OnCo
trialsTrialNegative

LACC (Laparoscopic Approach to Cervical Cancer)

Keyhole surgery, assumed equivalent, turned out to be worse: more recurrences and more deaths than open surgery, reversing practice overnight.

4.5-year disease-free survival 86.0% vs 96.5% and OS HR for death 6.00 with minimally invasive surgery (NEJM 2018); the final analysis (2024) confirmed inferiority. Guidelines now recommend open radical hysterectomy; tumour spillage from uterine manipulators and CO2 is the leading hypothesis. Trials of protective manoeuvres (RACC, ROCC) are ongoing.

Setting
Early-stage cervical cancer (IA1 with LVSI to IB1): minimally invasive vs open radical hysterectomy
Phase
Phase 3
Sponsor
MD Anderson
Registry
Headline result
4.5-year DFS 86.0% vs 96.5%; death HR 6.00 with MIS.
Reported
2018
Enrolled
631
Replication
Confirmed by the SEER/NCDB cohort (Melamed, NEJM 2018) and the SUCCOR European cohort.

Outcomes

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In plain words
What these results mean for people, not percentages
631 people took part
Disease-free survival at 4.5 yearsprimarysurrogate endpoint
  • 86 vs 96.5 out of 100 alive without the cancer coming back at 4.5 years with Minimally invasive compared with Open surgery; 10.5 fewer per 100.
  • On this measure the first group did worse, not better.
  • Put another way, the treated group had about 274 percent higher chance of the event at any given time (hazard ratio 3.74, likely range 1.63 to 8.58).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Early-stage cervical cancer (IA1 with LVSI to IB1): minimally invasive vs open radical hysterectomy. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

631 participants enrolled.

Disease-free survival at 4.5 yearsprimary
HR 3.74 (1.63–8.58)
Minimally invasive86 of 100
n = 319
Open surgery96.5 of 100
n = 312
Source
EndpointArmnValueHR (95% CI)pSource
Disease-free survival at 4.5 yearsprimaryMinimally invasive31986%3.74 (1.63–8.58)link
Open surgery31296.5%
Replication
Confirmed by the SEER/NCDB cohort (Melamed, NEJM 2018) and the SUCCOR European cohort.

Connected

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