Chemotalk Newsletter, Vol. 74: June 1, 2014
Hello, Everyone...welcome to June. Two important stories to cover, but first a thought from yours truly:
We don't need this information until we need it. And then we need it very much. So if you're a reader and wondering what this all has to do with you, the information you're getting will register somewhere in your memory, so that if and when you, or someone you know, does need it, you can send that person in the right direction.
F.D.A. DISCOURAGES PROCEDURE IN UTERINE SURGERY
By Denise Grady
Doctors should stop using a procedure performed on tens of thousands of American women a year in the course of uterine surgery, because it poses a risk of spreading cancerous tissue, the Food and Drug Administration declares.
The procedure, power morcellation, involves using a device to cut tissue into pieces that can be pulled out through the tiny incisions made during minimally invasive surgery. The devices, known as morcellators, have been widely used in laparoscopic operations to remove fibroid tumors from the uterus, or to remove the entire uterus.
The action does not take them off the market or ban their use but "discourages" doctors from using them in hysterectomies or fibroid surgery.*
Morcellators were allowed onto the market in the 1990s without the usual clinical trials in patients because they were similar to other devices that had already been approved -- a process that critics of the agency say can lead too safety problems like the one that has now been recognized.
The F.D.A. became concerned about morcellators because of recent news reports about patients apparently harmed by them, said Dr. William Maisel, deputy director for science and chief scientist of the agency's Center for the Devices and Radiological Health.
A case in Boston, first reported in December (2013), drew national attention to the cancer risk. The patient was Dr. Amy Reed, 40, an anesthesiologist and mother of six children, the youngest a 1-year-old. Dr. Reed had a hysterectomy because of fibroids in October, at Brigham and Women's Hospital. A biopsy after the surgery found a hidden sarcoma, an aggressive type of cancer. Morcellation had spread the tumor around inside her pelvis and abdomen, causing advanced, Stage 4 cancer.
Dr. Reeds husband, Dr. Hooman Noorchashm, is a cardiothoracic surgeon, and he said he was horrified to learn that tissue had been minced up inside his wife's body. One rule that surgeons are taught, he said, is that cancers or potentially cancerous tissue should be removed whole and not broken up or cut, to avoid spreading the disease.
the couple began a relentless campaign to stop morcellation, hoping to spare other women from what had happened to Dr, Reed. They contacted reporters, hospitals, other doctors, legislators, the F.D.A., and medical societies, sending thousands of emails. They feel their efforts to save other women from what happened to Dr. Reed has paid off.
"I think it's a major step in the right direction," Dr. Noorchashm said.
BUT HE ADDED THAT THE AGENCY SHOULD HAVE DONE MORE, LIKE TAKING THE DEVICES OFF THE MARKET.
About a half-million women a year have hysterectomies to remove the uterus, and some 50,000 of those operations involve power morcellation of tissue containing fibroid tumors, the agency said.
Fibroids themselves are benign, but can sometimes hide cancers. If an unsuspected cancer is present, as in Dr. Reed's case, the rapidly spinning blades of a morcellator can spray cancer cells around and speed the progression of the disease.
Sarcomas are a particular concern, because they are aggressive and almost never detectable with imaging or other tests before surgery. The diagnosis is usually made only after surgery, when the tissue is biopsied. By then, if a morcellator was used, it is too late to prevent the spread of the cancer, and the woman's changes of long-term survival are significantly worsened, the agency said.
The Food and Drug Administration said that one of the 350 women who have a hysterectomy or fibroid removed have unsuspected sarcomas. That figure, based on a review of the medical literature, was considerably higher than earlier estimates that gynecologists had been using, which ranged from one in 500 to one in 10,000, Dr. Maisel said.
Dr. Maisel said the although his agency had the authority to ban morcellators, it had chosen not to because there might still be some women for whom the procedure is a good option. When fibroids are large, morcellation may be required if a patient wants minimally invasive surgery, which avoids big incisions, shortens recovery time and reduces the risk of blood loss, infections and other complications.
Dr. Maisel said that doctors and patients could weigh that risks on a case-by-case basis, adding that sarcomas are more common in older women. The agency emphasized that women must be informed of the risks, something that has not been routinely done, in part because the threat was thought to be vanishingly small. Indeed, MANY WOMEN HAVING HYSTERECTOMIES WERE NOT EVEN TOLD THAT MORCELLATION WAS BEING PERFORMED.
The drug agency is continuing to study the procedure and the devices and will meet with an advisory panel to review them, probably this summer, Dr. Maisel said.
For women who want to avoid morcellation, the agency listed other ways to deal with fibroids, including various operations that do not use the devices, drug therapy, techniques that shrink fibroids by blocking a uterine artery, and high-intensity focused ultrasound.
Some doctors and hospitals have said that morcellation can be made safer by performing it inside a bag to prevent tissue from spraying around.
But Dr. Maisel warned: "It is not a panacea. It will not completely remove the risk." Bags can tear, he said. And not all surgeons are trained in using them. The bags make it harder for doctors to see what they are doing, and there have been reports of organ damage during procedures involving them.
For Dr. Reed and her family, the results of her surgery have been devastating. The prognosis for advanced uterine sarcomas is dismal. She had her husband researched the disease, and decided that her best hope lay in radical surgery.
In November, a month after the hysterectomy, she had a grueling seven-hour operation in which a surgeon removed her appendix, gallbladder, ovaries and other tissue in which the sarcoma might have spread, and then pumped her abdomen and pelvis full of heated CHEMOTHERAPY.
The surgeon estimated that she now has an 80% chance of surviving 10 years. After the surgery, she underwent more chemotherapy. She has one more round to go, her sixth. She hopes to return to work in June. But soon after that, she and her husband will leave their jobs in Boston and move with their six children to the Philadelphia area, to be closer to their families.
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*So...just wondering...What happens to those women who don't read this story and whose doctors choose to ignore the F.D.A.'s warning?
CLINICAL TRIALS AND CANCER
A clinical trial is a study that compares one or more cancer treatments. The goal of every clinical trial is to determine if a new treatment approach is effective and safe. Effective means that the new treatment improves survival for patients with cancer--or produces the same response as the established treatment with fewer side effects. In cancer clinical trials, one arm of the study is always the current "standard of care," which means the best available treatment for that cancer.
Myths About Clinical Trials
Towards New Models for Clinical Trials
"Nationally, less than 3% of our patients participate in a clinical trial. Our system is hopelessly outdated." --Roger Cohen, MD, Abramson Cancer Center, University of Pennsylvania
The basic design for conducting clinical trials has not changed for 55 years. That's hard to believe when you consider how much medicine and science have advanced during that time frame. In 2010, The Institute of Medicine issued a report calling for "necessary, systematic changes to more efficiently design, review and conduct studies," and in April of this year, the National Cancer Institute created a new National Clinical Trials Network to "improve the speed and efficiency of cancer clinical trials, using fewer but larger groups of investigators and distributing resources in a more effective way."
What does that mean for today's cancer patients? It will take some time to answer that question, but here is a brief look at some of the key issues.
New Designs: Thinking differently about how to measure the results of clinical trials opens the door to new ways of conducting these studies. Studying one mutation with one drug for many diseases: Dr. Solit points out that many driver mutations-- the ones that "drive" the development and progress of cancer-- are found in multiple cancer types. The HER2 mutation, for example, is most closely associated with breast cancer, but also occurs in a small percentage of patients with several other cancers. It is possible to design trials that test a new drug against that mutation in multiple diseases. "If you have the mutation, you respond to the drugs available to treat it," he says.
Studying one disease with many drugs for many mutations: Lung cancer is a good example of a disease in which there are several known mutations that can be targeted with different drugs. It's important to identify all of these mutations, even the very low incidence ones, and target them whenever possible.
Adaptive Trials: The best example of this approach is the I-SPY2 Trial for breast cancer patients. This trial includes a number of studies to test new neoadjuvant treatments for women with breast cancer-meaning the treatment takes place before the surgery. The primary measure of success is whether a woman achieves a complete pathological response, or the disappearance of all evidence of disease. Another major difference is that investigators use data from the trial as it progresses to predict which women will respond to which therapies, to evaluate the drug's performance and then adapt the trial design, and individual participation, to the results. This is a far more fluid, and complex approach, one that allows for rapid development of new drugs and agents. It is also an important way to test new drugs in patients who have earlier stages of cancer.
New eligibility requirements that make it easier for patients, and their physicians, to enroll in clinical trials: National and international databases to collect and analyze information
Accelerated approval for promising new drugs by the FDA
"These are new paradigms for studies, Dr. Solit says, "and new paths for approving these drugs."
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I can relate. See you next month.
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And if you have any thoughts of how this newsletter could be improved, please email me directly, at Elaine@elainejesmer.com.