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Controversy still exists on the optimal surgical resection for potentially curable gastric cancer. Much better long-term survival has been reported in retrospective/non-randomized studies with D 2 resections that involve a radical extended regional lymphadenectomy than with the standard D 1 resections. In this paper we report the long-term survival of patients entered into a randomized study, with follow-up to death or 3 years in 96% of patients and a median follow-up of 6.5 years. In this prospective trial D 1 resection (removal of regional perigastric nodes) was compared with D 2 resection (extended lymphadenectomy to include level 1 and 2 regional nodes). Central randomization followed a staging laparotomy.
Out of 737 patients with histologically proven gastric adenocarcinoma registered, 337 patients were ineligible by staging laparotomy because of advanced disease and 400 were randomized. The 5-year survival rates were 35% for D 1 resection and 33% for D 2 resection (difference –2%, 95% CI = –12%–8%). There was no difference in the overall 5-year survival between the two arms (HR = 1.10, 95% CI 0.87–1.39, where HR > 1 implies a survival benefit to D 1 surgery). Survival based on death from gastric cancer as the event was similar in the D 1 and D 2 groups (HR = 1.05, 95% CI 0.79–1.39) as was recurrence-free survival (HR = 1.03, 95% CI 0.82–1.29). In a multivariate analysis, clinical stages II and III, old age, male sex and removal of spleen and pancreas were independently associated with poor survival. These findings indicate that the classical Japanese D 2 resection offers no survival advantage over D 1 surgery. However, the possibility that D 2 resection without pancreatico-splenectomy may be better than standard D 1 resection cannot be dismissed by the results of this trial. © 1999 Cancer Research Campaign