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Top Line: Watching the never-ending reruns of Dr. Now has us searching for some good gastric surgery trials.
The Study: We’ve seen recently that a more minimally invasive approach to esophagectomy may reduce complication rates and possibly even improve survival. What about gastrectomy? At least three large trials are asking this question, but it’s a little more tricky with gastric cancer due to the call for D2 node dissections. In the CLASS-01 trial, over 1000 patients planning to undergo distal gastrectomy with D2 node dissection for tumors involving the lower or middle-third of the stomach were randomized to an open or laparoscopic approach. Importantly, nobody got FLOT (or anything else for that matter) before surgery. While short-term safety outcomes have been reported, here we have have the primary outcome of disease-free survival: at 3 years the rate was noninferior after laparoscopic (77%) versus open (78%) gastrectomy. Interestingly, 20-25% of patients ended up with pT1 tumors that didn’t technically meet study criteria. In a post-hoc analysis where these patients were removed, non-inferiority was still met. However, when all patients with stage I (pT1-2N0 or pT1N1) disease were omitted, non-inferiority was not met. While not significant, there was an apparent separation in outcomes with more advanced stages of disease.
Bottom Line: Laparoscopic distal gastrectomy and D2 node dissection appears non-inferior to open surgery in patients with “locally advanced” gastric cancer not receiving neoadjuvant therapy. | Yu, JAMA 2019
The Study: We’ve seen recently that a more minimally invasive approach to esophagectomy may reduce complication rates and possibly even improve survival. What about gastrectomy? At least three large trials are asking this question, but it’s a little more tricky with gastric cancer due to the call for D2 node dissections. In the CLASS-01 trial, over 1000 patients planning to undergo distal gastrectomy with D2 node dissection for tumors involving the lower or middle-third of the stomach were randomized to an open or laparoscopic approach. Importantly, nobody got FLOT (or anything else for that matter) before surgery. While short-term safety outcomes have been reported, here we have have the primary outcome of disease-free survival: at 3 years the rate was noninferior after laparoscopic (77%) versus open (78%) gastrectomy. Interestingly, 20-25% of patients ended up with pT1 tumors that didn’t technically meet study criteria. In a post-hoc analysis where these patients were removed, non-inferiority was still met. However, when all patients with stage I (pT1-2N0 or pT1N1) disease were omitted, non-inferiority was not met. While not significant, there was an apparent separation in outcomes with more advanced stages of disease.
Bottom Line: Laparoscopic distal gastrectomy and D2 node dissection appears non-inferior to open surgery in patients with “locally advanced” gastric cancer not receiving neoadjuvant therapy. | Yu, JAMA 2019
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