Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• Effectiveness in Identifying Residual Tumors: Pegulicianine fluorescence-guided surgery (pFGS) identified residual tumor in 27 out of 357 patients. Among these, 22 had negative cavity orientations based on standard margin evaluation, indicating that pFGS detected additional cancer not identified by standard methods. The sensitivity was 49.3% and specificity was 85.2%.
• Patient Population: The study included 392 patients with stage 0 to 3 breast cancer, comprising 316 with invasive cancer and 76 with in situ cancer. No specific differences in effectiveness outcomes were noted between these subgroups.
• Comparison to Standard Methods: Pegulicianine-guided surgery helped avoid second surgeries in 9 of 62 patients with positive margins, demonstrating its potential benefit over standard surgical approaches.
• Administration of pegulicianine was stopped in six patients due to adverse events, and two patients experienced grade 3 serious adverse events related to the drug.
• The study does not specify significant safety concerns or adverse effects in particular population subgroups.