Novel Intraoperative Molecular Test for Sentinel Lymph Node Metastases in Patients With Early-Stage Breast Cancer

2008 ◽  
Vol 26 (20) ◽  
pp. 3338-3345 ◽  
Author(s):  
Thomas B. Julian ◽  
Peter Blumencranz ◽  
Kenneth Deck ◽  
Pat Whitworth ◽  
Donald A. Berry ◽  
...  

PurposeAn accurate, intraoperative sentinel lymph node (SLN) test could decrease delayed axillary dissections. Molecular tests may be more sensitive than current intraoperative tests but historically have not been rapid enough and have not been properly validated. We present the results from a large, prospective evaluation of the first rapid molecular SLN test, the Breast Lymph Node (BLN) Assay.MethodsA beta trial (n = 304) to determine the threshold levels of mammaglobin and cytokeratin 19 correlating with metastasis greater than 0.2 mm and a validation trial (n = 416) to validate the threshold cutoffs were conducted. Alternating portions from each SLN were processed for histology and the BLN Assay.ResultsBLN Assay performance against extensive permanent-section histology verified by central pathology review was similar to that expected of standard permanent-section histology: sensitivity, 87.6%; specificity, 94.2%; positive predictive value, 86.2%; and negative predictive value (NPV), 94.9%. In 319 patients with both frozen-section hematoxylin and eosin results and BLN Assay results, the BLN Assay had higher sensitivity (95.6%) and NPV (98.2%) than frozen section (sensitivity, 85.6%; NPV, 94.5%). The assay can be performed in approximately 36 to 46 minutes for one to three nodes.ConclusionThe BLN Assay allows a rapid evaluation of 50% of each SLN. Comparison with permanent-section histology on adjacent node pieces evaluated by expert pathologists indicated that the BLN Assay was more sensitive than current intraoperative techniques while maintaining high specificity. These data indicate that the assay may be clinically useful for intraoperative or postoperative axillary lymph node dissection decisions.

2008 ◽  
Vol 74 (5) ◽  
pp. 423-427
Author(s):  
Flavia E. Davit ◽  
Patrick Gatmaitan ◽  
Gerard Garguilo

Sentinel lymph node biopsy has become an accepted procedure for staging the axilla in early stage breast cancer. Our objectives were to review our practice of sentinel lymph node (SLN) mapping in breast cancer, to determine the impact of frozen section (FS) analysis of the SLN on patient management, and to compare our results to national data. We retrospectively reviewed the medical records of our patients with breast cancer who underwent SLN mapping with or without axillary lymph node dissection (ALND) between 1999 and 2006. During this period, 478 patients were treated for breast cancer, with 227 patients undergoing SLN mapping. The SLN was identified in 201 patients, with a positive SLN found in 52 patients (25.9%). There was a discrepancy between the intraoperative analysis (FS/touch prep) and final pathology in 20 patients (11.3%). Nineteen of those patients had a negative FS with positive final pathology. Six of these patients underwent completion ALND. One patient had a false-positive FS with a negative ALND. No axillary recurrences were observed. Eight patients (3.5%) developed postoperative complications. Our practice has been to use intraoperative evaluation of the SLN to reduce the number of patients requiring a secondary ALND. In our study, six patients returned to the operating room for a completion ALND. Our complication rate and axillary recurrence rates were similar to national data.


2008 ◽  
Vol 23 (1) ◽  
pp. 10-17 ◽  
Author(s):  
F. Révillion ◽  
V. Lhotellier ◽  
L. Hornez ◽  
A. Leroy ◽  
M.C. Baranzelli ◽  
...  

At the Centre Oscar Lambret, the anticancer centre of the North of France, sentinel lymph node (SLN) procedures are routinely performed for localized (T0–T1, N0, M0) breast carcinoma without any previous treatment, in order to prevent the deleterious effects of axillary lymph node dissection. The present study was undertaken to assess if the expression in the tumor of a panel of 19 genes would allow to predict histological SLN involvement. We looked at cytokeratin 19 (CK19), mucin-1 (MUC1), mammaglobin (MGB1), cyclin D1 (CCND1), the four members of the HER/ErbB growth factor receptor family (EGFR, HER2–4), insulin-like growth factor-1 receptor (IGF-1R), estradiol receptors (ERcx, ERβ), progesterone receptor (PR), vascular endothelial growth factors (VEGF, VEGF-C), urokinase-like plasminogen activator (uPA), matrix metalloproteinases 2 and 9 (MMP2, MMP9), ets-related transcription factor ERM, and E-cadherin (CDH1). Their expression was quantified by real-time RT-PCR in 134 breast cancer samples and the relationships with SLN metastases were analyzed. A slight increase (35–40%) in CK19 and HER3 expression was observed in the tumors of patients with SLN metastases compared to those of patients without metastases, even if neither CK19 expression nor HER3 expression allowed to distinguish patients with micrometastases from patients with macrometastases. We conclude that the tumoral expression of biological parameters involved in cell proliferation or playing a critical role in the metastatic process, including tumor invasion and angiogenesis, is not strongly associated with SLN metastases.


2019 ◽  
Vol 18 ◽  
pp. 153303381882110 ◽  
Author(s):  
Willard Wong ◽  
Illana Rubenchik ◽  
Sharon Nofech-Mozes ◽  
Elzbieta Slodkowska ◽  
Carlos Parra-Herran ◽  
...  

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.


2009 ◽  
Vol 12 (3) ◽  
Author(s):  
J. Reeder ◽  
S. Puhalla ◽  
V. Vogel

AbstractThe most important predictor of outcome for women with early stage breast cancer is the presence or absence of metastases in the axillary lymph nodes. In the era of sentinel lymph node biopsies and improved pathology techniques, micrometastatic disease can be diagnosed. The question of whether or not to treat these women as if they have nodal disease remains in doubt. In order to further explore this topic, we identified two cases of women with nodal micrometastases at our institution. A literature review of PUBMED and SABCS abstracts was then performed. In this article, we discuss our results and the emerging clinical debate about the management of nodal micrometastases.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11584-e11584
Author(s):  
H. Kawaguchi ◽  
H. Shigematsu ◽  
C. Koga ◽  
E. Mori ◽  
S. Nishimura ◽  
...  

e11584 Background: In woman with breast cancer, sentinel lymph node (SLN) biopsy (SLNB) provides staging information and a favorable effect on quality of life if the SLN does not have metastasis. While many reports already showed safety and reliability about SLNB for breast cancer patients in Western countries, few reports have published from Asian countries. Our purpose of this study is to prove the technical success, accuracy and safety of this method for Asian population. Methods: We did feasibility study of 183 patients from 2000 to 2002. After that, we evaluated detection rate, positive rate, axillary relapse rate in 1,000 consecutive patients who underwent sentinel lymph node biopsy for breast cancer at a single institute in Japan from 2002 to August 2008. In this series, both radioactive agent (technetium) and vital blue die (indigocarmine) were used to investigate the SLNs. Results: We could accurately predict SLNs in 994 (99.4%) of the 1,000 patients. The proportion of technical success was high regardless of surgeon's experience. Intraoperative frozen section histology showed that positive SLNs were found in 176 (17.7%) patients (13 micrometastasis and 163 macrometastasis). Defenitive histology found metastasis in 24 cases who defined as negative by the frozen section examination. 15 of 24 (62.5%) cases underwent delayed axillary lymph node dissection (ALND) after definitive histology. The histological concordance between frozen section and permanent sections of SLNs was 97.6%. Finally, 796 patients were followed up without ALND. With a median follow-up time of 3.5 years (0.5–5.2), axillary lymph node recurrence were occurred in 5 patients (5 of 796, 0.6%). The relapse time since SLNB ranged from 16 to 33 months. There were not any patients with allergic reactions. Conclusions: This is the report about observation study including more than 1,000 patients from Asian country. SLNB is seemed to be a safe and acceptably accurate method for Asian early breast cancer patients. No significant financial relationships to disclose.


2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 117-117
Author(s):  
Archana Radhakrishnan ◽  
Paula Silverman ◽  
Robert R. Shenk ◽  
Cheryl L. Thompson

117 Background: Racial disparities in outcomes continue to persist amongst breast cancer (BC) patients (pts). Standard of care for the surgical evaluation of early BC has changed from axillary lymph node dissection being recommended for axillary staging to sentinel lymph node biopsy (SLNB) for clinically node-negative pts. SLNB, however, can be deferred if findings would not alter treatment plans. The goal of this study is to determine if SLNB rates differ by race, age, insurer, community vs academic setting or surgeon. Causes contributing to disparities will be considered. Methods: Pts undergoing primary surgery for early stage BC from 2010-2011 at our academic teaching hospital and two affiliated community medical centers were identified from the tumor registry. Data abstracted included demographics, insurance type, medical center and surgeon. For pts without SLNB, clinical information was confirmed with medical record review. Unadjusted comparison of factors for pts who did and did not have SLNB was evaluated with a t-test or chi square test. Logistic regression modeling assessed significance of demographic and clinical factors predicting SLNB. Results: 499 pts were identified; 114 (23%) were black, 373 (75%) white, and 12 (2%) others/unknown race. SLNB was performed in 443 (89%) of total pts, without racial differences (86% of black and 89% of white pts (p=0.31) had SLNB). Average age of pts who had SLNB was younger (60.4) than those who did not (76.3) (p<0.01). As compared to those with managed care insurance (97%) or Medicaid (91%), only 78% of Medicare pts had SLNB (p<0.01). There was no statistical difference in SLNB rates between academic and community medical centers or by surgeon. Chart review determined that the standard of care was met in 55/56 pts who did not have SLNB; reasons for no SLNB include advanced age (range 79-95), in-breast recurrences, and positive nodes pre-operatively. Conclusions: Utilization rates of SLNB did not differ between black and white BC pts. Differences were seen based on age and insurer. Although only 89% of pts had SLNB, careful evaluation for reasons reveals medically appropriate treatment in almost all cases. These results suggest cautionary interpretation of large database findings.


Cancer ◽  
2003 ◽  
Vol 97 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Ashesh B. Jani ◽  
Anirban Basu ◽  
Ruth Heimann ◽  
Samuel Hellman

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