LEADING Australian colorectal surgeons have urged caution in the use of laparoscopic-assisted resection for rectal cancer until long-term survival and local recurrence outcomes from two trials are known.
The two studies published in JAMA— one based in Australia and New Zealand and the other in the US — failed to show that laparoscopic-assisted resection for rectal cancer was no worse than open surgery according to three surgical outcomes: total mesorectal excision, clear circumferential resection margin (CRM) and clear distal resection margin. (1), (2)
Dr Andrew Stevenson, lead author of the Australian study and chief investigator for the Australian Laparoscopic Cancer Rectum Trial (ALaCaRT), told MJA InSight the trial was one of the largest surgical trials ever conducted in Australia or New Zealand, and was “an important step in analysing our approach to treating rectal cancer”.
“The results were excellent, whether done laparoscopically or open, and certainly world-class. But, at the end of the day, we didn’t show laparoscopic surgery to be non-inferior to open surgery”, said Dr Stevenson, who is also director of colorectal surgery at Royal Brisbane Hospital.
Overall, the ALaCaRT trial found that successful resection was achieved in 85% of the 475 enrolled patients with clinical stage 1–3 rectal adenocarcinoma. Successful resection was achieved in 82% of the laparoscopic group, and 89% of the open surgery group. The CRM was clear in 93% of the laparoscopic group and 97% of the open surgery group.
Similar findings were reported in the US study, with successful resection reported in about 82% of the laparoscopic group and 87% of the open surgery group. The US trial enrolled 486 patients with stage 2–3 rectal cancer.
Dr Stevenson told MJA InSight that follow-up over the next 3 years would shed light on the survival and recurrence rates associated with each procedure.
He said early subgroup analysis suggested that for more difficult rectal cancer surgeries — for example, in patients who had had radiotherapy, had higher body mass index and for larger tumours — open surgery might be preferred for pelvic dissection, particularly for surgeons who did not routinely use laparoscopic-assisted resection for rectal cancer.
The 26 surgeons who participated in the Australian trial were selected according to strict eligibility criteria.
“[If] these carefully selected, highly trained surgeons have not been able to establish non-inferiority, there should be an element of caution and perhaps further emphasis on training for laparoscopic surgery for rectal cancer”, Dr Stevenson said.
A JAMA editorial concluded that the studies did not signal a moratorium on laparoscopic-assisted resection, “but surgeons must proceed in a judicious manner to ensure that patients are informed about the benefits and risks associated with minimally invasive and open operations”. (3)
Associate Professor Christopher Young, colorectal surgeon and head of the department of colorectal surgery at Sydney’s Royal Prince Alfred Hospital, agreed that the overall results from the trial were “very good”.
Professor Young, who uses the hybrid approach to surgery used in the open arm of the ALaCaRT trial, said it was reassuring that this approach was “justified and supported” by these trials.
While the studies did not rule out the use of laparoscopic surgery, surgeons who did use this method should measure and record their data, he said.
“[Data on] the local recurrence and the survival rates may have ramifications because that’s what matters in the long run”, he said. “All we care about is the length of our life and the quality of our life.”
Professor Marc Gladman, professor of colorectal surgery at the Sydney Medical School, University of Sydney, said the study emphasised the high quality of surgery being performed in Australia. He commended the US and local researchers on the design of the trials.
“It’s an important step forward as we look to best practice and how best to treat patients with these conditions”, he said.
Professor Gladman said some questions pertinent to patients had been answered in the ALaCaRT trial, such as an overall 30-day survival rate of more than 99% and the avoidance of a stoma in more than 90% of cases, but an answer to the crucial question of long-term survival was yet to come.
“These trials have raised significant questions”, he said. “If we are going to continue to offer minimally invasive techniques, it’s even more important that patients are carefully counselled and informed of these risks in light of the recent published data against the perceived benefits.”
(Photo: Anastasiia Lieonova / shutterstock)