SAVI SCOUT® localization of metastatic axillary lymph node prior to neoadjuvant chemotherapy for targeted axillary dissection: a pilot study.

PURPOSE: In clinically node-positive breast cancer, axillary staging after neoadjuvant chemotherapy (NAC) is optimized with targeted axillary dissection (TAD), which includes removal of the biopsy-proven metastatic lymph node (LN) in addition to sentinel lymph nodes (SLN). Localization of the clipped node is currently performed post-NAC; however, technical limitations can make detection and localization of the treated LN challenging. We prospectively evaluated the feasibility of localizing the metastatic LN with a SAVI SCOUT® reflector (SAVI) prior to NAC for targeted removal at surgery. METHODS: Twenty-five patients with stage 2/3 breast cancer underwent ultrasound-guided localization of the biopsy-proven LN with SAVI prior to NAC. After NAC, patients with clinical response underwent TAD. Primary outcome measures were rate of successful localization, days between insertion of SAVI and axillary surgery, frequency of retrieval of clipped node, and frequency of SAVI-LN as SLN. RESULTS: After NAC, 23/25 (92%) had clinical axillary down-staging and underwent TAD. Two patients with persistent palpable axillary disease underwent ALND for initial staging. Axillary surgery was performed at an average of 141 days post-SAVI insertion and the SAVI was successfully retrieved in all cases. Among 23 patients undergoing TAD, the SAVI was retrieved within a LN in all patients, whereas clip migration was observed in two patients. The median SLN removed was 4, and SAVI-LN was SLN in 22/23 patients. Axillary pCR rate was 44%. CONCLUSION: Localizing a metastatic LN with SAVI reflector prior to NAC for targeted removal at surgery is feasible and may provide technical and logistical advantages over axillary localization post-NAC. CLINICAL TRIAL REGISTRY: Clinical trials.gov identifier: NCT03411070.

A comparison of two non-radioactive alternatives to wire for the localization of non-palpable breast cancers.

PURPOSE: Multiple wire-free technologies for localization of non-palpable breast cancers have emerged as satisfactory alternatives to wire. However, no study has compared two non-radioactive wire-free approaches to one another. The purpose of this study was to compare outcomes among LOCalizer™ radiofrequency identification (RFID), SAVI Scout® (SAVI), and wire localization (WL). METHODS: This was a retrospective, cross-sectional cohort study of patients undergoing lumpectomy for non-palpable breast cancer at a single institution between August 2017 and February 2019. Patients were divided into three cohorts based on localization technique: RFID, SAVI or WL. Operative times and average tumor volumes were compared using one-way analysis of variance. Positive margin and re-excision rates were compared with Fisher's exact test. RESULTS: Among 104 patients who underwent lumpectomy for non-palpable breast cancer, 33 patients (31.7%) had RFID, 21 (20.2%) had SAVI, and 50 (48.0%) had WL. Operative times were 79 min for RFID, 81 min for SAVI, and 78 min for WL (p = 0.91). Volume of tissue resected was 36.3 cm3, 31.7 cm3, and 35.3 cm3 for RFID, SAVI, and WL, respectively (p = 0.84). Positive margin rates (RFID 3.0% vs SAVI 9.5% vs WL 8.0%, p = 0.67) and re-excision rates (RFID 6.1% vs SAVI 9.5% vs WL 10.0%, p = 0.82) were similar across groups. CONCLUSIONS: Wire-free localization technologies have been compared to WL demonstrating similar efficacy. Our study suggests that RFID and SAVI Scout also perform similarly to one another. Physicians and institutions may consider more nuanced features of each localization system rather than performance alone when choosing a wire-free alternative.

Microchipping the breast: an effective new technology for localizing non-palpable breast lesions for surgery.

PURPOSE: Use of a wire to localize a non-palpable breast lesion for surgery is standard but archaic. We sought to evaluate a new radiofrequency localization system (RFLS) as an effective, non-radioactive alternative to the wire. METHODS: Patients who required surgical excision of a non-palpable breast lesion were consented for the study. Patients underwent localization with a radiofrequency Tag and surgical removal guided by the handheld LOCalizer probe. The primary study endpoint was successful placement and retrieval of the Tag, and secondary endpoints included marker migration; days prior to surgery of Tag insertion; patient, radiologist, and surgeon experience; distance of Tag from skin; and positive margin and re-excision rates for cancer. RESULTS: Fifty patients had successful placement and retrieval of the radiofrequency Tag. Likert questionnaire data revealed that most patients thought the procedure went smoothly and was easier than expected. Radiologists and surgeons thought that the Tag was as reliable as the wire. Of the 33 patients who had surgery for in situ or invasive cancer, one had a positive margin on final pathology (3%) and two underwent re-excision (6%). CONCLUSIONS: Data from this pilot study suggest that the RFLS is an effective localization system for non-palpable breast lesions intended for surgical removal. Unlike most other technologies, the LOCalizer probe detects distance from the Tag, and this unique feature may have contributed to the low positive margin rate seen in this study. The RFLS appears to offer advantages over current localization procedures and should be explored as an alternative to wire. ClinicalTrials.gov Identifier: NCT03202472.

Assessing the Effect of Lifetime Contralateral Breast Cancer Risk on the Selection of Contralateral Prophylactic Mastectomy for Unilateral Breast Cancer.

INTRODUCTION: Contralateral prophylactic mastectomy (CPM) rates are rising, with fear implicated as a contributing factor. This study used a contralateral breast cancer (CBC) risk stratification tool to assess whether the selection of CPM is reflective of future CBC risk. PATIENTS AND METHODS: This retrospective study evaluated 404 women with unilateral breast cancer treated with breast conservation, unilateral mastectomy, or bilateral mastectomy within a single multidisciplinary clinic. Women were evaluated by the Manchester risk tool to calculate lifetime CBC risk. Logistic regression analysis was used to evaluate whether CBC risk was associated with CPM, and the clinical rationale for prophylactic mastectomy justification was recorded. RESULTS: Sixty-two percent underwent breast conservation, 18% unilateral mastectomy, and 20% bilateral mastectomy. In the CPM cohort, 36% had > 20% calculated lifetime CBC risk. In the invasive cohort, younger age (odds ratio 2.65, P < .0001) and genetic mutation positivity (odds ratio 35.39, P = .019) independently predicted CPM. Other contributing factors included benign contralateral breast findings (29%) and recommendations against breast conservation due to disease burden (28%). Six percent selected CPM as a result of an unsubstantiated fear regarding breast cancer. CONCLUSION: The majority of women (63%) who selected CPM had < 20% CBC risk. In these lower-risk women selecting CPM, factors increasing reasonable fear dominated surgical choice (81% of this subset).

Predictors associated with MRI surveillance screening in women with a personal history of unilateral breast cancer but without a genetic predisposition for future contralateral breast cancer.

PURPOSE: For women with a personal history of breast cancer (PHBC), no validated mechanisms exist to calculate future contralateral breast cancer (CBC) risk. The Manchester risk stratification guidelines were developed to evaluate CBC risk in women with a PHBC, primarily for surgical decision making. This tool may be informative for the use of MRI screening, as CBC risk is an assumed consideration for high-risk surveillance. METHODS: Three hundred twenty-two women with a PHBC were treated with unilateral surgery within our multidisciplinary breast clinic. We calculated lifetime CBC risk using the Manchester tool, which incorporates age at diagnosis, family history, genetic mutation status, estrogen receptor positivity, and endocrine therapy use. Univariate and multivariate logistic regression analyses (UVA/MVA) were performed, evaluating whether CBC risk predicted MRI surveillance. RESULTS: For women with invasive disease undergoing MRI surveillance, 66% had low, 23% above-average, and 11% moderate/high risk for CBC. On MVA, previous mammography-occult breast cancer [odds ratio (OR) 18.95, p < 0.0001], endocrine therapy use (OR 3.89, p = 0.009), dense breast tissue (OR 3.69, p = 0.0007), mastectomy versus lumpectomy (OR 3.12, p = 0.0041), and CBC risk (OR 3.17 for every 10% increase, p = 0.0002) were associated with MRI surveillance. No pathologic factors increasing ipsilateral breast cancer recurrence were significant on MVA. CONCLUSIONS: Although CBC risk predicted MRI surveillance, 89% with invasive disease undergoing MRI had <20% calculated CBC risk. Concerns related to future breast cancer detectability (dense breasts and/or previous mammography-occult disease) predominate decision making. Pathologic factors important for determining ipsilateral recurrence risk, aside from age, were not associated with MRI surveillance.

Increasing Appropriate BRCA1/2 Mutation Testing: The Role of Family History Documentation and Genetic Counseling in a Multidisciplinary Clinic.

BACKGROUND: Findings show that 5-10 % of women with a diagnosis of breast cancer (BCa) have actionable genetic mutations. The National Comprehensive Cancer Network guidelines for testing to detect BRCA1/2 mutations include personal history (PH) variables such as age of 45 years or younger and a family history (FH) variables. Rates of FH documentation and overall rates of appropriate referral for genetic testing are low, ranging from about 30 to 60 %. The authors hypothesized that an upfront FH documentation and inclusion of a genetics counselor in a multidisciplinary clinic (MDC) setting would increase rates of appropriate referral for genetic testing. METHODS: The study enrolled 609 consecutive women with non-metastatic BCa seen in consultation between June 2012 and December 2015 at a multidisciplinary clinic. Rates of FH documentation and referral for genetic testing to detect BRCA1/2 mutations were assessed before and after inclusion of a genetic counselor in the MDC. RESULTS: The rates of FH documentation and appropriate referral were 100 and 89 %, respectively. Half (50 %) of the patients had only FH-based indications for testing. All the patients with PH-based indications were referred. The inclusion of a genetic counselor significantly increased appropriate referral rates among those with only FH-based indications (62 vs. 92 %) and overall (80 vs. 96 %) (p < 0.0001 for both). Among the 12 % of the patients with actionable mutations, 60 % were 45 years of age or younger, whereas 30 % had only FH-based testing indications. CONCLUSIONS: This report shows substantially higher FH documentation and appropriate genetic testing rates than prior reports. Many patients with indications for genetic testing may have only FH-based indications for testing, and this subset may account for the sizable proportion of patients with newly diagnosed BCa who have actionable mutations.