Feasibility and validation of the targeted axillary dissection technique in the axillary staging of breast cancer after neoadjuvant therapy: Definitive results.

AIM: to study the feasibility and value of "Targeted Axillary Dissection" (TAD) in cN1 breast cancer (BC) patients undergoing neoadjuvant chemotherapy (NACT), in order to avoid unnecessary axillary lymph node dissection (ALND). MATERIALS AND METHODS: Design: Prospective observational study. INCLUSION CRITERIA: Patients with histologically confirmed cN1 staging BC and treated with NACT between January 2016 and August 2019 who accomplished clinical response. METHOD: Fine-Needle Aspiration (FNA) positive axillary nodes were marked with a metallic clip prior to neoadjuvant treatment. All patients were summited to TAD and ALND. Analysis of data: We performed [1]: a feasibility analysis of clinical, radiological and pathological variables, as well as difficulties and complications of the TAD [2]; a diagnostic test study of the sentinel lymph node biopsy (SLNB), clipped lymph node biopsy (BCLIP) and their combination (TAD), using ALND as the Gold Standard. RESULTS: 60 patients were included. 43 patients (71.7%) had a complete clinical lymph node response to NACT. Neither limitations nor complications in clip placement were found. Intraoperative location of the clipped node was problematic in 7 cases (11.7%). The pathological complete response rate (pCR) was 30.5% (18 patients) and ypN0 staging rate was 38.3% (23 patients). Sensitivity values of each technique were: SLNB: 80.9% (95%CI: 61.8-100); BCLIP: 80.8% (95%CI: 63.7-97.8); TAD: 92.6% (95%CI: 80.9-100) with negative predictive values of: SLNB: 84.6% (95%CI: 68.8-100); BCLIP: 81.0% (95%CI: 63.7-97.8); TAD: 91.3% (95%CI: 77.6-100). CONCLUSION: TAD is feasible and valid to rule out axillary metastatic involvement in cN1 breast cancer patients who respond to NACT.

Development of a predictive score of axillary lymph node dissection based on targeted axillary dissection in patients with breast cancer diagnosis, affected lymph nodes, and neoadjuvant treatment.

AIM: To determine predictive factors of axillary lymph node dissection (ALND) results in breast cancer (BC) patients undergoing neoadjuvant chemotherapy (NACT), and subsequent staging using Targeted Axillary Dissection (TAD). MATERIAL AND METHOD: Case-control study between January 2016 and August 2019. Patients with BC, cN1 staging, marked with a metallic clip prior to NACT, and subsequently staged with TAD and ALND were included. They were divided into 2 groups: ALND patients with or without metastatic involvement (group 1 and group 2, respectively). We carried out a univariate analysis comparing clinical, radiological, surgical and pathological variables, and a logistic regression, (dependent variable: positive result of ALND; independent variables: number of suspicious lymph nodes in diagnostic ultrasound, positive hormone receptors, HER2 positive, complete clinical-radiological response to NACT, positive TAD, and biopsy of ≤2 nodes in TAD). A score for prediction of a metastatic ALND was proposed, with an internal validation study. RESULTS: 60 patients were included: Group 1: 33 (55.0%); Group 2: 27 (45.0%). Tumor size (Odds Ratio (OR) = 1.67; 95%CI 1.02-2.74), number of suspected nodes in ultrasound (OR = 2.20; 95%CI 1.01-4, 77), HER2 positive (OR 0.04; 95%CI 0.003-0.54), clinical-radiological response to NACT (OR = 0.07; 95%CI 0.01-0.75), and positive TAD (OR 15.48; 95%CI 1.68-142.78) were independent predictors of a positive result in ALND. We developed a "positive ALND predictive score", with good calibration (Hosmer-Lemeshow test: p = 0.65), and discrimination (AUC = 0.93; 95% CI 0, 87-0.99), with highest Youden index (0.7) at cut-off point of 17% risk of positive ALND (sensitivity = 100%; specificity = 70%). CONCLUSION: Tumor size, number of suspected nodes, positive HER2, response to NACT, and metastatic TAD are independent predictors of ALND. The predictive score for positive ALND would be a good indicator to safely omit ALND.

El problema de la estadificación axilar en el cáncer de mama tras quimioterapia neoadyuvante. Papel de la disección axilar dirigida y tipos de marcadores ganglionares / The problem of axillary staging in breast cancer after neoadjuvant chemotherapy. Role of targeted axillary dissection and types of lymph node markers

La disección axilar dirigida (DAD) consiste en una nueva técnica de estadificación axilar que combina la biopsia selectiva del ganglio centinela (BSGC) y la biopsia del ganglio marcado con clip (BCLIP) en la misma cirugía, para reestadificar a las pacientes con cáncer de mama con ganglios axilares positivos tratadas mediante quimioterapia neoadyuvante (QTNA). Para su realización, previo a la QTNA, se punciona el ganglio metastásico de manera ecoguiada y se deja un marcador en su interior, para biopsiarlo de manera dirigida en la cirugía posterior. Existen numerosos marcadores: desde clips de acero, titanio o ácido poliglicólico hasta semillas de radioyodo o ferromagnéticas, que difieren en su método de localización y recuperación (arpón, sonda de detección gamma, o sonda magnética). El objetivo de este trabajo es realizar una revisión sistemática del estado actual de la DAD, así como explicar las diferentes técnicas y tipos de marcaje axilar, con base en la evidencia disponible

Targeted axillary dissection (TAD) consists of a new axillary staging technique that combines sentinel lymph node biopsy (SLNB) and clipped lymph node biopsy (CLNB) in the same surgery, in order to re-stage patients with breast cancer and positive axillary lymph nodes undergoing neoadjuvant chemotherapy (NAQT). Prior to the NAQT, the affected lymph node is punctured and a solid marker is left inside echo-guided, in order to biopsy it in the subsequent surgery. There are numerous types of markers: metallic (steel, titanium or polyglycolic acid clips), radioiodine or ferromagnetic seeds, which differ in the method of location (wire, gamma-detection or magnetic probe). The aim of this study is to perform a systematic review about the current status of the TAD, as well as to explain the different techniques and types of axillary marking, based on the current available evidence

Ultrasound staging in breast cancer: A decision-making oriented approach to axillary metastatic burden prediction.

PURPOSE: The possibility of avoiding axillary lymphadenectomy (AL) in patients with breast cancer (BC) after positive sentinel lymph node biopsy (SLNB) and low metastatic burden (< ó = 2 positive lymph nodes) has put into question the role of axillary ultrasound due to the risk of overtreatment after positive axillary lymph node biopsy with low metastatic burden. Our aim was to identify clinical and ultrasound features to detect low and high metastatic burden. METHODS: A retrospective study of 405 BC patients with primary surgical treatment with axillary ultrasound examination and subsequent AL after positive fine needle aspiration (FNA) or SLNB. The low and high tumor burdens after AL were correlated with clinical and ultrasound variables: lymph node morphology (UN1 to UN5), number of suspicious lymph nodes, and Berg level. RESULTS: Positive FNA, lymph node morphology UN4 (focal thickening with displacement of the fatty hilum) or UN5 (complete replacement of the fatty hilum) and >2 suspicious lymph nodes were significantly associated with "high metastatic burden". Lymph node morphology UN2 and UN3, even after FNA+, lymph node morphology UN4 after FNA-, and suspicious lymph nodes at Berg level I were low metastatic burden criteria. Lymph node morphology UN5, lymph node morphology UN4 after FNA+, two nodes or more with UN4/UN5 morphology, and suspicious lymph nodes at Berg levels II and III with FNA+ were associated with high metastatic burden. CONCLUSIONS: Axillary lymph node ultrasound data for patients with early BC allows predicting the axillary metastatic burden, guiding the optimal clinical management of the axilla.

The problem of axillary staging in breast cancer after neoadjuvant chemotherapy. Role of targeted axillary dissection and types of lymph node markers. / El problema de la estadificación axilar en el cáncer de mama tras quimioterapia neoadyuvante. Papel de la disección axilar dirigida y tipos de marcadores ganglionares.

Targeted axillary dissection (TAD) consists of a new axillary staging technique that combines sentinel lymph node biopsy (SLNB) and clipped lymph node biopsy (CLNB) in the same surgery, in order to re-stage patients with breast cancer and positive axillary lymph nodes undergoing neoadjuvant chemotherapy (NAQT). Prior to the NAQT, the affected lymph node is punctured and a solid marker is left inside echo-guided, in order to biopsy it in the subsequent surgery. There are numerous types of markers: metallic (steel, titanium or polyglycolic acid clips), radioiodine or ferromagnetic seeds, which differ in the method of location (wire, gamma-detection or magnetic probe). The aim of this study is to perform a systematic review about the current status of the TAD, as well as to explain the different techniques and types of axillary marking, based on the current available evidence.

Validation of the targeted axillary dissection technique in the axillary staging of breast cancer after neoadjuvant therapy: Preliminary results.

AIM: To study the feasibility and validity of ultrasound-guided pre-chemotherapy marking of metastatic axillary lymph nodes followed by targeted axillary dissection (TAD), in breast cancer patients undergoing neoadjuvant chemotherapy (NACT). MATERIAL AND METHOD: Prospective diagnostic test study conducted between January 2016 and March 2018. Patients with breast cancer and indication for NACT, cN1 or cN2 axillary staging, were included. A clip was placed in the affected lymph node prior to NACT. A sentinel lymph-node biopsy (SLNB) and a clipped lymph-node biopsy (BCLIP) were conducted, followed by axillary lymph node dissection (ALND). Location rate (LR) and negative predictive value (NPV) were evaluated, taking SLNB, BCLIP and their combination (TAD) as evaluated tests and metastatic involvement in the ALND specimen as the gold standard. RESULTS: Twenty-three patients were included in the study. Sentinel lymph node could only be detected in 19 cases (LR = 80.61%), whereas BCLIP was successful in 22 (LR = 95.65%). The sentinel lymph node coincided with the marked lymph node in 14 patients (60.9%). We found a NPV for the SLNB of 0.85 (95%CI: 0.61-1.0), whereas for TAD it was 1.00 (95%CI: 0.74-1.0). CONCLUSION: TAD is a feasible test for axillary restaging after NACT, with a higher success rate than SLNB.

Evidencias y controversias de la categoría 3 del Breast Imaging Reporting and Data System® en enfermedad mamaria / Evidences and controversies in Breast Imaging Reporting and Data System® category 3

La valoración clínica combinada con distintas exploraciones complementarias, principalmente la mamografía y la ecografía, constituye la aproximación habitual en el diagnóstico de una lesión sospechosa de mama en pacientes sintomáticas. En el caso de mujeres asintomáticas sometidas a cribado poblacional, la mamografía y/o la ecografía suponen el establecimiento de la sospecha y el inicio de cualquier protocolo diagnóstico. Sin embargo, ninguna de estas tecnologías aplicada aisladamente o en combinación es capaz de diferenciar el 100% de las lesiones malignas, por lo que resulta necesario en muchas ocasiones recurrir a la biopsia para confirmar el diagnóstico. Un alto porcentaje de estas biopsias resultan finalmente benignas, pero a costa de una inevitable morbilidad asociada (que no es exclusivamente la ansiedad) para la paciente y un aumento en el consumo de recursos. En el sistema Breast Imaging Reporting and Data System®, la categoría 3 (hallazgo probablemente benigno) es la que mayor variabilidad interobservador presenta, no solo en la descripción, sino también en el manejo, esto es seguimiento o biopsia. Encontrar el equilibrio entre no perder la posibilidad de un diagnóstico precoz y no abusar de pruebas intervencionistas, con la mayor eficacia y garantía para la paciente al menor coste, es el desafío que se plantea: un desarrollo conceptual y/o tecnólogico que mejore el rendimiento diagnóstico de estas exploraciones y nos permita tomar decisiones adecuadas en este contexto de variabilidad(AU)

A clinical assessment including several complementary tests such as mammography and ultrasound, mainly, is the gold standard in the diagnosis of suspicious breast images in symptomatic women. For asymptomatic women under breast screening, both techniques establish the grade of suspicion and the initial diagnostic workup. However, none of these technologies, applied alone or in combination, have a 100% accuracy and a biopsy is frequently needed to confirm the diagnosis. A high percentage of these biopsies are finally benign, which certainly means a high cost in terms of morbidity —which stands not only for anxiety— and resources. The Breast Imaging Reporting and Data System® 3 category (probably benign finding) is the most ambiguous one in the ACR lexicon system. A considerable inter-observer variability has been published both in the classifying process and the management —biopsy or follow-up— of the assessed lesions. The challenge in this setting is finding a correct balance between early diagnosis and invasive testing. A conceptual and/or technical framework leading to improve diagnostic performance in this category is imperative to allow us to make the right decisions in this context of variability(AU)