?

If we use the highest figures, a woman who seeks a hysterectomy for fibroids has a 1 in 350 chance of having some type of sarcoma instead. We don’t have good figures on how many women will die or die sooner, solely due to power morcellation. (Some women with slow-growing sarcoma will not die; some with aggressive disease would have died anyway or, like me, they will respond to treatment.) Similarly, we don’t have good statistics on how many women will suffer and/or die if power morcellation is banned and they have to have traditional abdominal surgery.

Dr. Noorchashm says morcellation equals stage IV, the stage when cancer is considered incurable. But the oncologists with whom I talked do not agree.

“In my opinion, if a patient has had a morcellation hysterectomy, but has not had further surgery to determine whether there is residual/newly spread disease, then we do not really know her stage,” said Martee L. Hensley, M.D., MSc, renowned for her research on uterine leiomyosarcoma (uLMS). “If her imaging does not show measurable metastatic disease, then we cannot say she is definitely stage IV.”

Next she discussed two different staging systems — FIGO (by the International Federation of Gynecology and Obstetrics) and AJCC (by the American Joint Committee on Cancer) — for uterine sarcoma.

“If a post-morcellation patient has a second surgery and is found to have tumor either grossly or microscopically that is outside the uterus, then, at least by AJCC staging, that would be stage IV disease,” she said. “There are differences between the old FIGO staging, the new FIGO staging, and AJCC staging. FIGO puts local spread of disease in lower-stage groups but ignores grade, size, mitotic rate; AJCC calls disease outside the organ metastatic but includes grade and size as important parameters. Neither staging system performs well in terms of providing accuracy for prognosis. We do not know whether the prognosis for a morcellation-created stage IV patient differs from a non-morcellation stage IV patient. It is unlikely that morcellation would be the sole factor to drive the prognosis in a stage IV patient.”

Dr. Hensley is an attending physician in gynecologic medical oncology at Memorial Sloan-Kettering Cancer Center in New York. To better predict survival, she and her colleagues have developed a nomogram that includes more factors than the other staging systems.

For example, two women could have Stage I disease, with the LMS contained in the uterus. But one could have the worst factors, as my tumor did, while the other had a tumor that barely qualified as LMS. Would we expect the women to have the same prognosis, even though both were stage I?

Another hypothetical situation: One woman goes to her doctor, who discovers her uLMS has spread to her lungs, where she has many tumors. There’s no doubt that she has systemic disease — LMS cells traveled through her bloodstream and found a hospitable climate in her lungs. Another woman has morcellation, and soon afterward, a doctor discovers a few bits of cancer have implanted in her abdomen and are growing. They didn’t get there via the bloodstream; they were put there mechanically. Would we expect the women to have the same prognosis, even though both were stage IV? How do we know if the second woman has systemic disease?

“But both women are incurable,” said Brian Van Tine, MD, Ph.D, director of the sarcoma program at Barnes and Jewish Hospital at Washington University in St. Louis.

In the morcellation debate, there has been confusion between treatment and prognosis, Dr. Van Tine said. He said medical oncologists should consider patients who have had power morcellation to be of highest risk, whether or not they have metastases. This means considering chemotherapy after surgery and following their cases closely.

As far as prognosis goes, however, he would not label people without metastases as stage IV or consider them terminal. Warning women via the media that they risk dying of cancer if they undergo power morcellation is one thing. But, he said, it would be cruel to tell women who have already had the procedure that they have little chance of survival, if they don’t have metastatic disease.

Some also use prognostic figures incorrectly. Using government statistics, the American Cancer Society says a woman with Stage I uLMS has a 63 percent chance of being alive in five years. A woman with stage IV disease has only a 14 percent chance of surviving that long, the ACS says.

But this is based on the original diagnosis, not what happens later. For example, if a woman is stage I originally, but a year later LMS is found in her lungs, she can’t say that she went from a 63 percent chance to a 14 percent chance. The same is true for the uLMS nomogram developed by Memorial Sloan-Kettering. If you get metastases after your original diagnosis, you can’t use that fact to find out your current chance of survival. Your chances of survival are still better, on average, than someone who had metastases at the time of her original diagnosis.

Women with uterine sarcoma should have been told the risks of power morcellation. Now, let’s not deprive them of hope.

Suzie Siegel worked as a reporter and editor at The Tampa Tribune from 1988-99.

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