随机对照临床试验比较胃癌行 D1 或 D2 胃切除术的生存情况。

Randomized clinical trial comparing survival after D1 or D2 gastrectomy for gastric cancer.

机构信息

Division of Surgical Oncology, Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Turin, Italy.

出版信息

Br J Surg. 2014 Jan;101(2):23-31. doi: 10.1002/bjs.9345.

DOI:10.1002/bjs.9345

PMID:24375296

Abstract

BACKGROUND

It is still unclear whether D2 lymphadenectomy improves the survival of patients with gastric cancer and should therefore be performed routinely or selectively. The aim of this multicentre randomized trial was to compare D2 and D1 lymphadenectomy in the treatment of gastric cancer.

METHODS

Between June 1998 and December 2006, patients with gastric adenocarcinoma were assigned randomly to either D1 or D2 gastrectomy. Intraoperative randomization was implemented centrally by telephone. Primary outcome was overall survival; secondary endpoints were disease-specific survival, morbidity and postoperative mortality.

RESULTS

A total of 267 eligible patients were allocated to either D1 (133 patients) or D2 (134) resection. Morbidity (12.0 versus 17.9 per cent respectively; P = 0.183) and operative mortality (3.0 versus 2.2 per cent; P = 0.725) rates did not differ significantly between the groups. Median follow-up was 8.8 (range 4.5-13.1) years for surviving patients and 2.4 (0.2-11.9) years for those who died, and was not different in the two treatment arms. There was no difference in the overall 5-year survival rate (66.5 versus 64.2 per cent for D1 and D2 lymphadenectomy respectively; P = 0.695). Subgroup analyses showed a 5-year disease-specific survival benefit for patients with pathological tumour (pT) 1 disease in the D1 group (98 per cent versus 83 per cent for the D2 group; P = 0.015), and for patients with pT2-4 status and positive lymph nodes in the D2 group (59 per cent versus 38 per cent for the D1 group; P = 0.055).

CONCLUSION

No difference was found in overall 5-year survival between D1 and D2 resection. Subgroup analyses suggest that D2 lymphadenectomy may be a better choice in patients with advanced disease and lymph node metastases.

REGISTRATION NUMBER

ISRCTN11154654 (http://www.controlled-trials.com).

摘要

背景

D2 淋巴结清扫术是否能改善胃癌患者的生存状况尚不清楚，因此，D2 淋巴结清扫术应该常规进行还是选择性进行仍存在争议。本多中心随机试验的目的是比较胃癌患者接受 D2 和 D1 淋巴结清扫术的效果。

方法

1998 年 6 月至 2006 年 12 月，入组的胃腺癌患者被随机分配至 D1 或 D2 胃切除术组。通过中央电话进行术中随机分组。主要终点是总生存；次要终点是疾病特异性生存、发病率和术后死亡率。

结果

共 267 例符合条件的患者被分配至 D1（133 例）或 D2（134 例）切除术组。两组的发病率（分别为 12.0%和 17.9%；P = 0.183）和手术死亡率（分别为 3.0%和 2.2%；P = 0.725）无显著差异。在两组中，中位随访时间分别为存活患者的 8.8 年（范围 4.5-13.1 年）和死亡患者的 2.4 年（0.2-11.9 年），且在两组之间无差异。两组的 5 年总生存率无差异（D1 和 D2 淋巴结清扫术分别为 66.5%和 64.2%；P = 0.695）。亚组分析显示，D1 组病理肿瘤（pT）1 期患者的 5 年疾病特异性生存率更高（98%比 D2 组的 83%；P = 0.015），D2 组 pT2-4 期和阳性淋巴结患者的 5 年生存率更高（59%比 D1 组的 38%；P = 0.055）。