The latest updates appear here. A follow-up story is posted here.
Last August, Stephen A. Chagares, a breast surgeon, made an announcement that startled some of his colleagues at New Jersey’s Monmouth Medical Center.
At internal meetings and in a press release, Chagares declared that he would perform a robotic mastectomy—a new and relatively untested minimally invasive surgical procedure. According to the press release, his first patient, Yvonne Zucco, 56, was being treated for stage IIa breast cancer.
“Dr. Chagares is proud and honored to lead the first program of its kind in the United States,” declared the press release dated Aug. 23, 2018. “Robotic Mastectomy with immediate reconstruction opens the door to a new era of mastectomy and a new outlook for patients, offering a modern approach to an operation which has been so physically, emotionally, and psychologically scarring until now.”
Following this announcement and additional marketing by Chagares, his colleagues at Monmouth, a teaching affiliate of the Rutgers Robert Wood Johnson Medical School, started to raise questions:
Is it safe to use a robotic surgical system in breast cancer? How would you do it? Is it necessary? Where are the oncologic data supporting the procedure? Might Chagares be proposing a solution in search of a problem?
When new surgical techniques are used in patients with cancer or in tissues that might harbor cancer, surgeons must ensure that malignancies—diagnosed or undiagnosed—will not be sent flying through the patients’ bodies. This is a basic principle of cancer surgery.
FDA regulations require that significant risk studies intended to evaluate the safety and effectiveness of a device must first receive an Investigational Device Exemption.
FDA
The only way to know that harm is avoided is to ask the right questions and design studies to answer those questions. Monitoring patients in the short term and relying on patient satisfaction metrics is not a guarantee of long-term safety, experts say. When you don’t look for long-term consequences, you don’t find them.
At Monmouth Medical Center, Chagares didn’t propose to perform robotic mastectomies under a surgical trial protocol, insiders say. For the latest developments, click here.
Zucco, the patient, seemed happy with the procedure and the outcome. “I am robotic mastectomy, I am a cancer survivor. I sought many opinions and consultations in order to decide how I wanted my mastectomy performed,” she wrote in a comment thread on Chagares’s Facebook page. “I educated myself and know the research and data. I am also fully aware of my operation, the outcome and all discussions at Breast Center Conferences. There are other people out there that have done their research and decided this is the best option for them. They should be given this opportunity just like me!”
Chagares declined to speak with this reporter, stating that protection of patient confidentiality is involved. Zucco didn’t respond to a Facebook message.
In December, Monmouth halted the use of minimally invasive robotic mastectomy in all surgical indications, issuing a statement that cited safety concerns. The hospital declined to discuss its rationale for signing off on the surgeries and ultimately halting them.
Breast cancer experts say that two principal indications for the procedure include patients with breast cancer and patients with BRCA mutations who would be eligible for prophylactic mastectomy.
High-risk patients must be operated on according to oncologic surgical principles, cancer surgeons say. This requires en bloc removal of malignant breast tissue, making sure that the entire gland is taken out in one piece and with good margins. This also applies to breast tissue with the potential to develop into cancer, experts say.
These surgical principles ensure that any mass containing cancer or undetected malignancies isn’t broken up, thereby reducing the risk of disseminating cancer cells.
Chagares isn’t the only surgeon to perform robotic mastectomies. The Cancer Letter has found that the procedure has been performed in at least one other U.S. institution, Northwell Health’s Long Island Jewish Medical Center.
There is no consensus on the procedure. Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, for example, fundamentally disagree on robotic mastectomy. Multiple academic institutions, including MD Anderson and the University of Pennsylvania, have plans to study robotic mastectomies in surgical trials. MSK has no such plans.
In March 2018, surgeons at Northwell Health performed a robotic bilateral prophylactic mastectomy on a 45 year-old woman in an “off-label” setting, with approval from the institution’s Institutional Review Board for a “practice of medicine” protocol.
Now, Northwell Health, MD Anderson, and two institutions in Chicago are in the process of drafting a trial protocol to evaluate the safety and effectiveness of robotic mastectomy. The study is funded by Intuitive Surgical, the dominant manufacturer of robotic surgical devices.
The multicenter trial is designed to study the procedure in patients with breast cancer and patients who would be eligible for prophylactic mastectomy. Penn’s protocol aims to enroll only patients with BRCA mutations.
Usually, minimally invasive robotic procedures are employed for surgery in hard-to-reach-and-see parts of the human anatomy. Robotic arms can enhance vision and precision, enabling surgeons to manipulate and excise tissue deep within the body. In many situations, the robot eliminates the need for large incisions required for open surgery, speeding recovery, and reducing the risk for postoperative surgical morbidity and other complications.
The premier device for robotic surgery, the da Vinci Surgical System, made by Intuitive Surgical, requires a sizable investment. The price tag ranges between $500,000 and $2.5 million, and surgeons who specialize in minimally invasive procedures and hospitals that own these machines are understandably focused on expanding the uses for this equipment.
FDA sounds a note of caution
In the absence of long-term safety data, off-protocol use of robotic mastectomy is inappropriate, said Laurie Kirstein, a breast surgical oncologist at Memorial Sloan Kettering Cancer Center.
“We don’t do [robotic mastectomies] currently,” Kirstein said to The Cancer Letter. “We do not believe the safety of this procedure for cancer treatment has been demonstrated and do not think it should be performed outside of an IRB approved protocol with appropriate informed consent.
“We discussed it as a group under the leadership of our chief of breast surgery, Dr. Monica Morrow, fairly recently in the last few months, to assess the procedure from an oncologic perspective. It’s very hard to adopt a new procedure that hasn’t been really tested, when the one we have is so good, and we know is safe.”
A conversation with Kirstein appears here.
FDA’s stance on this controversy has just changed in recent weeks.
In December 2018, in the course of reporting this story, The Cancer Letter queried FDA about whether robotic surgical devices should be used for mastectomy.
“Does FDA plan on issuing an advisory or guidance to curtail the routine use of robotic mastectomy outside the confines of a prospective clinical trial and absence of Level I data?” this reporter asked the agency.
On Feb. 28, FDA issued a safety advisory, indicating that device manufacturers looking to market surgical tools for use in the prevention or treatment of cancer may now be required to study long-term oncologic endpoints in surgical trials “for time periods much longer than 30 days” (The Cancer Letter, March 1).
“At this point, given the recent FDA statement on robotic surgery and since the safety of the procedure has not been demonstrated, it’s not something we are pursuing at Memorial Sloan Kettering,” Kirstein said.
FDA’s communication could be interpreted as signaling changes in the way medical devices are regulated—specifically, surgical tools that are used in settings where cancer could be present.
The advisory reads: “The FDA encourages academic and research institutions, professional societies, robotically-assisted surgical device experts, and manufacturers to establish patient registries to gather data on the use of robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. Patient registries may help characterize surgeons’ learning curves, assess long-term clinical outcomes, and identify problems early to help enhance patient safety.”
Chagares appears to have read this communication as encouragement from the agency to expand the use of the technology. On his Facebook page, the surgeon wrote: “I was even more pleased to see Actions bullet point #3 wherein the FDA clearly ‘encourages… use of robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer.’”
Though Chagares’s plans ran into opposition from the outset, he did initially receive approval from the hospital’s Institutional Review Board to perform bilateral robotic nipple-sparing mastectomies on at least two patients—Zucco, and Brian Thomson, a 34 year-old man who, according to a press release, experienced rapid growth of painful breast tissue.
“On Sept. 28, Brian and Dr. Chagares made history with the first male bilateral robotic nipple-sparing mastectomy ever performed in the world,” Chagares wrote in the Oct. 5, 2018 press release. “Dr. Chagares is proud and honored to offer this surgery to his patients of any gender identity. Dr. Chagares and his patient, Brian Thomson, are available to interview should media outlets see fit to include this historical event in their publications.”
A version of this press release appears here.
Multiple sources with direct knowledge of the situation who spoke on condition that their names would not be used said that Chagares, who reportedly did not propose a clinical trial protocol, didn’t receive an okay from FDA to use the da Vinci robot on Zucco and Thomson in an investigational setting. For the latest developments, click here.
Generally, it’s legal to use a drug or device in an indication that has not been cleared or approved by FDA, because the agency doesn’t regulate the practice of medicine.
“Health care professionals generally may legally prescribe or use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients,” FDA said to The Cancer Letter. “In some cases, such use may expose health care professionals to legal liability.”
In this instance, FDA considers robotic mastectomies to be of “significant risk,” which means surgeons and institutions are required to seek an exemption from the agency to study the procedure on-protocol, officials said.
“FDA regulations require that significant risk studies intended to evaluate the safety and effectiveness of a device must first receive an Investigational Device Exemption,” FDA officials said. “Therefore, while individual health care providers may make individual treatment decisions in the best interests of their patients, any health care provider or health care facility formally studying the safety and effectiveness of the da Vinci for mastectomy would be expected to have an IDE.”
Ari Brooks, director of endocrine and oncologic surgery, director of the Integrated Breast Center at the University of Pennsylvania Health System and professor of clinical surgery at Penn Medicine, said he will not perform robotic mastectomies outside an investigational setting.
“Absolutely not! No. I’m not doing anything until I have an FDA IDE. I’m not doing it until there’s consent and it’s IRB-approved,” Brooks said to The Cancer Letter. “I’m not doing it. I’m not screwing around.”
A conversation with Brooks appears here.
Brooks, who has written a trial protocol for prophylactic robotic mastectomies, but after the FDA advisory he has revised that protocol to include assessment of cancer-related outcomes. His study isn’t funded by industry.
“That was my [original] intention, to do only prophylactic, that the first trial would probably be 20 patients, maybe 30, because that’s the learning curve,” Brooks said. “And it would be all just looking at cosmetic and satisfaction and that’s it. And that was the study.
“As soon as the FDA announcement came out, I got some emails asking me to start having some meetings with the leadership of the hospital to find out how to move forward. We asked how we’re going to do this after the FDA advisory, and, well, we’re just going to have to tell the patients we have to follow them after surgery for 10 to 20 years. And that’s what we’ll do.
“I conceded that with these patients, we have to follow them long-term. So, we will. I don’t have a problem with that,” Brooks said. “And, you know, it’s right. It’s a good thing, really. They shouldn’t just study patients for 30 days.
“I get it. At a hospital up north, they’re like, ‘Oh yeah, we’ll take anything out with a robot.’ We don’t learn anything from that.
“So, no, it has to be done as a study.”
“Best day ever in surgery”
An Aug. 23 press release issued on Chagares’s behalf by a practice with which he is affiliated describes robotic mastectomies as “groundbreaking.”
“Dr. Stephen Chagares, a board certified General and Breast Surgeon also certified in robotic surgery, is proud to offer this option to breast cancer patient Yvonne Zucco,” the press release states. “After learning about the benefits of the RNSM, Ms. Zucco eagerly made an appointment with Dr. Stephen Chagares and his colleague Dr. Andrew Elkwood of The Plastic Surgery Center, in their Monmouth County offices.”
Last October, local media characterized robotic mastectomy as a “breakthrough.”
One local news outlet declared that Chagares was leading “the way into the future with a procedure that will change the lives of many breast cancer and BRCA-positive patients … Chagares is clearly moved by what this will mean for so many women, saying that his first RNSM procedure was his best day ever in surgery.”
Zucco, the patient, was diagnosed with stage IIa cancer in her left breast, and underwent four months of chemotherapy. According to a press release, Chagares removed “breast tissue via a single incision under the armpit.”
In December, Monmouth Medical Center halted the use of the procedure.
“At Monmouth Medical Center, patient safety is our utmost priority,” hospital administrators said to The Cancer Letter. “As such, we are constantly assessing the safety of our procedures and the services we perform. After evaluating robotic mastectomy, Monmouth Medical Center has decided to suspend the procedure until further review.”
I’m not doing anything until I have an FDA IDE. I’m not doing it until there’s consent and it’s IRB-approved. I’m not doing it. I’m not screwing around.
Ari D. Brooks
The institution is a member of the RWJBarnabas Health system and a teaching affiliate of the Rutgers Robert Wood Johnson Medical School. According to its website, the health system treats over three million patients a year, employs 32,000 people in the region, and provides comprehensive cancer services.
The hospital’s suspension of robotic mastectomies had national implications in the ongoing debate over whether the procedure is safe, necessary, and cost-effective.
The American Cancer Society estimated that about 266,120 new cases of invasive breast cancer would be diagnosed in 2018. According to a 2017 report, 106,295 breast reconstruction procedures were performed that year by members of the American Society of Plastic Surgeons—a 39% increase in procedural volume since 2000.
The number of women undergoing mastectomies every year in the U.S. may exceed 200,000, since less than half of all women who require mastectomy are currently offered breast reconstruction surgery, and fewer than 20% elect to undergo immediate reconstruction.
The moratorium on robotic mastectomies at Monmouth was enacted in response to concerns from the medical staff, sources said.
“The concern for the robotic mastectomy is that the first part of the dissection is actually done blindly,” said MSK’s Kirstein. “There is no visualization, and the robot is only really used for the far-medial, or the piece that is closest to the chest bone. So, there’s a concern about being able to see what you’re doing and making sure you’re actually getting out enough tissue.
“There were concerns for other surgeons, where they took out the tissue in pieces, rather than in one en bloc section—so it’s very hard or impossible to evaluate margins, for example, for a cancer, if you haven’t taken it out in one piece. You’ve sort of chopped it up into pieces. And so, oncologically, we know that’s not the right way to treat patients.”
On his website, Chagares states that he has “obtained specialty training in breast surgery at Memorial Sloan Kettering Cancer Center in New York City and is a board certified breast surgeon.”
It’s unclear what Chagares means by “specialty training in breast surgery” at MSK, officials at the cancer center say.
“We have a record from 1990 for Stephen Chagares as a non-employee rotating Surgery Resident from Monmouth Medical Center,” an MSK spokesperson said to The Cancer Letter. “It looks like he did a two-month rotation here during his intern/PGY 1 year from 9/1/1990 through 10/31/1990.
“We were not able to determine whether that two-month rotation involved the breast surgical service, but I believe the duration of his experience at MSK speaks for itself. We are reviewing the matter and his claims.”
A spokesperson for Chagares disputed MSK’s statement.
“Dr. Chagares is still in the OR. I may be able to help as I used to work for my father who was a general/breast surgeon many moons ago,” the spokesperson, Marianne Maggs, said in an email to The Cancer Letter. “Dr. Chagares did receive specialty training in breast surgery at Memorial Sloan Kettering Cancer Center. I do not know, off the top of my head, specifically the ‘amount of time’ designated by the Monmouth Medical Center Residency Program for their speciality breast training.
“I know it was completed as part of the MMC Residency Program guidelines. In 1990, breast surgery was a standard pillar of general surgery and breast fellowships did not exist. Twenty-nine years ago, most breast surgeons weren’t afforded the opportunity for this speciality training. MMC had an excellent working relationship with MSKCC.”
The press release announcing the procedure on Zucco states that Chagares had also received specialty training in Italy: “Dr. Chagares, a board-certified breast surgeon, has been performing mastectomies for 23 years and robotic operations for years. Upon invitation to The European Institute of Oncology in Milan, Italy, Dr. Chagares trained under Dr. Antonio Toesca, the pioneer of robotic mastectomy.”
Toesca didn’t respond to questions from The Cancer Letter.
Toesca is listed as principal investigator on a prospective randomized trial sponsored by the European Institute of Oncology, according to ClinicalTrials.gov. The protocol was posted on Feb. 21, 2018, last updated on Jan. 15, and has an actual enrollment of 82 participants.
“This project is a superiority trial comparing robotic nipple sparing mastectomy and immediate breast robotic reconstruction with conventional open technique,” the protocol states. “The primary endpoint is to evaluate patient satisfaction.”
The estimated completion date for the trial is Dec. 31, 2019.
“When they’re done with enrollment, he’ll give us the one-month follow-up on those endpoints—the cosmetic satisfaction and all that,” said Penn’s Brooks, who is not involved in the Toesca study.
The secondary endpoints in Toesca’s study include “post-operative outcome considering complications, post-operative pain, reduction of the average length of stay of patients, long term oncological outcome of the two different surgical techniques.”
“Then, you’re going to have to hold your breath for another five to 10 years to get the data for the recurrences and other oncologic endpoints,” Brooks said. “There’s nothing. The study needs to be done.”
MSK’s breast surgery team, too, has concluded that there are no prospective clinical trial data proving that robotic mastectomy doesn’t worsen cancer outcomes.
“Zero. There are no studies doing that,” Kirstein said. “The only study that has been published so far was an Italian study, in which they reported patient-reported outcomes such as patient satisfaction, length of stay and cosmetic outcome. That’s it. There were no volumetric studies, there were no cancer-related studies. Nothing.
“The technique has also become a little bit more popular in the United States, without, so far, any data showing that it’s oncologically safe.”
Intuitive Surgical cautioned a surgeon
Asked by this reporter about the controversy at Monmouth, a spokesperson for Intuitive Surgical said the company had cautioned “a surgeon” about off-label use of its device.
The company didn’t identify the surgeon who had been thus cautioned.
“In accordance with federal and international regulations, Intuitive’s policy is not to support, promote, or train on off-label procedures performed using our surgical systems,” company officials said to The Cancer Letter. “When Intuitive learned that a surgeon intended to perform a mastectomy using the da Vinci Surgical System, Intuitive reminded the surgeon that the procedure was off label and encouraged the surgeon to follow appropriate procedures at his institution for performing off-label procedures.
“No Intuitive representative participated in or observed the procedure.”
Monmouth’s decision came shortly after an internal review conducted at MSK came to a similar conclusion.
“When you are going to change what you do drastically, you really should have Level I data showing that it’s at least not inferior to what you’re doing,” Kirstein said. “This is a major change, a major deviation. A major change in the standard of care and in the technique.”
MSK breast surgeons decided that they would not perform the procedure, whether at the mother ship in New York City or at a satellite campus, MSK Monmouth, located a 20-minute drive from Monmouth Medical Center.
“The issue for us is that you have a procedure that is going to be much longer than your standard mastectomy,” said Kirstein, who also treats patients at MSK Monmouth. “It’s a lot more expensive than your standard mastectomy, and we’re not really sure that it’s cosmetically better in the long run than what we already do for, let’s say, a nipple-sparing mastectomy or other ways to do it.”
Before the Feb. 28 FDA safety communication, surgical trials on robotic mastectomy had to account only for the safety and effectiveness of the procedure in the short term—without an experimental design that controls for cancer-related endpoints. This means that, to date, robotic mastectomy has not been demonstrated to be either superior or non-inferior in the oncologic setting, when compared to standard-of-care procedures.
“The only studies that have been done for the robotic mastectomy have been on cosmesis and patient satisfaction and length of stay and things like that,” Kirstein said. “There have been no studies whatsoever to show if it’s oncologically equivalent, or not inferior, to what we already do in terms of recurrence and whether that recurrence risk impacts overall survival.”
MD Anderson: “Immediate and long-term outcomes”
With the FDA safety communication, it’s no longer possible to dismiss the worst-case scenario, whereby novel minimally invasive procedures lower survival of patients who are otherwise healthy—especially when there is a significant risk of exposure or dissemination of existing or undetected disease.
When new procedures go into routine use without anyone asking life-and-death questions, patients may die of metastatic disease without anyone ever knowing that their lives had been shortened—or how and why.
Patients who give the procedure a five-star rating four weeks after surgery may be dead three years from now, because their disease had been inadvertently spread during surgery.
“We are not currently doing [robotic mastectomies],” said Kelly Hunt, chair of the Department of Breast Surgical Oncology, and a professor in the Division of Surgery at MD Anderson Cancer Center. “However, we have a couple of surgeons who have been credentialed in robotic surgery, and one principal investigator with over 12 years of robotic experience.”
A conversation with Hunt and colleague Jesse C. Selber, director of clinical research, MD Anderson Cancer Center, appears here.
“We wrote a protocol and will be investigating this procedure in a prospective study,” Hunt said to The Cancer Letter.
Proponents of robotic mastectomy say that, since the technical aspects of the robotic surgery are similar to the open procedure, there is no reason to believe that the oncologic outcomes would be different.
“The challenge of nipple-sparing mastectomies is trying to achieve a precise dissection through a small incision with minimal illumination and a limited ability to see and reach tissue planes,” said Jesse Selber, professor and director of clinical research at the Department of Plastic Surgery at MD Anderson. “The robot provides the surgeon with a crystal clear, magnified, front-row seat to the most-technically difficult part of a nipple-sparing mastectomy. We think this could result in better outcomes.
“It’s important to make clear that the oncologic principles of the robotic mastectomy are identical to the open procedure,” Selber said to The Cancer Letter. “The plane of dissection is identical; the way the specimen is removed, oriented and labeled is identical; the margin evaluation and permanent pathologic evaluation is identical.”
In the trial, the robotic procedure will only be used in patients with C-cup breasts and smaller, Selber said.
“This is often the upper limit of size for patients considered for open nipple-sparing mastectomy. After the robotic dissection is complete, the entire breast specimen is removed en bloc, or in one piece, through the same incision in which the ports were placed,” Selber said. “Before we extend the procedure to more technically challenging, larger-breasted patients, we want to make sure it’s feasible and effective in patients who meet standard, open nipple-sparing mastectomy criteria.”
The initial version of the trial protocol does not include cancer-related outcomes as primary endpoints, because it is designed to assess 30-day safety and feasibility for evaluation by FDA.
“The safety and feasibility study we are proposing is not adequately powered to draw conclusions about oncologic outcomes,” Selber said. “Recurrence is a longer-term outcome, so the time horizon needed to establish recurrence rates must be measured in years, like the cervical cancer study from MD Anderson you just referenced.
“This is very different than establishing the safety and feasibility of a technique, which evaluates 30-day morbidity of the operation itself. A study of oncologic outcomes would require hundreds of patients and years of data collection. That work absolutely needs to be done, but would be scientifically inconclusive in the context of a study designed to evaluate the feasibility of a surgical technique.
“That said, oncologic outcomes will be secondary endpoints in the study, which means they will be officially tracked and reported on for the study period. And we will certainly follow all of the study patients with routine surveillance for the rest of their lives, as with all our cancer patients.”
After FDA issued the Feb. 28 advisory, an MD Anderson spokesperson said:
“At MD Anderson, patient safety is paramount. Our experts are working with the FDA for appropriate clearances prior to initiating any studies on minimally invasive surgical approaches to mastectomy in select patients,” the spokesperson said to The Cancer Letter. “Any study also will be subject to MD Anderson’s Institutional Review Board approval and monitoring for quality and safety. This research will explore immediate and long-term outcomes of the procedure.”
Six years of unpleasant surprises
If surgeons do not account for confounding variables that may have an impact on oncologic outcomes—i.e. unintentional fragmentation or exposure of malignant tissue, and incomplete removal of breast tissue—MSK’s Kirstein and other experts say that robotic mastectomy could:
Lower overall survival for patients who have breast cancer by increasing the risk of dissemination of disease via exposure of malignant tissue fragments,
Spread incidental or preoperatively undetected cancers, which are found in about one in 10 women undergoing prophylactic mastectomies,
Exponentially increase the risk of disease recurrence,
Increase the risk of disease onset in patients with BRCA mutations, and
Worsen survival outcomes in patients who undergo mastectomy, who would no longer receive screening for malignancies that may develop because of leftover tissue.
“Just recently, the study out of MD Anderson on robotic hysterectomies for cancer was published, suggesting poorer outcome with the robotic surgery,” Kirstein said. “None of those studies have been undertaken in breast cancer and robotic surgery, and that is concerning.”
Minimally invasive procedures can be useful, and in many surgical specialties they offer an improvement over the standard of care. However, in settings where robust prospective clinical and epidemiological data have not been generated, surgeons cannot make assumptions, experts say.
“Memorial’s decision is very reasonable, especially in light of The New England Journal of Medicine studies that showed that minimally invasive surgery worsened outcomes in patients who underwent laparoscopic and robotic radical hysterectomies,” said Otis Brawley, the Bloomberg Distinguished Professor of Oncology and Epidemiology at the Johns Hopkins School of Medicine. “That’s a very recent finding.”
Are minimally invasive surgical specialties especially prone to adopting new procedures and technologies as the standard of care—before prospective Level I safety data is generated?
After six years of unpleasant surprises, many experts agree that this trend has been painfully well documented in gynecology and gynecologic oncology:
By 2013, power morcellation had become a standard of care over 20 years, without prospective studies that controlled for cancer-related outcomes. The procedure, which breaks up uterine tissue, contributed to harm and early deaths in a subset of women—who number in the hundreds, if not thousands—by disseminating occult or missed malignancies (How Medical Devices Do Harm, The Cancer Letter).
In April 2018, Yale University researchers found that when all uterine cancers are taken into account, prevalence of cancers undetected at the initiation of hysterectomies was almost as high as one in 70, in contrast to FDA’s one-in-350 estimate that focused on missed sarcomas and the 1 in 10,000 frequency of leiomyosarcoma cited by gynecologists for decades (The Cancer Letter, May 18, 2018).
In October 2018, two groundbreaking papers published in The New England Journal of Medicine by gynecologic oncologists demonstrated that women who were subjected to minimally invasive surgery for early-stage cervical cancer were four times more likely to die from that disease within three years, three times more likely to have a recurrence within three years, and had shorter survival, compared to women who underwent open surgery (The Cancer Letter, Nov. 2, 2018).
“These results highlight the hazards of assuming the oncologic equivalence of a new method of performing a cancer operation and adopting it widely in the absence of Level I evidence,” Stephen Rubin, chief of the Division of Gynecologic Oncology, professor in Department of Surgical Oncology, and Paul Grotzinger and Wilbur Raab Chair in Surgical Oncology at Fox Chase Cancer Center, said to The Cancer Letter.
This is very different than establishing the safety and feasibility of a technique, which evaluates 30-day morbidity of the operation itself. A study of oncologic outcomes would require hundreds of patients and years of data collection.
Jesse C. Selber
The debate over power morcellation and minimally invasive approaches to cervical cancer show that surgeons shouldn’t make assumptions, said Brian Slomovitz, director of the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology at the University of Miami, Miller School of Medicine, and co-leader of the Gynecologic Cancers Site Disease Group at Sylvester Comprehensive Cancer Center.
“It shows that, in a clear way, we can’t make assumptions in anything we do. The assumption that robotic surgery would be just as good as open surgery is clearly demonstrated here that it’s not a fair assumption,” Slomovitz said to The Cancer Letter. “We need to carefully evaluate the way we’re doing things and not just assume that one way is good because it’s associated with a shorter hospital stay, or it’s associated with small incisions.
“As surgeons who care for patients that could have deadly diseases, ‘getting the tumor out’ is not simply the answer, but how we get the tumor out and in what fashion, and whether that affects the biology and aggressiveness of the disease—we learn that here, and we learned that in morcellation for sarcoma and other uterine cancers, that it does matter.”
If these experts are right, without epidemiological data, and in the absence of studies with oncologic outcomes as primary endpoints:
Surgeons cannot assume that the tissue, especially tumors or masses that are at risk for developing cancer, is benign.
Surgeons cannot assume that new techniques are oncologically safe—i.e. minimally invasive procedures would not spread existing disease or undetected disease.
Surgeons cannot assume that innovative changes to the standard of care would yield outcomes that are superior to established techniques, particularly in settings where cancer-related outcomes are a concern.
When surgeons innovate, how much rigor should be required? And how much risk is acceptable?
If surgeons realize, retrospectively, that patients who might have otherwise done well have been sacrificed for a decade or two at the altar of innovation—they will find that saying “Oops, sorry…” isn’t good enough.
Who is responsible for preventing avoidable harm?
“I strongly, strongly believe that our academic institutions need to lead these studies,” Penn’s Brooks said. “Otherwise, we would still be doing radical hysterectomies for early-stage cervical cancer patients with the robot.
“I think we should not avoid these studies because of the fear that something bad could happen. Until you study, you don’t know.
“If it’s a long study, it’s a long study. I’m not that old. I’ll be around when it’s done.”
The latest updates appear here. A follow-up story is posted here.
