MarginProbe Significantly Reduces Re-Excision Rate in DCIS

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(ChemotherapyAdvisor) – Use of MarginProbe resulted in a significantly reduced re-excision rate in women with ductal carcinoma in situ (DCIS) treated with breast-conserving surgery, according to results of a study presentation at the 8th European Breast Cancer Conference, Vienna, Austria, on March 23.

By significantly reducing re-excision rate, infection rate may be lowered and a patient's cosmesis improved.

MarginProbe (Dune Medical Devices, Caesarea, Israel), a device that includes a disposable hand-held probe and a console, is based on radiofrequency spectroscopy, and is designed to detect differences in dielectric properties between normal and malignant breast tissue.

The multicenter, single arm, postmarket study was performed from September 2009 to May 2010 on 55 patients at three German sites. MarginProbe was used as an adjunctive tool to the current practice. All specimens were sent for paraffin-embedded pathological analysis. Procedure success was defined as both negative margins after initial breast-conserving surgery and early identification of an extended lesion, with conversion to mastectomy instead of performing a re-excision.

Of 39 patients available for analysis, use of MarginProbe led to a reduction in the re-excision rate by 54%, to 15% (P<0.01) (surgical margin width, 5mm) vs. a historical re-excision rate of 38.8% for this population. Procedure success depended on the definition of clean margin width: 5mm, 64%; 2mm, 77%; 1mm, 90%. Resected average main specimen tissue volume was 37cc. On average, tissue volume associated with false positive margins was 8.1cc per patient. “Due to the current discussions regarding margin width criteria, we also calculated re-excision rates using 2mm and 1mm margin widths. For this definition, re-excision rates were 13% and 7%, respectively,” the investigators noted.

Other presentations at EBCC-8 focused on the utility of MarginProbe:
· When standard of care postsurgical pathology, the MarginProbe system and intraoperative frozen section analysis (FSA) were compared, both MarginProbe and FDA were found to reduce repat surgery rates significantly.

· Adjunctive use of the MarginProbe system significantly improved surgical outcomes in 596 patients, reducing re-excisions by 57%.

· MarginProbe was found easy to incorporate in routine clinical practice and reduced the rate of repeat surgeries.

Abstract (Enter "Thill” in the author box to search for Abstract #506)

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