Cervical/uterine cancer: green dye offers SLN mapping advantage

  • Frumovitz M & al.
  • Lancet Oncol
  • 21 Aug 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In women with cervical and uterine cancers, sentinel lymph node (SLN) mapping with indocyanine green dye and near-infrared imaging identified significantly more sentinel and bilateral sentinel nodes vs standard isosulfan blue dye with white light.

Why this matters

  • Indocyanine green with near-infrared imaging may become the new standard in SLN mapping.

Study design

  • FILM study: 180 patients with cervical/uterine cancers were randomly assigned to SLN mapping with either isosulfan blue dye (with near-infrared imaging) followed by indocyanine green dye (with white light) or indocyanine green (with near-infrared imaging) followed by isosulfan blue (with white light).
  • Funding: Novadaq.

Key results

  • Noninferiority analysis in per-protocol population (n=163; 485 sentinel nodes).
    • Mean number of nodes per patient, 3.2.
    • Indocyanine green identified significantly more SLNs (97% vs 47%; Pnoninferiority<.0001 vs blue dye.>
    • Indocyanine green identified ≥1 SLN (98% vs 76%; P<.0001 and bilateral sln class="">81% vs 32%; P<.0001 in more patients vs blue dye.>
  • Superiority analysis in modified intent-to-treat population (n=176; 545 sentinel nodes).
    • Mean number of nodes per patient, 3.1.
    • Indocyanine green identified significantly more SLNs (96% vs 46%; Psuperiority<.0001>
    • Indocyanine green identified ≥1 SLN (95% vs 74%; P<.0001 and bilateral sln vs p in more patients.>

Limitations

  • Sensitivity, negative predictive value not evaluated.

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