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Abstract
Historically there has been a high rate of surgical interventions to obtain clear margins for breast cancer patients undergoing breast conserving local therapy. An intraoperative margin assessment tool (MarginProbe) has been approved for use in the US since 2013. This study is the first compilation of data from routine use of the device, to assess the impact of device utilization on re-excision rates. We present a retrospective, observational, review from groups of consecutive patients, before and after the implementation of intraoperative use of the device during lumpectomy procedures. Lesions were localized by standard methods. The intraoperative margin assessment device was used on all circumferential margins of the main specimen, but not on any additional shavings. A positive reading by the device led to an additional shaving of the corresponding cavity location. Specimens were also, when feasible, imaged intra-operatively by X-ray, and additional shavings were taken if needed based on clinical assessment. For each surgeon, historical re-excision rates were established based on a consecutive set of patients from a time period proximal to initiation of use of the device. From March 2013 to April 2014 the device was routinely used by 4 surgeons in 3 centers. In total, 165 cases lumpectomy cases were performed. Positive margins resulted in additional re-excision procedures in 9.7% (16/165) of the cases. The corresponding historical set from 2012 and 2013 consisted of 186 Lumpectomy cases, in which additional re-excision procedures were performed in 25.8% (48/186) of the cases. The reduction in the rate of re-excision procedures was significant 62% (P < 0.0001). Use of an intraoperative margin assessment device contributes to achieving clear margins and reducing re-excision procedures. As in some cases positive margins were found on shavings, future studies of interest may include an analysis of the effect of using the device on the shavings intra-operatively.
Highlights
Breast conservation surgery followed by radiation is the recommended treatment (National Institute of Health 2014) for most early stage (I & II) breast cancer
This treatment approach has been shown to be equivalent to treatment by mastectomy (Veronesi et al 2002; Fisher et al 2002)
The device has been evaluated in several multicenter trials, see review in (Thill et al 2013), where patients were randomized to standard of care techniques for margin evaluation versus standard of care with additional use of MP
Summary
In the US a breast conserving approach amounts to 60-75% of the procedures for treatment of early stage breast cancer (Katipamula et al 2009; Cancer Trends Progress Report – 2011). The device has been evaluated in several multicenter trials, see review in (Thill et al 2013), where patients were randomized to standard of care techniques for margin evaluation versus standard of care with additional (adjunctive) use of MP. These studies have shown that adjunctive use of MP leads to a > 50% reduction in the rate of re-excision procedures. MP has been approved for use in the US since the beginning of 2013
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