Purpose: A positive margin status after breast conserving surgery (BCS) is one of the strongest predictors for local recurrence of intraductal (DCIS) and invasive carcinoma. As much as 20-50 % of patients with BCS need to undergo a second operation to receive free margins. In this study we tested the clinical performance of MarginProbe© (Dune Medical Devices, Paoli, PA, USA), a device for the intraoperative evaluation of surgical margins.
Methods: A prospective clinical study was performed: The device was utilized in BCS of 150 patients treated at a single facility from November 2012 to June 2013. The re-excision rate was compared to the re-excision rate of a historical group of 172 patients treated with BCS at the same hospital without the application of the device. We analyzed whether the results of MarginProbe© are affected by the morphology, grading, size of the tumor, breast density, age, BMI or the use of marker-wires.
Results: The application of MarginProbe© resulted in an overall decreased re-excision rate of 14.6 %. In the subgroup of DCIS the re-excision rate was reduced from 61.7 to 23.1 %. In the subgroup of invasive lobular carcinomas the re-excision rate decreased from 37.0 to 19.0 %. MarginProbe© results were not affected by grading, tumor size, breast density, age, BMI or marker-wire application.
Conclusion: MarginProbe© detects positive margins in invasive carcinoma, DCIS as well as in invasive lobular carcinoma. The device decreases the re-excision rate after BCS significantly. It does not interfere with any of the factors we examined.
Keywords: Breast conserving therapy; Free-margins breast cancer; MarginProbe©; Re-excision rate breast cancer.