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 - 27/05/14

Doi : 10.1016/S1470-2045(14)70205-0

Seung-Yong Jeong, ProfMD ^a,^e, Ji Won Park, MD ^a,^e, Byung Ho Nam, ProfPhD ^f, Sohee Kim, MS ^f, Sung-Bum Kang, MD ^h, Seok-Byung Lim, MD ^l, Hyo Seong Choi, MD ^g, Duck-Woo Kim, MD ^h, Hee Jin Chang, MD ^g, Dae Yong Kim, MD ^g, Kyung Hae Jung, ProfMD ^m, Tae-You Kim, ProfMD ^b, Gyeong Hoon Kang, ProfMD ^c, Eui Kyu Chie, MD ^d, Sun Young Kim, MD ^g, Dae Kyung Sohn, MD ^g, Dae-Hyun Kim, MD ^g, Jae-Sung Kim, ProfMD ⁱ, Hye Seung Lee, MD ^j, Jee Hyun Kim, MD ^k, Jae Hwan Oh, ProfMD ^g,^⁎
^a Department of Surgery, Seoul National University College of Medicine, Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul, South Korea
^b Division of Medical Oncology and Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea
^c Department of Pathology, Seoul National University Hospital, Seoul, South Korea
^d Department of Radiation Oncology, Seoul National University Hospital, Seoul, South Korea
^e Cancer Research Institute, Seoul National University, Seoul, South Korea
^f Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, South Korea
^g Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea
^h Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea
ⁱ Department of Radiation Oncology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea
^j Department of Pathology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea
^k Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea
^l Department of Colon and Rectal Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
^m Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea

^*Correspondence to: Prof Jae Hwan Oh, Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang 410-769, South Korea

Summary

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.

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Plan

Introduction

Methods

Study design and participants

Randomisation and masking

Procedures

Outcomes

Statistical analysis

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Vol 15 - N° 7

P. 767-774 - juin 2014 Retour au numéro

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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 - 27/05/14

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