新辅助放化疗后中低位直肠肿瘤的开腹与腹腔镜手术比较（COREAN 试验）：一项开放标签、非劣效、随机对照临床试验的生存结局。
Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial.
机构信息
Department of Surgery, Seoul National University College of Medicine, Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul, South Korea; Cancer Research Institute, Seoul National University, Seoul, South Korea.
Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
出版信息
Lancet Oncol. 2014 Jun;15(7):767-74. doi: 10.1016/S1470-2045(14)70205-0. Epub 2014 May 15.
BACKGROUND
Compared with open resection, laparoscopic resection of rectal cancers is associated with improved short-term outcomes, but high-level evidence showing similar long-term outcomes is scarce. We aimed to compare survival outcomes of laparoscopic surgery with open surgery for patients with mid-rectal or low-rectal cancer.
METHODS
The Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial was an open-label, non-inferiority, randomised controlled trial done between April 4, 2006, and Aug 26, 2009, at three centres in Korea. Patients (aged 18-80 years) with cT3N0-2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy were randomly assigned (1:1) to receive either open or laparoscopic surgery. Randomisation was stratified by sex and preoperative chemotherapy regimen. Investigators were masked to the randomisation sequence; patients and clinicians were not masked to the treatment assignments. The primary endpoint was 3 year disease-free survival, with a non-inferiority margin of 15%. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00470951.
FINDINGS
We randomly assigned 340 patients to receive either open surgery (n=170) or laparoscopic surgery (n=170). 3 year disease-free survival was 72·5% (95% CI 65·0-78·6) for the open surgery group and 79·2% (72·3-84·6) for the laparoscopic surgery group, with a difference that was lower than the prespecified non-inferiority margin (-6·7%, 95% CI -15·8 to 2·4; p<0·0001). 25 (15%) patients died in the open group and 20 (12%) died in the laparoscopic group. No deaths were treatment related.
INTERPRETATION
Our results show that laparoscopic resection for locally advanced rectal cancer after preoperative chemoradiotherapy provides similar outcomes for disease-free survival as open resection, thus justifying its use.
FUNDING
National Cancer Center, South Korea.
背景
与开放切除术相比，腹腔镜直肠切除术与短期结果改善相关，但高水平证据表明其长期结果相似的情况较为罕见。本研究旨在比较新辅助放化疗后中低位直肠肿瘤患者接受腹腔镜手术与开放手术的生存结局。
方法
比较新辅助放化疗后中低位直肠癌开放与腹腔镜手术（COREAN）试验为一项开放标签、非劣效性、随机对照试验，于 2006 年 4 月 4 日至 2009 年 8 月 26 日在韩国的 3 个中心进行。接受术前放化疗的 cT3N0-2M0 中低位直肠肿瘤患者（年龄 18-80 岁）被随机（1:1）分配至接受开放手术或腹腔镜手术。随机化按照性别和术前化疗方案分层。研究者对随机序列设盲；患者和临床医生对治疗分配设盲。主要终点为 3 年无病生存率，非劣效性边界为 15%。分析采用意向治疗。该试验在 ClinicalTrials.gov 注册，编号为 NCT00470951。
结果
我们将 340 例患者随机分配至接受开放手术（n=170）或腹腔镜手术（n=170）。开放手术组的 3 年无病生存率为 72.5%（95%CI 65.0-78.6），腹腔镜手术组为 79.2%（72.3-84.6），差异低于预设的非劣效性边界（-6.7%，95%CI -15.8 至 2.4；p<0.0001）。开放组有 25 例（15%）患者死亡，腹腔镜组有 20 例（12%）患者死亡。无死亡与治疗相关。
解释
我们的研究结果表明，新辅助放化疗后局部进展期直肠肿瘤行腹腔镜切除术的无病生存率与开放切除术相似，因此可以使用腹腔镜切除术。
资金来源
韩国国家癌症中心。
Zotero 插件