Does Preoperative MRI Reduce Positive Margins after Breast-Conserving Surgery?

BACKGROUND: Breast-conserving surgery (BCS) is a mainstay for breast cancer management, and obtaining negative margins is critical. Some have advocated for the use of preoperative magnetic resonance imaging (MRI) in reducing positive margins after BCS. We sought to determine whether preoperative MRI was associated with reduced positive margins. PATIENTS AND METHODS: The SHAVE/SHAVE2 trials were multicenter trials in ten US centers with patients with stage 0-3 breast cancer undergoing BCS. Use of preoperative MRI was at the discretion of the surgeon. We evaluated whether or not preoperative MRI was associated with margin status prior to randomization regarding resection of cavity with shave margins. RESULTS: A total of 631 patients participated. Median age was 64 (range 29-94) years, with a median tumor size of 1.3 cm (range 0.1-9.3 cm). Patient factors included 26.1% of patients (165) had palpable tumors, and 6.5% (41) received neoadjuvant chemotherapy. Tumor factors were notable for invasive lobular histology in 7.0% (44) and extensive intraductal component (EIC) in 32.8% (207). A preoperative MRI was performed in 193 (30.6%) patients. Those who underwent preoperative MRI were less likely to have a positive margin (31.1% versus 38.8%), although this difference was not statistically significant (p = 0.073). On multivariate analysis, controlling for patient and tumor factors, utilization of preoperative MRI was not a significant factor in predicting margin status (p = 0.110). Rather, age (p = 0.032) and tumor size (p = 0.040) were the only factors associated with margin status. CONCLUSION: These data suggest that preoperative MRI is not associated margin status; rather, patient age and tumor size are the associated factors.

Omission of Radiation in Conservative Treatment for Breast Cancer: Opportunity for De-escalation of Care.

INTRODUCTION: De-escalation of breast cancer treatment aims to reduce patient and financial toxicity without compromising outcomes. Level I evidence and National Comprehensive Cancer Network guidelines support omission of adjuvant radiation in patients aged >70 y with hormone-sensitive, pT1N0M0 invasive breast cancer treated with endocrine therapy. We evaluated radiation use in patients eligible for guideline concordant omission of radiation. METHODS: Subgroup analysis of patients eligible for radiation omission from two pooled randomized controlled trials, which included stage 0-III breast cancer patients undergoing breast conserving surgery, was performed to evaluate factors associated with radiation use. RESULTS: Of 631 patients, 47 (7.4%) met radiation omission criteria and were treated by 14 surgeons at eight institutions. The mean age was 75.3 (standard deviation + 4.4) y. Majority of patients identified as White (n = 46; 97.9%) and non-Hispanic (n = 44; 93.6%). The mean tumor size was 1.0 cm; 37 patients (88.1%) had ductal, 4 patients (9.5%) had lobular, and 17 patients (40.5%) had low-grade disease. Among patients eligible for radiation omission, 34 (72.3%) patients received adjuvant radiation. Those who received radiation were significantly younger than those who did not (74 y, interquartile range = 4 y, versus 78 y, interquartile range = 11 y, P = 0.03). There was no difference in radiation use based on size (P = 0.4), histology (P = 0.5), grade (P = 0.7), race (P = 1), ethnicity (P = 0.6), institution (P = 0.1), gender of the surgeon (P = 0.7), or surgeon (P = 0.1). CONCLUSIONS: Fewer than 10% of patients undergoing breast conservation met criteria for radiation omission. Nearly three-quarters received radiation therapy with younger age being a driver of radiation use, suggesting ample opportunity for de-escalation, particularly among younger eligible patients.

Parental insulin resistance is associated with unhealthy lifestyle behaviours independently of body mass index in children: The Feel4Diabetes study.

Parental health is associated with children's health and lifestyles. Thus, the aim of the present study was to assess lifestyle behaviours of children of parents with insulin resistance (IR) and at risk of type 2 diabetes. 2117 European families from the Feel4Diabetes-study were identified as being at risk for diabetes with the FINDRISC questionnaire and included in the present study. One parent and one child per family were included. Parental IR was considered when homeostasis model assessment (HOMA) was equal or higher than 2.5. Children's screen-time, physical activity and diet were assessed and clustered by K-means. Weight and height were measured and children's body mass index (BMI) was calculated. For children, a Healthy Diet Score (HDS) was calculated. Linear regression and multilevel logistic regression analyses were performed to assess the associations between parental IR and children's lifestyle behaviours in 2021. Children of parents with IR had higher BMI (p < 0.001) and spent more screen time (p = 0.014) than those of non-IR parents. Children of parents with IR had a lower value in the breakfast and vegetable components of the HDS (p = 0.008 and p = 0.05). Four lifestyle clusters were found. Children of IR parents had higher odds of being in a non-healthy cluster (OR: 1.19; 95%CI: 1.001-1.437). CONCLUSION: Having an IR parent was associated with a high screen time and an increased probability of having an unhealthy lifestyle pattern in children. These data point out that children's lifestyles should be assessed in families with IR parents to provide tailored interventions. WHAT IS KNOWN: • Children with diabetic or insulin-resistant parents could also develop this condition. • Unhealthy lifestyles are directly related with insulin resistance even in children. WHAT IS NEW: • Children from parents with insulin resistance have higher chances of unhealthy lifestyles. • A higher BMI was found for those children with an insulin-resistant parent.

Resection of Cavity Shave Margins in Stage 0-III Breast Cancer Patients Undergoing Breast Conserving Surgery: A Prospective Multicenter Randomized Controlled Trial.

OBJECTIVE: Single-center studies have demonstrated that resection of cavity shave margins (CSM) halves the rate of positive margins and re-excision in breast cancer patients undergoing partial mastectomy (PM). We sought to determine if these findings were externally generalizable across practice settings. METHODS: In this multicenter randomized controlled trial occurring in 9 centers across the United States, stage 0-III breast cancer patients undergoing PM were randomly assigned to either have resection of CSM ("shave" group) or not ("no shave" group). Randomization occurred intraoperatively, after the surgeon had completed their standard PM. Primary outcome measures were positive margin and re-excision rates. RESULTS: Between July 28, 2016 and April 13, 2018, 400 patients were enrolled in this trial. Four patients (2 in each arm) did not meet inclusion criteria after randomization, leaving 396 patients for analysis: 196 in the "shave" group and 200 to the "no shave" group. Median patient age was 65 years (range; 29-94). Groups were well matched at baseline for demographic and clinicopathologic factors. Prior to randomization, positive margin rates were similar in the "shave" and "no shave" groups (76/196 (38.8%) vs. 72/200 (36.0%), respectively, P = 0.604). After randomization, those in the "shave" group were significantly less likely than those in the "no shave" group to have positive margins (19/196 (9.7%) vs. 72/200 (36.0%), P < 0.001), and to require re-excision or mastectomy for margin clearance (17/196 (8.7%) vs. 47/200 (23.5%), P < 0.001). CONCLUSION: Resection of CSM significantly reduces positive margin and re-excision rates in patients undergoing PM.

Does Breast Cancer Subtype Impact Margin Status in Patients Undergoing Partial Mastectomy?

BACKGROUND: Molecular subtype in invasive breast cancer guides systemic therapy. It is unknown whether molecular subtype should also be considered to tailor surgical therapy. The present investigation was designed to evaluate whether breast cancer subtype impacted surgical margins in patients with invasive breast cancer stage I through III undergoing breast-conserving therapy. METHODS: Data from 2 randomized trials evaluating cavity shave margins (CSM) on margin status in patients undergoing partial mastectomy (PM) were used for this analysis. Patients were included if invasive carcinoma was present in the PM specimen and data for all 3 receptors (ER, PR, and HER2) were known. Patients were classified as luminal if they were ER and/or PR positive; HER2 enriched if they were ER and PR negative but HER2 positive; and TN if they were negative for all 3 receptors. The impact of subtype on the margin status was evaluated at completion of standard PM, prior to randomization to CSM versus no CSM. Non-parametric statistical analyses were performed using SPSS Version 26. RESULTS: Molecular subtype was significantly correlated with race (P = .011), palpability (P = .007), and grade (P < .001). Subtype did not correlate with Hispanic ethnicity (P = .760) or lymphovascular invasion (P = .756). In this cohort, the overall positive margin rate was 33.7%. This did not vary based on molecular subtype (positive margin rate 33.7% for patients with luminal tumors vs 36.4% for those with TN tumors, P = .425). DISCUSSION: Molecular subtype does not predict margin status. Therefore, molecular subtype should not, independent of other factors, influence surgical decision-making.

Does Localization Technique Matter for Non-palpable Breast Cancers?

BACKGROUND: There are several techniques for localization of non-palpable breast tumors, but comparisons of these techniques in terms of margin positivity and volume of tissue resected are lacking. METHODS: Between 2011-2013 and 2016-2018, 2 randomized controlled trials involving 10 centers across the United States accrued 631 patients with stage 0-3 breast cancer, all of whom underwent breast conserving surgery. Of these, 522 had residual non-palpable tumors for which localization was required. The localization technique was left to the discretion of the individual surgeon. We compared margin positivity and volume of tissue resected between various localization techniques. RESULTS: The majority of the patients (n = 465; 89.1%) had wire localization (WL), 50 (9.6%) had radioactive seed (RS) localization, and 7 (1.3%) had Savi Scout (SS) localization. On bivariate analysis, there was no difference in terms of margin positivity (37.8% vs. 28.0% vs. 28.6%, P = .339) nor re-excision rates (13.3% vs. 12.0% vs. 14.3%, P = .961) for the WL, RS, and SS groups, respectively. Further, the volume of tissue removed was not significantly different between the 3 groups (71.9 cm3 vs. 55.8 cm3 vs. 86.6 cm3 for the WL, RS, and SS groups, respectively, P = .340). On multivariate analysis, margin status was affected by tumor size (OR = 1.336; 95% CI: 1.148-1.554, P<.001) but not by type of localization (P = .670). CONCLUSIONS: While there are a number of methods for tumor localization, choice of technique does not seem to influence volume of tissue resected nor margin status.

Are we choosing wisely? Drivers of preoperative MRI use in breast cancer patients.

INTRODUCTION: Factors contributing to the use of preoperative MRI remain poorly understood. METHODS: Data from a randomized controlled trial of stage 0-3 breast cancer patients undergoing breast conserving surgery between 2016 and 2018 were analyzed. RESULTS: Of the 396 patients in this trial, 32.6% had a preoperative MRI. Patient age, race, ethnicity, tumor histology, and use of neoadjuvant therapy were significant predictors of MRI use. On multivariate analysis, younger patients with invasive lobular tumors were more likely to have a preoperative MRI. Rates also varied significantly by individual surgeon (p < 0.001); in particular, female surgeons (39.9% vs. 24.0% for male surgeons, p = 0.001) and those in community practice (58.9% vs. 14.2% for academic, p < 0.001) were more likely to order preoperative MRI. Rates declined over the two years of the study, particularly among female surgeons. CONCLUSIONS: Preoperative MRI varies with patient age and tumor histology; however, there remains variability by individual surgeon.

Factors Affecting Time to Surgery in Breast Cancer Patients.

BACKGROUND: We sought to determine factors affecting time to surgery (TTS) to identify potential modifiable factors to improve timeliness of care. METHODS: Patients with clinical stage 0-3 breast cancer undergoing partial mastectomy in 2 clinical trials, conducted in ten centers across the US, were analyzed. No preoperative workup was mandated by the study; those receiving neoadjuvant therapy were excluded. RESULTS: The median TTS among the 583 patients in this cohort was 34 days (range: 1-289). Patient age, race, tumor palpability, and genomic subtype did not influence timeliness of care defined as TTS ≤30 days. Hispanic patients less likely to have a TTS ≤30 days (P = .001). There was significant variation in TTS by surgeon (P < .001); those practicing in an academic center more likely to have TTS ≤30 days than those in a community setting (55.1% vs 19.3%, P < .001). Patients who had a preoperative ultrasound had a similar TTS to those who did not (TTS ≤30 days 41.9% vs 51.9%, respectively, P = .109), but those who had a preoperative MRI had a significantly increased TTS (TTS ≤30 days 25.0% vs 50.9%, P < .001). On multivariate analysis, patient ethnicity was no longer significantly associated with TTS ≤30 (P = .150). Rather, use of MRI (OR: .438; 95% CI: .287-.668, P < .001) and community practice type (OR: .324; 95% CI: .194-.541, P < .001) remained independent predictors of lower likelihood of TTS ≤30 days. CONCLUSIONS: Preoperative MRI significantly increases time to surgery; surgeons should consider this in deciding on its use.

Impact of Cavity Shave Margins on Margin Status in Patients with Pure Ductal Carcinoma In Situ.

BACKGROUND: We examined the impact of cavity shave margins (CSMs) on margin status in patients with pure ductal carcinoma in situ (DCIS) undergoing partial mastectomy (PM). METHODS: One hundred and nine patients from 2 multicenter, randomized controlled trials were identified with pure DCIS (no invasive cancer). Surgeons performed their best PM, with specimen radiography and resection of selective margins per surgeon discretion. Patients were then randomized to have CSM resected or not. A positive margin was defined as <2 mm from ink. RESULTS: Median patient age was 63 years; median size of DCIS was 1.20 cm; 43.6% of patients had high-grade DCIS; and 58 (53.2%) patients were randomized to take CSM. The "shave" and "no-shave" groups were well-matched for age, race, ethnicity, palpability, grade, and size of DCIS. Although 33 (56.9%) of the patients in the shave group had a positive margin before randomization, only 12 (20.7%) had a positive margin after randomization to CSM (p < 0.001). In the no-shave group, 17 patients (33.3%) had a positive margin. Controlling for size and grade of DCIS, taking CSM resulted in a nearly 65% reduction in the positive-margin rate (odds ratio 0.366; 95% CI, 0.136 to 0.981; p = 0.046). Size of DCIS remained an independent predictor of positive margins in the model (odds ratio 1.646; 95% CI, 1.227 to 2.209; p = 0.001). CONCLUSIONS: CSM reduces positive-margin rates in patients with pure DCIS, and can be a practical solution for DCIS patients who tend to have a high rate of margin positivity.

Making Use of Comparable Health Data to Improve Quality of Care and Outcomes in Diabetes: The EUBIROD Review of Diabetes Registries and Data Sources in Europe.

Background: Registries and data sources contain information that can be used on an ongoing basis to improve quality of care and outcomes of people with diabetes. As a specific task of the EU Bridge Health project, we carried out a survey of diabetes-related data sources in Europe. Objectives: We aimed to report on the organization of different sources of diabetes information, including their governance, information infrastructure and dissemination strategies for quality control, service planning, public health, policy and research. Methods: Survey using a structured questionnaire to collect targeted data from a network of collaborating institutions managing registries and data sources in 17 countries in the year 2017. Results: The 18 data sources participating in the study were most frequently academic centres (44.4%), national (72.2%), targeting all types of diabetes (61.1%) covering no more than 10% of the target population (44.4%). Although population-based in over a quarter of cases (27.8%), sources relied predominantly on provider-based datasets (38.5%), fewer using administrative data (16.6%). Data collection was continuous in the majority of cases (61.1%), but 50% could not perform data linkage. Public reports were more frequent (72.2%) as well as quality reports (77.8%), but one third did not provide feedback to policy and only half published ten or more peer reviewed papers during the last 5 years. Conclusions: The heterogeneous implementation of diabetes registries and data sources hampers the comparability of quality and outcomes across Europe. Best practices exist but need to be shared more effectively to accelerate progress and deliver equitable results for people with diabetes.

Problems with the use of breast conservation therapy for breast cancer in a patient with neurofibromatosis type 1: a case report.

Patients with neurofibromatosis type I and breast cancer represent a subset of people who may be considered at high risk for secondary cancers after conventional whole breast radiation therapy and breast conservation surgery. A case of a 49-year-old woman with neurofibromatosis type I is presented. She was diagnosed with a 1.1-cm right breast infiltrating ductal carcinoma. Clinical, diagnostic imaging, and pathologic features are discussed. Her initial treatment plan of breast conserving therapy was thwarted when her sentinel node biopsy was positive for micrometastatic disease in 1/14 lymph nodes. She elected to have a bilateral simple mastectomy. This case addresses the rare dilemma of offering breast conservation therapy as a viable option for patients with neurofibromatosis type I. Current data on radiation-induced secondary cancers such as sarcoma after treatment for breast and other cancers are reviewed.

Pregnancy-associated breast cancer patients can safely undergo lymphatic mapping.

As more women put off pregnancy until their 30s and beyond, the possibility of pregnancy-associated breast cancer (PABC) will rise. Treatment options for patients with PABC need to consider possible harm to the fetus. The goal of this study is to review our institution's experience with sentinel lymph node (SLN) biopsies in patients with PABC. A prospectively accrued breast Institutional Review Board (IRB) approved data base was searched under separate IRB approval for cases of SLN biopsy in patients with PABC. Ten patients were identified between 1994 and 2006 out of 5,563 patients. A chart review was performed on all 10 patients. Ten patients with PABC and an average gestation age of 15.8 weeks underwent SLN biopsy. All patients successfully mapped. Positive SLN were identified in 5/10 patients (50%) while there was no evidence of metastases in 5/10 patients (50%). 9/10 (90%) of patients went on to deliver healthy children without any reported problems. One patient (10%) decided to terminate her pregnancy in the first trimester following surgery prior to the start of chemotherapy. SLN biopsy can safely be performed in patients with PABC with minimal risk to the fetus. By performing a SLN biopsy, a large proportion of patients with PABC may be spared the risk of a complete axillary lymph node dissection.

An update of sentinel lymph node mapping in patients with ductal carcinoma in situ.

OBJECTIVE: The purpose of our study is to further clarify the incidence of ductal carcinoma in situ (DCIS) patients that are upstaged upon final pathology and/or have metastatic disease in the axilla. METHODS: All patients were diagnosed with DCIS or DCIS with microinvasion (DCISm) on their diagnostic biopsy and received a sentinel lymph node (SLN) biopsy between 1994 and 2004. Six hundred seventy-five patients were divided into 613 patients with DCIS and 62 patients with DCISm. RESULTS: Sixty-six of 675 (10%) were upstaged to invasive cancer. Fifty-five of 613 (9%) patients with DCIS were upstaged, whereas 11 of 62 (18%) patients with DCISm were upstaged. Forty-nine of 675 (7%) patients had +SLN. Twenty-two of 49 (45%) patients with +SLN had invasive carcinoma or DCISm on final histology. CONCLUSIONS: After review of histology, grade, type of biopsy, and mammographic findings, the combined findings of high grade, mass by mammography, and microinvasion predict patients at higher risk for invasive carcinoma. Selective utilization of SLN biopsy in DCIS is recommended.

Clinical trial designs for rare diseases: studies developed and discussed by the International Rare Cancers Initiative.

BACKGROUND: The past three decades have seen rapid improvements in the diagnosis and treatment of most cancers and the most important contributor has been research. Progress in rare cancers has been slower, not least because of the challenges of undertaking research. SETTINGS: The International Rare Cancers Initiative (IRCI) is a partnership which aims to stimulate and facilitate the development of international clinical trials for patients with rare cancers. It is focused on interventional--usually randomized--clinical trials with the clear goal of improving outcomes for patients. The key challenges are organisational and methodological. A multi-disciplinary workshop to review the methods used in ICRI portfolio trials was held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed. RESULTS: The IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made for each design. INTERPRETATION: Trials can be designed using a wide array of possibilities. There is no 'one size fits all' solution. In order to make progress in the rare diseases, decisions to change practice will have to be based on less direct evidence from clinical trials than in more common diseases.

Benign mechanical transport of breast epithelial cells to sentinel lymph nodes.

The evaluation of sentinel lymph nodes (SLNs) for the presence of malignant epithelial cells is essential to the staging of breast cancer patients. Recently, increased attention has focused on the possibility that epithelial cells may reach SLNs by benign mechanical means, rather than by metastasis. The purpose of this study was to test the hypothesis that pre-SLN biopsy breast massage, which we currently use to facilitate the localization of SLNs, might represent a mode of benign mechanical transport. We studied 56 patients with invasive and/or in situ ductal carcinoma and axillary SLNs with only epithelial cells and/or cell clusters (< or =0.2 mm in diameter and not associated with features of established metastases) detected predominantly in subcapsular sinuses of SLNs on hematoxylin and eosin- and/or anti-cytokeratin-stained sections. No patient had an SLN involved by either micro- or macro-metastatic carcinoma. Epithelial cells and cell clusters, < or =0.2 mm in size and without features of established metastases, occurred more frequently in the SLNs of patients who underwent pre-SLN biopsy breast massage (P < 0.001, chi2 test). The latter finding supports the hypothesis that pre-SLN biopsy breast massage is a mode of benign mechanical transport of epithelial cells to SLNs.

Local recurrence in lumpectomy patients after imprint cytology margin evaluation.

BACKGROUND: This is a follow-up study to our previously reported data on local recurrence rates in patients whose lumpectomy margins were evaluated by intraoperative imprint cytology (IIC(M)). The purpose of this study was to compare local recurrence rates for patients whose lumpectomy margins were evaluated with IIC(M) with local recurrence rates of those not evaluated by IIC(M). METHODS: A total of 1713 patients underwent lumpectomy treatment for breast cancer from 1988 to 2001 were prospectively entered into a computerized database and subsequently included in this study. Of the patients, 520 (group 1) had their surgery performed at an outside institution where conventional margin analysis was performed. Another 1193 (group 2) had their surgery performed at our institution where margins were evaluated by IIC(M). For each histologic type and for the overall sample, probabilities of recurrence with time were estimated using the method of Kaplan and Meier. RESULTS: IIC(M) overcomes sampling error inherent in the frozen section analysis and results in a diminished incidence of overall 5-year local recurrence from 8.8% to 2.8% (P <0.0001). The recurrence rates for each respective histologic subtype are reported for both absolute recurrences and probability of recurrence with time. CONCLUSIONS: IIC(M) provides an accurate evaluation of lumpectomy margins for patients undergoing breast-conservation treatment. IIC(M) was associated with an overall lower local recurrence rate. This series defined the utility of intraoperative imprint cytology for evaluation of margins in patients undergoing breast-conservation treatment.

Cytokeratin staining for intraoperative evaluation of sentinel lymph nodes in patients with invasive lobular carcinoma.

BACKGROUND: Frozen section and intraoperative imprint cytology (IIC(N)) are 2 methods used for intraoperative pathologic assessment of sentinel lymph nodes (SLNs). The SLN evaluation of patients with invasive lobular carcinoma (ILC) results in a relatively high number of false-negative results using either of these methods. The purpose of this study was to evaluate the added benefits that intraoperative immunohistochemical-cytokeratin staining (I(CK-IHC)) can bring to IIC(N) in the evaluation of SLN in patients with ILC. METHODS: A total of 59 breast cancer patients with ILC underwent an SLN biopsy evaluated by our standard IIC(N) assessment in addition to I(CK-IHC). The results of IIC(N) with I(CK-IHC) were compared with the final histopathologic assessment consisting of standard hematoxylin and eosin staining and additional cytokeratin staining of nodes. RESULTS: Intraoperative evaluation of SLN using IIC(N) and I(CK-IHC) correctly diagnosed the nodal status in 45 of 59 (76.3%) patients. On final histopathologic assessment, 31 of 59 (52.5%) patients were found to have positive nodes. Using I(CK-IHC), 17 of these 31 positive cases (54.8%) were detected. Using IIC(N) alone, without the benefit of I(CK-IHC), only 13 of 31 (41.9%) positive cases were detected intraoperatively. CONCLUSIONS: For patients with ILC, I(CK-IHC) staining in addition to IIC(N) improves accuracy over using IIC(N) alone. In this study, I(CK-IHC) staining demonstrated a 12.9% improvement in the detection of SLN metastases in patients with ILC. Cytopathologists should consider employing I(CK-IHC) staining to evaluate the touch-imprint slides of SLN in ILC patients.

The clinical relevance of positive sentinel nodes only versus positive nonsentinel lymph nodes in breast cancer patients.

BACKGROUND: The purpose of this study was to determine the difference in clinical outcomes for patients with histologically positive sentinel lymph nodes (SLN+) compared with patients with histologically positive nonsentinel second echelon lymph nodes (NSLN+). METHODS: Eight hundred thirteen node positive patients from a prospectively accrued database of 3200 patients who underwent sentinel node mapping were evaluated. In all, 506 of the 813 patients (62%) were SLN+ only and 307 of the 813 patients (38%) were SLN+ plus at least one NSLN+. Patients' overall survival and disease-free survival were obtained and statistical analyses performed comparing the two groups. RESULTS: As the number of NSLN+ increased, there was a significant difference in disease-free survival (P = 0.001) and overall survival (P = 0.003) between those patients who had 0 to 4 NSLN+ and those who had 5 or more NSLN+. The SLN+ only patients did not show significant differences with respect to survival, based on the number of SLN+ (overall survival, disease-free survival; P = 0.742). CONCLUSIONS: The survival (overall survival, disease-free survival) for patients with 3 or more SLN+ was not statistically different than for patients with 1 or 2 SLN+ (P = 0.742). However, an alteration of biologic behavior was observed when multiple NSLN+ contain metastatic breast cancer. Involvement of 5 or more NSLN+ portends a significantly (P = 0.001) worse prognosis, regardless of the number of SLN+.

Completion axillary lymph node dissection minimizes the likelihood of false negatives for patients with invasive breast carcinoma and cytokeratin positive only sentinel lymph nodes.

OBJECTIVE: To document the incidence of metastatic disease in complete axillary lymph node dissections (CALND) of patients with invasive carcinoma after a sentinel lymph node (SLN) biopsy, positive only by immunohistochemical staining for cytokeratin (CK-IHC). METHODS: Sections of all SLNs, negative by routine histology, were immunostained and examined for cytokeratin positive cells. Sections of lymph nodes from CALND specimens were interpreted using routine hematoxylin and eosin (H&E) staining. RESULTS: A total of 409 patients (29.6%) had metastatic disease in at least one sentinel lymph node on H&E examination. Of 971 H&E negative patients, 78 (8.0%) were positive only by CK-IHC. Sixty-two of the CK-IHC positive only patients underwent CALND. Nine of these 62 patients (14.5%) had metastases identified in the CALND specimen. CONCLUSIONS: Because 14.5% of patients with invasive breast cancer and SLNs positive only by CK-IHC were found to have H&E positive lymph nodes on CALND, we conclude first, that CK-IHC should be used to evaluate SLNs, and second, that CALND should be considered when SLNs are positive by CK-IHC only. This approach will result in an absolute reduction of the false negative rate (absolute false negative rate reduced by 2.6% in our series).