"These findings were not surprising, because our experience and prior retrospective studies had shown this," Dr. Davit Aghayan and Dr. Bjorn Edwin, both of Oslo University Hospital in Rikshospitalet, told Reuters Health by email. "Earlier reports of our trial demonstrated also that laparoscopy was associated with fewer complications, faster recovery, better quality of life, and was cost-effective compared to open surgery" at 30 days. (https://bit.ly/3pACue8 and https://bit.ly/3nsPHDO)
"In this report, we showed that the laparoscopic approach does not jeopardize long-term oncologic outcomes," they said. "As the trial was not designed to primarily examine differences in survival, small-to-moderate differences in either direction cannot be excluded."
The predefined secondary end point analysis published in the Annals of Internal Medicine included 133 patients with colorectal liver metastases who underwent laparoscopic surgery and 147 who underwent open surgery between 2012-2016. The mean age for both groups was about 66; 54% were men in the open group and 65% in the laparoscopic group.
At a median follow-up of 70 months, five-year overall survival rates were 54% in the laparoscopic group and 55% in the open group (hazard ratio, 0.93).
Median recurrence-free survival was 17 months in the laparoscopic group and 16 months in the open group (HR, 1.09.)
Disease recurred in 80 patients (67%) in the laparoscopic group and 82 (62%) in the open group. The most common sites of recurrence were the liver, lungs, and peritoneum.
Five-year recurrence-free survival was 30% in the laparoscopic group and 36% in the open group (HR, 1.09).
In multivariable regression analysis, factors associated with poor outcomes were Eastern Cooperative Oncology Group performance status, involvement of the lymph nodes in the primary tumor, size of the largest liver metastasis, and presence of extrahepatic disease at liver surgery.
The authors note that the trial was not powered to detect differences in secondary end points and was not designed to address a noninferiority hypothesis for survival outcomes.
Drs. Aghayan and Edwin said, "The next step is to explore new aspects of minimally invasive liver surgery. We are currently involved in two multicenter, multinational, randomized controlled trials bringing more evidence to this field."
Dr. Anton Bilchik, chief of gastrointestinal research and of medicine at John Wayne Cancer Institute at Providence Saint John's Health Center in Santa Monica, California, commented in an email to Reuters Health, "The findings provide reassurance that patients undergoing minimally invasive surgery for colorectal liver metastases do not have adverse oncologic outcomes compared with open surgery. While this may be expected, this is the first randomized trial to support it."
"Larger trials are always needed," he said, "but experienced hepatobiliary surgeons have already changed their practices to include less invasive surgery for liver metastases."
"Minimally invasive surgery requires additional training and skill," he noted. "The liver is one of the most vascular organs in the body and inexperience can result in major blood loss. Safety is therefore essential in selecting an approach. An open operation done well is far more important than a laparoscopic procedure with a complication and adverse outcome."
"Patients with extensive scar tissue from previous surgery or tumors in challenging locations may be better candidates for open surgery," he added.
By Marilynn Larkin
SOURCE: https://bit.ly/2UvKgHB Annals of Internal Medicine, online November 16, 2020.
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