Cuschieri A, Weeden S, Fielding J, Bancewicz J, Craven J, Joypaul V, Sydes M, Fayers P
University Department of Surgery, Ninewells Hospital and Medical School, Dundee, UK.
Br J Cancer. 1999 Mar;79(9-10):1522-30. doi: 10.1038/sj.bjc.6690243.
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 D2 resections that involve a radical extended regional lymphadenectomy than with the standard D1 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 D1 resection (removal of regional perigastric nodes) was compared with D2 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 D1 resection and 33% for D2 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 D1 surgery). Survival based on death from gastric cancer as the event was similar in the D1 and D2 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 D2 resection offers no survival advantage over D1 surgery. However, the possibility that D2 resection without pancreatico-splenectomy may be better than standard D1 resection cannot be dismissed by the results of this trial.
对于潜在可治愈的胃癌,最佳手术切除方式仍存在争议。回顾性/非随机研究表明,与标准D1切除相比,D2切除(包括根治性扩大区域淋巴结清扫)的长期生存率要高得多。本文报告了一项随机研究中患者的长期生存情况,96%的患者随访至死亡或3年,中位随访时间为6.5年。在这项前瞻性试验中,将D1切除(切除胃周区域淋巴结)与D2切除(扩大淋巴结清扫,包括第1和第2区域淋巴结)进行了比较。中心随机分组在分期剖腹探查后进行。在737例经组织学证实的胃腺癌登记患者中,337例因疾病进展在分期剖腹探查时不符合条件,400例被随机分组。D1切除的5年生存率为35%,D2切除的为33%(差异-2%,95%可信区间=-12%-8%)。两组的总体5年生存率无差异(风险比=1.10,95%可信区间0.87-1.39,其中风险比>1意味着D1手术有生存获益)。以胃癌死亡作为事件的生存率在D1组和D2组中相似(风险比=1.05,95%可信区间0.79-1.39),无复发生存率也是如此(风险比=1.03,95%可信区间0.82-1.29)。在多变量分析中,临床分期II和III期、老年、男性以及脾脏和胰腺切除与生存不良独立相关。这些发现表明,传统的日本D2切除在生存方面并不优于D1手术。然而,本试验结果不能排除不进行胰脾切除的D2切除可能优于标准D1切除的可能性。