腹腔镜辅助手术与开放手术治疗结肠癌的随机临床试验的长期结果

The long-term results of a randomized clinical trial of laparoscopy-assisted versus open surgery for colon cancer.

作者信息

Lacy Antonio M, Delgado Salvadora, Castells Antoni, Prins Hubert A, Arroyo Vicente, Ibarzabal Ainitze, Pique Josep M

机构信息

Department of Surgery, Centro de Investigaciones Biomédicas Esther Koplowitz, IMDiM, IDIBAPS, Hospital Clínic, University of Barcelona, Spain.

出版信息

Ann Surg. 2008 Jul;248(1):1-7. doi: 10.1097/SLA.0b013e31816a9d65.

DOI:10.1097/SLA.0b013e31816a9d65

PMID:18580199

Abstract

OBJECTIVE

The aim of this study was to compare the long-term outcome of laparoscopy-assisted colectomy (LAC) and open colectomy (OC) for nonmetastatic colon cancer.

METHODS

From November 1993 to July 1998 all patients with adenocarcinoma of the colon were assessed for entry in this single center, clinically randomized trial. Adjuvant therapy and postoperative follow-up were similar in both groups. The primary endpoint was cancer-related survival and secondary endpoints were probability of overall survival and probability of being free of recurrence. Data were analyzed according the intention-to-treat principle.

RESULTS

Two hundred and nineteen patients entered the study (111 LAC group and 108 OC group). The median follow-up was 95 months (range, 77-133). There was a tendency of higher cancer-related survival (P = 0.07, NS) and overall survival (P = 0.06, NS) for the LAC group. Probability of cancer-related survival was higher in the LAC group (P = 0.02) when compared with OC. The regression analysis showed that LAC was independently associated with a reduced risk of tumor relapse (hazard ratio 0.47, 95% CI 0.23-0.94), death from a cancer-related cause (0.44, 0.21-0.92) and death from any cause (0.59, 0.35-0.98).

CONCLUSIONS

LAC is more effective than OC in the treatment of colon cancer.

摘要

目的

本研究旨在比较腹腔镜辅助结肠切除术（LAC）和开放性结肠切除术（OC）治疗非转移性结肠癌的长期疗效。

方法

从1993年11月至1998年7月，对该单中心临床随机试验纳入的所有结肠癌腺癌患者进行评估。两组的辅助治疗和术后随访相似。主要终点是癌症相关生存率，次要终点是总生存率和无复发概率。根据意向性治疗原则分析数据。

结果

219例患者进入研究（LAC组111例，OC组108例）。中位随访时间为95个月（范围77 - 133个月）。LAC组有癌症相关生存率（P = 0.07，无统计学意义）和总生存率（P = 0.06，无统计学意义）更高的趋势。与OC组相比，LAC组癌症相关生存率更高（P = 0.02）。回归分析显示，LAC与肿瘤复发风险降低（风险比0.47，95%可信区间0.23 - 0.94）、癌症相关死亡（0.44，0.21 - 0.92）和任何原因导致的死亡（0.59，0.35 - 0.98）独立相关。