Intraoperative Lymph Node Assessment (Touch Preparation Only) for Metastatic Breast Carcinoma in Neoadjuvant and Non-neoadjuvant Settings.

CONTEXT.­: Touch preparation (TP) alone is discouraged for intraoperative lymph node (LN) assessment in the neoadjuvant setting (NAS) owing to overall low sensitivity in detecting metastatic breast cancer. OBJECTIVE.­: To compare the sensitivity, specificity, and negative predictive value of intraoperative LN assessment via TP and examine potential causes of discrepancies along with the clinical, radiologic, and pathologic parameters in the NAS and non-neoadjuvant setting (NNAS). DESIGN.­: A total of 99 LNs from 47 neoadjuvant patients and 108 LNs from 56 non-neoadjuvant patients were identified. Discordant cases were reviewed retrospectively to reveal the discrepancy reasons. Clinical, radiologic, and pathologic data were obtained from chart review and the pathology CoPath database. RESULTS.­: The sensitivity, specificity, and negative predictive value of TP in NAS and NNAS were 34.2% versus 37.5%, 100% versus 100%, and 70.9% versus 90.2%, respectively. In NAS, discrepancy reasons were interpretation challenge due to lobular histotype, poor TP quality secondary to therapy-induced histomorphologic changes, and undersampling due to small tumor deposits (≤2 mm); the latter was the major reason in NNAS. More cases with macrometastasis were missed in NAS compared to NNAS (14 of 25 versus 1 of 10). The parameters associated with discrepancy were lobular histotype, histologic grade 2, estrogen receptor positivity, HER2 human epidermal growth factor receptor 2 negativity, multifocality, and pathologic tumor size greater than 10 mm in NAS; and lymphovascular space involvement and pathologic tumor size greater than 20 mm in NNAS. CONCLUSIONS.­: In NAS, intraoperative TP alone should be used very cautiously owing to a high false-negative rate of macrometastasis, especially for patients with invasive lobular carcinoma and known axillary LN metastasis before neoadjuvant therapy.

Positive margins after mastectomy in patients with invasive lobular carcinoma of the breast: Incidence and management strategies.

BACKGROUND: Surgical treatment of invasive lobular carcinoma (ILC) is challenging due to its diffuse growth pattern, and the positive margin rate after mastectomy is poorly described. METHODS: We retrospectively determined the positive margin rate in those with stage I-III ILC undergoing mastectomy. We evaluated the relationship between management strategy and recurrence free survival (RFS). RESULTS: In 357 patients, the positive margin rate was 10.6% overall and 18.7% in those with T3 tumors. Having a positive margin was associated with significantly shorter RFS on multivariate analysis (p = 0.01). Undergoing additional local treatment (radiation or re-excision) for a positive margin was significantly associated with improved RFS (p = 0.004). Older women with positive margins were significantly less likely to undergo additional local therapy. CONCLUSIONS: Even mastectomy fails to clear margins in a high proportion of patients with large ILC tumors, a finding which may warrant testing neoadjuvant strategies even prior to planned mastectomy.

Cost-effectiveness of different surgical treatment approaches for early breast cancer: a retrospective matched cohort study from China.

BACKGROUND: Both breast-conserving surgery and breast reconstruction surgery are less popular in China, although they can improve patients' quality of life. The main reason comes from the economy. There is currently no economic evaluation of different surgical treatment options for early breast cancer. Our study aims to assess the economic impact and long-term cost-effectiveness of different surgical treatments for early breast cancer. The surgical approaches are including mastectomy (MAST), breast-conserving therapy (BCT), and mastectomy with reconstruction (MAST+RECON). METHODS: Based on demographic data, disease-related information and other treatments, we applied propensity score matching (PSM) to perform 1: 1 matching among patients who underwent these three types of surgery in the tertiary academic medical center from 2011 to 2017 to obtain a balanced sample of covariates between groups. A Markov model was established. Clinical data and cost data were obtained from the medical records. Health utility values were derived from clinical investigations. Strategies were compared using an incremental cost-effectiveness ratio (ICER). RESULTS: After PSM, there were 205 cases in each group. In the matched data set, the distribution of covariates was fully balanced. The total cost of MAST, MAST+RECON and BCT was $37,392.84, $70,556.03 and $82,330.97, respectively. The quality-adjusted life year (QALYs) were 17.11, 18.40 and 20.20, respectively. Compared with MAST, MAST+RECON and BCT have an ICER of $25,707.90/QALY and $14,543.08/QALY, respectively. The ICER of BCT vs. MAST was less than the threshold of $27,931.04. The reliability and stability of the results were confirmed by Monte Carlo simulation and sensitivity analysis. CONCLUSIONS: We believe that in the context of the limited resources in China, after comparing the three surgical approaches, BCT is the more cost-effective and preferred solution.

Adherence to post-surgery follow-up assessment and its association with sociodemographic and disease characteristics in patients with breast cancer in Central China.

BACKGROUND: Follow-up after curative surgery is increasingly recognized as an important component of breast cancer care. Although current guideline regulates the follow-ups, there are no relevant studies on the adherence to it in China. This study investigated the post-surgery follow-up and explored its association with patients, tumor and treatment characteristics. METHODS: A total of 711 patients underwent surgical treatment in Shanxi Bethune Hospital from March 2012 to May 2018 were included in this study. Baseline sociodemographic, tumor, and treatment characteristics were obtained from the hospital electronic medical records. The post-surgery follow-up was reviewed and assessed from the patient's follow-up examination record. Factors associated with the first three-year follow up was evaluated using logistic regression analysis. RESULTS: The annual follow-up rate after surgery decreased gradually from 67.1% at the 1st year, 60.2% at the 3rd year to 51.9% at the 4th year, and 43.5% at the 5th year. Loss of follow-up during the first 3 years after surgery was significantly associated with older age (> 65 years), lower medical insurance coverage, axillary lymph node dissection, and less intensity of systemic treatment. CONCLUSION: A significant downtrend of annual follow-up rate for breast cancer survivors was confirmed in this study. Loss of follow-up within the first 3 years after surgery was associated with both patient's characteristics and treatment. These results will provide evidence to help clinicians to develop tailored patient management after curative surgery.

PD-L1 diagnostics in the neoadjuvant setting: implications of intratumoral heterogeneity of PD-L1 expression in triple negative breast cancer for assessment in small biopsies.

PURPOSE: PD-L1 expression is a predictive biomarker for anti-PD-L1 immunotherapy in triple negative breast cancer (TNBC). In the neoadjuvant setting, immunohistochemical (IHC) evaluation of PD-L1 expression can only be performed on small tissue biopsies. In our study we investigated heterogeneity of PD-L1 expression in TNBC, and how reliably PD-L1 expression in small tissue samples reflects PD-L1 expression in larger tumor sections in TNBC. METHODS: Tissue microarrays (TMAs) were constructed from surgical specimens of 110 patients with TNBC. TMAs contained 4 cores (1 mm in diameter) per patient. To evaluate PD-L1 expression, TMAs were stained with PD-L1 IHC 22C3 PharmDx. Single-core PD-L1 expression was compared to overall PD-L1 expression of each patient's tumor, to ascertain how often small samples of tumor tissue show the same PD-L1 expression as larger tumor samples. RESULTS: Our study found substantial heterogeneity of PD-L1 expression between different TMA cores from the same patient. Heterogeneity was greater in immune cells (ICs) than in tumor cells, in large part due to the uneven distribution of ICs in the tumor. For IC PD-L1 expression, we found that sensitivity can be as low as 0.81 for detecting PD-L1 expression at the 1% threshold most commonly used in breast cancer. Negative predictive value for ICs was 0.7. CONCLUSIONS: There is substantial heterogeneity of PD-L1 expression between small tissue samples from the same TNBC tumor, especially for IC expression. This poses challenges for evaluation of PD-L1 expression in the neoadjuvant setting. Negative biopsies should prompt further investigation, and multiple biopsies might be necessary.

Preoperative assessment of breast cancer: Multireader comparison of contrast-enhanced MRI versus the combination of unenhanced MRI and digital breast tomosynthesis.

PURPOSE: To compare the sensitivity for breast cancer (BC) and BC size estimation of preoperative contrast-enhanced magnetic resonance imaging (CEMRI) versus combined unenhanced magnetic resonance imaging (UMRI) and digital breast tomosynthesis (DBT). PATIENTS AND METHODS: We retrospectively included 56 women who underwent DBT and preoperative 1.5 T CEMRI between January 2016-February 2017. Three readers with 2-10 years of experience in CEMRI and DBT, blinded to pathology, independently reviewed CEMRI (diffusion-weighted imaging [DWI], T2-weighted imaging, pre- and post-contrast T1-weighted imaging) and a combination of UMRI (DWI and pre-contrast T1-weighted imaging) and DBT. We calculated per-lesion sensitivity of CEMRI and UMRI + DBT, and the agreement between CEMRI, UMRI and DBT versus pathology in assessing cancer size (Bland-Altman analysis). Logistic regression was performed to assess features predictive of cancer missing. RESULTS: We included 70 lesions (64% invasive BC, 36% ductal carcinoma in situ or invasive BC with in situ component). UMRI + DBT showed lower sensitivity (86-89%) than CEMRI (94-100%), with a significant difference for the most experienced reader only (p = 0.008). False-positives were fewer with UMRI + DBT (4-5) than with CEMRI (18-25), regardless of the reader (p = 0.001-0.005). For lesion size, UMRI showed closer limits of agreement with pathology than CEMRI or DBT. Cancer size ≤1 cm was the only independent predictor for cancer missing for both imaging strategies (Odds ratio 8.62 for CEMRI and 19.16 for UMRI + DBT). CONCLUSIONS: UMRI + DBT showed comparable sensitivity and less false-positives than CEMRI in the preoperative assessment of BC. UMRI was the most accurate tool to assess cancer size.

Is Bigger Better?: The Effect of Hospital Consolidation on Index Hospitalization Costs and Outcomes Among Privately Insured Recipients of Immediate Breast Reconstruction.

OBJECTIVES: To examine the relationship between hospital market competition and inpatient costs, procedural markup, inpatient complications, and length of stay among privately insured patients undergoing immediate reconstruction after mastectomy. METHODS: A retrospective cross-sectional analysis of privately insured female patients undergoing immediate breast reconstruction in the 2009 to 2011 Nationwide Inpatient Sample was performed. The Herfindahl-Hirschman index was used to describe hospital market competition; associations with outcomes were explored via hierarchical models adjusting for patient, hospital, and market characteristics. RESULTS: A weighted total of 42,411 patients were identified; 5920 (14.0%) underwent free flap reconstruction. In uncompetitive markets, 6.8% (n=857) underwent free flap reconstruction, compared with 13.6% (n=2773) in highly competitive markets and 24.6% (n=2290) in moderately competitive markets. For every 5 additional hospitals in a market, adjusted costs were 6.6% higher (95% CI: 2.8%-10.5%), for free flap reconstruction, and 5.1% higher (95% CI: 2.0%-8.4%) for nonfree flap reconstruction. Similarly, higher procedural markup was associated with increased hospital market competition both for nonfree flap reconstruction (5.5% increase, 95% CI: 1.1%-10.1%) and for free flap reconstruction (8.2% increase, 95% CI: 1.8%-15.0%). Notably, there was no association between incidence of inpatient complications or extended length of stay and hospital market competition among either free flap or nonfree flap reconstruction patients. CONCLUSIONS: Decreasing market competition was associated with lower inpatient costs and equivocal clinical outcomes. This suggests that some of the economies of scale, access to capital and care delivery efficiencies gained from increased market power following hospital mergers are passed onto payers and consumers as lower costs.

Digital Breast Tomosynthesis for Intraoperative Margin Assessment during Breast-Conserving Surgery.

BACKGROUND: Intraoperative margin assessment for breast cancer patients undergoing segmental mastectomy (SM) enables identification of positive margins, with immediate excision of additional tissue to obtain negative margins. OBJECTIVE: The aim of this study was to determine the ability of digital breast tomosynthesis (DBT) to detect positive margins compared with an institution's standard extensive processing (SEP). METHODS: SM specimens underwent intraoperative SEP with two-dimensional (2D) imaging of the intact and sliced specimen, with review by a breast radiologist and gross assessment by a breast pathologist. Findings guided the surgeon to excise additional tissue. DBT images of intact specimens were prospectively obtained and retrospectively reviewed by a breast radiologist. A positive margin was defined as tumor at ink. RESULTS: Ninety-eight patients underwent 99 SMs. With SEP, 14 (14%) SM specimens had 19 positive margins. SEP did not detect 3 of the 19 positive margins, for a sensitivity of 84%, specificity of 78%, positive predictive value (PPV) of 11%, and negative predictive value (NPV) of 99%. Moreover, DBT did not detect 5 of the 19 positive margins, for a sensitivity of 74% (p > 0.05), specificity of 91% (p < 0.05), PPV of 21.5%, and NPV of 99%. With SEP guidance to excise additional tissue, six cases had final positive margins, with SEP not identifying three of these cases and DBT not identifying two. Pathology from the second surgery of these patients showed either no additional malignancy or only focal ductal carcinoma in situ. CONCLUSIONS: DBT is an accurate method for detecting positive margins in breast cancer patients undergoing SM, performing similar to institutional labor-intensive, intraoperative standard processing.

Intraoperative Assessment of Sentinel Lymph Nodes in Breast Cancer Patients Post-Neoadjuvant Therapy.

BACKGROUND: Shift toward minimizing axillary lymph node dissection in patients with breast cancer post neoadjuvant therapy has led to the assessment of sentinel lymph nodes by frozen section intraoperatively to determine the need for axillary lymph node dissection. However, few studies have examined the accuracy of sentinel lymph node frozen section after neoadjuvant therapy. Our objective is to compare the accuracy of sentinel lymph node frozen section in patients with breast cancer with and without neoadjuvant therapy and to identify features that may influence accuracy. DESIGN: We identified 161 sentinel lymph node frozen section from 77 neoadjuvant therapy patients and 255 sentinel lymph node frozen section from 88 non-neoadjuvant therapy patients diagnosed between 2010 and 2016 in 2 institutions. The frozen section diagnoses were compared to the final diagnoses, and clinicopathologic data were analyzed. RESULTS: The sensitivity, specificity, and accuracy of frozen section analysis were comparable between neoadjuvant therapy patients and non-neoadjuvant therapy patients (71.9% vs 50%, 100% vs 100%, and 88.3% vs 81.8%). Nine (11.7%) of 77 neoadjuvant therapy patients had discordant results, most often due to undersampling (tumor absent on frozen section slide). Four of these patients subsequently underwent axillary lymph node dissection. Discordant results (all false negatives) were significantly more likely in neoadjuvant therapy patients with Estrogen Receptor-positive/HER2-negative status, and in sentinel lymph node with pN1mic and pN0i+ deposits; age, preneoadjuvant therapy lymph node status, histotype, nuclear grade, tumor size, and response to neoadjuvant therapy showed no significant differences. For non-neoadjuvant therapy cases, large tumor size, lobular histotype, and sentinel lymph node with pN1mic and pN0i+ were associated with false-negative frozen section assessment. CONCLUSION: Sentinel lymph node frozen section diagnosis post-neoadjuvant therapy has comparable sensitivity, specificity, and accuracy to the sentinel lymph node frozen section diagnosis in the non-neoadjuvant therapy setting.

Practical approaches to automated digital image analysis of Ki-67 labeling index in 997 breast carcinomas and causes of discordance with visual assessment.

The Ki-67 labeling index (LI) is an important prognostic factor in breast carcinoma. The Ki-67 LI is traditionally calculated via unaided microscopic estimation; however, inter-observer and intra-observer variability and low reproducibility are problems with this visual assessment (VA) method. For more accurate assessment and better reproducibility with Ki-67 LI, digital image analysis was introduced recently. We used both VA and automated digital image analysis (ADIA) (Ventana Virtuoso image management software) to estimate Ki-67 LI for 997 cases of breast carcinoma, and compared VA and ADIA results. VA and ADIA were highly correlated (intraclass correlation coefficient 0.982, and Spearman's correlation coefficient 0.966, p<0.05). We retrospectively analyzed cases with a greater than 5% difference between VA and ADIA results. The cause of these differences was: (1) tumor heterogeneity (98 cases, 56.0%), (2) VA interpretation error (32 cases, 18.3%), (3) misidentification of tumor cells (26 cases, 14.9%), (4) poor immunostaining or slide quality (16 cases, 9.1%), and (5) Estimation of non-tumor cells (3 cases, 1.7%). There were more discrepancies between VA and ADIA results in the group with a VA value of 10-20% compared to groups with <10% and ≥20%. Although ADIA is more accurate than VA, there are some limitations. Therefore, ADIA findings require confirmation by a pathologist.

Understanding Disparities in Breast Cancer Care in Memphis, Tennessee.

Although significant progress has been made in improving breast cancer survival, disparities among racial, ethnic, and underserved groups still exist. The goal of this investigation is to quantify racial disparities in the context of breast cancer care, examining the outcomes of recurrence and mortality in the city of Memphis. Patients with a biopsy-proven diagnosis of breast cancer from January 1, 2002, through December 31, 2012, were obtained from the tumor registry. Black patients were more likely to have advanced (II, III, or IV) clinical stage of breast cancer at diagnosis versus white patients. Black breast cancer patients had a two times higher odds of recurrence (95% confidence interval: 1.4, 3.0) after adjusting for race and clinical stage. Black breast cancer patients were 1.5 times more likely to die (95% confidence interval: 1.2, 1.8), after adjusting for race; age at diagnosis; clinical stage; ER, PR, HER2 status; and recurrence. Black women with stages 0, I, II, and III breast cancer all had a statistically significant longer median time from diagnosis to surgery than white women. Black patients were more likely to have advanced clinical stages of breast cancer at diagnosis versus white patients on a citywide level in Memphis. Black breast cancer patients have higher odds of recurrence and mortality when compared with white breast cancer patients, after adjusting for appropriate demographic and clinical attributes. More work is needed to develop, evaluate, and disseminate interventions to decrease inequities in timeliness of care for breast cancer patients.

A novel modality for intraoperative margin assessment and its impact on re-excision rates in breast conserving surgery.

BACKGROUND: A single center retrospective chart review was performed examining the ability of a novel radiofrequency probe (Margin Probe; Dune Medical Devices, Caesarea, Israel) for intraoperative margin assessment to reduce the number of reexcisions in breast-conserving surgery. METHODS: Reexcision rates were evaluated in one-hundred and twenty consecutive patients before and after the institution of the device. Utility of the device was evaluated by comparing intraoperative feedback with postoperative pathology reports. RESULTS: Two hundred and forty patient subjects were reviewed in total. There was a significant decrease in the re-lumpectomy rate (50%, p = 0.039) in the device group without increasing the total volume of tissue resected. CONCLUSIONS: The use of the MarginProbe device as an adjunct to the standard of care resulted in reduction of positive margins after lumpectomy and the number of re-excisions, significantly improving outcomes in breast-conserving surgery at our institution.

Influence of Distance to Hospital and Insurance Status on the Rates of Contralateral Prophylactic Mastectomy, a National Cancer Data Base study.

INTRODUCTION: We evaluated the impact of travel distance and insurance status on contralateral prophylactic mastectomy (CPM) rates in breast cancer. METHODS: We queried the National Cancer Data Base (NCDB) for women >18 years of age with a nonmetastatic primary breast cancer of ductal, lobular, or mixed histology. Patient- and facility-specific CPM rates were calculated based on insurance, race, and distance to treatment center. Standard univariable and multivariable regression analysis was performed. RESULTS: Overall, the CPM rate was 6.5% for the 864,105 patients identified. Most patients traveled <20 miles to a treatment center (79.5%) and had private insurance or Medicare (58.3 and 33.4%, respectively). In general, younger, White, non-Hispanic, and privately insured patients residing further from a treatment center was associated with increased rates of CPM. However, distance to the treatment center and insurance type had a greater absolute impact on rates of CPM for Black and Hispanic patients. Absolute CPM rate increases for patients >100 miles from a treatment center compared with those <20 miles from a treatment center were observed to be greater for Black and Hispanic patients (3.5 and 3.9%, respectively) compared with White and non-Hispanic patients (2.5 and 2.6%). Additionally, further patient travel distance was associated with higher treatment center-specific CPM rates. CONCLUSION: Increased travel distance is independently associated with increased rates of CPM for all patients and increased facility-specific rates of CPM. Black and Hispanic patients were found to be more vulnerable to the impact of travel distance and insurance status on rates of CPM.

Cavity Shaving Reduces Involved Margins and Reinterventions Without Increasing Costs in Breast-Conserving Surgery: A Propensity Score-Matched Study.

BACKGROUND: Currently, reinterventions for involved margins after breast-conserving surgery remain common. The aim of this study was to assess the capability of the cavity shave margins (CSM) technique to reduce positive margin rates and reoperations compared with simple lumpectomy (SL). The impact of CSM on the various biological portraits of breast cancer and costs were also investigated. METHODS: A retrospective review of 976 consecutive patients from a single center was performed; 164 patients underwent SL and 812 received CSM. All patients were treated with an oncoplastic approach. and involved margins and reoperations were compared for each group. To avoid selection bias, propensity score-matched analysis was performed before applying a logistic regression model. Main outcomes were reanalyzed for each biological portrait, and surgery and hospitalization costs for SL and CSM were compared. RESULTS: Clear margins were found in 98.3% of patients in the CSM group versus 74.4% of patients in the SL group (p < 0.001). The reoperation rate was 18.9% in the SL group and 1.9% in the CSM group (p < 0.001). After propensity score-matched logistic regression, odds ratio (OR) for positive final margin status was 6.2 (95% confidence interval [CI] 2.85-13.46; p < 0.001) without CSM, while OR for reintervention was 5.46 (95% CI 2.21-13.46; p < 0.001). CSM significantly reduced positive margins and reexcisions for Luminal A, Luminal B, and triple-negative breast cancers (p < 0.001, p < 0.001, and p = 0.0137, respectively). SL had higher global costs compared with CSM: €193,630.6 versus €177,830 for 100 treated patients (p = 0.009). CONCLUSIONS: CSM reduces reexcisions, mainly in luminal breast cancers, without increasing costs.

Economic Impact of Routine Cavity Margins Versus Standard Partial Mastectomy in Breast Cancer Patients: Results of a Randomized Controlled Trial.

OBJECTIVE: The aim of the study was to compare costs associated with excision of routine cavity shave margins (CSM) versus standard partial mastectomy (PM) in patients with breast cancer. BACKGROUND: Excision of CSM reduces re-excision rates by more than 50%. The economic implications of this is, however, unclear. METHODS: Between October 21, 2011 and November 25, 2013, 235 women undergoing PM for Stage 0-III breast cancer were randomized to undergo either standard PM ("no shave", n = 116) or have additional CSM taken ("shave", n = 119). Costs from both a payer and a hospital perspective were measured for index surgery and breast cancer surgery-related care through subsequent 90 days. RESULTS: The 2 groups were well-matched in terms of baseline characteristics. Those in the "shave" group had a longer operative time at the initial surgery (median 76 vs 66 min, P < 0.01), but a lower re-excision rate for positive margins (13/119 = 10.9% vs 32/116 = 27.6%, P < 0.01). Actual direct hospital costs associated with operating room time ($1315 vs. $1137, P = 0.03) and pathology costs ($1195 vs $795, P < 0.01) were greater for the initial surgery in patients in the "shave" group. Taking into account the index surgery and the subsequent 90 days, there was no significant difference in cost from either the payer ($10,476 vs $11,219, P = 0.40) or hospital perspective ($5090 vs $5116, P = 0.37) between the "shave" and "no shave" groups. CONCLUSIONS: Overall costs were not significantly different between the "shave" and "no shave" groups due to significantly fewer reoperative surgeries in the former.

Clinical and pathological assessment of high-risk ductal and lobular breast lesions: What surgeons must know.

Terminology in pathology is sometimes over-complicated and may be misinterpreted by clinicians facing patients and having difficulty answering questions posed by them. This may especially be true for some breast lesions with an increased risk of malignant transformation, the complex terminology of which reflects attempts to stratify them according to potential risk. On the basis of morphological and molecular features, both ductal and lobular proliferations have been classified and named in different ways by pathologists, and this often makes it difficult for the treating physicians and the patients to fully understand the nature of the lesions and their associated risks. In order to clarify pathology reports, unambiguous and simple terms are needed.

Intra-operative assessment of excised breast tumour margins using ClearEdge imaging device.

INTRODUCTION: Breast conserving surgery (BCS) aims to remove a breast cancer completely and obtain clear margins. Complete excision is essential to reduce the risk of local recurrence. The ClearEdge™ (CE) imaging device examines margins of excised breast tissue intra-operatively. The aim of this study was to investigate the potential of the device in detecting margin involvement in patients having BCS. METHODS: In Phase-1 58 patients underwent BCS and had 334 margins assessed by the device. In Phase-2 the device was used in 63 patients having BCS and 335 margins were assessed. Patients with margins considered close or involved by the CE device were re-excised. RESULTS: The margin assessment accuracies in Phase-1 and Phase-2 compared to permanent section pathology were very similar: sensitivity (84.3% and 87.3%), specificity (81.9% and 75.6%), positive predictive value (67.2% and 63.6%), and negative predictive value (92.2% and 92.4%). The false positive rate (18.1% and 24.4%) and false negative rate (15.7% and 12.7%) were low in both phases. In Phase-2 re-excision rate was 37%, but in the 54 where the CE device was used appropriately the re-excision rate was 17%. Had all surgeons interpreted all images appropriately and re-excised margins detected as abnormal by the device in Phase-2 then the re-excision rate would have been 7%. CONCLUSION: This study shows that the CE device has potential to reduce re-excision after BCS and further randomized studies of its value are warranted.

The impact of breast cancer biological subtyping on tumor size assessment by ultrasound and mammography - a retrospective multicenter cohort study of 6543 primary breast cancer patients.

BACKGROUND: Mammography and ultrasound are the gold standard imaging techniques for preoperative assessment and for monitoring the efficacy of neoadjuvant chemotherapy in breast cancer. Maximum accuracy in predicting pathological tumor size non-invasively is critical for individualized therapy and surgical planning. We therefore aimed to assess the accuracy of tumor size measurement by ultrasound and mammography in a multicentered health services research study. METHODS: We retrospectively analyzed data from 6543 patients with unifocal, unilateral primary breast cancer. The maximum tumor diameter was measured by ultrasound and/or mammographic imaging. All measurements were compared to final tumor diameter determined by postoperative histopathological examination. We compared the precision of each imaging method across different patient subgroups as well as the method-specific accuracy in each patient subgroup. RESULTS: Overall, the correlation with histology was 0.61 for mammography and 0.60 for ultrasound. Both correlations were higher in pT2 cancers than in pT1 and pT3. Ultrasound as well as mammography revealed a significantly higher correlation with histology in invasive ductal compared to lobular cancers (p < 0.01). For invasive lobular cancers, the mammography showed better correlation with histology than ultrasound (p = 0.01), whereas there was no such advantage for invasive ductal cancers. Ultrasound was significantly superior for HR negative cancers (p < 0.001). HER2/neu positive cancers were also more precisely assessed by ultrasound (p < 0.001). The size of HER2/neu negative cancers could be more accurately predicted by mammography (p < 0.001). CONCLUSION: This multicentered health services research approach demonstrates that predicting tumor size by mammography and ultrasound provides accurate results. Biological tumor features do, however, affect the diagnostic precision.

Margins in breast conserving surgery: The financial cost & potential savings associated with the new margin guidelines.

INTRODUCTION: In this study, we compare the indications for re-excision, the findings of additional tumor in the re-excision specimen as they relate to margin status, and costs associated with re-excision based on recent new consensus statements. MATERIALS AND METHODS: A retrospective analysis was performed on 462 patients with invasive breast carcinoma who underwent at least one lumpectomy between January 2011 and December 2013. Postoperative data was analyzed based on where additional disease was found, as it relates to the margin status of the initial lumpectomy and the additional direct costs associated with additional procedures. RESULTS: Of the 462 patients sampled, 149 underwent a re-excision surgery (32.2%). Four patients underwent mastectomy as their second operation. In the 40 patients with additional disease found on re-excision, 36 (90.0%) of them had a positive margin on their initial lumpectomy. None of the four mastectomy patients had residual disease. The mean cost of the initial lumpectomy for all 462 patients was $2118.01 plus an additional $1801.92 for those who underwent re-excision. DISCUSSION: A positive margin was most predictive of finding residual tumor on re-excision as would be expected. Using old criteria only 0.07% (4/61) of patients who had undergone re-excision with a 'clear' margin, had additional tumor found, at a total cost of $106,354.11. Thus, the new consensus guidelines will lead to less overall cost, at no clinical risk to patients while reducing a patient's surgical risk and essentially eliminating delays in adjuvant care.

Triple assessment of sentinel lymph node metastasis in early breast cancer using preoperative CTLG, intraoperative fluorescence navigation and OSNA.

BACKGROUND: Sentinel lymph node biopsy (SLNB) became a standard surgical procedure for patients with early breast cancer; however, the optimal method of sentinel lymph node (SLN) identification remains controversial. The current study presents the protocol of our institution for preoperative and intraoperative SLN detection. METHODS: Fifty female patients with early breast cancer and clinically node-negative axilla were enrolled in this study. All patients underwent preoperative CT lymphography (CTLG), intraoperative SLNB using fluorescence navigation, intraoperative one-step nucleic acid amplification (OSNA) and postoperative hematoxylin and eosin histopathological analysis. Prediction of metastasis by CTLG and detection of metastasis by OSNA were compared to results of histopathology as standard reference. RESULTS: SLN were identified by preoperative CTLG and intraoperative SLNB with fluorescence navigation in all patients, the identification rate was 100 %. SLN metastases were detected as positive by OSNA in 9 patients (18 %), 4 were (++), 4 were (+) and 1 was (+I). SLN metastases were detected as positive by histopathology in 10 patients (20 %). The concordance rate between OSNA and permanent sections was 90 %. The negative predictive value of CTLG was 80 %. CONCLUSION: Use of CTLG and fluorescence navigation made performing SLNB with high accuracy possible in institutions that cannot use the radioisotope method. OSNA provided accurate intraoperative method, allowing for completion of axillary node dissection during surgery and avoidance of second surgical procedure in patients with positive SLNs, thereby reducing patient distress and, finally, saving hospital costs.