As many as 40% of lumpectomies leave positive margins that necessitate a second surgery, but a novel fluorescent imaging agent used along with a direct visualization system may improve complete resection rates, new phase 3 findings show.
Local recurrence followingincreases the risk of dying from breast cancer, and the risk of local recurrence is directly linked to inadequate tumor removal during lumpectomy. In about 20% to 40% of lumpectomies, positive margins are identified after surgery.
To prevent surgeons from performing a smaller than standard lumpectomy in anticipation of using the pegulicianine fluorescence-guided system, patients were randomly assigned to the pegulicianine fluorescence-guided surgery group or the control group. The groups were revealed only after the surgeon completed the standard lumpectomy.
The agent produces a signal at sites of residual tumor, and a handheld probe illuminates the cavity during surgery. A tumor detection algorithm then analyzes and displays the images to the surgeon in real time — an overall process that adds about 7 minutes to the operative procedure, the authors say.
Overall, the authors say that pegulicianine fluorescence-guided surgery removed residual tumor or avoided second surgeries in 10% of patients in the trial. Serious adverse events included grade 3 hypersensitivity in one patient and an anaphylactic reaction in another. The other four adverse events included an allergic reaction, milder hypersensitivity, nausea, and pegulicianine extravasation. All adverse events resolved, and patients proceeded to standard lumpectomy.
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