The Impact of L-Dex(®) Measurements in Assessing Breast Cancer-Related Lymphedema as Part of Routine Clinical Practice.

PURPOSE: With improved survivorship, the prevalence of breast cancer-related lymphedema (BCRL) continues to increase, leading to impairment of a patients' quality of life. While traditional diagnostic methods are limited by an inability to detect BCRL until clinically apparent, bioimpedance spectroscopy (BIS) has been shown to detect subclinical BCRL. The purpose of this study is to evaluate the role of BIS in the early detection of BCRL, as well as assessment of response to BCRL treatment. METHODS: A retrospective review of 1,133 patients treated between November 2008 and July 2013 at two surgical practices was performed. Eligible patients (n = 326) underwent preoperative and postoperative L-Dex measurements. Patients were identified as having subclinical lymphedema if they were asymptomatic and the L-Dex score increased >10 U above baseline and were monitored following treatment. Patients were stratified by lymph node dissection technique [sentinel lymph node biopsy (SLNB) vs. axillary lymph node dissection (ALND)] and receipt of BCRL treatment. RESULTS: The average age of the cohort was 56.2 years old, and mean follow-up was 21.7 months. Of the 326 patients, 210 underwent SLNB and 116 underwent ALND. BCRL was identified by L-Dex in 40 patients (12.3%). The cumulative incidence rate of subclinical lymphedema was 4.3% for SLNB (n = 9) and 26.7% for ALND (n = 31). Of those diagnosed with BCRL, 50% resolved following treatment, 27.5% underwent treatment without resolution, and 22.5% had resolution without treatment. The prevalence of persistent, clinical BCRL was 0.5% for SLNB and 8.6% for ALND. CONCLUSION: This study demonstrates both the feasibility and clinical utility of implementing L-Dex measurements in routine breast cancer care. L-Dex identified patients with possible subclinical BCRL and allowed for assessment of response to therapy.

A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision.

OBJECTIVES: This study was a multicenter evaluation of the SAVI SCOUT(®) breast localization and surgical guidance system using micro-impulse radar technology for the removal of nonpalpable breast lesions. The study was designed to validate the results of a recent 50-patient pilot study in a larger multi-institution trial. The primary endpoints were the rates of successful reflector placement, localization, and removal. METHODS: This multicenter, prospective trial enrolled patients scheduled to have excisional biopsy or breast-conserving surgery of a nonpalpable breast lesion. From March to November 2015, 154 patients were consented and evaluated by 20 radiologists and 16 surgeons at 11 participating centers. Patients had SCOUT(®) reflectors placed up to 7 days before surgery, and placement was confirmed by mammography or ultrasonography. Implanted reflectors were detected by the SCOUT(®) handpiece and console. Presence of the reflector in the excised surgical specimen was confirmed radiographically, and specimens were sent for routine pathology. RESULTS: SCOUT(®) reflectors were successfully placed in 153 of 154 patients. In one case, the reflector was placed at a distance from the target that required a wire to be placed. All 154 lesions and reflectors were successfully removed during surgery. For 101 patients with a preoperative diagnosis of cancer, 86 (85.1 %) had clear margins, and 17 (16.8 %) patients required margin reexcision. CONCLUSIONS: SCOUT(®) provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.

Breast cancer care in the community: challenges, opportunities, and outcomes.

In the USA, 80% of patients with breast cancer are treated by community breast surgeons. NCDB data indicate that there are only small differences in outcomes between lower volume cancer programs and higher volume programs. There is some evidence that breast cancer patients of high-volume breast focused surgeons may have improved outcomes. This article discusses the challenges community breast surgeons face and some ways that the quality of care could be monitored and improved. Quality reporting programs of the Commission on Cancer and Mastery of Breast Surgery Program of the American Society of Breast Surgeons are recommended as tools to track and improve outcomes in breast cancer care.

Factors influencing the number of sentinel lymph nodes identified in patients with breast cancer.

BACKGROUND: Although the sentinel lymph node (SLN) is defined as the first node draining a tumor, multiple nodes are often identified. Few SLNs are required for adequate staging; removal of more may be unnecessary. The objective of this study was to determine factors influencing the number of SLN identified. METHODS: The University of Louisville Breast Sentinel Lymph Node Study was used to determine correlates of identifying greater than 4 SLNs by using univariate and multivariate analyses. RESULTS: An SLN was identified in 3,882 of 4,131 patients (94%). The median number of SLN identified was 2 (range 1-18); 90% had < or = 4 SLNs identified. Palpable tumors, surgeon inexperience, and dermal injection were associated with greater than 4 SLNs identified. All 3 of these factors remained significant on multivariate analysis. CONCLUSIONS: Palpable tumors often have greater than 4 SLNs identified, and the use of intradermal injection increases this probability.

Are 3 sentinel nodes sufficient?

HYPOTHESIS: It has recently been proposed that only 3 sentinel lymph nodes (SLNs) are required for an adequate SLN biopsy. Others have advocated removing all nodes that are blue, hot, at the end of a blue lymphatic channel, or palpably suspicious or that have radioactive counts of 10% or greater of the most radioactive SLN. Our objective was to determine the false-negative rate (FNR) associated with limiting SLN biopsy to 3 nodes. DESIGN: Multicenter prospective study. SETTING: Both academic and private practice. PATIENTS: A total of 4131 patients underwent SLN biopsy followed by completion axillary node dissection. MAIN OUTCOME MEASURE: The FNR associated with 3-node SLN biopsy. RESULTS: Of the 4131 patients in this study, an SLN was identified in 3882 (94.0%). The median number of SLNs identified was 2; more than 3 SLNs were removed in 738 patients (17.9%). Of the patients in whom a SLN was identified, 1358 (35.0%) were node positive. The overall FNR in this study was 7.7%. In 89.7% of node-positive patients, a positive SLN was found in the first 3 SLNs removed. If SLN biopsy had been limited to the first 3 nodes, the FNR would be 10.3% (P = .005 compared with removing >3 SLNs). The FNR increased with the strategy of limiting SLN biopsy to fewer SLNs (P<.001). CONCLUSION: Removing only 3 SLNs cannot be recommended, because it is associated with a substantially increased FNR.

Factors determining adequacy of axillary node dissection in breast cancer patients.

With increased focus on quality assurance, a complete axillary lymph node dissection (ALND) has been defined as the removal of 10 or more lymph nodes (LN). The objective of this study was to determine which patient, physician, and geographic factors predict the adequacy of ALND in breast cancer patients. The University of Louisville Breast Cancer Sentinel Lymph Node Study is a multicenter, prospective study of 4,131 patients, all of whom had a sentinel node biopsy and completion ALND. Univariate and multivariate analyses were performed to determine which factors were independently associated with the removal of 10 or more LN. Of the 4,131 patients in this study, the median number of LN removed was 11 (range; 3-45). Ten or more LN were removed in 3,213 (77.8%) patients. The median patient age in this study was 60 (range; 27-100), with a median tumor size of 1.5 cm (range; 0.1-11.0 cm). On univariate analysis, patient age, tumor size, and palpability were correlated with adequacy of ALND. Academic affiliation and percentage of breast practice were significant physician factors predictive of adequacy of ALND. Both geographic region and community size were significantly correlated with adequacy of ALND. On multivariate analysis, patient age (p = 0.024), surgeon academic affiliation (p < 0.001), percentage breast practice (p < 0.001), and community size (p = 0.003) were significant determinants of adequacy of ALND. Younger patients were more likely to have an adequate ALND. Surgeons in academic practice had a higher rate of adequate ALND, as did those practicing in larger communities. Surgeons with a more breast experience had a lower rate of adequate ALND. Patient age, surgeon academic affiliation, and breast experience, as well as community size are all significant factors predictive of adequacy of ALND.

Predicting patients at low probability of requiring postmastectomy radiation therapy.

BACKGROUND: Postmastectomy radiation therapy (PMRT) is recommended for patients with four or more positive lymph nodes (LN+). Given the ramifications of PMRT for immediate reconstruction, we sought to create a model using preoperative and intraoperative factors to predict which patients with a positive sentinel lymph node will have less than four LN+. METHODS: The database from a prospective multicenter study of 4,131 patients was used for this analysis. Patients with one to three positive sentinel lymph nodes (SLN) and tumors < 5 cm (n = 1,133) in size were randomly divided into a training set (n = 580) and a test set (n = 553). Multivariate logistic regression was used on the training set to create a prediction rule that was subsequently validated in the test set. RESULTS: Median patient age was 57 (range, 27-100) years, and median tumor size was 2.0 (range, 0.2-4.8) cm. In the training set, factors associated with having four or more LN+ on multivariate analysis were: tumor size [odds ratio (OR) = 2.087; 95% confidence interval (CI): 1.307-3.333, P = 0.002), number of positive SLN (P < 0.0005), and proportion of positive SLN (OR = 3.602; 95% CI: 2.100-6.179, P < 0.005). A predictive model was established with a point assigned to each positive SLN, T2 (vs. T1), and if proportion of positive SLN was > 50%, for a maximum of five points. In both the training and test sets, patients with one point had a low probability of having four or more LN+ (3.8% and 3.3%, respectively). CONCLUSION: Tumor size, number of positive SLN, and the proportion of positive SLN influence whether patients will have four or more LN+. A simple model can predict the probability of requiring PMRT.

Prediction of sentinel lymph node-only disease in women with invasive breast cancer.

BACKGROUND: The purpose of this study was to create a model that predicts which breast cancer patients will have sentinel lymph node (SLN)-only metastasis. METHODS: SLN-positive breast cancer patients (N = 1,253) were analyzed. Multivariate analysis was performed to identify factors predicting SLN-only disease; a prediction rule was created. RESULTS: Median tumor size was 2 cm. The median number of SLNs removed was 2; the median number of positive SLNs was 1. Multivariate analysis found tumor size, number of positive SLN, and proportion of SLN positive were significant predictors of SLN-only disease (P < .001). A prediction rule with 1 point being given for >1 positive SLN, 1 point for >50% of SLN positive, and up to 4 points for tumor size (T1a = 1, T1b or T1c = 2, T2 = 3, and T3 = 4) was established. Ninety-five percent of patients with 1 point had SLN-only disease (P < .0001). CONCLUSION: An integer-based model may predict SLN-only disease and may be useful in determining whether completion axillary lymph node dissection is required.

Factors associated with surgical options for breast carcinoma.

BACKGROUND: Breast conservation surgery (BCS) and mastectomy have equivalent survival outcomes for women with breast carcinoma, but treatment decisions are affected by many factors. The current study evaluated the impact of patient and physician factors on surgical decision-making. METHODS: Statistical analyses were performed on a prospective multicenter study of patients with invasive breast carcinoma. Patient, physician, and geographic factors were considered. RESULTS: Of 4086 patients, BCS was performed in 2762 (67.6%) and mastectomy was performed in 1324 (32.4%). The median tumor size was 1.5 cm (range, < 0.1-9.0 cm) in patients undergoing BCS and 1.9 cm (range, 0.1-11.0 cm) in patients undergoing mastectomy (P < 0.00001). The median age of patients undergoing BCS was 59 years (range, 27-100 yrs), whereas patients who underwent mastectomy were older (median age of 63 yrs, range, 27-96 yrs [P < 0.00001]). Physicians in academic practices performed more lumpectomies than those who were not in an academic practice (70.9% vs. 65.7%; P = 0.001). More breast conservation procedures were performed by surgeons with a higher percentage of breast practice (P = 0.012). Geographic location was found to be significant, with the Northeast having the highest rate of breast conservation (70.8%) and the Southeast having the lowest (63.2%; P = 0.002). On multivariate analysis, patient age (odds ratio [OR]: 1.455; 95% confidence interval [95% CI], 1.247-1.699 [P < 0.001]), tumor size (P < 0.001), tumor palpability (OR: 0.613; 95% CI, 0.524-0.716 [P < 0.001]), histologic subtype (P = 0.018), tumor location in the breast (P < 0.001), physician academic affiliation (OR: 1.193; 95% CI: 1.021-1.393 [P = 0.026]), and geographic location (P = 0.045) were found to be significant. CONCLUSIONS: Treatment decisions were found to be related to patient clinicopathologic features, surgeon academic affiliation, and geographic location. Future studies will elucidate the communication and psychosocial factors that may influence patient decision-making.

Surgeon and community factors affecting breast cancer sentinel lymph node biopsy.

BACKGROUND: We sought to determine whether the results of sentinel lymph node (SLN) biopsy are related to practice and community factors. METHODS: This prospective study included more than 300 surgeons from a variety of practice environments. Most surgeons had minimal experience with SLN biopsy prior to this study. Patients underwent attempted SLN biopsy, followed by completion axillary dissection. Univariate and multivariate analyses were performed to assess factors related to the SLN identification rate and the false negative rate. RESULTS: A total of 4131 patients were enrolled. SLN identification rate was 93%; the false negative (FN) rate was 7.9%. The only factor that was significantly associated with improved SLN identification rate (odds ratio [OR] 1.60, 95% confidence interval [CI] 1.12 to 2.36, P = .0126) and FN rate (OR 2.39, 95% CI 1.32 to 4.79, P = .0073) was surgeon experience (>20 SLN cases). CONCLUSIONS: Surgeon experience is the major factor that contributes to improved SLN biopsy results. SLN biopsy can be performed equally well by community and academic surgeons.

Biopsy type does not influence sentinel lymph node status.

BACKGROUND: This study sought to determine whether the type of biopsy examination independently affects sentinel lymph node (SLN) status in breast cancer patients. METHODS: A prospective multicenter study of patients who had SLN biopsy examination followed by axillary node dissection was analyzed to determine whether the type of biopsy examination influenced SLN status. RESULTS: Of the 3853 patients studied, 32% had a positive SLN. Patients were diagnosed by fine-needle (N = 293), core-needle (N = 2154), excisional (N = 1386), or incisional (N = 20) biopsy procedures. The rates of SLN positivity for these groups were 45%, 32%, 29%, and 65%, respectively (P < .001). Other factors predictive of SLN status included: patient age (P < .001), tumor size (P < .001), tumor palpability (P < .001), number of SLN removed (P < .001), type of surgery (mastectomy vs. lumpectomy) (P < .001), histologic subtype (P = .048), and the use of immunohistochemistry (P < .001). All of these factors remained significant in the multivariate model except for histologic subtype and biopsy examination type. CONCLUSIONS: Biopsy examination type does not independently influence the risk for nodal metastasis.

Effect of lymphoscintigraphy drainage patterns on sentinel lymph node biopsy in patients with breast cancer.

BACKGROUND: Sentinel lymph node (SLN) biopsy examination is an accepted method of staging breast cancer patients. SLN biopsy examination in patients with drainage to the internal mammary chain (IMC) nodes is controversial. METHODS: A prospective study of SLN biopsy examination followed by axillary dissection was analyzed to determine how surgeons manage patients with IMC drainage and the rates of axillary SLN identification and positivity in these cases. RESULTS: Lymphoscintigraphy was performed in 2196 (53.2%) of the 4131 patients in this study. IMC drainage was noted in 80 patients (3.6%). An axillary SLN was identified in 29 of the 40 patients with IMC drainage alone (72.5%). The rate of finding a positive axillary lymph node did not differ based on the lymphoscintigraphic pattern (P = .470). CONCLUSIONS: Most surgeons do not perform IMC SLN biopsy procedures. Even when lymphoscintigraphy shows isolated drainage to IMC nodes, axillary SLNs usually are identified. Lymphoscintigraphy therefore has limited usefulness.

Factors predicting failure to identify a sentinel lymph node in breast cancer.

BACKGROUND: Although sentinel lymph node (SLN) biopsy is widely accepted as a minimally invasive method of nodal staging, failure to identify an SLN mandates a level I/II axillary node dissection. The purpose of this study was to elucidate factors that independently predict failure to identify an SLN. METHODS: Using a large multicenter prospective study of SLN biopsy for patients with invasive breast cancer, we performed univariate and multivariate regression analyses to determine clinicopathologic factors predictive of failure to identify an SLN. RESULTS: Of the total 4131 patients in the study, an SLN was not identified in 249 (6.0%). Tumor location (P = .409), biopsy type (P = .079), surgery type (P = .380), and histologic subtype (P = .999) were not significant predictors of failure to identify an SLN. On multivariate analysis, age greater than 60 years (OR = 1.469; 95% CI, 1.116-1.934, P = .006), nonpalpable tumors (OR = 0.639; 95% CI, 0.479-0.852, P = .002), injection technique with blue dye alone (OR = 0.389, 95% CI, 0.259-5.86, P < .001), and surgical experience of less than 10 SLN biopsy cases (OR = 1.886; 1.428-2.492, P < .001) were significant independent predictors of failure to identify an SLN. Optimal SLN biopsy technique using an intradermal and/or subareolar injection of radioactive colloid and blue dye can improve SLN identification rates regardless of patient and tumor characteristics. CONCLUSIONS: Patient age and tumor palpability significantly affect the ability to identify an SLN in patients with breast cancer. Optimal injection technique can significantly improve sentinel node identification rate regardless of these factors.

Sentinel lymph node biopsy for breast cancer: improvement in results over time.

Many modifications in the technique of sentinel lymph node (SLN) biopsy for breast cancer have taken place since it was first introduced. This analysis was undertaken to determine, in a large multi-institutional study, whether SLN biopsy results have improved over time. Patients with clinical stage T1-2, N0 breast cancer were enrolled in this prospective study between August 1997 and February 2002. SLN biopsy was performed using blue dye and/or radioactive colloid along with completion level I/II axillary dissection in all patients. The majority of subjects included in this study represent the surgeons' initial experience with SLN biopsy for breast cancer. Statistical comparison of the SLN identification (ID) rate and false-negative (FN) rate were performed by chi-squared analysis. A total of 3370 subjects from 300 surgeons were enrolled in the study. Collectively the SLN ID rate, as well as the mean number of SLNs removed per patient has improved, while the FN rate has remained fairly constant over time. The improved ID rate may be related to improved technical details, while the FN rate has not changed significantly. This highlights the ongoing need for surgeons to perform backup axillary dissection during their initial learning phase.

Frequency of sentinel lymph node metastases in patients with favorable breast cancer histologic subtypes.

BACKGROUND: The need for axillary nodal staging in favorable histologic subtypes of breast cancer is controversial. METHODS: Patients with clinical stage T1-2, N0 breast cancer were enrolled in a prospective, multi-institutional study. All patients underwent sentinel lymph node (SLN) biopsy followed by completion level I/II axillary dissection. RESULTS: SLN were identified in 3,106 of 3,324 patients (93%). Axillary metastases were found in 35% and 40% of patients with infiltrating ductal carcinoma and infiltrating lobular carcinoma, respectively. Among tumor subtypes, positive nodes were found in 17% of patients with pure tubular carcinoma, 7% of patients with papillary cancer, 6% of patients with colloid (mucinous) carcinoma, 21% of patients with medullary carcinoma, and 8% of patients with DCIS with microinvasion. CONCLUSIONS: Patients with favorable breast cancer subtypes have a significant rate of axillary nodal metastasis. Axillary nodal staging remains important in such patients; SLN biopsy is an ideal method to obtain this staging information.

The effect of prior breast biopsy method and concurrent definitive breast procedure on success and accuracy of sentinel lymph node biopsy.

BACKGROUND: It has been suggested that sentinel lymph node (SLN) biopsy for breast cancer may be less accurate after excisional biopsy of the primary tumor compared with core needle biopsy. Furthermore, some have suggested an improved ability to identify the SLN when total mastectomy is performed compared with lumpectomy. This analysis was performed to determine the impact of the type of breast biopsy (needle vs. excisional) or definitive surgical procedure (lumpectomy vs. mastectomy) on the accuracy of SLN biopsy. METHODS: The University of Louisville Breast Cancer Sentinel Lymph Node Study is a prospective multi-institutional study. Patients with clinical stage T1-2, N0 breast cancer were eligible. All patients underwent SLN biopsy and completion level I/II axillary dissection. Statistical comparison was performed by chi(2) analysis. RESULTS: A total of 2206 patients were enrolled in the study. There were no statistically significant differences in SLN identification rate or false-negative rate between patients undergoing excisional versus needle biopsy. The SLN identification and false-negative rates also were not statistically different between patients who had total mastectomy compared with those who had a lumpectomy. CONCLUSIONS: Excisional biopsy does not significantly affect the accuracy of SLN biopsy, nor does the type of definitive surgical procedure.