Conference Coverage

VIDEO: Indocyanine green finds more sentinel lymph nodes

 

Key clinical point: Indocyanine green surpassed isosulfan blue for sentinel lymph node mapping in a pivotal trial.

Major finding: Researchers mapped sentinel lymph nodes in 96% of patients with indocyanine green and in 74% with isosulfan blue.

Study details: FILM, a multicenter, randomized phase 3 trial with 176 patients.

Disclosures: FILM was sponsored by Novadaq/Stryker, the company developing the ICG PINPOINT imaging system. Dr. Frumovitz has been a consultant to Novadaq/Stryker and Genentech and has received research funding from Novadaq/Stryker and Navidea. Dr. Backes has been a consultant to Tesaro and has received research funding from Clovis, Eisai, and ImmunoGen. Dr. Buda had no disclosures.

Source: Frumovitz MM. SGO 2018, Abstract 12. Backes FJ. SGO 2018, Abstract 13.

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Evidence favoring indocyanine green changes practice

The results from the FILM trial are potentially practice changing. The findings presented by Michael M. Frumovitz, MD, and his associates showed that indocyanine green is superior to isosulfan blue dye for mapping sentinel lymph nodes in patients with stage I endometrial or cervical cancer. The results also showed that using both dyes was no better than using indocyanine green alone.

Dr. Brent Smith

Dr. Brent Smith

Mapping sentinel lymph nodes using indocyanine green requires a near-infrared fluorescence imaging camera to detect labeled lymph nodes. This equipment is already in place at many U.S. cancer centers, and after this approach receives Food and Drug Administration approval, the necessary equipment will likely be acquired by many additional centers, which thereby will allow many more patients to have access to the benefits of this technology.

The report by Floor J. Backes, MD, addressed an important and still unresolved question in treating patients with stage I or II endometrial cancer: What is the significance of finding isolated tumor cells in sentinel lymph nodes in these patients? The retrospective findings she presented showed that the presence of isolated tumor cells had no apparent effect on recurrence-free survival, recurrence pattern, or patient response to various treatments. This suggested th at treatment decisions in these patients should depend on other high-risk uterine factors but not on whether some lymph nodes contained isolated tumor cells.

Brent Smith, MD , is a gynecologic oncologist at the Ohio State University, Columbus. He had no disclosures. Dr. Smith made these comments in a video interview.


 

REPORTING FROM SGO 2018

Limelight Video

– Indocyanine green (ICG) worked better than isosulfan blue for mapping sentinel lymph nodes (SLNs) in a pivotal phase 3 trial with 176 patients who had stage I endometrial or cervical cancer.

Four injections of ICG resulted in detection of 96% of the identified SLNs in these patients, including bilateral SLNs in 78% of the patients. In contrast, four injections with isosulfan blue dye led to detection of 74% of all SLNs and identified bilateral SLNs in 31% of the patients, Michael M. Frumovitz, MD, said at the annual meeting of the Society for Gynecologic Oncology.

Mitchel L. Zoler/MDedge News

Dr. Michael M. Frumovitz

These findings should result in Food and Drug Administration approval for using indocyanine green plus the near-infrared camera system tested in the study (the PINPOINT system) on these types of patients, said Dr. Frumovitz, a professor of gynecologic oncology and reproductive medicine at the University of Texas MD Anderson Cancer Center in Houston; he noted that the developing company has already submitted the data to the agency. He attributed the superior performance of the ICG-based system to easier detection of the dye once it reaches SLNs.

The FILM trial randomized 176 patients with stage I endometrial or cervical cancer at eight centers in the United States or Canada between December 2015 and May 2017. Patients first received one of the tagging agents and then the second, and then underwent mapping using white light to detect blue-tagged SLNs and near-infrared light to find green-tagged SLNs. The patients were aged 63 years on average, and 96% had endometrial cancer.

The researchers identified 279 sentinel lymph nodes that stained only green, nine SLNs that stained only blue, and 248 SLNs tagged with both dyes. They confirmed tumor cells within all nine of SLNs tagged with blue dye only, in 95% of those tagged with ICG only, and in 92% of the SLNs stained with both dyes. The isosulfan blue dye identified SLNs in two patients who did not have any SLNs detected by the ICG, whereas the ICG identified SLNs in 22 patients who did not have any SLNs detected using the blue dye. Sixteen patients had metastatic disease that had moved to 21 SLNs. The ICG system identified all 21 involved lymph nodes; the blue dye identified 13 of the 21 affected SLNs (62%).


Dr. Frumovitz and his associates designed FILM as primarily a test of noninferiority. The per-protocol analysis with 163 patients showed that ICG was noninferior to isosulfan blue (P less than .001). Once the results demonstrated noninferiority, the study protocol allowed the researchers to test for superiority in the full, intention-to-treat cohort of 176 patients. The results showed that ICG was significantly superior to isosulfan blue (P less than .001). In addition, ICG treatment produced no allergic or other adverse reactions, Dr. Frumovitz said.

Once ICG and the associated near-infrared detection camera receive FDA marketing approval, “I think this will become the standard within 5 years,” he predicted in an interview.

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