日本临床肿瘤学组JCOG0404研究中评估腹腔镜手术与开腹手术治疗结直肠癌的随机对照试验的短期和长期结果的过渡性影响

Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

作者信息

Fujii Shoichi, Akagi Tomonori, Inomata Masafumi, Katayama Hiroshi, Mizusawa Junki, Ota Mitsuyoshi, Saito Shuji, Kinugasa Yusuke, Yamaguchi Shigeki, Sato Takeo, Kitano Seigo

机构信息

Department of Gastroenterological Surgery Yokohama City University Medical Center Yokohama Japan.

Department of Gastroenterological and Pediatric Surgery Oita University Oita Japan.

出版信息

Ann Gastroenterol Surg. 2019 Mar 26;3(3):301-309. doi: 10.1002/ags3.12245. eCollection 2019 May.

DOI:10.1002/ags3.12245

PMID:31131359

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6524094/

Abstract

BACKGROUND

The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short-term outcomes and equal long-term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given during the registration period might have affected the outcomes.

AIM

To evaluate outcomes according to the registration periods.

METHODS

The overall registration period was divided into three periods (first: 2004-2005, second: 2006-2007 and third: 2008-2009). Short-term and long-term outcomes were compared between registration periods.

RESULTS

In total, 1057 patients were registered. Numbers of patients undergoing each approach for each of the three periods (1st/2nd/3rd) were 528 for OP (106/244/178) and 529 for LAP (106/246/177). Operation time (minutes) did not change between the periods for OP (160/156/161) or LAP (205/211/219). Blood loss (mL) gradually decreased in the latter two periods: (119/80/75) for OP and (35/28/25) for LAP. Incidence of complications (%) decreased in the latter periods for OP (27.6/20.3/21.3), whereas that for LAP remained consistently low (14.3/14.8/13.6). There was no particular trend in 5-year overall survival and recurrence-free survival depending on the period regardless of treatment. D3 dissection rates were 95% or more for all periods in both groups.

CONCLUSIONS

Operation time and survival rates did not change over time, whereas blood loss in OP improved in the latter periods. Quality control applied in this trial might have been effective in producing such safe endpoints. (ClinicalTrials.gov, number NCT00147134, UMIN Clinical Trials Registry, number C000000105.).

摘要

背景

JCOG0404随机对照试验旨在比较腹腔镜手术（LAP）与开放手术（OP）治疗II/III期结肠癌的疗效，结果显示LAP的短期疗效更好，长期疗效与OP相当。手术的技术器械以及登记期间使用的抗癌药物可能影响了疗效。

目的

根据登记期间评估疗效。

方法

将整个登记期间分为三个阶段（第一阶段：2004 - 2005年，第二阶段：2006 - 2007年，第三阶段：2008 - 2009年）。比较各登记阶段的短期和长期疗效。

结果

总共登记了1057例患者。三个阶段中每个阶段接受每种手术方式的患者数量，OP组（第一/第二/第三阶段）分别为528例（106/244/178例），LAP组为529例（106/246/177例）。OP组各阶段的手术时间（分钟）无变化（160/156/161），LAP组也无变化（205/211/219）。后两个阶段的失血量（mL）逐渐减少：OP组为（119/80/75），LAP组为（35/28/25）。OP组后期并发症发生率（%）下降（27.6/20.3/21.3），而LAP组一直保持较低水平（14.3/14.8/13.6）。无论治疗方式如何，5年总生存率和无复发生存率在各阶段均无特定趋势。两组各阶段的D3淋巴结清扫率均达到95%或更高。