By Will Boggs MD
NEW YORK (Reuters Health) - 29/5/2019
Laparoscopic gastrectomy is noninferior to open distal gastrectomy in patients with locally advanced gastric cancer, researchers from China report.
"The short-term safety and long-term efficacy results of the current study indicate that for locally advanced gastric cancer laparoscopic distal gastrectomy is noninferior to open distal gastrectomy in terms of survival benefit and has the advantages of being less invasive and enabling a faster postoperative recovery," Dr. Jiafu Ji from Peking University Cancer Hospital and Institute, in Beijing, told Reuters Health by email.
Laparoscopic distal gastrectomy with limited lymphadenectomy is recommended for patients with early gastric cancer. But surgery for locally advanced gastric cancer is technically more challenging because of the requirement to dissect D2 lymph nodes.
Dr. Ji and colleagues in the CLASS-01 randomized controlled trial compared laparoscopic distal gastrectomy and open distal gastrectomy in a noninferiority study including 1,056 patients with locally advanced gastric cancer (stage T2, T3, or T4a tumor without metastatic disease or bulky lymph nodes).
The three-year disease-free survival rates were 76.5% in the laparoscopic group and 77.8% in the open-gastrectomy group, a difference that satisfied the prespecified noninferiority criterion, the researchers report in the May 28 issue of JAMA.
The lack of significant difference in three-year disease-free survival persisted after adjusting for age, tumor size, pathologic T stage, pathologic N stage and adjuvant chemotherapy.
The three-year overall survival rates were also similar in the laparoscopic group (83.1%) and open group (85.2%) before and after controlling for age, tumor size, pathologic T stage, and pathologic N stage.
In subgroup analyses, disease-free survival rates for patient with pathologic stage I were marginally better with laparoscopic surgery (96.5% vs. 91.3% for open surgery; log-rank P=0.05). They were similar in the two groups for patients with pathologic stage II (87.5% vs. 86.8%, respectively), and were nominally worse for the laparoscopic group than for the open group for patients with pathologic stage III (58.0% vs. 63.8%; log-rank P=0.23) and pathologic stage IV (20.8% vs. 58.3%; log-rank P=0.13).
Overall survival rates did not differ between the groups stratified by pathologic stage, although there was a trend towards worse overall survival after laparoscopic surgery among patients with pathologic stage IV (20.0% vs. 66.7%; P=0.06).
"Globally, patients of advanced stage still comprise the largest amount of gastric cancer cases, and our results support laparoscopic gastrectomy as a safe and effective alternative to the traditional open approach for these patients," Dr. Ji said. "Prudence and caution may be needed when applying laparoscopic gastrectomy to patients with later stages."
"Other factors, including medical costs, patient preference, quality of life, and so on, should also be taken into account when choosing between laparoscopic and open gastrectomy in these patients," he said. "Shared decision making or decision aids can be helpful under such circumstances."
Dr. Mikito Inokuchi from Musashino Redcross Hospital, in Tokyo, who recently reported similar outcomes of laparoscopic gastrectomy and open gastrectomy in Japanese patients with locally advanced gastric cancer, told Reuters Health by email, "Laparoscopic distal gastrectomy (LDG) is oncologically safe for locally advanced gastric cancer in general; however, it remains unclear that LDG should be performed in far-advanced gastric cancer."
"LDG with D2 lymphadenectomy will become one of the standard treatments as well as open distal gastrectomy in patients with locally advanced gastric cancer," said Dr. Inokuchi, who was not involved in the study.