TY - JOUR
T1 - A Single institution’s randomized double-armed prospective study of lumpectomy margins with adjunctive use of the MarginProbe in nonpalpable breast cancers
AU - Geha, Rula C.
AU - Taback, Brett
AU - Cadena, Lisa
AU - Borden, Billie
AU - Feldman, Sheldon
N1 - Funding Information:
Breast conservation surgery (BCS) is a widely used and preferred option for the management of early-stage breast cancers.1 BCS is less disfiguring than complete removal of the breast tissue as with mastectomy. Up to 75% of American women elect to have BCS and outcomes for BCS and radiation vs mastectomy are equivalent in terms of tumor control provided the surgical margins are clear.2-6 However, up to 30% of patients who underwent BCS prior to the 2014 SSO-ASTRO Consensus No Tumor on Ink Guideline required a second operation for positive margins on ex vivo pathology evaluation.7,8 The odds of having a re-excision for invasive cancer post Consensus Guideline are now reported as 1 in 5; however, an analysis of Medicare claims for over 291?000 lumpectomy patients found overall re-excision rates ranging from 0% to 91%.9,10 Studies have shown that local recurrence is significantly higher when positive margins are not excised.11 Additionally, recent research reports a 2-8-fold increase in local recurrence after re-excision for positive margins vs patients with clear margins in the initial lumpectomy surgery.12 Better margin assessment of lumpectomy specimens at initial surgery is needed to avoid re-excision procedures. The MarginProbe (Dune Medical Devices Ltd) was developed to provide real-time intraoperative assessment of lumpectomy margins. The device, used as an adjunct to Standard of Care, measures the local electrical properties (in the radiofrequency range) of breast tissue. These properties are dependent on membrane potential, nuclear morphology, and cellular connectivity and vascularity that differ between normal and malignant tissue.13 Per the manufacturer, the device's sensing diameter is 7?mm. The device provides a positive or negative reading for each measurement taken, with the threshold for a positive reading set based on measurements directly compared to pathology results. In previous studies, the diagnostic performance yielded 70%-100% sensitivity and 70%-87% specificity, depending on the cancer features and size. The performance was similar for all histologic types, including ductal carcinoma in situ and invasive lobular carcinoma. In a previous multicenter trial in which patients were randomized to usual surgical technique vs usual technique with adjunctive use of the MarginProbe, the rate of re-excision surgery was reduced by 56% in the device arm of the trial. There was no difference in cosmetic outcomes between usual surgical technique and usual surgical technique plus adjunctive use of the MarginProbe.13-15 Schnabel et al published a multicenter randomized prospective study of assessing lumpectomy margin using the MarginProbe in patients with nonpalpable breast cancers. The study reported a significant increase in identification of positive margins in the device arm at 62% vs 22% in the control arm. Of note, of 134 patients with positive margins identified and further excised, 30 (22%) resulted in disease extending to the new final margin. (MarginProbe is not used on shavings.) Including these patients with ?persistent positives,? the study reports a total re-excision rate of 19.8% in the device arm compared with 25.8% in the control arm (6% absolute, 23% relative reduction). The difference in tissue volume removed was not significant.16 Columbia University participated in this study. Upon examining out own data, we observed that we had a lower re-excision rate than that reported in the Schnabel et al study. We postulate that this is due to thicker shavings taken by our surgeon when a margin was deemed positive, resulting in fewer ?persistently positive? margins due to disease extending to new final margins.
PY - 2020/11
Y1 - 2020/11
N2 - Breast conservation surgery (BCS) aims to excise all cancerous tissue while minimizing the amount of healthy breast tissue removed. Up to 30% of patients undergoing BCS require a second operation for re-excision to obtain negative margins. Previous studies reported a lower re-excision rate with intraoperative use of the MarginProbe device (Dune Medical Devices). This device utilizes radiofrequency spectroscopy to detect differences between cancerous and normal tissue. From July 2009 to January 2010, our institution enrolled 46 patients electing for BCS in a prospective double-arm randomized controlled trial and had a significantly lower re-excision rate than that reported in the multicenter trial. Intraoperatively, after performing conventional lumpectomy with excision of any additional shavings deemed necessary based on palpation and visual inspection alone, patients were then randomized. In the device arm, the surgeon used the MarginProbe to interrogate the lumpectomy specimen, taking additional shavings from the cavity surfaces corresponding to the parts of the specimen read as positive by the device. In the control arm, only standard intraoperative assessments were performed. All specimens were evaluated by pathologists who were blinded to the study arm. In this population, 72% had invasive ductal carcinoma (IDC), 20% had ductal carcinoma in situ (DCIS), and 8% had invasive lobular carcinoma (ILC). Average age was 64 years old. The average size of the specimen was 5.6 cm, the average volume was 37.8 cm3, and the average weight was 32.7 g. The mean size of DCIS was 1.4 cm. For invasive specimens, 32 were T1 and 7 were T2. Prior to randomization, 43 patients were thought to have positive or close margins and therefore underwent additional shavings. Twenty-three patients were randomized to the device arm and 23 to the control arm. In the device arm, 14 (60%) patients had IDC, 7 (30%) had DCIS, and 2 (8%) had ILC, vs the control arm where 19 (82%) patients had IDC, 2 (8%) had DCIS, and 2 (8%) had ILC. Eight (35%) patients in the control group vs 1 (4%) in the device group underwent re-excision for margin involvement (P <.05). The use of the MarginProbe device at our institution significantly improved the ability of our surgeons to obtain clear margins during initial BCS. Our results show a lower re-excision rate (4%) than those published in the multicenter trial (19.8%). We postulate that in the face of more patients having DCIS in our device group (30%), our surgeons responded by taking thicker shavings when the MarginProbe device reported margin involvement during the initial lumpectomy, resulting in greater success achieving clear final margins on the shaved tissue and a significantly lower re-excision rate than previously reported with the MarginProbe device.
AB - Breast conservation surgery (BCS) aims to excise all cancerous tissue while minimizing the amount of healthy breast tissue removed. Up to 30% of patients undergoing BCS require a second operation for re-excision to obtain negative margins. Previous studies reported a lower re-excision rate with intraoperative use of the MarginProbe device (Dune Medical Devices). This device utilizes radiofrequency spectroscopy to detect differences between cancerous and normal tissue. From July 2009 to January 2010, our institution enrolled 46 patients electing for BCS in a prospective double-arm randomized controlled trial and had a significantly lower re-excision rate than that reported in the multicenter trial. Intraoperatively, after performing conventional lumpectomy with excision of any additional shavings deemed necessary based on palpation and visual inspection alone, patients were then randomized. In the device arm, the surgeon used the MarginProbe to interrogate the lumpectomy specimen, taking additional shavings from the cavity surfaces corresponding to the parts of the specimen read as positive by the device. In the control arm, only standard intraoperative assessments were performed. All specimens were evaluated by pathologists who were blinded to the study arm. In this population, 72% had invasive ductal carcinoma (IDC), 20% had ductal carcinoma in situ (DCIS), and 8% had invasive lobular carcinoma (ILC). Average age was 64 years old. The average size of the specimen was 5.6 cm, the average volume was 37.8 cm3, and the average weight was 32.7 g. The mean size of DCIS was 1.4 cm. For invasive specimens, 32 were T1 and 7 were T2. Prior to randomization, 43 patients were thought to have positive or close margins and therefore underwent additional shavings. Twenty-three patients were randomized to the device arm and 23 to the control arm. In the device arm, 14 (60%) patients had IDC, 7 (30%) had DCIS, and 2 (8%) had ILC, vs the control arm where 19 (82%) patients had IDC, 2 (8%) had DCIS, and 2 (8%) had ILC. Eight (35%) patients in the control group vs 1 (4%) in the device group underwent re-excision for margin involvement (P <.05). The use of the MarginProbe device at our institution significantly improved the ability of our surgeons to obtain clear margins during initial BCS. Our results show a lower re-excision rate (4%) than those published in the multicenter trial (19.8%). We postulate that in the face of more patients having DCIS in our device group (30%), our surgeons responded by taking thicker shavings when the MarginProbe device reported margin involvement during the initial lumpectomy, resulting in greater success achieving clear final margins on the shaved tissue and a significantly lower re-excision rate than previously reported with the MarginProbe device.
KW - MarginProbe
KW - breast cancer
KW - breast surgery
KW - intraoperative margin assessment
KW - margin thickness
UR - http://www.scopus.com/inward/record.url?scp=85089080653&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85089080653&partnerID=8YFLogxK
U2 - 10.1111/tbj.14004
DO - 10.1111/tbj.14004
M3 - Article
AN - SCOPUS:85089080653
VL - 26
SP - 2157
EP - 2162
JO - Breast Journal
JF - Breast Journal
SN - 1075-122X
IS - 11
ER -