LACC
Laparoscopic Approach to Cervical Cancer: minimally invasive versus abdominal radical hysterectomy for early-stage cervical cancer
N = 631NCT00614211
- Population
- Stage IA1 (with lymphovascular invasion), IA2 or IB1 squamous-cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
- Design
- Randomised trial of minimally invasive surgery (laparoscopic or robot-assisted) versus open abdominal radical hysterectomy. Primary outcome: disease-free survival at 4.5 years, with non-inferiority claimed if the lower boundary of the two-sided 95% CI of the between-group difference (minimally invasive minus open) was greater than -7.2 percentage points. 319 patients were assigned to minimally invasive surgery and 312 to open surgery; the registry lists 636.
- Primary endpoint
- DFS
- Arms
- Minimally invasive radical hysterectomy (experimental, n = 319): Laparoscopic (84.4% of those who underwent it) or robot-assisted (15.6%) radical hysterectomy
- Open abdominal radical hysterectomy (control, n = 312): Open abdominal radical hysterectomy
- People
- Ramirez PT
DFSHR 3.74 (95% CI 1.63–8.58)Δ 36-month DFS−5.9 pointsOSHR 6.00 (95% CI 1.77–20.30)Δ 36-month OS−5.2 pointsDFSHR 3.91 (95% CI 2.02–7.58)Δ 54-month DFS−11 points
Show the numbers
| Endpoint | Analysis | Minimally invasive radical hysterectomy | Open abdominal radical hysterectomy | Effect |
|---|---|---|---|---|
| DFSRandomised patients (319 minimally invasive, 312 open); the abstract does not name the analysis population | primaryRamirez 2018 | 91.2% at 3 y; 86% at 54 mo | 97.1% at 3 y; 96.5% at 54 mo | HR 3.74 (95% CI 1.63–8.58)Disease-free survival at 4.5 years was the primary outcome: 86.0% vs 96.5%, a difference of -10.6 percentage points (95% CI, -16.4 to -4.7) against a non-inferiority margin of -7.2. The hazard ratio is for disease recurrence or death from cervical cancer, minimally invasive versus open. |
| OSRandomised patients (319 minimally invasive, 312 open); the abstract does not name the analysis population | primaryRamirez 2018 | 93.8% at 3 y | 99% at 3 y | HR 6.00 (95% CI 1.77–20.30)Overall survival was reported as an association (3-year rates); hazard ratio is for death from any cause, minimally invasive versus open. |
| DFSEnrolled patients (631: 319 minimally invasive, 312 open); the abstract does not name the analysis population | long term-updateRamirez 2024 | 85% at 54 mo | 96% at 54 mo | HR 3.91 (95% CI 2.02–7.58)P<.001Final-analysis update in a Clinical Trial Update article. At 4.5 years the difference was -11.1 points (95% CI, -15.8 to -6.3; P = .95 for non-inferiority). |
| OSEnrolled patients (631: 319 minimally invasive, 312 open); the abstract does not name the analysis population | finalRamirez 2024 | 90.6% at 54 mo | 96.2% at 54 mo | HR 2.71 (95% CI 1.32–5.59)P=0.007Overall survival at 4.5 years; hazard ratio is for death from any cause, minimally invasive versus open. |
| Endpoint | Analysis | Minimally invasive radical hysterectomy | Open abdominal radical hysterectomy | Effect |
|---|---|---|---|---|
| DFSRandomised patients (319 minimally invasive, 312 open); the abstract does not name the analysis population | primaryRamirez 2018 | 91.2% at 3 y; 86% at 54 mo | 97.1% at 3 y; 96.5% at 54 mo | HR 3.74 (95% CI 1.63–8.58)Disease-free survival at 4.5 years was the primary outcome: 86.0% vs 96.5%, a difference of -10.6 percentage points (95% CI, -16.4 to -4.7) against a non-inferiority margin of -7.2. The hazard ratio is for disease recurrence or death from cervical cancer, minimally invasive versus open. |
| OSRandomised patients (319 minimally invasive, 312 open); the abstract does not name the analysis population | primaryRamirez 2018 | 93.8% at 3 y | 99% at 3 y | HR 6.00 (95% CI 1.77–20.30)Overall survival was reported as an association (3-year rates); hazard ratio is for death from any cause, minimally invasive versus open. |
| DFSEnrolled patients (631: 319 minimally invasive, 312 open); the abstract does not name the analysis population | long term-updateRamirez 2024 | 85% at 54 mo | 96% at 54 mo | HR 3.91 (95% CI 2.02–7.58)P<.001Final-analysis update in a Clinical Trial Update article. At 4.5 years the difference was -11.1 points (95% CI, -15.8 to -6.3; P = .95 for non-inferiority). |
| OSEnrolled patients (631: 319 minimally invasive, 312 open); the abstract does not name the analysis population | finalRamirez 2024 | 90.6% at 54 mo | 96.2% at 54 mo | HR 2.71 (95% CI 1.32–5.59)P=0.007Overall survival at 4.5 years; hazard ratio is for death from any cause, minimally invasive versus open. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 3.74 | 1.63–8.58 |
| OS | 6 | 1.77–20.3 |
| DFS | 3.91 | 2.02–7.58 |
| OS | 2.71 | 1.32–5.59 |
- Minimally invasive radical hysterectomy (experimental)
- Open abdominal radical hysterectomy (control)
Data table (modelled values)
| Months | Minimally invasive radical hysterectomy | Open abdominal radical hysterectomy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 15 | 96.4% | 98.7% |
| 29 | 93.0% | 97.6% |
| 44 | 88.9% | 96.8% |
| 58 | 86.0% | 96.5% |
Appears in
Sources
Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, et al. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018;379(20):1895-1904.
Ramirez PT, Robledo KP, Frumovitz M, Pareja R, Ribeiro R, Lopez A, et al. LACC Trial: Final Analysis on Overall Survival Comparing Open Versus Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer. J Clin Oncol. 2024;42(23):2741-2746.