FDA Calls for Patient Registries to Track Robotically Treated Cancers

The US Food and Drug Administration’s (FDA’s) recent warning about robotic surgery for treating or preventing cancer came as a surprise to some physicians, given the technology’s pervasive reach and widespread consumer enthusiasm.

But, the federal agency’s cautionary statement, issued in February, ¹ may not slow down the use of robotics in cancer any time soon, the physicians said, despite a lack of FDA marketing authorization and scant data on safety or efficacy for any cancer-related surgeries.

“There are doctors out there who are very comfortable with robotics,” having performed hundreds of these procedures over the past decade, said Michael Sabel, MD, chief of oncologic surgery at Michigan Medicine (at the University of Michigan in Ann Arbor). “And, some people always push the envelope with new technologies,” he said, so cancer patients need to ask how many of these procedures a physician has done, the advantages of a certain surgical approach over less-costly approaches, and patients should always get a second opinion.

The apparent trigger for the FDA’s safety warning arose, at least in part, from a multicenter randomized trial comparing minimally invasive surgery (either laparoscopic or robotic-assisted surgery) to open surgery for radical hysterectomies. The study in more than 600 women with early-stage cervical cancer found preliminary evidence of lower rates of disease-free and overall survival in those treated with robotic-assisted devices.²

However, in its safety communication, the agency also took note of a general increase in the use of these devices in cancer, overall, without sufficient long-term data on patient outcomes, or surveillance monitoring beyond 30 days. It encouraged academic and research institutions, professional societies, and device manufacturers to set up patient registries in the near future, to assess clinical outcomes, and identify problems early on to enhance patient safety.

“As time goes on and the learning curve changes, the benefits of robotic surgery may well prove greater than that of other approaches,” suggested Dr Sabel, who is an expert with the American Society of Clinical Oncology. Although he uses robotics in general surgery, he said the FDA’s cautionary statement on treating cancers is “absolutely correct,” highlighting the need to better assess claims of less blood loss, shorter hospital stays, and other advantages over traditional surgery.

Between January 2016 and December 2018, the FDA received 32 medical device reports referring to cancer and the use of robotically-assisted devices. Four of these reports in the publicly available MAUDE database³ described patients who died undergoing hysterectomies after their cancers spread. A fifth patient treated with a robotic device sustained serious injury.

According to the FDA, none of these cases appeared to be caused by system error or device malfunction, nor are operative and postoperative complications considered unique to robotic surgeries. “These complications may be related (instead) to poor surgical technique, aggressive tumor biology, and other factors unrelated to the device,” wrote FDA press officer, Stephanie Caccomo, in response to questions.

The possibility of metastasis has been raised in the past with minimally invasive surgeries, in particular for colon resections, Dr Sabel said, with the same issue now arising in other cancers, necessitating further study. Of greatest surprise to him? The use of robotic-assisted devices to perform mastectomies. “The incision might be smaller, but with a lot of additional cost,” he said.

Estimates of the price for a single robot range between $1.5 million to $2 million or more. And, in a research letter published in the Journal of the American Medical Association last year, researchers used data from Intuitive Surgical to conclude the estimated cost for each procedure: $3,568.00 ⁴ Intuitive Surgical in Sunnyvale, California, is considered the dominant robotics player in the market. The volume of robotic surgeries reached 877,000 in 2017, up from 136,000 in 2008. It is unclear what percentage or robotic surgeries were performed for cancer treatment.

“Surgeons who do these procedures need to be heard,” said Leonard Lichtenfeld, MD, deputy chief medical officer for the American Cancer Society in Atlanta, Georgia. But, ever since robots first started showing up in the nation’s hospitals, he said, experts have been asking questions not only about cost, but also about the clinical differences in morbidity and mortality between surgical approaches — both in terms of open surgeries and laparoscopic techniques.

“Sometimes, we think a technology is better and then we believe it’s better without the evidence to back up that assumption,” Dr Lichtenfeld said. Head-to-head surgical comparisons are still lacking.

Unlike drugs, however, where there’s an incentive to demonstrate that “at the very least a drug is not inferior to the one being used,” Dr Lichtenfeld said, “there’s no such requirement for technology.” Whether that will change with the FDA’s warning, he said, remains to be seen.  “I have to admit I was a little surprised,” he said, referring to the agency’s action. “It (robotic surgery) has become a well-established procedure for many cancers, including colon cancer.”

As for Intuitive Surgical, no formal response to the FDA’s warning has been posted on the manufacturer’s website. But, the maker of the widely used da Vinci system indicated shortly after FDA’s statement that “more than 15,000 peer-reviewed articles, in aggregate, support the safety and effectiveness of robotic-assisted surgery.”⁵ And, the company also said, the agency has issued clearances for certain types of surgical procedures done in cancer patients, such as hysterectomies, prostatectomies, and colectomies. But, as the FDA later clarified, those clearances were only awarded for the purpose of short-term patient follow-up.

References

1.  The US Food and Drug Administration. FDA cautions patients, providers about using robotically-assisted surgical devices for mastectomy and other cancer-related surgeries. Published February 28, 2019. Accessed March 17, 2019.
2. Ramirez, PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Eng J Med. 2018;379(20):1895-1904.
3. MAUDE: Manufacturer and User Facility Device Experience. FDA. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed April 1, 2019.
4. Childers CP, Maggard-Gibbons M. Estimation of the acquisition and operating costs for robotic surgery. JAMA. 2018;320(8):835-836.
5. Ross C. FDA sounds an alarm on using robotic devices in cancer surgeries, citing concerns about safety and results. STAT. Published February 28, 2019. Accessed April 1, 2019.

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