COREAN
Needs reviewOpen versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial)
N = 340NCT00470951
- Population
- Patients with cT3N0-2M0 mid or low rectal cancer after preoperative chemoradiotherapy
- Design
- Open-label, non-inferiority randomised trial at three centres in Korea (April 2006 to August 2009). Patients aged 18 to 80 years with cT3N0-2M0 mid or low rectal cancer who had received preoperative chemoradiotherapy were randomised 1:1 to open or laparoscopic surgery, stratified by sex and preoperative chemotherapy regimen. Total mesorectal excision was done 6 to 8 weeks after chemoradiotherapy (50.5 Gy over 5.5 weeks); adjuvant chemotherapy for 4 months. Primary endpoint 3-year disease-free survival with a non-inferiority margin of 15%; analysis by intention to treat.
- Primary endpoint
- DFS
- Arms
- Open surgery (control, n = 170): Open total mesorectal excision after preoperative chemoradiotherapy
- Laparoscopic surgery (experimental, n = 170): Laparoscopic total mesorectal excision after preoperative chemoradiotherapy
- People
- Jeong SY, senior author Oh JH
Δ 36-month DFS+6.7 pointsΔ 120-month DFS+5 pointsΔ 120-month OS+2.7 pointsΔ 120-month Local recurrence after rectal surgery−5.5 points
Show the numbers
| Endpoint | Analysis | Laparoscopic surgery | Open surgery | Effect |
|---|---|---|---|---|
| DFS3-year disease-free survival (primary endpoint) | primaryJeong 2014 | 79.2% at 3 y (72.3–84.6%) | 72.5% at 3 y (65.0–78.6%) | P<0.0001Difference -6.7% (95% CI -15.8 to 2.4; p<0.0001), as printed in the abstract, which states that the difference was lower than the prespecified non-inferiority margin of 15%. The printed difference equals the open-arm value minus the laparoscopic-arm value (72.5 - 79.2), so the interval is in the open-minus-laparoscopic direction; in laparoscopic-minus-open terms it is +6.7 (-2.4 to 15.8), whose lower limit is far from a 15 point margin (arithmetic on the printed numbers; the Methods text on the test was not readable). The abstract's interpretation: similar disease-free survival. 25 (15%) open and 20 (12%) laparoscopic patients had died; no deaths were treatment related. |
| DFSModified intention-to-treat population (randomised participants who provided follow-up data; two laparoscopic-group patients lost to follow-up were not included)10-year disease-free survival | long term-updatemedian follow-up 143 monthsPark 2021 | 64.3% at 10 y (56.0–71.5%) | 59.3% at 10 y (51.1–66.5%) | P=0.20Median follow-up 143 months (IQR 122 to 156). Stratified hazard ratio for open versus laparoscopic surgery, adjusted for ypT, ypN and tumour regression grade: 1.05 (95% CI 0.74 to 1.49). |
| OSModified intention-to-treat population (randomised participants who provided follow-up data)10-year overall survival | long term-updatemedian follow-up 143 monthsPark 2021 | 76.8% at 10 y (69.6–82.5%) | 74.1% at 10 y (66.8–80.0%) | P=0.44Stratified hazard ratio for open versus laparoscopic surgery, adjusted for ypT, ypN and tumour regression grade: 0.94 (95% CI 0.63 to 1.43). |
| Local recurrence after rectal surgeryModified intention-to-treat population (randomised participants who provided follow-up data)10-year local recurrence | long term-updatemedian follow-up 143 monthsPark 2021 | 3.4% at 10 y (1.4–7.9%) | 8.9% at 10 y (5.2–15.0%) | P=0.050Stratified hazard ratio for open versus laparoscopic surgery, adjusted for ypT, ypN and tumour regression grade: 2.22 (95% CI 0.78 to 6.34). |
| Endpoint | Analysis | Laparoscopic surgery | Open surgery | Effect |
|---|---|---|---|---|
| DFS3-year disease-free survival (primary endpoint) | primaryJeong 2014 | 79.2% at 3 y (72.3–84.6%) | 72.5% at 3 y (65.0–78.6%) | P<0.0001Difference -6.7% (95% CI -15.8 to 2.4; p<0.0001), as printed in the abstract, which states that the difference was lower than the prespecified non-inferiority margin of 15%. The printed difference equals the open-arm value minus the laparoscopic-arm value (72.5 - 79.2), so the interval is in the open-minus-laparoscopic direction; in laparoscopic-minus-open terms it is +6.7 (-2.4 to 15.8), whose lower limit is far from a 15 point margin (arithmetic on the printed numbers; the Methods text on the test was not readable). The abstract's interpretation: similar disease-free survival. 25 (15%) open and 20 (12%) laparoscopic patients had died; no deaths were treatment related. |
| DFSModified intention-to-treat population (randomised participants who provided follow-up data; two laparoscopic-group patients lost to follow-up were not included)10-year disease-free survival | long term-updatemedian follow-up 143 monthsPark 2021 | 64.3% at 10 y (56.0–71.5%) | 59.3% at 10 y (51.1–66.5%) | P=0.20Median follow-up 143 months (IQR 122 to 156). Stratified hazard ratio for open versus laparoscopic surgery, adjusted for ypT, ypN and tumour regression grade: 1.05 (95% CI 0.74 to 1.49). |
| OSModified intention-to-treat population (randomised participants who provided follow-up data)10-year overall survival | long term-updatemedian follow-up 143 monthsPark 2021 | 76.8% at 10 y (69.6–82.5%) | 74.1% at 10 y (66.8–80.0%) | P=0.44Stratified hazard ratio for open versus laparoscopic surgery, adjusted for ypT, ypN and tumour regression grade: 0.94 (95% CI 0.63 to 1.43). |
| Local recurrence after rectal surgeryModified intention-to-treat population (randomised participants who provided follow-up data)10-year local recurrence | long term-updatemedian follow-up 143 monthsPark 2021 | 3.4% at 10 y (1.4–7.9%) | 8.9% at 10 y (5.2–15.0%) | P=0.050Stratified hazard ratio for open versus laparoscopic surgery, adjusted for ypT, ypN and tumour regression grade: 2.22 (95% CI 0.78 to 6.34). |
Appears in
Sources
Jeong SY, Park JW, Nam BH, Kim S, Kang SB, Lim SB, et al. 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. Lancet Oncol. 2014;15(7):767-74.
Park JW, Kang SB, Hao J, Lim SB, Choi HS, Kim DW, et al. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): 10-year follow-up of an open-label, non-inferiority, randomised controlled trial. Lancet Gastroenterol Hepatol. 2021;6(7):569-577.