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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

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Authors
Jeong, Seung-Yong; Park, Ji Won; Nam, Byung Ho; Kim, Sohee; Kang, Sung-Bum; Lim, Seok-Byung; Choi, Hyo Seong; Kim, Duck-Woo; Chang, Hee Jin; Kim, Dae Yong; Jung, Kyung Hae; Kim, Tae-You; Kang, Gyeong Hoon; Chie, Eui Kyu; Kim, Sun Young; Sohn, Dae Kyung; Kim, Dae-Hyun; Kim, Jae-Sung; Oh, Jae Hwan
Issue Date
2014-06
Publisher
ELSEVIER SCIENCE INC
Citation
The Lancet Oncology, Vol.15, pp. 767-774
Keywords
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 trial의약학
Abstract
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 NCT0040951. 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.
ISSN
1470-2045
Language
English
URI
http://hdl.handle.net/10371/116875
DOI
https://doi.org/10.1016/S1470-2045(14)70205-0
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College of Medicine/School of Medicine (의과대학/대학원)Surgery (외과학전공)Journal Papers (저널논문_외과학전공)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
College of Medicine/School of Medicine (의과대학/대학원)Pathology (병리학전공)Journal Papers (저널논문_병리학전공)
College of Medicine/School of Medicine (의과대학/대학원)Radiation Oncology (방사선종양학전공)Journal Papers (저널논문_방사선종양학전공)
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