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Purpose: The ACOSOG Z0011 (Z11) trial assessed the benefit of axillary dissection (ALND) for breast cancer patients with sentinel lymph node (SLN) metastases; however, Z11 excluded patients with ≥ 3 positive SLNs. We analyzed trends in ALND omission in patients with ≥ 3 positive SLNs. Methods: Women with ≥ 3 positive SLNs who underwent breast-conserving surgery (BCS) or mastectomy between 2018 and 2020 in the National Cancer Database were included using SLN codes initiated in 2018. Patients with stage IV disease, recurrent breast cancer, and who underwent neoadjuvant chemotherapy were excluded. A multivariable logistic regression model was utilized to determine the proportion who received ALND and factors associated with ALND omission. A subgroup analysis was performed among patients who met the remainder of the Z11 inclusion criteria (BCS, T1/T2 breast cancer). Results: We identified 3654 patients with ≥ 3 positive SLNs. ALND was omitted in 37% of patients, and omission significantly increased from 2018 to 2020 (29% vs. 41%, p < 0.0001). Older age, lower grade tumors, no radiation, non-academic facility, BCS, more SLNs examined and fewer positive SLNs were significantly associated with ALND omission. 942 patients with ≥ 3 positive SLNs met the remainder of the Z11 inclusion criteria. ALND was omitted in 49% of these patients, and omission increased from 2018 to 2020 (44% vs. 49%, p = 0.22). Conclusion: Approximately one-third of patients with ≥ 3 positive SLNs do not undergo ALND; omission of ALND increased from 2018 to 2020. Studies assessing oncologic outcomes of patients with ≥ 3 positive SLNs who do and do not receive ALND are required. [ABSTRACT FROM AUTHOR]

Abstract Background Ultrasound, along with ultrasound-guided fine needle aspiration, is currently used for the axillary evaluation of breast cancer patients in order to identify candidates for axillary lymph node dissection. The aim of this study is to evaluate the accuracy of this tool in correctly identifying patients who may or may not benefit from axillary clearance in light of the ACOSOG Z0011 trial recommendations. Methods One hundred one patients (65 with positive US-FNA with corresponding axillary lymph node dissection (ALND), and 36 with negative US-FNA with corresponding ALND/sentinel lymph node biopsy) were studied for the number of involved axillary lymph nodes, tumor clinicopathologic features, and axillary radiologic findings. Results From the positive US-FNA group, 43% of patients had two or fewer positive lymph nodes upon ALND pathologic examination. In the US-FNA negative group, the negative predictive value for detecting axillary disease was 72.7%. With both groups combined, the sensitivity, specificity, PPV, and NPV of US-FNA for selecting patients based on axillary disease burden were 86%, 51.7%, 57%, and 83.3%, respectively. Conclusion Based on Z0011 guidelines, US-FNA is not a reliable tool in triaging patients in need for ALND and leads to overtreatment of 43% patients when positive, while depriving a small but significant percentage of patients from necessary therapy, when negative.

Abstract Objectives Available evidence on axillary surgery has accumulated dramatically in the last two decades in favor of less invasive care. The aim of this paper is to study 16-years trends in the surgical management of the axilla in a large population-based data set of screen-detected breast cancers in Italy and to document at what extent recommendations have been adopted in actual clinical care. Material and methods This is a retrospective cohort study documenting the surgical management of the axilla in primary breast cancer patients over time. We retrieved from the Italian database of screen-detected cancers 41213 cases diagnosed in women aged 50–69 between years 2000 and 2015 in twelve Italian Regions. Results In pN0 cases, an increasing trend (p < 0.001) in the number of patients who received sentinel lymph node biopsy (SLNB) as the only axillary staging procedure was observed. In pN + cases SLNB was the only staging procedure in an increasing number of patients (p < 0.001) especially since the publication of the ACOSOG-Z0011 paper. In ductal carcinoma in situ (DCIS) SLNB was more frequent in mastectomies and in high grade and large lesions. However, 45% of low grade, small DCIS over the whole time period had some form of axillary surgery. Conclusion This large series of screen-detected cases documents a strong time trend in the direction of reducing axillary surgery and hence potential harms from treatment. The continuing practice of SLNB in low risk DCIS is of concern in an era of increasing awareness towards overdiagnosis and overtreatment. Highlights • Invasiveness of axillary surgery decreased dramatically in the last two decades. • Completion ALND in N+ patients decreased since publication of the Z0011 paper. • Smaller size, low grade and ER + are inversely associated to completion ALND. • Sentinel lymph node biopsy in low risk DCIS shows large variation in use. [ABSTRACT FROM AUTHOR]

Introduction: Axillary node status is a predictor of breast cancer survival. Axillary node dissection (ALND) following positive sentinel node biopsy (SLNB) is challenged by the American College of Surgeons Z0011 trial, where clinically/radiologically node-negative, SLNB positive early stage patients failed to derive therapeutic benefit from ALND at 6 years. Aims: To quantify the rates of non-sentinel lymph node positivity after ALND in all breast cancer stages. To assess Z0011 trial result application to an Irish patient population. Methods: Retrospective review of a prospectively maintained database of clinically node-negative patients undergoing breast conserving surgery and ALND for a positive SLNB from January 2011 to January 2012. Results: Of 174 new breast cancers diagnosed, 144 underwent surgery of which 127 patients were clinically/radiologically node-negative; 46 patients were SLNB positive; 34 (73.9 %) proceeded to ALND. Of 9 T1 tumours, 3 (33.3 %) had further positive nodes on ALND. Of 24 T2 tumours, 11 (45.8 %) had further positive nodes on ALND. All 3 (100 %) T3/T4 tumours had further positive nodes on ALND. Mean numbers of sentinel and axillary nodes harvested were 2.3 and 15.2, respectively. In the SLNB positive, ALND negative group, 12 of 18 (66.7 %) patients were <60 years versus 14 of 17 (82.4 %) in the SLNB positive, ALND positive group. This may be indicative that younger women have a trend toward node positivity following ALND for a positive SLNB. Conclusion: These data suggest that a significant proportion (41.9 %) of T1/T2 tumours undergoing ALND following positive SLNB have further positive nodes. It may be premature to exclude ALND in patients with T1/T2 tumours following a positive SLNB. [ABSTRACT FROM AUTHOR]

Background: In breast cancer patients fulfilling the Z0011 trial criteria, axillary lymph node dissection (ALND) is reserved for patients with a high nodal burden of ≥3 metastatic nodes. In this group of patients, to avoid an ALND, neoadjuvant chemotherapy (NACT) could be given instead to achieve nodal pathological complete response (pCR). However, the benefit of NACT in achieving nodal pCR and avoiding ALND in this group of patients is unknown. We aimed to determine the nodal pCR rate in this group of patients who otherwise would have needed an ALND., Methods: cT1-2N0 breast cancer patients, with histologically proven nodal metastasis, who underwent NACT were identified from a prospectively maintained database. The sonographic criteria of ≥3 abnormal nodes, which has been reported as highly predictive of high nodal burden, was then used to identify the high nodal burden group. Nodal pCR was determined based on the ALND following NACT., Results: Twenty-four patients with high nodal burden were identified. Mean age was 55.2 years. 91.7% had invasive ductal carcinoma and 29.2% had grade III cancer. 54.2% achieved nodal pCR which was associated with ypT (P=0.006). Nodal pCR was 75%, 70% and 30% in the triple negative, human epidermal growth factor receptor2 (HER2) positive and ER/PR+HER2- tumors, respectively., Conclusions: In the postulated T1-2 breast cancer patients with high nodal burden, needing an upfront ALND, NACT could result in nodal pCR of 54.2%, with higher pCR in certain subtypes. Hence, to minimize ALND risk, NACT should be offered in this high nodal burden group., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-22-7/coif). The authors have no conflicts of interest to declare., (2022 Gland Surgery. All rights reserved.)

Abstract: The standard of practice in breast cancer surgery is that all patients with a positive sentinel node mandate an axillary lymph node dissection (ALND). Recently, this dogma has been challenged by a trial from ACOSOG (American College Of Surgeons Oncology Group) (Trial Z0011) which demonstrated that patients (without clinically/radiologically apparent axillary metastases) undergoing breast conserving surgery (i.e lumpectomy followed by whole breast radiotherapy) with positive sentinel nodes failed to derive any significant benefit by having an axillary lymph node dissection (ALND) . The logical progression from this study is to question the validity of performing routine axillary lymph node dissections on all patients with positive sentinel lymph nodes (SLN). In addition to the Z0011 trial, there is emerging data that additional patients exist who fail to derive any benefit from axillary surgery. The aim of this article is to discuss the potential subpopulations of patients that may avoid unnecessary ALND in the modern era of breast cancer management. [Copyright &y& Elsevier]