LACE
Laparoscopic Approach to Cancer of the Endometrium (LACE): total laparoscopic versus total abdominal hysterectomy for stage I endometrioid endometrial cancer
Phase 3N = 760NCT00096408
- Population
- Women with treatment-naive stage I endometrioid endometrial cancer
- Design
- Multinational, randomised equivalence trial in which 27 surgeons from 20 tertiary gynaecological cancer centres in Australia, New Zealand and Hong Kong randomised 760 women with stage I endometrioid endometrial cancer between 7 October 2005 and 30 June 2010 to total laparoscopic hysterectomy (TLH, n = 407) or total abdominal hysterectomy (TAH, n = 353). The primary outcome was disease-free survival at 4.5 years after randomisation, with a prespecified equivalence margin of 7% or less. The trial had two stages: stage 1 compared quality of life up to 6 months after surgery (361 enrolled in the quality-of-life substudy, 332 analysed); stage 2 tested disease-free survival.
- Primary endpoint
- DFS
- Arms
- Total abdominal hysterectomy (control, n = 353): Total abdominal hysterectomy (TAH)
- Total laparoscopic hysterectomy (experimental, n = 407): Total laparoscopic hysterectomy (TLH)
- People
- Janda M
Δ 54-month DFS+0.3 pointsΔ Recurrence of endometrial cancer+0.2 pointsΔ All-cause mortality+0.6 pointsΔ Postoperative adverse events of grade 3 or higher−11.6 points
Show the numbers
| Endpoint | Analysis | Total laparoscopic hysterectomy | Total abdominal hysterectomy | Effect |
|---|---|---|---|---|
| DFSRandomised women (760); analysis population not stated in the abstractInterval between surgery and the date of first recurrence, including disease progression, or the development of a new primary cancer, or death, assessed at 4.5 years after randomisation | primarymedian follow-up 4.5 yearsJanda 2017 | 81.6% at 54 mo | 81.3% at 54 mo | P=.007Rate difference 0.3% favouring TLH (95% CI -5.5% to 6.1%); the P value is for equivalence against the prespecified 7% margin, which was met. 679 (89%) of 760 completed the trial. |
| Recurrence of endometrial cancerRandomised women (760); analysis population not stated in the abstract | primaryJanda 2017 | 8.1% | 7.9% | P=.9328/353 vs 33/407; risk difference 0.2% (95% CI -3.7% to 4.0%). Secondary outcome. |
| All-cause mortalityRandomised women (760); analysis population not stated in the abstract | primaryJanda 2017 | 7.4% | 6.8% | P=.7624/353 vs 30/407 deaths; the abstract reports these as overall survival, with risk difference 0.6% (95% CI -3.0% to 4.2%). Secondary outcome. |
| Postoperative adverse events of grade 3 or higherStage 1 quality-of-life substudy, intention to treat (332 analysed: 190 TLH, 142 TAH) | interimJanda 2010 | 11.6% | 23.2% | P=0.00433/142 vs 22/190. Intraoperative adverse events were similar (TAH 5.6%, TLH 7.4%; P = 0.53). |
| Endpoint | Analysis | Total laparoscopic hysterectomy | Total abdominal hysterectomy | Effect |
|---|---|---|---|---|
| DFSRandomised women (760); analysis population not stated in the abstractInterval between surgery and the date of first recurrence, including disease progression, or the development of a new primary cancer, or death, assessed at 4.5 years after randomisation | primarymedian follow-up 4.5 yearsJanda 2017 | 81.6% at 54 mo | 81.3% at 54 mo | P=.007Rate difference 0.3% favouring TLH (95% CI -5.5% to 6.1%); the P value is for equivalence against the prespecified 7% margin, which was met. 679 (89%) of 760 completed the trial. |
| Recurrence of endometrial cancerRandomised women (760); analysis population not stated in the abstract | primaryJanda 2017 | 8.1% | 7.9% | P=.9328/353 vs 33/407; risk difference 0.2% (95% CI -3.7% to 4.0%). Secondary outcome. |
| All-cause mortalityRandomised women (760); analysis population not stated in the abstract | primaryJanda 2017 | 7.4% | 6.8% | P=.7624/353 vs 30/407 deaths; the abstract reports these as overall survival, with risk difference 0.6% (95% CI -3.0% to 4.2%). Secondary outcome. |
| Postoperative adverse events of grade 3 or higherStage 1 quality-of-life substudy, intention to treat (332 analysed: 190 TLH, 142 TAH) | interimJanda 2010 | 11.6% | 23.2% | P=0.00433/142 vs 22/190. Intraoperative adverse events were similar (TAH 5.6%, TLH 7.4%; P = 0.53). |
Appears in
Sources
Janda M, Gebski V, Davies LC, Forder P, Brand A, Hogg R, et al. Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer: A Randomized Clinical Trial. JAMA. 2017;317(12):1224-1233.
Janda M, Gebski V, Brand A, Hogg R, Jobling TW, Land R, et al. Quality of life after total laparoscopic hysterectomy versus total abdominal hysterectomy for stage I endometrial cancer (LACE): a randomised trial. Lancet Oncol. 2010;11(8):772-80.