Korean Trial Shows Similar Disease-Free Survival With Laparoscopic vs Open Surgery in Mid- or Low-Rectal Cancer After Neoadjuvant Chemoradiotherapy
In the noninferiority COREAN trial reported in The Lancet Oncology, Jeong et al found that laparoscopic surgery was associated with disease-free survival similar to that with open surgery for mid- or low-rectal cancer.
Study Details
In this open-label trial, 340 patients with cT3N0–2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy at three centers in Korea were randomly assigned between April 2006 and August 2009 to receive laparoscopic (n = 170) or open surgery (n = 170). Randomization was stratified by sex and preoperative chemotherapy regimen. The primary endpoint was 3-year disease-free survival, with a noninferiority margin of 15%, in the intention-to-treat population.
The laparoscopic and open surgery groups were generally balanced for age (mean, 58 and 59 years), body mass index (≤ 25 kg/m2 in 63% and 62%), American Society of Anesthesiologists grade (I in 41% and 38%, II in 56% and 58%), carcinoembryonic antigen level (≤ 5 ng/mL in 92% and 91%), clinical classification (eg, cN+ in 65% and 69%), tumor distance from anal verge (eg, 3–6 cm in 39% and 35%, 6–9 cm in 41% and 38%), preoperative chemotherapy (eg, fluoropyrimidines alone in 92% in both, capecitabine, irinotecan, and cetuximab [Erbitux] in 6% and 8%), and postoperative chemotherapy (fluoropyrimidines alone in 88% in both, oxaliplatin-based in 6% and 8%).
With regard to surgical and pathologic data, the laparoscopic and open surgery groups were generally balanced for procedure (abdominoperitoneal resection in 11% and 14%, low anterior resection in 89% and 86%), tumor differentiation (well or moderately in 96% in both), circumferential resection margin (negative in 97% and 96%), and macroscopic quality of total mesorectal resection (complete or nearly complete in 92% ad 88%), but differences were observed in tumor regression grade scale (1 in 15% and 21%, 2 in 44% and 52%, 3 in 18% and 14%, 4 in 24% and 13%; P = .03), ypT classification (eg, ypT0/ypTis/ypT2 in 56% vs 42%; P = .01), and ypN classification (eg, ypN0 in 79% and 66%; P = .002).
Disease-Free Survival
No significant difference was observed between the open surgery and laparoscopic groups in 3-year disease-free survival (72.5% vs 79.2%, hazard ratio [HR] stratified by sex and preoperative chemotherapy = 1.23, P = .34). The difference was lower than the prespecified noninferiority margin (−6.7%, P < .0001). On multivariate analysis adjusting for the nonbalanced variables and factors significant on univariate analysis (ypT classification, ypN classification, and tumor regression grade scale), the hazard ratio for progression-free survival for open vs laparoscopic surgery was 0.98 (P = .94) There was no difference between groups in stage-specific analysis.
Overall Survival
Death occurred in 15% of patients in the open surgery group and in 12% in the laparoscopic group. No deaths were treatment-related. There were no differences between groups in 3-year overall survival (90.4% vs 91.7%, HR = 1.25, 95% confidence interval [CI] = 0.69–2.26) or local recurrence (4.9% vs 2.6%, HR = 2.47, 95% CI = 0.77–7.88).
The investigators concluded, “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.”
Jae Hwan Oh, MD, of the National Cancer Center, Goyang, is the corresponding author for The Lancet Oncology article.
The study was funded by the National Cancer Center, South Korea. The study authors reported no potential conflicts of interest.
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