Laparoscopic versus open surgery for rectal cancer: individual patient data meta-analysis of the ALaCaRT and Z6051 randomized trials
Phase meta-analysisN = 935
- Population
- Individual patient data from the 935 patients included from ALaCaRT and ACOSOG Z6051 (cT1-3 N0-2 M0 rectal adenocarcinoma per the abstract; the full text also lists M1 patients in ALaCaRT)
- Design
- Planned prospective individual patient data meta-analysis of the ALaCaRT and ACOSOG Z6051 trials (patients with cT1-3 N0-2 M0 rectal adenocarcinoma): combined data set of 935 patients allocated to open (457) or laparoscopic (478) proctectomy (ALaCaRT 473 of 475 randomised and Z6051 462 of 486 included). Pathologically successful resection was defined as complete or near-complete total mesorectal excision, a clear circumferential resection margin (more than 1 mm) and a clear distal margin (more than 1 mm). The non-inferiority margin for disease-free survival was an absolute difference of 5% at least 3 years after surgery. The analysis was not specifically powered for survival endpoints.
- Arms
- Open proctectomy (control, n = 457): Open proctectomy
- Laparoscopic proctectomy (experimental, n = 478): Laparoscopic proctectomy
- People
- Brown KGM, senior author Simes J
Δ Successful resection (pathological composite)−4.8 pointsΔ 36-month DFS−1.3 pointsΔ 36-month Locoregional recurrence after rectal surgery+3.4 points
Show the numbers
| Endpoint | Analysis | Laparoscopic proctectomy | Open proctectomy | Effect |
|---|---|---|---|---|
| Successful resection (pathological composite)Combined data set of 935 patients (ALaCaRT and Z6051), allocated to open or laparoscopic proctectomyPathologically successful resection: complete or near-complete total mesorectal excision, clear circumferential margin and clear distal margin | finalBrown 2026 | 85.1% | 89.9% | Pooled estimate 4.6% difference favouring open surgery (95% CI -8.6% to -0.5%, laparoscopic minus open): the Results text states it as favouring open surgery and the abstract prints the point estimate without a sign. Counts 407 (85.1%) vs 411 (89.9%); odds ratio 0.645 (95% CI 0.434 to 0.960; P = 0.031) adjusted for trial. |
| DFSCombined data set of 935 patients less the 23 ALaCaRT patients with metastatic disease at baseline, who were excluded from the DFS and OS analyses (full text)3-year disease-free survival | finalmedian follow-up 60.2 monthsBrown 2026 | 75.2% at 3 y (71.1–79.2%) | 76.5% at 3 y (72.5–80.6%) | Pooled difference -1.5% (95% CI -7.2% to 4.2%). Non-inferiority of laparoscopic surgery was not demonstrated because the lower one-sided 95% CI (-6.3% to 100%) crossed -5%. Median follow-up 60.2 months (IQR 49.9 to 61.1). |
| Locoregional recurrence after rectal surgeryCombined data set of 935 patients; the full text excludes the 23 ALaCaRT patients with metastatic disease from the DFS and OS analyses and does not say whether they were also excluded from this competing-risk analysis3-year locoregional recurrence | finalmedian follow-up 60.2 monthsBrown 2026 | 5.4% at 3 y (3.3–7.5%) | 2% at 3 y (0.7–3.4%) | Pooled estimate 3.1% difference (95% CI 0.6% to 5.6%). |
| Endpoint | Analysis | Laparoscopic proctectomy | Open proctectomy | Effect |
|---|---|---|---|---|
| Successful resection (pathological composite)Combined data set of 935 patients (ALaCaRT and Z6051), allocated to open or laparoscopic proctectomyPathologically successful resection: complete or near-complete total mesorectal excision, clear circumferential margin and clear distal margin | finalBrown 2026 | 85.1% | 89.9% | Pooled estimate 4.6% difference favouring open surgery (95% CI -8.6% to -0.5%, laparoscopic minus open): the Results text states it as favouring open surgery and the abstract prints the point estimate without a sign. Counts 407 (85.1%) vs 411 (89.9%); odds ratio 0.645 (95% CI 0.434 to 0.960; P = 0.031) adjusted for trial. |
| DFSCombined data set of 935 patients less the 23 ALaCaRT patients with metastatic disease at baseline, who were excluded from the DFS and OS analyses (full text)3-year disease-free survival | finalmedian follow-up 60.2 monthsBrown 2026 | 75.2% at 3 y (71.1–79.2%) | 76.5% at 3 y (72.5–80.6%) | Pooled difference -1.5% (95% CI -7.2% to 4.2%). Non-inferiority of laparoscopic surgery was not demonstrated because the lower one-sided 95% CI (-6.3% to 100%) crossed -5%. Median follow-up 60.2 months (IQR 49.9 to 61.1). |
| Locoregional recurrence after rectal surgeryCombined data set of 935 patients; the full text excludes the 23 ALaCaRT patients with metastatic disease from the DFS and OS analyses and does not say whether they were also excluded from this competing-risk analysis3-year locoregional recurrence | finalmedian follow-up 60.2 monthsBrown 2026 | 5.4% at 3 y (3.3–7.5%) | 2% at 3 y (0.7–3.4%) | Pooled estimate 3.1% difference (95% CI 0.6% to 5.6%). |