Five-year overall survival after laparoscopic distal gastrectomy for locally advanced gastric cancer is on par with that of open surgery, according to new data from the Chinese CLASS-01 trial.
Laparoscopic gastrectomy has grown increasingly popular in Eastern countries. Previous research has found that the minimally invasive approach is associated with outcomes similar to those with open gastrectomy. However, most studies have involved early-stage disease, researchers note in their article, which was published online October 20 in JAMA Surgery..
The new findings provide “further evidence for the safety and efficacy of laparoscopic gastrectomy for patients assessed preoperatively as having locally advanced cancer,” write Guoxin Li, MD, PhD, of Nanfang Hospital, Southern Medical University, in Guangzhou, China, and colleagues.
The CLASS-01 trial, conducted at 14 centers in China between 2012 and 2014, included more than 1000 patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases. These patients, none of whom received neoadjuvant therapy, were randomly assigned to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy.
Earlier results from the CLASS-01 trial, published in 2019 in JAMA, revealed no significant difference in 3-year disease-free survival — the study’s primary endpoint — among patients undergoing laparoscopic (77%) vs open (78%) surgery. The authors also previously reported similar rates of postoperative morbidity in the laparoscopic (15%) and open (13%) groups.
In the latest analysis, the overall survival rate was 73% in the laparoscopic group and 76% in the open group 5 years out. For patients with stage I tumors, 5-year survival was 90% with laparoscopy vs 89% with open surgery. For stage II and stage III tumors, the rates were 79% vs 85% and 59% vs 60%. None of these differences was significant after adjusting for age, sex, body mass index, performance status, comorbidities, tumor size, histologic features, and chemotherapy.
The team notes that although more than 20 patients in each group crossed over to the other group, “analyses of the per-protocol population after we excluded these crossover patients produced the same long-term results.”
The authors also note that because this study was conducted in China, “it is not clear whether the findings will be the same in Western countries, where total or proximal gastrectomy is more common.”
At first glance, however, the findings do appear to be similar. In the first Western multicenter, randomized trial comparing laparoscopic with open gastrectomy, published earlier this year, researchers in the Netherlands found no significant differences in 1-year overall mortality, complications, readmissions, quality of life, or length of hospital stay between the two groups. The laparoscopic approach was associated with less blood loss, but it also took longer. The Dutch researchers concluded that their results “support the application of laparoscopic gastrectomy as a safe alternative to open gastrectomy in experienced centers.”
Like the Dutch researchers, Li and colleagues stressed that laparoscopic procedures were performed by “experienced surgeons at high-volume, specialized institutions,” and so their results could be hard to generalize “to surgeons with less-intensive training.”
The group is currently planning a trial dubbed CLASS-03 to examine the safety of laparoscopic gastrectomy after neoadjuvant therapy.
The researchers have disclosed no relevant financial relationships.
JAMA Surg. Published online October 20, 2021. Abstract