D2 dissection improves disease-specific survival in advanced gastric cancer patients: 15-year follow-up results of the Italian Gastric Cancer Study Group D1 versus D2 randomised controlled trial

Background: The extended lymphadenectomy (D2) was recently introduced in several guidelines as the optimal treatment for gastric cancer, based only on the 15-year follow-up results of the Dutch randomised trial, while the British Medical Research Council (MRC) study failed to demonstrate a survival benefit over the more limited D1 dissection. The Italian Gastric Cancer Study Group randomised controlled trial (RCT) was also undertaken to compare D1 versus D2 gastrectomy, and a tendency to improve survival in patients with advanced resectable disease (pT > 1Nþ) was documented despite negative results in the entire patient population. Now we present the 15-year follow-up results of survival and gastric cancer-related mortality. Methods: Between June 1998 and December 2006, eligible patients with gastric cancer who signed the informed consent were randomised at 5 centres to either D1 or D2 gastrectomy. Intraoperative randomisation was implemented centrally by phone call. Primary outcome was overall survival (OS); secondary end-points were disease-specific survival, postoperative morbidity and mortality. Analyses were by intention to treat. Strict quality control measures for surgery, lymph node removal, pathology and patient follow-up were implemented and monitored.