Dataset Information

Axillary management in patients with clinical node-negative early breast cancer and positive sentinel lymph node: a systematic review and meta-analysis.

ABSTRACT:

Background

The omission of axillary lymph node dissection (ALND) or axillary radiation (AxRT) remains controversial in patients with clinical node-negative early breast cancer and a positive sentinel lymph node.

Methods

We conducted a comprehensive review by searching PubMed, Embase, Web of Science, and Cochrane databases (up to November 2023). Our primary outcomes were overall survival (OS), disease-free survival (DFS), locoregional recurrence (LRR), and axillary recurrence (AR).

Results

We included 26 studies encompassing 145,548 women with clinical node-negative early breast cancer and positive sentinel lymph node. Pooled data revealed no significant differences between ALND and sentinel lymph node biopsy (SLNB) alone in terms of OS (hazard ratio [HR]0.99, 95% confidence interval [CI] 0.91-1.08, p=0.84), DFS (HR 1.04, 95% CI 0.90-1.19, p=0.61), LRR (HR 0.76, 95% CI 0.45-1.20, p=0.31), and AR (HR 1.01, 95% CI 0.99-1.03, p=0.35). Similarly, no significant differences were observed between AxRT and SLNB alone for OS (HR 0.57, 95% CI 0.32-1.02, p=0.06) and DFS (HR 0.52, 95% CI 0.26-1.05, p=0.07). When comparing AxRT and ALND, a trend towards higher OS was observed the AxRT group (HR 0.08, 95% CI 0.67-1.15), but the difference did not reach statistical significance (p=0.35, I² = 0%). Additionally, no significant differences significance observed for DFS or AR (p=0.13 and p=0.73, respectively) between the AxRT and ALND groups.

Conclusion

Our findings suggest that survival and recurrence rates are not inferior in patients with clinical node-negative early breast cancer and a positive sentinel lymph node who receive SLNB alone compared to those undergoing ALND or AxRT.

SUBMITTER: Li C

PROVIDER: S-EPMC10800700 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Axillary management in patients with clinical node-negative early breast cancer and positive sentinel lymph node: a systematic review and meta-analysis.

Li Changzai C Zhang Pan P Lv Jie J Dong Wei W Hu Baoshan B Zhang Jinji J Zhu Hongcheng H

Frontiers in oncology 20240108

<h4>Background</h4>The omission of axillary lymph node dissection (ALND) or axillary radiation (AxRT) remains controversial in patients with clinical node-negative early breast cancer and a positive sentinel lymph node.<h4>Methods</h4>We conducted a comprehensive review by searching PubMed, Embase, Web of Science, and Cochrane databases (up to November 2023). Our primary outcomes were overall survival (OS), disease-free survival (DFS), locoregional recurrence (LRR), and axillary recurrence (AR). ...[more]

PMID: 38260843

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Project description:BackgroundIn clinically node-negative (cN0) early stage breast cancer (EBC) undergoing primary systemic treatment (PST), post-treatment positive sentinel lymph node (SLN+) directs axillary lymph node dissection (ALND), with uncertain impacts on outcomes and increased morbidities.Patients and methodsWe conducted an observational study on imaging-confirmed cN0 EBC, who underwent PST and breast surgery that resulted in SLN+ and underwent ALND. The association among baseline/postsurgical clinic-pathological factors and positive nonsentinel additional axillary lymph nodes (non-SLN+) was analyzed with logistic regression. LASSO regression (LR) identified variables to include in a predictive score of non-SLN+ (ALND-predict). The accuracy and calibration were assessed, an optimal cut-point was then identified, and in silico validation with bootstrap was undertaken.ResultsNon-SLN+ were detected in 22.2% cases after ALND. Only progesterone receptor (PR) levels and macrometastatic SLN+ were independently associated to non-SLN+. LR identified PR, Ki67, and type and number of SLN+ as the most efficient covariates. The ALND-predict score was built based on their LR coefficients, showing an area under the curve (AUC) of 0.83 and an optimal cut-off of 63, with a negative predictive value (NPV) of 0.925. Continuous and dichotomic scores had a good fit (p = 0.876 and p = 1.00, respectively) and were independently associated to non-SLN+ [adjusted odds ratio (aOR): 1.06, p = 0.002 and aOR: 23.77, p < 0.001, respectively]. After 5000 bootstrap-adjusted retesting, the estimated bias-corrected and accelerated 95%CI included the aOR.ConclusionsIn cN0 EBC with post-PST SLN+, non-SLN+ at ALND are infrequent (~22%) and independently associated to PR levels and macrometastatic SLN. ALND-predict multiparametric score accurately predicted absence of non-SLN involvement, identifying most patients who could be safely spared unnecessary ALND. Prospective validation is required.

Project description:BackgroundThis systematic review and meta-analysis aimed to study the evidence on the efficacy and safety of omitting axillary lymph node dissection (ALND) for patients with clinically node-negative but sentinel lymph node (SLN)-positive breast cancer using all the available evidence.MethodsThe Embase, Medline, and Cochrane Library databases were searched through February 25, 2023. Original trials that compared only the sentinel lymph node biopsy (SLNB) with ALND as the control group for patients with clinically node-negative but SLN-positive breast cancer were included. The primary outcomes were axillary recurrence rate, total recurrence rate, disease-free survival (DFS), and overall survival (OS). Meta-analyses were performed to compare the odds ratio (OR) in rates and the hazard ratios (HR) in time-to-event outcomes between both interventions. Based on different study designs, tools in the revised Cochrane risk of bias tool were used for randomized trials and the risk of bias in nonrandomized studies of interventions to assess the risk of bias for each included article. Funnel plots and Egger's test were used for the publication's bias assessment.ResultsIn total, 30 reports from 26 studies were included in the systematic review (9 reports of RCTs, 21 reports of retrospective cohort studies). According to our analysis, omitting ALND in patients with clinically node-negative but SLN-positive breast cancer had a similar axillary recurrence rate (OR = 0.95, 95% confidence interval (CI): 0.76-1.20), DFS (HR = 1.02, 95% CI: 0.89-1.16), and OS (HR = 0.97, 95% CI: 0.92-1.03), but caused a significantly lower incidence of adverse events and benefited in locoregional recurrence rate (OR = 0.76, 95% CI: 0.59-0.97) compared with ALND.ConclusionFor patients with clinically node-negative but SLN-positive breast cancer (no matter the number of the positive SLN), this review showed that SLNB alone had a similar axillary recurrence rate, DFS, and OS, but caused a significantly lower incidence of adverse events and showed a benefit for the locoregional recurrence compared with ALND. An OS benefit was found in the Macro subset that used SLNB alone versus complete ALND. Therefore, omitting ALND is feasible in this setting.Trial registrationCRD 42023397963.

Project description:IntroductionBreast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects.Methods and analysesThis multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival.DiscussionThis study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity.Ethics and disseminationThe Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results.Trial registrationClinicalTrials.gov, identifier number NCT04889924.

Dataset Information

Axillary management in patients with clinical node-negative early breast cancer and positive sentinel lymph node: a systematic review and meta-analysis.

Background

Methods

Results

Conclusion

Publications

Axillary management in patients with clinical node-negative early breast cancer and positive sentinel lymph node: a systematic review and meta-analysis.

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