Near-Infrared Fluorescence With Indocyanine Green Dye vs Isosulfan Blue Dye for Detecting Sentinel Nodes in Gynecologic Cancers
In the phase III FILM study reported in The Lancet Oncology, Frumovitz et al found that near-infrared fluorescence imaging with indocyanine green dye identified more sentinel nodes vs isosulfan blue dye in women with clinical stage I endometrial or cervical cancer undergoing curative surgery. There was no difference in pathologic confirmation of nodal tissue between the two approaches.
Study Details
In the within-patient comparison study, 180 patients with clinical stage I endometrial or cervical cancer undergoing curative surgery were randomized between December 2015 and June 2017 to lymphatic mapping with isosulfan blue dye visualized by white light followed by indocyanine green visualized by near-infrared imaging, or vice-versa. The modified intent-to-treat population included 176 patients who underwent the intervention. The per-protocol population included 163 patients (with 13 patients excluded for protocol violations). The primary outcome was efficacy of intraoperative indocyanine green with near-infrared fluorescence imaging vs isosulfan blue dye in identifying lymph nodes.
Mapping Efficacy
In the per-protocol population, 517 sentinel nodes were identified, with 478 (92%) confirmed as lymph nodes on pathologic processing—219 (92%) of 238 nodes that were both blue and green, all 7 nodes that were blue only, and 252 (95%) of 265 that were green only (P = .33). Seven sentinel lymph nodes were not stained but were removed for suspicious appearance on visual examination. Overall, 471 (97%) of 485 lymph nodes were identified with the green dye and 226 (47%) with the blue dye (difference = 50%, P < .0001).
In the modified intention-to-treat population, 545 nodes were identified, with 513 (94%) confirmed as lymph nodes on pathologic processing—229 (92%) of 248 nodes that were both blue and green, all 9 nodes that were blue only, and 266 (95%) of 279 that were green only (P = .30). Nine sentinel lymph were not stained but were removed for suspicious appearance. Overall, 495 (96%) of 513 nodes were identified with the green dye and 238 (46%) with the blue dye (difference = 50%, P < .0001).
The investigators concluded, “Indocyanine green dye with near-infrared fluorescence imaging identified more sentinel nodes than isosulfan blue dye in women with cervical and uterine cancers, with no difference in the pathological confirmation of nodal tissue between the two mapping substances.”
They noted, “As lymphatic mapping and sentinel node biopsy become the standard of care in the surgical treatment of cervical and uterine cancers, improving sentinel node detection, particularly detection of bilateral sentinel nodes, will become the focus of research. As shown in this study, the incorporation of indocyanine green cervical injection and near-infrared imaging into the mapping procedure could represent an improvement over existing approaches (ie, blue dye, radiocolloid, or both) and might in the future become a standard method in these and other solid tumors.”
The study was funded by Novadaq.
Michael Frumovitz, MD, of the Department of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, is the corresponding author of The Lancet Oncology article.
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