A prospective validation cohort study of a prediction model on non-sentinel lymph node involvement in early breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 559-559
Author(s):  
Xingfei Yu ◽  
Linyan Zhou ◽  
Chen Yang ◽  
Yang Yu ◽  
Daobao Chen ◽  
...  

559 Background: Early breast cancer (cT1-2N0) with one or two sentinel lymph node (SLN) involved may avoid axillary lymph node dissection (ALND) if follow by radiotherapy supported by Z0011 and AMAROS trials. However, only less than one-third of those patients have positive non-sentinel lymph node (nSLN) and can truly benefit from radiotherapy or ALND in those two trials. It is necessary to identify the risk of nSLN metastasis before local treatment decision. We previously developed a predictive model for nSLN involvement using circulating CK19 mRNA level combined with contrast-enhanced ultrasound (CEUS) score (ASCO2017 poster 239, NCT02992067) in a training set. To evaluate the predict effect of this model, we designed a further study using the model prospectively in a validation set (NCT03280134). Methods: We identified early breast cancer cases in Zhejiang Cancer Hospital from July 2017 to June 2018. The level of circulating CK19 mRNA tested by qRT-PCR and CEUS scores were collected before surgery in each case. Patients with 1~2 SLN involved were enrolled and continued for ALND. The estimated percentage of nSLN-involved were calculated both by our model formula and the Memorial Sloan-Kettering Cancer Center (MSKCC) nomogram. The predictive accuracy and false negative rates (FNR) were evaluated and the area under curve (AUC) was compared between two predictive models. Results: Totally, 235 patients diagnosed as early breast cancer with 1~2 SLN involved were enrolled and 35.36% of them were nSLN involved after ALND. The total accuracy and FNR by our model for nSLN-involved prediction was 94.89% and 6.02%, respectively. The AUC was 0.952 (95%CI, 0.922~0.982), significantly higher than that in MSKCC model 0.880 (95%CI, 0.833~0.927). Furthermore, only CK19 mRNA level (HR = 40.091, 95%CI, 13.663~117.635) and CEUS score (HR = 2.009, 95%CI 1.158~3.485) are significantly related to nSLN involvement in both univariate and multivariate analysis, adjusted by age, menopause statue, tumor size, histological grade, estrogen receptor, progesterone receptor and human epidermalgrowth factor receptor-2 expression. Conclusions: Our model using CK19 mRNA and CEUS score showed potential predictive value of nSLN before surgery in early breast cancer patients. Further validation in larger multicenter cohort is warranted before changing clinical practice.

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Zhu-Jun Loh ◽  
Kuo-Ting Lee ◽  
Ya-Ping Chen ◽  
Yao-Lung Kuo ◽  
Wei-Pang Chung ◽  
...  

Abstract Background Sentinel lymph node biopsy (SLNB) is the standard approach for the axillary region in early breast cancer patients with clinically negative nodes. The present study investigated patients with false-negative sentinel nodes in intraoperative frozen sections (FNSN) using real-world data. Methods A case–control study with a 1:3 ratio was conducted. FNSN was determined when sentinel nodes (SNs) were negative in frozen sections but positive for metastasis in formalin-fixed paraffin-embedded (FFPE) sections. The control was defined as having no metastasis of SNs in both frozen and FFPE sections. Results A total of 20 FNSN cases and 60 matched controls from 333 SLNB patients were enrolled between April 1, 2005, and November 31, 2009. The demographics and intrinsic subtypes of breast cancer were similar between the FNSN and control groups. The FNSN patients had larger tumor sizes on preoperative mammography (P = 0.033) and more lymphatic tumor emboli on core biopsy (P < 0.001). Four FNSN patients had metastasis in nonrelevant SNs. Another 16 FNSN patients had benign lymphoid hyperplasia of SNs in frozen sections and metastasis in the same SNs from FFPE sections. Micrometastasis was detected in seven of 16 patients, and metastases in nonrelevant SNs were recognized in two patients. All FNSN patients underwent a second operation with axillary lymph node dissection (ALND). After a median follow-up of 143 months, no FNSN patients developed breast cancer recurrence. The disease-free survival, breast cancer-specific survival, and overall survival in FNSN were not inferior to those in controls. Conclusions Patients with a larger tumor size and more lymphatic tumor emboli have a higher incidence of FNSN. However, the outcomes of FNSN patients after completing ALND were noninferior to those without SN metastasis. ALND provides a correct staging for patients with metastasis in nonsentinel axillary lymph nodes.


2021 ◽  
Vol 20 (3) ◽  
Author(s):  
Loh Soon Khang ◽  
Suraya Baharudin ◽  
Juliana Abdul Latiff ◽  
Siti Aishah Mahamad Dom ◽  
Shahrun Niza Suhaimi

INTRODUCTION: Introduction: Sentinel lymph node biopsy (SLNB) is now recognized as the standard of care for early breast cancer patients with negative axillary lymph nodes. Various approaches for Sentinel Lymph Node (SLN) identification using either the blue dye method or scintigraphy alone or their combination have been proposed. However, this method is costly and may not be applicable in certain developing countries. SLNB involving the use of indocyanine green (ICG) offers several advantages, and it is valid and safe when in direct comparison with the blue dye method and scintigraphy. Hence, we performed SLNB using this method in early breast cancer as the first center that involves the use of ICG in Malaysia. We performed validation study on this method with the aims to determine its sensitivity and safety profile. MATERIALS AND METHODS: This is a validation and non-randomised prospective observational study involving 20 patients underwent SLNB wherein ICG is used for localisation. The patients were recruited according to the recommendations stipulated in the Malaysia Clinical Practice Guideline. RESULT: The average number of SLNs removed per patient was 4.0 (range, 3–6) with sentinel lymph nodes detection rate at 98.75% (79/80). The false negative rate is at 5%. No adverse events were observed in all cases. CONCLUSION: The ICG fluorescence method is simple, reliable and safe. Moreover, it demonstrates a high SLN detection rate with a low false-negative rate, and it does not require a special instrument for radioisotope use.


2019 ◽  
Vol 6 (6) ◽  
pp. 2126
Author(s):  
Anshika Arora ◽  
Neena Chauhan ◽  
Sunil Saini ◽  
Nishish Vishwakarma ◽  
Tanvi Luthra

Background: Evaluation of axilla using sentinel lymph node biopsy (SLNB) is the standard of care in node negative early breast cancer. Intra operative assessment of SLNB with frozen section (FS) often guides the surgeon regarding decision for level of axillary dissection. The aim of this study was to evaluate accuracy of FS of SLNB in these patients with histopathology examination (HPE) as the gold standard.Methods: This study was performed between July 2017 and November 2018. After gross evaluation of SLNB, nodes were cut in half and frozen; the other half was preserved for HPE. For FS, nodes were sectioned to 4 mm width and examined.Results: A total of 61 patients underwent SLNB, 55 patients undergoing intra-operative FS. The mean age was 53 years (range 30-84, ± 15.09 SD), primary tumor was clinically T1 in 23.6%, T2 in 76.4% patients. A median of four sentinel nodes were identified, mean size 13.84 mm. On FS SLNB was positive for metastasis in 14 (25.5%), on HPE in 16 (29.1%) patients. There were 13 true positive, 38 true negative, 3 false negative and 1 false positive result for FS. The sensitivity, specificity, positive and negative predictive value, false negative and false positive rates were 81.25%, 97.44%, 92.86%, 92.73%, 18.75% and 2.56% respectively in this study. The overall accuracy of FS of SLNB in early carcinoma breast was found to be 92.73%.Conclusions: An intra-operative FS of the SLN in node negative early breast cancer is a highly sensitive tool in axilla management.


2018 ◽  
Vol 07 (02) ◽  
pp. 132-136
Author(s):  
Vedant Kabra ◽  
R. Aggarwal ◽  
S. Vardhan ◽  
M. Singh ◽  
R. Khandelwal ◽  
...  

AbstractAxillary lymph node involvement is a very important poor prognostic factor in the clinical staging and management of breast cancer patients. Traditionally, axillary lymph node dissection (ALND) has been used for determining the status of the axillary lymph nodes. More recently the sentinel lymph node biopsy (SLNB) procedure has gained wider acceptance as the standard of care, having the advantage of being less invasivewhile providing good accuracy. This expert group used data from published literature, practical experience and opinion of a large group of academic oncologists to arrive at these practical consensus recommendations in regards with the use of the two different procedures and other issues in patients with early breast cancer for the benefit of community oncologists.


Medicina ◽  
2020 ◽  
Vol 56 (3) ◽  
pp. 127 ◽  
Author(s):  
Dalia Rukanskienė ◽  
Vincentas Veikutis ◽  
Eglė Jonaitienė ◽  
Milda Basevičiūtė ◽  
Domantas Kunigiškis ◽  
...  

Background and objectives: With improved diagnostic means of early breast cancer, the percentage of cases with metastasis in axillary lymph nodes has decreased from 50–75% to 15–30%. Lymphadenectomy and sentinel lymph node biopsy are not treatment procedures, as they aim at axillary nodal staging in breast cancer. Being surgical interventions, they can lead to various complications. Therefore, recently much attention has been paid to the identification of non-invasive methods for axillary nodal staging. In many countries, ultrasound is a first-line method to evaluate axillary lymph node status. The aim of this study was to evaluate the prognostic value of ultrasound in detecting intact axillary lymph nodes and to assess the accuracy of ultrasound in detecting a heavy nodal disease burden. The additional objective was to evaluate patients’ and tumor characteristics leading to false-negative results. Materials and Methods: A total of 227 women with newly diagnosed pT1 breast cancer were included to this prospective study conducted at the Breast Surgery Unit, Clinic of Surgery, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, between May 1, 2016, and May 31, 2018. All patients underwent preoperative axillary ultrasound examination. Ultrasound data were compared with the results of histological examination. The accuracy and true-negative rate of ultrasound were calculated. The reasons of false-negative results were analyzed. Results: Of the 189 patients who had normally appearing axillary lymph nodes on preoperative ultrasound (PAUS-negative), 173 (91.5%) patients were also confirmed to have intact axillary lymph nodes (node-negative) by histological examination after surgery. The accuracy and the negative predictive value of ultrasound examination were 84.1% and 91.5%, respectively. In ≥3 node-positive cases, the accuracy and the negative predictive value increased to 88.7% and 98.3%, respectively. In total, false-negative results were found in 8.5% of the cases (n = 16); in the PAUS-negative group, false-negative results were recorded only in 1.6% of the cases (n = 3). The results of PAUS and pathological examination differed significantly between patients without and with lymphovascular invasion (LV0 vs. LV1, p < 0.001) as well as those showing no human epidermal growth factor receptor 2 (HER2) expression and patients with weakly or strongly expressed HER2 (HER2(0) vs. HER2(1), p = 0.024). Paired comparisons revealed that the true-negative rate was significantly different between the LV0 and LV1 groups (91% vs. 66.7%, p < 0.05), and the false-negative rate was statistically significant different between the HER2(0) and HER2(1) groups (10.5% vs. 1.2%, p < 0.05). Evaluation of other characteristics showed both the groups to be homogenous. Conclusions: Negative axillary ultrasound excluded axillary metastatic disease in 91.5% of the patients. PAUS had an accuracy of 88.7% in detecting a heavy nodal disease burden. With the absence of lymphovascular invasion (LV0), we can rely on PAUS examination that axillary lymph nodes are intact (PAUS-negative), and this patients’ group could avoid sentinel lymph node biopsy. Patients without HER2 expression are at a greater likelihood of false-negative results; therefore, the findings of ultrasound that axillary lymph nodes are intact (PAUS-negative results) should be interpreted with caution.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21068-21068 ◽  
Author(s):  
G. W. Sauer ◽  
N. Schneiderhahn-Marra ◽  
C. Kurzeder ◽  
K. Koretz ◽  
R. Kreienberg ◽  
...  

21068 Background: Axillary lymph node dissection (ALND) still remains the standard treatment for breast cancer patients with sentinel lymph node (SLN) metastases. However, since only 40% to 60% of patients show additional lymph involvement, complete ALND offers no additional benefit for almost 50% of patients but carries a significant risk of axillary morbidity. In an attempt to achieve a more precise prediction for the individual patient a multivariable logistic-regression analysis of a large data set of eight histopathological variables has been published by the Memorial Sloan-Kettering Cancer Center (MSKCC) that predicts the likelihood of metastases in Non-SLNs with a ROC of 0,71. To achieve a more precise estimation of additional lymph node involvement preoperatively we analysed molecular markers of potential predictive value. Methods: Beside histopathological variables, fifty proteins of potential prognostic and predictive value were preoperatively quantified in lysates from 120 core needle biopsies with multiplex sandwich immunoassays. Biopsies, taken at the Breast Cancer Center of the University of Ulm Medical School, were classified as invasive mammary carcinomas. Variables which could be used to improve the accuracy of prediction of non-sentinel lymph node (NSLN) involvement were defined. Results: We demonstrated appropriate sensitivity, reproducibility, and robustness for this protein microarray technology to characterize proteins in core needle biopsies and generate reliable data sets. In an initial univariate data analysis (Mann Whitney test) six of the analysed parameters (TIMP2, p= 0,027; FasR, p = 0,0025; MIF, p= 0,030; FGF-2, p= 0,0020, PDGF AA/BB p= 0,027; RANTES p= 0,024) correlated with NSLN involvement beside known histopathological variables (i.e. tumor size, p= 0,006; grading, p = 0,0009). Conclusions: We defined molecular markers of diagnostic value to predict NSLN involvement. This might be an acceptable substitute to the known histopathological variables by the MSKCC nomogram to predict potential NSLN involvement preoperatively. No significant financial relationships to disclose.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Smriti Karki ◽  
Yasmin Hassen ◽  
Arunmoy Chakravorty ◽  
Karolina Ajauskaite ◽  
Ekambaram Dinkara Babu

Abstract Aims NICE guidelines have not defined the timing of Sentinel Lymph Node Biopsy (SLNB) with respect to neoadjuvant chemotherapy (NACT). While there is an ongoing debate, the emerging consensus is in favour of SLNB following NACT in clinically node-negative (cN0) patients which confers the advantage of better prognostic outcomes as a negative SLNB negates further Axillary Lymph Node Dissection (ALND) and prevents patients having further unnecessary surgery. Thus, the aim of the study was to establish whether unnecessary ALND can be safely avoided by performing SLNB after NACT. Method Retrospective case records review of all patients treated with ALND at a single institution was undertaken from January 2018 to December 2019. Results 73 patients had ALND in this time frame. Patients received SLNB before NACT and ALND was performed if they were found node-positive on SLNB. Out of 73 patients, 24 patients had no further nodal disease, 26 had 1-2 macrometastasis and 23 had 3 or more macrometastasis on ALND. 57/73 patients had early breast cancer (T1/T2). 21/57 were cN0 but and 5/21 had NACT following SLNB and ALND after NACT. Of the 5 patients, 2 (40%) had no nodal disease on ALND. Conclusion 40% patients could have avoided ALND if SLNB was done after NACT. Also, 68% (50/73) patients who had ALND only had &lt;2 lymph node macrometastasis. This data implies that patients with early breast cancer may be getting subjected to a second operation which not only is unnecessary but also may have debilitating complications.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yang Yu ◽  
Zhijun Wang ◽  
Zhongyin Wei ◽  
Bofan Yu ◽  
Peng Shen ◽  
...  

Abstract Background It is reported that appropriately 50% of early breast cancer patients with 1–2 positive sentinel lymph node (SLN) micro-metastases could not benefit from axillary lymph node dissection (ALND) or breast-conserving surgery with whole breast irradiation. However, whether patients with 1–2 positive SLN macro-metastases could benefit from ALND remains unknown. The aim of our study was to develop and validate nomograms for assessing axillary non-SLN metastases in patients with 1–2 positive SLN macro-metastases, using their pathological features alone or in combination with STMs. Methods We retrospectively reviewed pathological features and STMs of 1150 early breast cancer patients from two independent cohorts. Best subset regression was used for feature selection and signature building. The risk score of axillary non-SLN metastases was calculated for each patient as a linear combination of selected predictors that were weighted by their respective coefficients. Results The pathology-based nomogram possessed a strong discrimination ability for axillary non-SLN metastases, with an area under the receiver operating characteristic (ROC) curve (AUC) of 0.727 (95% CI: 0.682–0.771) in the primary cohort and 0.722 (95% CI: 0.653–0.792) in the validation cohort. The addition of CA 15–3 and CEA can significantly improve the performance of pathology-based nomogram in the primary cohort (AUC: 0.773 (0.732–0.815) vs. 0.727 (0.682–0.771), P < 0.001) and validation cohort (AUC: (0.777 (0.713–0.840) vs. 0.722 (0.653–0.792), P < 0.001). Decision curve analysis demonstrated that the nomograms were clinically useful. Conclusion The nomograms based on pathological features can be used to identify axillary non-SLN metastases in breast cancer patients with 1–2 positive SLN. In addition, the combination of STMs and pathological features can identify patients with patients with axillary non-SLN metastases more accurately than pathological characteristics alone.


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