Researchers randomized 1,039 patients with clinical stage T2, T3, or T4a gastric cancer without distant metastases or bulky nodes 1:1 to undergo laparoscopic distal gastrectomy or open distal gastrectomy with D2 lymphadenectomy. The clinical trial was conducted at 14 centers in China.
Overall survival rates at five years were 72.6% in with laparoscopic distal gastrectomy and 76.3% with open distal gastrectomy, a difference that wasn't statistically significant, researchers report in JAMA surgery.
"Our work is the first level I evidence for the use of laparoscopic distal gastrectomy for locally advanced gastric cancer," said lead senior study author Dr. Guoxin Li, professor and director of general surgery at Nanfang Hospital and Southern Medical University in Guangzhou, China.
"However, this trial was done in a Chinese population, thus, surgeons must keep in mind that the validation in Western populations is warranted, especially for the patients who need total gastrectomy," Dr. Li said by email.
Five-year overall survival outcomes were based on a per-protocol analysis, which included 481 patients in the laparoscopic distal gastrectomy group and 477 patients in the open distal gastrectomy groups, excluding people who didn't adhere to their treatment plans.
The median follow-up period was 71 months, and there were 33 patients (3.2%) who were lost to follow up.
The majority of patients were men in both the laparoscopic distal gastrectomy group (73.2%) and the open distal gastrectomy group (66.5%). The mean age of patients was similar in the laparoscopic distal gastrectomy group (56.5 years) and in the open distal gastrectomy group (55.8 years).
Even though all the patients were diagnosed with tumors staged at T2 or higher, there were 248 people (23.9%) who were found to have T1 tumors during the study.
Five-year overall survival rates were highest among people with T1 tumors in both the laparoscopic distal gastrectomy group (90.0%) and in the open distal gastrectomy group (88.5%). Five-year overall survival dropped for patients with T2 tumors (79.1% with laparoscopic vs 84.5% with open procedures) and with T3 tumors (58.6% and 59.5%, respectively).
In analysis excluding the 248 people with T1 tumors, there was no significant difference in gastric-cancer related death and fatalities from other causes between the groups receiving laparoscopic versus open distal gastrectomy, the study also found.
One limitation of the study is that all the procedures were done in China, where treatment protocols differ from the U.S. and other Western nations where neoadjuvant therapy is typically recommended, researchers note.
All the surgeons in the trial had advanced training in oncology surgery and experience with high volumes of distal gastrectomy, and it's possible that results would differ for less experienced surgeons with different training backgrounds, the authors also point out.
SOURCE: https://bit.ly/3pi10RE JAMA Surgery, online October 20, 2021.
By Lisa Rapaport
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