Diagnostic accuracy and surgical outcomes of fluorescence-guided surgery in breast cancer: a systematic review and meta-analysis.

BACKGROUND: Intraoperative evaluation of breast surgical margins is essential for reducing re-excision rates in lumpectomy patients. Fluorescence-guided surgery (FGS) has emerged as a promising technique to enhance intraoperative detection of cancer and optimize surgical outcomes. We performed a meta-analysis to assess the diagnostic accuracy of FGS and its effect on positive margin and reoperation rates. METHODS: A systematic search was conducted in PubMed, Embase, Web of Science, and the Cochrane Library for articles published from inception up to October 3, 2025. The primary outcome was diagnostic accuracy (sensitivity and specificity). Secondary outcomes included positive margin rates and reoperation rates, analyzed as mean differences derived from within-study comparisons of pre- and post-implementation data. Statistical analyses were performed using Stata 18.0 and R 4.4.2. RESULTS: 18 studies comprising 1283 patients were included. 11 studies evaluating diagnostic accuracy demonstrated a pooled sensitivity of 0.72 (95% CI: 0.62–0.81; I2 = 65.97%) and specificity of 0.75 (95% CI: 0.67–0.81; I2 = 93.96%), with a summary area under the curve (AUC) of 0.80 (95% CI: 0.76–0.83). Regarding surgical outcomes, the pooled positive margin rate was 14% (95% CI: 0.08–0.21; I2 = 53.5%) and the reoperation rate was 10% (95% CI: 0.05–0.16; I2 = 72.2%). FGS was associated with a 16% (95% CI: 0.09–0.23; I2 = 47.4%) absolute reduction in reoperations. Key limitations included significant heterogeneity across studies regarding fluorophores, imaging systems, tumor types, and the unit of analysis used. CONCLUSION: FGS demonstrates tangible clinical impact by moderately improving diagnostic accuracy and reducing both positive margin and reoperation rates. While the technique offers real-time visual feedback and a strong safety profile, standardizing operative protocols and validating tumor-specific probes are necessary to address current variations in practice and establish FGS as a mainstay in breast surgery.