Score One for Minimally Invasive Cancer Surgery

'This is news and this is important'

Nick Mulcahy

June 03, 2019

CHICAGO — The reputation of minimally invasive surgery for cancer has taken some serious hits in the past couple of years. For example, a major US randomized trial showed that high-tech approaches to surgery for cervical cancer resulted in worse overall survival compared with traditional open surgery.

Asmund Avdem Fretland, MD

Minimally invasive approaches to cancer surgery are often championed because of short-term benefits such as less time spent in hospital and improved cosmesis, but crucial longer term oncologic outcomes data are often lacking.

Now, a first-of-its-kind randomized clinical trial puts a positive light on laparoscopy — with longer term outcome data.

Norwegian investigators showed that the minimally invasive surgery for liver metastases in patients with colorectal cancer is equivalent with open surgery in terms overall survival.

Median overall survival was 81 months in the open surgery arm (n = 147) and 80 months in the laparoscopic surgery arm (n = 133; P = .91), reported lead study author Asmund Avdem Fretland, MD, Oslo University Hospital, Norway.

He spoke at a press conference here at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

Previously, the Norwegian investigators reported that the study's 30-day outcomes were superior for the minimally invasive surgery approach — in terms of complications, hospital stays, and quality of life.

"Laparoscopic surgery was better for patients at no additional cost to society," summarized Fretland, explaining that financial costs were also equivalent between arms.

The stakes are high for this surgery, pointed out Nancy Baxter, MD, head of general surgery, St. Michael's Hospital, Toronto, who acted as an ASCO expert at the meeting press conference.

"Liver resection for colon cancer spread to the liver can be curative for patients," she explained to reporters, adding that the resection is the standard of care.

In other words, this is a rare example in oncology where a patient with metastatic cancer can be cured with surgery.

Baxter added that the new study shows that the minimally invasive approach, with its multiple short-term benefits, has "no downside" in the longer term. "This is news and this is important," she summarized.

Standard open surgery is still "safe and effective," emphasized Baxter, who pointed out that the current study took place at high-volume academic centers.

Only 22% of liver resections in this patient population have surgery via laparoscopy in the United States, said Baxter. She also explained that not every single liver resection can be done with this minimally invasive approach, which is "technically challenging" in this setting. Because of this, "it is really important we have excellent data to show it is equivalent," she added.

Two other randomized, multicenter clinical trials are now underway globally to compare the two surgery approaches, Fretland commented. He also provided some historical context: The approach was pioneered in the early 1990s and has spread to multiple centers.

"It's more and more accepted to do laparoscopic liver surgery," he said.

Paul Curcillo, MD, chief, minimally invasive surgery, Fox Chase Cancer Center, Philadelphia, said that patients at his center are ready to undergo adjuvant chemotherapy only 7 to 10 days after laparoscopic surgery for liver metastasis. With open surgery, that period of time can be as long as 8 to 10 weeks, he told Medscape Medical News.

Curcillo congratulated the Norwegian team with performing a much longer trial than has ever been done before in this setting with laparoscopy. "I give them a lot of credit," he said, explaining that the field, in its relative newness, had not moved past proof of concept studies with short-term outcomes.

With laparoscopy, several relatively small incisions are used. One incision is used to insert the scope that sends images of the abdominal cavity to a monitor for the surgeon. Other incisions provide openings for the insertion of tools to perform the operation. The small incisions contrast with the longer single incision of open surgery that generates more morbidity.

In the new study, the 5-year overall survival was 56% among the open surgery arm and 57% among the laparoscopic surgery arm.

The minimally invasive approach was also comparable to the open approach for recurrence-free survival, with a 5-year rate of 31% in the open surgery arm and 29% among the laparoscopic surgery arm (P = .73).

FDA Concerned About Safety of These Surgeries

Monica Bertagnolli, MD, chief, surgical oncology, Dana-Farber Cancer Institute, Boston, believes that, in general, much more rigorous studies of minimally invasive cancer surgery are needed. What is most important, said Bertagnolli emphatically, is cancer outcomes — and not short-term benefits.

The recent results showing inferior oncological outcomes after minimally invasive surgery (versus open surgery) are "very, very sobering and we are taking this very seriously," she commented to Medscape Medical News.

The US Food and Drug Administration is also concerned about the quality of evidence related to sanctioning the use of minimally invasive devices.

In February, the FDA issued a safety communication to healthcare providers about the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries that are not already FDA approved, as reported by Medscape Medical News

The agency urged caution about any such use, noting that robotic devices are approved for use in prostate cancer but not in most cancers.

The FDA letter hinted that the agency will hold robotic devices used for cancer surgery to a higher standard than other 510K devices going forward — by requiring long-term cancer outcomes data and not just 30-day complications rate data.

"To date, the FDA's evaluation of robotically assisted surgical devices has generally focused on determining whether the complication rate at 30 days is clinically comparable to other surgical techniques," the agency said.

"To evaluate robotically assisted surgical devices for use in the prevention or treatment of cancer, including breast cancer, the FDA anticipates these uses would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days," the agency said in the recent letter.

The study was supported by the South-East Norway Regional Health Authority. Baxter, Curcillo, and Bertagnolli have disclosed no relevant financial relationships.

2019 American Society of Clinical Oncology (ASCO) Annual Meeting: Abstract LBA3516. Presented June 3, 2019.

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