Cervical cancer: minimally invasive surgery fails phase 3 LACC trial

  • Ramirez PT & al.
  • N Engl J Med
  • 31 Oct 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In patients with cervical cancer undergoing radical hysterectomy, minimally invasive surgery (MIS) was associated with a higher recurrence rate and shorter survival vs open surgery.
  • The study was closed because of a higher death rate with MIS.

Why this matters

  • MIS demonstrated similar survival and fewer complications vs open surgery in retrospective studies.
  • Current guidelines recommend either procedure despite insufficient data supporting MIS, which has led to its widespread use.

Study design

  • Phase 3 randomized Laparoscopic Approach to Cervical Cancer (LACC) Trial.
  • 631 (vs planned 740) patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer were randomly assigned to MIS (n=319) or open surgery (n=312).
  • Funding: University of Texas M.D. Anderson Cancer Center; Medtronic.

Key results

  • At 4.5 years, DFS was significantly lower with MIS vs open surgery (86.0% vs 96.5%; Pnoninferiority=.87).
  • In the MIS and open surgery groups, respectively:
    • 19 and 3 patients died.
    • 27 and 7 patients had recurrences.
  • MIS was associated with worse:
    • 3-year DFS (91.2% vs 97.1%; HR, 3.74; 95% CI, 1.63-8.58).
    • 3-year OS (93.8% vs 99.0%; HR, 6.00; 95% CI, 1.77-20.30).
    • 3-year cancer-specific mortality (4.4% vs 0.6%; HR, 6.56; 95% CI, 1.48-29.00).

Limitations

  • Trial stopped early because of higher rates of death in MIS group.

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