LASRE
Laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): 3-year survival outcomes of a multicentre, randomised, controlled, non-inferiority trial
N = 1,070NCT01899547
- Population
- Individuals aged 18 to 75 years with cT1-2N0, cT3-4aN0 or cT1-4aN1-2 rectal adenocarcinoma within 5 cm of the dentate line
- Design
- Multicentre, randomised, controlled, non-inferiority trial at 22 tertiary hospitals in China (November 2013 to June 2018). Individuals aged 18 to 75 years with histologically confirmed cT1-2N0, cT3-4aN0 or cT1-4aN1-2 rectal adenocarcinoma within 5 cm of the dentate line were randomised 2:1 to laparoscopic or open surgery; 1070 were randomised and 1039 were in the modified intention-to-treat analysis. Primary outcome 3-year disease-free survival; non-inferiority was a lower limit of the one-sided 97.5% CI for the group difference (laparoscopic minus open) greater than -10%. Not masked.
- Primary endpoint
- DFS
- Arms
- Open surgery (control): Open surgery for low rectal cancer
- Laparoscopy-assisted surgery (experimental): Laparoscopy-assisted surgery for low rectal cancer
- People
- Jiang W, LASRE trial investigators
Δ 36-month DFS+1.6 pointsΔ 36-month OS−2 pointsΔ 36-month Locoregional recurrence after rectal surgery+1.4 points
Show the numbers
| Endpoint | Analysis | Laparoscopy-assisted surgery | Open surgery | Effect |
|---|---|---|---|---|
| DFSModified intention-to-treat population (685 laparoscopic, 354 open); excludes patients with distant metastasis found at surgery and those who did not undergo surgery or had local resection only3-year disease-free survival, from surgery to locoregional recurrence, distant metastasis or death from any cause (primary outcome) | primaryJiang 2025 | 81.4% at 3 y (78.2–84.1%) | 79.8% at 3 y (75.2–83.6%) | P=0.56Hazard ratio 0.92 (95% CI 0.69 to 1.23; the abstract does not label the direction, which is consistent with laparoscopic relative to open because laparoscopic DFS is higher); p=0.56 refers to the hazard ratio. Difference between groups (laparoscopic minus open) 1.60% (one-sided 97.5% CI -3.34 to infinity); p<0.0001 for non-inferiority against a margin of -10%. |
| OSModified intention-to-treat population (685 laparoscopic, 354 open)3-year overall survival (secondary outcome) | primaryJiang 2025 | 91.7% at 3 y (89.3–93.5%) | 93.7% at 3 y (90.6–95.8%) | P=0.24Hazard ratio 1.34 (95% CI 0.82 to 2.19); the abstract does not label the direction, which is consistent with laparoscopic relative to open because laparoscopic OS is lower. |
| Locoregional recurrence after rectal surgeryModified intention-to-treat population (685 laparoscopic, 354 open)3-year locoregional recurrence (secondary outcome) | primaryJiang 2025 | 3.7% at 3 y (2.5–5.3%) | 2.3% at 3 y (1.1–4.3%) | P=0.22Hazard ratio 1.64 (95% CI 0.74 to 3.63); the abstract does not label the direction, which is consistent with laparoscopic relative to open because laparoscopic locoregional recurrence is higher. |
| Endpoint | Analysis | Laparoscopy-assisted surgery | Open surgery | Effect |
|---|---|---|---|---|
| DFSModified intention-to-treat population (685 laparoscopic, 354 open); excludes patients with distant metastasis found at surgery and those who did not undergo surgery or had local resection only3-year disease-free survival, from surgery to locoregional recurrence, distant metastasis or death from any cause (primary outcome) | primaryJiang 2025 | 81.4% at 3 y (78.2–84.1%) | 79.8% at 3 y (75.2–83.6%) | P=0.56Hazard ratio 0.92 (95% CI 0.69 to 1.23; the abstract does not label the direction, which is consistent with laparoscopic relative to open because laparoscopic DFS is higher); p=0.56 refers to the hazard ratio. Difference between groups (laparoscopic minus open) 1.60% (one-sided 97.5% CI -3.34 to infinity); p<0.0001 for non-inferiority against a margin of -10%. |
| OSModified intention-to-treat population (685 laparoscopic, 354 open)3-year overall survival (secondary outcome) | primaryJiang 2025 | 91.7% at 3 y (89.3–93.5%) | 93.7% at 3 y (90.6–95.8%) | P=0.24Hazard ratio 1.34 (95% CI 0.82 to 2.19); the abstract does not label the direction, which is consistent with laparoscopic relative to open because laparoscopic OS is lower. |
| Locoregional recurrence after rectal surgeryModified intention-to-treat population (685 laparoscopic, 354 open)3-year locoregional recurrence (secondary outcome) | primaryJiang 2025 | 3.7% at 3 y (2.5–5.3%) | 2.3% at 3 y (1.1–4.3%) | P=0.22Hazard ratio 1.64 (95% CI 0.74 to 3.63); the abstract does not label the direction, which is consistent with laparoscopic relative to open because laparoscopic locoregional recurrence is higher. |