Minimally invasive laparoscopic-assisted surgery did not result in better outcomes compared to open surgery for rectal cancer, according to two clinical trials.
Minimally invasive laparoscopic-assisted surgery did not result in better outcomes compared to standard open surgery for rectal cancer, according to a pair of randomized clinical trials from North America and Australia published in JAMA.
Surgical removal of tumor tissue remains the major way to treat rectal cancer. Yet, while laparoscopic-assisted surgery is thought to result in better outcomes for cancer patients, in rectal cancer, the minimally invasive procedure may not allow enough access for full resection.
In ALACART (Australasian Laparoscopic Cancer of the Rectum Trial), the success rates of laparoscopic and open surgery were 82% and 89%, respectively (P for non-inferiority = 0.38). This difference of 7% did not meet the trial’s prespecified non-inferiority margin of 8%. The circumferential resection margin was clear in 93% and 97% of patients in the laparoscopic and open surgery groups, respectively (P = .06).
The trial enrolled 475 patients with stage I–III rectal cancer, half of whom received preoperative radiotherapy. The surgeries were performed by 26 surgeons across 24 sites in Australia and New Zealand.
“Even though our trial was not designed to demonstrate whether one method of rectal dissection was superior to the other, the inability to establish non-inferiority suggests that surgeons should be cautious when considering the suitability of a laparoscopic approach for a patient with rectal cancer,” wrote researchers led by Andrew R. L. Stevenson, MB BS, FRACS, of the University of Queensland, Brisbane, Australia.
In the American College of Surgeons Oncology Group (ACOSOG) Z6051 trial, adequate surgical dissection was reported in 81.7% and 86.9% of patients in the minimally invasive and open surgery groups, respectively (P for non-inferiority = 0.41). Again, the difference of 5.3% did not meet the pre-specified non-inferiority margin of 6%. The study included 486 patients with stage II/III rectal cancer from 35 institutions in the United States and Canada.
“Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients,” wrote James Fleshman, MD, of Baylor University Medical Center, Dallas, and coauthors.
In the North American study, time of operation was significantly longer for laparoscopic resection (P < .001), while length of hospital stay and readmission within 30 days were similar between the two groups.
In the Australian study, time of operation was slightly shorter with open surgery (P = .007), and there were no differences between hospital stay length, intensive care unit stay, or use of analgesics.
“The studies do not signal a moratorium on these approaches, 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,” wrote Scott A. Strong, MD, and Nathaniel J. Soper, MD, of the Northwestern University Feinberg School of Medicine in Chicago, in an accompanying editorial.