Z0011

Over the past 2 decades, axillary surgical management for breast cancer patients has been reshaped after several practice-changing randomized clinical trials provided evidence to support the de-escalation of axillary surgery, specifically the omission of axillary lymph node dissection, for patients with positive axillary lymph nodes. One such practice-changing trial was the American College of Surgeons Oncology Group Z0011 trial, which showed that patients with clinical T1-2 breast tumors and limited nodal disease (1-2 positive sentinel lymph nodes) who underwent upfront breast-conserving therapy could be safely spared the morbidity of axillary lymph node dissection...

OBJECTIVES: Preoperative evaluation of axillary lymph node (ALN) status is an essential part of deciding the appropriate treatment. According to ACOSOG Z0011 trials, the new goal of the ALN status evaluation is tumor burden (low burden, < 3 positive ALNs; high burden, ≥ 3 positive ALNs), instead of metastasis or non-metastasis. We aimed to develop a radiomics nomogram integrating clinicopathologic features, ABUS imaging features and radiomics features from ABUS for predicting ALN tumor burden in early breast cancer...

BACKGROUND: The randomized trials which include ACOSOG Z0011 and IBCSG 23-01 had found that the survival rates were not different in patients with cT1/2N0 and 1-2 sentinel lymph node (SLN)-positive, macro/micrometastases who underwent breast-conserving therapy, and micrometastases who underwent total mastectomy (TM), when axillary lymph node dissection (ALND) was omitted. However, for patients with cT1/2N0 and 1-2 SLN macrometastases who underwent TM; there was still insufficient evidence from clinical studies to support whether ALND can be exempted...

Landmark trials (Z0011 and AMAROS) have demonstrated that axillary lymph node dissection (ALND) can be safely omitted in patients with breast cancer and 1-2 positive sentinel nodes. Extrapolating from these and other cardinal studies such as NSABP B-04, guidelines state that patients with 1-2 needle biopsy-proven positive lymph nodes undergoing upfront surgery can have sentinel lymph node biopsy (SLNB) alone. The purpose of this study is to systematically review the literature to identify studies examining the direct application of SLNB in such patients...

BACKGROUND: Some studies suggested that the patients included in the Z0011 trial may represent patients with ultrasound-negative axillary nodes and axillary invasion diagnosed by sentinel node (SN) biopsy. Nevertheless, the National Comprehensive Cancer Network (NCCN) guidelines recommend SN mapping if 1 or 2 suspicious lymph nodes are identified on axillary ultrasound (AU). The aim of this preliminary phase of the Multimodal Targeted Axillary Surgery (MUTAS) trial was to establish the accuracy of SN mapping in patients with axillary involvement undergoing upfront surgery...

The outbreak of the SARS-COVID-2 pandemic (COVID-19) had a significant effect on the organisation of healthcare systems. Surgical units saw a significant reduction in the volume of surgical procedures performed, with lengthening waiting lists as a consequence. We assessed the surgical activity in relation to breast cancer that took place at the University Hospital of Cagliari, Italy, from February 2018 to March 2022. Two phases were identified based on the epidemiological circumstances: Phase 1-February 2018 to February 2020; Phase 2-March 2020 to March 2022...

The axillary nodes' status is essential in determining the treatment algorithm according to complete clinical staging. Unnecessary axillary lymph node dissection (ALND) has been prevented after sentinel lymph node biopsy (SLNB) has occurred in current practice. However, approximately half of patients with positive SLNB do not have axillary metastatic lymph nodes. Our study aims to predict unnecessary ALND in patients with SLN metastases by evaluating the patients' clinicopathological data. In total, 221 patients with macrometastasis in SLNB who underwent completion ALND were evaluated retrospectively...

Local treatment of the axilla in clinically node-negative (cN0) early breast cancer patients with routine sentinel lymph node biopsy (SLNB) is debated after publication of ACOSOG Z0011 data in 2010. Currently, prospective randomized surgical trials investigating the omission of SLNB in upfront breast-conserving surgery (BCS) and in the neoadjuvant setting, respectively. Several prospective randomized trials (SOUND, INSEMA, BOOG 2013-08, and NAUTILUS) with axillary observation alone versus SLNB in cN0 patients and primary BCS have primary objectives to evaluate oncologic safety when omitting SLNB...

BACKGROUND: In the post-Z0011 era, sentinel lymph node (SLN) status and metastatic burden determine whether axillary management entails conservative sentinel lymph node biopsy (SLNB) or radical axillary lymph node dissection (ALND) in breast cancer patients. However, SLN status and metastatic burden cannot be evaluated preoperatively in clinical practice. This study explored the predictive value of contrast-enhanced ultrasound (CEUS) patterns of SLN to assess the nodal status and metastatic burden in early breast cancer patients...

Over the past decade, axillary management in breast cancer has fundamentally shifted. The former notion that any degree of axillary nodal involvement warrants axillary lymph node dissection (ALND) has been challenged. Following publication of the ACOSOG Z0011 trial, national trends demonstrated significant reductions in ALND performance. Axillary radiotherapy in lieu of ALND is a consideration for select patients with a positive sentinel lymph node, while ongoing studies are investigating the role of adjuvant regional radiotherapy in women with positive nodes prior to neoadjuvant chemotherapy...

BACKGROUND: Sentinel lymph node dissection (SLND) is an alternative to axillary lymph node dissection (ALND) for breast cancer surgery. But the criteria of SLND only for patients with limited disease in the sentinel node is disputed. METHODS: From the Surveillance, Epidemiology, and End Results (SEER) database, 2000-2015, we identified 97,296 early breast cancer females with 1-3 axillary lymph nodes macro-metastasis. Of them, 1-5 (axillary conservation group), 6-9, and ≥ 10 (ALND group) axillary lymph nodes were dissected in 28,639, 16,838, and 51,819 patients, respectively...

BACKGROUND: The American College of Surgeons Oncology Group Z0011 trial showed that complete axillary lymph node dissection (cALND) did not improve survival benefits in patients with one or two tumour-involved sentinel lymph nodes and undergoing breast conservation. Still, a considerable number of the Z0011-eligible patients continue to be treated with cALND in various countries. Given the potential economic gain from implementation of the Z0011 recommendations, we quantified population-level impacts of omitting cALND among Z0011-eligible patients in clinical practice...

The Total Tumor Load (TTL) concept has been demonstrated to accurately predict the status of the non-sentinel lymph nodes (NSLN) in breast cancer patients. In 2019, our center implemented the TTL cut-off of 30,000 CK19 mRNA copies/μL as sole criterion for deciding on performing ALND. This retrospective, unicentric, study analyzed 87 cT1-3N0 breast cancer patients treated consecutively in a period of two years and aimed to evaluate the performance of this criterion. Secondary objectives included the comparison of the criterion versus our previous Clinical Decision Rule (CDR) versus ACOSOG Z0011 criteria for avoiding an ALND in proportion of patients spared an ALND and in proportion of patients left with a surgically untreated metastasized axilla...

PURPOSE: Clinical application of the ACOSOG Z0011 trial results allows clinically node-negative breast cancer patients who meet criteria to avoid axillary dissection even when 1-2 sentinel lymph nodes (SLNs) are positive for metastatic disease. Intraoperative frozen section (iFS) analyses of SLNs were thought to reduce re-operation rates despite variable reported sensitivity and possibility of a false negative result. This study evaluated the rate of re-operations prevented by SLN iFS in a tertiary care hospital in Bangkok, Thailand, over a 6-year time-frame...

BACKGROUND: Recent studies have suggested that a significant proportion of patients with axillary nodal metastases diagnosed by pre-operative axillary ultrasound (AUS)-guided needle biopsy were over-treated with axillary lymph node dissection (ALND). The role of routine AUS and needle biopsy in early breast cancer was questioned. This review aims to determine if pre-operative AUS could predict the extent of axillary tumor burden and need of ALND. METHODS: PubMed and Embase literature databases were searched systematically for abnormal AUS characteristics and axillary nodal burden...

PURPOSE: This study aimed to evaluate whether axillary lymph node dissection (ALND) can be omitted in patients with 1-2 positive sentinel lymph nodes (SLNs) who received total mastectomy (TM). METHODS: Consecutive breast cancer patients with 1-2 positive SLNs were retrospectively reviewed from a multi-institutional database. Patients were divided into sentinel lymph node biopsy (SLNB) group and ALND group. Administration of adjuvant chemotherapy and survival were compared between groups...

Background Intraoperative frozen section analysis (FSA) of sentinel lymph nodes (SLNs) declined in the post American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial era. However, for those patients who do not meet the ACOSOG Z0011 criteria, FSA continues to be a valuable tool in intraoperative decision-making for axillary lymph node dissection (ALND). The aim of this study was therefore to retrospectively evaluate the benefit and accuracy of FSA of Z0011 criteria eligible versus ineligible patients and identify possible predictive factors for false negative results...

Based on the American College of Surgeons Oncology Group (ACOSOG)-Z0011, a useful nomogram has been constructed to identify patients who do not require intraoperative frozen sections to evaluate sentinel lymph nodes in the previous study. This study investigated the developed nomogram by ultrasonography (US) and positron emission tomography (PET)/computed tomography (CT) as a modality. In the training set, 89/1030 (8.6%) patients had three or more positive nodes. Larger tumor size, higher grade ultrasonographic ALN classification, and findings suspicious of positive ALN on PET/CT were associated in multivariate analysis...

Pathologic examination of the sentinel lymph nodes (SLNs) in patients with breast cancer has been impacted by the publication of practicing changing trials over the last decade. With evidence from the ACOSOG Z0011 trial to suggest that there is no significant benefit to axillary lymph node dissection (ALND) in early-stage breast cancer patients with up to 2 positive SLNs, the rate of ALND, and in turn, intraoperative evaluation of SLNs has significantly decreased. It is of limited clinical significance to pursue multiple levels and cytokeratin immunohistochemistry to detect occult small metastases, such as isolated tumor cells and micrometastases, in this setting...

BACKGROUND: In 2021, there is an increased global trend for sending sentinel lymph node biopsy (SLNB) specimens for permanent section (PS) without intraoperative frozen sections (FS). This pilot study conducted in Thailand determines the re-operation rate for SLNB without FS. METHOD: We retrospectively reviewed 239 SLNB cases without FS at King Chulalongkorn Memorial Hospital from April 2016 to April 2021. The patients were diagnosed with primary invasive breast cancer with clinically negative nodes...