Abstract
BACKGROUND: The benefits of breast conserving surgery for breast cancer patients are well established. To achieve adequate margins of excision, intraoperative management of breast margins is a critical factor through reducing reoperation for inadequate positive margin excision and associated morbidity and cost. Radiofrequency spectroscopy is a technology that could significantly reduce positive margins when used intraoperatively as an adjunct to other margin management methods. METHODS: A meta-analysis was completed with 10 publications comparing use of radiofrequency spectroscopy technology (MarginProbe) with standard margin assessment procedures. Three randomized controlled studies and seven retrospective studies comparing MarginProbe to historical controls were included. The primary endpoint was reduction of re-excision rates. Statistical significance level was set at the two-sided 5% level corresponding to two-sided 95% confidence intervals (CIs) of the pooled relative risk estimates. RESULTS: A total of 2335 patients from 10 publications were included in this meta-analysis. The overall relative reduction in re-excision rate was 0.49 (95% CI: 0.38-0.64, p < 0.001). Statistical methods were used to examine publication bias. CONCLUSION: Despite the limited randomized controlled trials available comparing radiofrequency spectroscopy to standard operation procedures, the data from the 10 studies demonstrate a statistically significant reduction in re-excision rate of 49% for MarginProbe usage, currently the only technology indicated for intraoperative identification of breast cancer tissue at the lumpectomy specimen margin.