Axillary Sentinel Lymph Node Biopsy Research Articles

Oncologic Outcomes for Different Axillary Staging Techniques in Patients with Nodal-Positive Breast Cancer Undergoing Neoadjuvant Systematic Treatment: A Cancer Registry Study.

Targeted approaches such as targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB) showed false-negative rates of < 10% compared with axillary lymph node dissection (ALND) in patients with nodal-positive breast cancer undergoing neoadjuvant systemic treatment (NAST). We aimed to evaluate real-world oncologic outcomes for different axillary staging techniques. We identified nodal-positive breast cancer patients undergoing NAST from 2016 to 2021 from the state cancer registry of Baden-Wuerttemberg, Germany. Invasive disease-free survival (iDFS) was assessed using Kaplan-Meier statistics and multivariate Cox regression models (adjusted for age, ypN stage, ypT stage, and tumor biologic subtype). A total of 2698 patients with a median follow-up of 24.7 months were identified: 2204 underwent ALND, 460 underwent SLNB (255 with ≥ 3 sentinel lymph nodes [SLNs] removed, 205 with 1-2 SLNs removed), and 34 underwent TAD. iDFS 3 years after surgery was 69.7% (ALND), 76.6% (SLNB with ≥ 3 SLNs removed), 76.7% (SLNB with < 3 SLNs removed), and 78.7% (TAD). Multivariate Cox regression analysis showed no significant influence of different axillary staging techniques on iDFS (hazard ratio [HR] for SLNB with < 3 SLNs removed 0.96, 95% confidence interval [CI] 0.62-1.50; HR for SLNB with ≥ 3 SLNs removed 0.86, 95% CI 0.56-1.3; HR for TAD 0.23, 95% CI 0.03-1.64; ALND reference), and for ypN+ (HR 1.92, 95% CI 1.49-2.49), triple-negative breast cancer (HR 2.35, 95% CI 1.80-3.06), and ypT3-4 (HR 2.93, 95% CI 2.02-4.24). These real-world data provide evidence that patient selection for de-escalated axillary surgery for patients with nodal-positive breast cancer undergoing NAST was successfully adopted and no early alarm signals of iDFS detriment were detected.

Abstract PS01-01: Feasibility and oncological safety of targeted axillary dissection or sentinel lymph node biopsy in patients with clinically node-positive disease after neoadjuvant chemotherapy in the prospective MF-1803 NEOSENTITURK-study

Abstract PS01-01: Feasibility and oncological safety of targeted axillary dissection or sentinel lymph node biopsy in patients with clinically node-positive disease after neoadjuvant chemotherapy in the prospective MF-1803 NEOSENTITURK-study

Abstract PO5-23-01: SentiNeo: A feasibility study on a magnetic approach to targeted axillary dissection and sentinel lymph node biopsy after neoadjuvant chemotherapy

Abstract Background Neoadjuvant chemotherapy (NAC) is increasingly used to treat certain breast cancer subtypes, and often, with good axillary response. Axillary management after NAC has become a contentious topic. Low detection rates and high false negative rates for sentinel lymph node biopsies (SLNB) could be due to the chemotherapy-induced fibrosis and blockage of the lymphatic drainage. Complete axillary response raises the dilemma of whether axillary clearance is still necessary after NAC in node positive patients. Targeted axillary dissection (TAD) is a safe alternative but the optimal method for index metastatic lymph node marking and lymphatic mapping of additional SLNs is largely undetermined. In SentiNeo, we study the feasibility and accuracy of using superparamagnetic iron oxides nanoparticles (SPIO) and magnetic seeds for axillary staging after NAC. Methods: Patients from two hospitals undergoing NAC were included: 40 without (cN0) and 40 with (cN+) axillary metastases. For cN0, SPIO was injected before and Technetium (Tc99) after NAC. For cN+, a magnetic clip was inserted into the index metastatic node together with SPIO injection before and Tc99 after NAC. Endpoints were 1) Index node detection and 2) SLN detection and concordance rates. Detection rate was defined as the proportion of patients who had SLNs detected as per tracer (using both magnetometer and gamma probe). Concordance was defined as the number of nodes marked by both SPIO and Tc99, divided by the total number of Tc99 marked nodes. As this is a feasibility study, no calculations for statistical significance were done. Results: All 80 patients have been included and 60 have completed NAC and surgery: 35 cN0 with SLNB and 25 cN+ with TAD. Overall, SLN detection rates (excluding the index nodes) were 83.3% (50/60) for SPIO and 76.7% (46/60) for Tc99. In cN0, SLN detection rate was 85.7% (30/35) for SPIO) and 88.6% (31/35) for Tc99. In cN+, the index node was found in 24 of 25 patients. One patient did not receive a magnetic clip due to administrative error. The SLN detection rate (excluding index nodes) was 80% (20/25) for SPIO) and 60% (15/25) for Tc99. In total, 142 lymph nodes were retrieved, of which 71 contained both tracers. The concordance was 84% (out of 84 nodes detected with Tc99, 71 were also detected with SPIO). However, the reversed concordance was only 55% (out of 129 nodes detected with SPIO, 71 were radioactive). The overall mean (median) number of retrieved nodes were 2.2 (2) for SPIO and 1.4 (1) for Tc99. Conclusions: In this pilot study we have shown that injecting SPIO before NAC is feasible with detection rates comparable to Tc99injected after NAC. More nodes were retrieved with SPIO and furthermore, we hypothesize that these nodes might be more representative than nodes detected with a tracer injected after NAC. Finding the index node using the SentiMag probe was easy. For SLN detection with SPIO the same probe was used, making the magnetic approach to axillary staging an appealing alternative with no need for an extra localisation before surgery or access to nuclear medicine facilities. These findings justify a larger study which is in planning. Table. Citation Format: Kian Chin, Roger Olofsson Bagge, Nushin Mirzaei, Anikó Kovács, Henrik Leonhardt, Pontus Zaar, Andreas Karakatsanis, Eirini Pantiora, Staffan Eriksson, Maria Ekholm, Alastair Thompson, Peter Barry, Michael Boland, Vivian Man, Ava Kwong, Fredrik Wärnberg. SentiNeo: A feasibility study on a magnetic approach to targeted axillary dissection and sentinel lymph node biopsy after neoadjuvant chemotherapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-23-01.

Abstract PO5-18-10: Omission of SLNB in triple-negative and HER2-positive breast cancer patients with radiologic and pathologic complete response in the breast after NAST: a single-arm, prospective surgical trial (EUBREAST-01 trial, GBG 104)

Abstract Background: Currently, axillary surgery for breast cancer is considered a staging procedure that does not seem to influence breast cancer mortality since the risk of developing metastasis depends mainly on the biological behavior of the primary (seed-and-soil model). Based on this, postsurgical therapy should be considered based on biological tumor characteristics. Retrospective data of cancer registry trials showed a strong correlation between breast pathologic complete response (pCR) and nodal pCR depending on intrinsic subtypes. Improvements in systemic treatments for breast cancer have increased the rates of pCR in patients receiving neoadjuvant systemic therapy (NAST), offering the opportunity to decrease, and perhaps eliminate, surgery in patients who have a pCR. Trial design: The EUBREAST network designed a clinical trial (NCT04101851) in which only patients with the highest likelihood of having a pCR after NAST (triple-negative or HER2-positive breast cancer) will be included, and type of surgery will be defined according to the response to NAST rather than on the classical T and N status at presentation. In the ongoing trial, axillary surgery will be eliminated (no axillary sentinel lymph node biopsy [SLNB]) for initially clinical node-negative (cN0) patients with radiologic complete remission (rCR) and a breast pCR (ypT0/ypTis) as determined in the lumpectomy specimen. The trial design is a multicenter single-arm study with a limited number of patients (N=440 as the screening population with an expected 80% pCR-rate) which might give practice-changing results in a short period, sparing the time and the costs of a randomized comparison. Patients will be recruited in European countries (Austria, Germany, Italy, and Spain) over 48 months. Inclusion criteria: -Written informed consent -Histologically confirmed unilateral primary invasive carcinoma of the breast (core biopsy). Multifocal or multicentric tumors are allowed if breast-conserving surgery (BCS) is planned. -Age at diagnosis at least 18 years -imaging techniques with estimated tumor stage between cT1-T3 before NAST -triple-negative (TNBC) or HER2-positive invasive breast cancer -TNBC is defined by: ER-negative (&amp;lt; 10% positive cells in IHC) and PgR-negative (&amp;lt; 10% positive cells in IHC), HER2-negative -clinically and sonographically tumor-free axilla before core biopsy (cN0/iN0) -in cases with cN0 and iN+, a negative core biopsy or fine-needle aspiration biopsy of the sonographically suspected lymph node is required -no evidence for distant metastasis (M0) -standard NAST with rCR -planned BCS with postoperative external whole-breast irradiation (conventional fractionation or hypofractionation) Primary objective: 3-year rate of axillary recurrence-free survival (ARFS) after BCS Statistics: The calculated total case number for per-protocol analysis is N=350, and the expected total number of screened patients is N=440. The assumption for acceptable 3-year ARFS ≥98.5% in the experimental arm is based on previous study findings. Timelines: -First patient in: January 2021 -Last patient in: December 2024 -Primary outcome analysis: Q1/2027 Current accrual: In June 2023, 255 patients were recruited; the majority of them in Germany. Contact: Prof. Dr. Toralf Reimer (eubreast-01@kliniksued-rostock.de), study chair Dr. Oreste D. Gentilini (gentilini.oreste@hsr.it), study co-chair Funding by Else Kroener-Fresenius Foundation, German Society of Senology, University of Rostock (Germany), and San Raffaele Hospital (Milan, Italy). Citation Format: Toralf Reimer, Bernd Gerber, Thorsten Kuehn, Nikola Bangemann, Anke Kleine-Tebbe, Andrea Stefek, Ulrike Doerste, Carolin Hammerle, Oliver Hoffmann, Alexander Hein, Isabel Rubio, Florentia Peintinger, Keyur Mehta, Sibylle Loibl, Edoardo Botteri, Oreste Gentilini. Omission of SLNB in triple-negative and HER2-positive breast cancer patients with radiologic and pathologic complete response in the breast after NAST: a single-arm, prospective surgical trial (EUBREAST-01 trial, GBG 104) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-18-10.

Abstract PO5-02-12: Comparison of survival outcomes according to axillary ultrasonography findings and cytology results in early-stage breast cancer patients

Abstract Purpose: Axillary lymph node dissection and sentinel lymph node biopsy are associated with increased risk of post-surgical complications including lymphedema and recent trials have raised questions about the therapeutic benefit of axillary operation in early-stage breast cancer patients. While treatment options for lymph nodes with negative findings on axillary ultrasonography (AUS) or positive findings on fine needle aspiration biopsy (FNAB) are evident, data regarding lymph nodes that are suspicious on AUS but negative by FNAB are limited. Thus, we aimed to compare clinicopathological characteristics of AUS positive and FNAB negative patients with those of AUS negative or FNAB positive patients. Materials and Methods: Medical records of patients who underwent breast cancer surgery between January 2010 and December 2017 were reviewed. Patients were grouped into the following three groups: (a) negative findings on AUS, (b) suspicious findings on AUS but negative on FNAB, (c) and FNAB positive. A total of 4,506 patients were included for analysis, with 3,771 patients with no suspicious lymph nodes on AUS, 557 patients who had suspicious AUS findings but were negative on FNAB, and 178 patients with positive findings on both AUS and FNAB. Primary endpoints were disease free survival (DFS) and recurrence free survival (RFS), and secondary endpoint was overall survival (OS). Results: At a median follow-up period of 92 months, DFS and RFS was significantly higher in the AUS negative group compared to the other two groups (10-year-DFS: 91.6% vs 87.5% vs 75.7%, 10-year-RFS: 95.0% vs 89.9% vs 77.1%, p &amp;lt; 0.001). In terms of OS, AUS negative group and the AUS positive and FNAB negative group did not show statistically significant survival difference (10-year-OS: 94.5% vs 92.8%, p = 0.061), while the FNAB positive group showed significantly lower survival rates (10-year-OS: 81.8%, p &amp;lt; 0.001). Multivariable analysis revealed that not AUS positive and FANB negative but positive FNAB was significantly associated with poor RFS. Moreover, hormone receptor (HR) positive and HER2 negative subtype showed poor DFS and RFS in subgroup analysis. Conclusion: Early breast cancer patients with suspicious findings on AUS but negative FNAB results had similar OS but inferior DFS and RFS compared to those with negative features on AUS, especially in HR(+)HER2(-) subtype. While further prospective trials are warranted to determine whether additional treatment is necessary, close surveillance is recommended for this subgroup of patients. Figure1. Overall survial and Disease free survival according to axillay US and FNAB status Table1. patients' characteristics Table2. prognostic factors for overall survival and disease free survival related to axillary US and FNAB status Citation Format: Suk Jun Lee. Comparison of survival outcomes according to axillary ultrasonography findings and cytology results in early-stage breast cancer patients [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-02-12.

Abstract PO3-12-02: SAFETY AND TOLERANCE OF THE USE OF SHOCK WAVE THERAPY IN LYMPHEDEMA SECONDARY TO THE TREATMENT OF BREAST CANCER

Abstract Introduction: Lymphedema is a very common complication of breast cancer treatment. The first-line therapeutic method for lymphedema is Complex Physical Therapy. An option currently mentioned as an adjuvant and non-invasive treatment for lymphedema secondary to breast cancer is Shockwave Therapy. Objectives: To evaluate the safety and tolerance of shockwave therapy for the treatment of upper limb lymphedema secondary to breast cancer treatment. Methods: This is a quasi-experimental study carried out with 17 women who underwent breast surgery associated with axillary lymphadenectomy or Sentinel Lymph Node Biopsy and who had upper limb lymphedema secondary to the treatment of breast cancer. All were treated with complex physical therapy prior to the study. Four sessions of Shockwave Therapy were applied, 4000 shocks at 0.06 mJ/mm2, 1 time per week for 4 consecutive weeks. For that, the participants were evaluated through the application of questionnaires and physical examination and underwent shock wave therapy for the upper limb ipsilateral to the surgery. Results: After the intervention, none of the participants had skin lesions, blisters, desquamation or hyperthermia of the limbs, and 17.65% had skin redness. Most patients reported no change in their social life and that they felt safer in daily activities and very satisfied with the treatment. The patients showed improvement in upper limb functionality after the intervention versus baseline (p=0.02). No difference in limb volume and shoulder range of motion over time for all movements performed was found after the intervention and at the evaluated intervals. In addition, improvements were observed in some domains of the quality-of-life questionnaires. Conclusion: Shockwave Therapy proved to be safe and tolerable in patients with lymphedema, with improved functionality and no significant change in the volume of the affected limb. Keywords: Extracorporeal shock wave therapy; Lymphedema; Breast cancer. Citation Format: Patricia Lima Ventura, Cinira Haddad, Vanessa Sanvido, Afonso Nazário, Gil Facina, Amanda Estevao, Samantha Lopes de Almeida Rizzi. SAFETY AND TOLERANCE OF THE USE OF SHOCK WAVE THERAPY IN LYMPHEDEMA SECONDARY TO THE TREATMENT OF BREAST CANCER [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-12-02.

Evaluation of targeted axillary dissection in node positive locally advanced breast cancer patients with complete pathological response to neoadjuvant chemotherapy

Background This study aimed to evaluate targeted axillary dissection in node locally advanced node positive breast cancer patients with complete pathological response to neoadjuvant chemotherapy. Patients and methods This is a prospective cohort study including 25 females diagnosed with locally advanced breast cancer with proven lymph node involvement who had complete pathological response to the neoadjuvant chemotherapy regarding the clipped previously involved lymph node. Lymph node biopsy and frozen section of the clipped lymph node after wire localization and the sentinel lymph node after patent blue dye injection was done. This is followed by paraffin section examination of the lymph node biopsy and 6 months follow-up for the patients. Results Twenty-four patients out of 25 patients had successful localization of the clipped and sentinel lymph node with no macrometastasis detected in frozen section. Twenty-two out of the 24 patients had no micrometastasis in paraffin section. Two of the 24 patients had micrometastasis on paraffin section and required axillary radiotherapy. One of the 25 patients failed localization of the clipped lymph node and received conventional axillary lymph node dissection. Two patients developed lymphedema, one of them after axillary radiotherapy, and the other one after axillary lymph node dissection. Conclusion The combination of targeted axillary dissection and sentinel lymph node biopsy can replace axillary clearance in patients with node positive locally advanced breast cancer with complete pathological response to neoadjuvant chemotherapy.

Mortality comparison between axillary lymph node dissection (ALND) and sentinel lymph node biopsy (SND) among breast cancer pantient: A meta-analysis and systematic review study

Introduction: Axillary lymph node dissection (ALND) is a crucial surgical procedure for breast cancer. It has guaranteed locoregional control of the disease, guided adjuvant therapy, and functioned as a staging tool. However, over the past 25 years, a more conservative approach has become the standard for surgical management of the axilla. Because sentinel lymph node biopsy (SNB) is less invasive and less morbid than axillary lymph node dissection (ALND), it has become the standard surgical procedure for axillary staging of clinically node-negative breast cancer. This study aimed to compare the mortality of breast cancer patients receiving ALND and SNB procedure. Methods: Our review includes randomized controlled trials of breast cancer patients undergoing ALND or SNB surgical techniques. A systematic literature search was performed from PubMed on December 2023 to search for articles reporting on survival rates between ALND vs SNB among breast cancer patients. The data obtained then underwent statistical evaluation, and a meta-analysis was conducted using Review Manager 5.4. In order to represent primary outcomes, the risk ratio was estimated using an inverse variance technique with a random-effects model. Heterogeneity was presented with total values, 95% confidence intervals (CI), and I values. Results: As many as 208 articles were found in the PubMed database search, and only six studies were included in this study. The six included trials all used chemotherapy and radiotherapy for systematic treatment. The length of follow-up varied from 33 months to 15 years. The total number of patients in the trials was 3,585, and the study period was from 2011 to 2023. The pooled analysis of the mortality outcomes showed that the heterogeneity of the data was low (I2 21%, p = 0.4). In the pooled analysis, the mortality of patients with SNB for surgical treatment was not significantly different compared to patients with ALND (OR:0.88; 95% CI:0.65-1.19). Conclusion: The mortality of patients undergoing SNB and ALND does not differ significantly, according to this pooled study. It demonstrates that the group without axillary dissection had a primary survival outcome that was not inferior to that of the dissection group.

The Introduction of Magtrace® Lymphatic Tracer for Axillary Sentinel Node Biopsy for Breast Cancer in a Rural Scottish District General Hospital: Initial Experience, Perspectives, Outcomes and Learning Curves

BackgroundMagtrace is a supraparamagnetic iron lymphatic tracer that has had increasing use in sentinel node biopsy (SNB) for breast cancer and has theoretical logistical benefits in centres where nanocolloid use may be associated with such issues. We describe our initial experience with the introduction of Magtrace into our routine practice by dual localisation with nanocolloid, comparing performance, and concordance. Materials and MethodsThis was prospective study of the first patients undergoing axillary SNB using Magtrace in a single centre. These patients had dual localisation with nanocolloid and Magtrace. Subjective global assessments of Magtrace and nanocolloid performance as well as objective signal strength and anatomical concordance were compared across multiple timepoints in the operative journey. ResultsA total of 30 consecutive patients underwent SNB within the timeframe of this study. While there were no failed SNB, 8 issues were reported including 4 issues of perceived imperfect localisation on global assessment. No patient had a failed or abandoned SNB, and only 1 case had a potential challenge in subsequent management after histopathological examination of the retrieved nodes. The majority of these issues occurred in the first half of the study period. There was overall weak to moderate positive correlation between Magtrace and nanocolloid signals of the retrieved sentinel nodes (Spearman's ρ = 0.392, P = .043). ConclusionThis study suggests that introducing Magtrace was feasible and safe in the context of a rural breast cancer service. A possible strategy to ameliorate the learning curve associated with these procedures is the routine dual localisation in the initial phases of performing Magtrace localisation.

Lymphedema and Axillary Sentinel Lymph Node Biopsy (SLNB) in Node-Negative Patients with Breast Cancer

Background: Breast cancer (BC) poses a significant health concern for females, often resulting in complications such as lymphedema due to treatment effects. Objectives: This study examines the link between lymphedema and the number of removed negative axillary lymph nodes (LNs) after sentinel lymph node biopsy (SLNB) in BC patients. Methods: A prospective study from 2016 to 2019 included 150 eligible women out of 1 600 BC patients who underwent axillary sentinel node biopsy (SNB). The prognostic value of isolated negative nodes and BMI in predicting lymphedema post-SLNB was analyzed. Results: Among 950 women receiving radiotherapy, 4% developed lymphedema. Notably, patients with lymphedema were younger (average age 53.34 years). BMI didn't differ significantly, but the number of removed sentinel LN-negatives was crucial. Patients with 4 - 5 nodes removed had an 89.47% likelihood, while those with 1 - 3 nodes had zero incidence. Conclusions: BC-related lymphedema significantly impacts patient well-being. Our study establishes a direct correlation between the number of removed negative LNs and the severity of edema, emphasizing the need for further research.

Axillary lymph node dissection in triple-negative or HER2-positive breast cancer patients with clinical N2 achieving pathological complete response after neoadjuvant therapy: Is it necessary?

Aim:This study aims to identify suitable candidates for axillary sentinel lymph node biopsy (SLNB) or targeted axillary dissection (TAD) among clinical N2 (cN2) triple-negative (TN) or HER2 positive (HER2+）breast cancer patients following neoadjuvant therapy（NAT）.Background: Despite the substantial axillary burden in cN2 breast cancer patients, high pathological response rates can be achieved with NAT in TN or HER2+ subtypes, thus enabling potential downstaging of axillary surgery.Methods: A retrospective analysis was conducted on data from the CSBrS-012 study, screening 709 patients with initial cN2, either HER2+ or TN subtype, from January 1, 2010 to December 31, 2020. The correlation between axillary pathologic complete response (pCR) (yPN0) and breast pCR was examined.Results: Among the 177 cN2 patients who achieved breast pCR through NAT, 138 (78.0 %) also achieved axillary pCR. However, in the 532 initial clinical N2 patients who did not achieve breast pCR, residual axillary lymph node metastasis persisted in 77.4 % (412/532) of cases. The relative risk of residual axillary lymph node metastasis in patients who did not achieve breast pCR was 12.4 (8.1–19.1), compared to those who did achieve breast pCR, P < 0.001.Conclusion: For cN2 TN or HER2+ breast cancer patients who achieve breast pCR following NAT, consideration could be given to downstaging and performing an axillary SLNB or TAD.

Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/Triple-Negative Breast Cancer Patients With Excellent Response.

The Avoid Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy (ASLAN) trial aims to demonstrate the oncologic safety of omitting axillary surgery in patients with excellent response after neoadjuvant chemotherapy (NACT) for early human epidermal growth factor 2 (HER2)-positive (+)/triple-negative breast cancer (TNBC) who have undergone breast-conserving surgery (BCS) and adjuvant radiotherapy. The ASLAN trial will provide crucial information that could change the procedure in highly selected patients undergoing axillary surgery after NACT. ASLAN is a prospective, multicenter, and single-arm surgical trial. The recruitment will be conducted among five tertiary care hospitals in the Republic of Korea. The total number of patients to be recruited will be 178, and we plan to complete patient enrollment by December 2023. The enrollment is considered among patients with HER2+ breast cancer (BC) or TNBC at clinical stage T1-3N0-1M0 who are expected to achieve breast pathological complete response (BpCR) based on a combination of radiologic imaging and physical examination after NACT. BCS was performed on eligible patients. After BCS, patients who showed BpCR were enrolled with the omission of sentinel lymph node biopsy (SLNB). The primary study endpoint upon completion of this trial is 5-year recurrence-free survival, and the secondary endpoints include the 5-year ipsilateral breast tumor recurrence interval, 5-year ipsilateral axillary recurrence interval, 5-year distant metastasis-free survival, 5-year BC-specific survival, 5-year overall survival, 5-year contralateral BC-free survival, re-operation rate according to breast biopsy after NACT, adverse events within 5 years, and quality of life. Several clinical trials are currently underway to determine whether SLNB can be omitted after NACT in patients with HER2+ BC or TNBC that are expected to achieve pathologic complete response. The ASLAN trial is expected to provide valuable clues regarding the feasibility of omitting axillary surgery in highly selected patients. ClinicalTrials.gov Identifier: NCT04993625. Registered on August 6, 2021. Clinical Research Information Service Identifier: KCT0006371. Registered on July 22, 2021.

Comparison between 18F-FDG PET/CT and diffusion-weighted imaging in detection of invasive ductal breast carcinoma.

Breast carcinoma is the most common type of cancer in females. This study aims to compare fluorine-18-fluorodeoxyglucose (18F-FDG) uptake pattern and apparent diffusion coefficient (ADC) value for the detection of the primary tumour and axillary metastases of invasive ductal breast carcinoma. This study included 40 breast carcinoma lesions taken from 39 patients. After staging by positron emission tomography-computed tomography (PET/CT) and diffusion-weighted magnetic resonance imaging (MRI), breast surgery with axillary lymph node dissection or sentinel lymph node biopsy was performed. Primary lesion detection rate for PET/CT and diffusion-weighted MRI was high with 39 of 40 lesions (97.5%). The sensitivity and specificity for the detection of metastatic lymph nodes in axilla were 40.9%, 88.9%, with 18F-FDG PET/CT scans and 40.9%, 83.3%, for dw-MRI, respectively. No significant correlation was detected between ADC and SUVmax or SUVmax ratios. Estrogen receptor (p=0.007) and progesterone receptor (p=0.036) positive patients had lower ADC values. Tumour SUVmax was lower in T1 than T2 tumour size (p=0.027) and progesterone receptor-positive patients (p=0.029). Tumour/background SUVmax was lower in progesterone receptor-positive patients (p=0.004). Tumour/liver SUVmax was higher in grade III patients (p=0.035) and progesterone receptor negative status (p=0.043). This study confirmed the high detection rate of breast carcinoma in both modalities. They have same sensitivity for the detection of axillary lymph node metastases, whereas the PET/CT scan had higher specificity. Furthermore, ADC, SUVmax and SUVmax ratios showed some statistical significance among the patient groups according to different pathological parameters.

Clinical Experience of Axillary Radiotherapy for Node-positive Breast Cancer

AimsPatients with breast cancer who have positive lymph nodes are currently recommended axillary node clearance (ANC) or regional nodal irradiation (RNI). ANC is associated with complications such as lymphoedema, brachial plexopathy and shoulder stiffness. The AMAROS Group showed RNI to be non-inferior to ANC with regards to survival and recurrence, and with a better quality of life. We conducted a large real-world population study to show our centre's experience with the use of RNI and to contribute to the current discussion around the management of node-positive breast cancer. Materials and methodsWe evaluated patients who received RNI as opposed to ANC between 2006 and 2009 (n = 190). Patients had a range of cancer subtypes/grades. All had positive axillary disease, identified by axillary node sampling or sentinel lymph node biopsy. Systemic therapy was given as per standard protocol. Our data were compared with those of patients who had RNI (n = 681) in AMAROS. Patients were followed up retrospectively and overall survival, breast cancer-specific survival, distant metastasis-free survival, locoregional recurrence and toxicity were recorded, including lymphoedema, brachial plexopathy and shoulder stiffness. Survival analysis was performed on R via the Kaplan–Meier method. Univariate and multivariate analyses were also performed. Toxicity data were reported as percentages. Patients meeting POSNOC trial criteria (one to two positive sentinel lymph nodes, macrometastasis, receiving adjuvant chemotherapy) including if oestrogen receptor-positive (stratified POSNOC) were identified for subgroup analysis in the regression model. ResultsLocoregional recurrence was 3.16% versus AMAROS RNI of 1.82%. Overall survival was slightly lower in our population, but cancer-specific survival was higher than AMAROS. Lymphoedema rates were 5.8% versus AMAROS 11% in RNI and 23% in ANC arms, respectively. Brachial plexopathy was 1.6% and arm/shoulder stiffness 7.4%. AMAROS conducted a quality of life survey pertaining to arm/shoulder stiffness, mobility and function, which seemed to affect about 18% in the RNI arm. Univariate analysis revealed POSNOC status, especially if also oestrogen receptor-positive, to be a low risk group with hazard ratio 0.42 (0.20–0.83, P = 0.015). Extracapsular extension of lymph node metastasis was a poor prognostic factor; hazard ratio 4.39 (1.45–14.0, P = 0.009). ConclusionWe support the conclusion of the AMAROS trial with survival and recurrence following RNI being non-inferior to ANC, and with similarly favourable toxicity data. We support the continuing use of RNI as a treatment option for patients with node-positive breast cancer. Further research is required to answer the key questions regarding personalised management for node-positive breast cancer, with regards to de-escalation and also intensification for the patients exhibiting adverse tumour biology.

Fine-needle aspiration biopsy of axillary lymph nodes: Areliable diagnostic tool for breast cancer staging.

Pathologic evaluation of sentinel lymph node biopsy (SLNB) samples is crucial for axillary staging in patients newly diagnosed with breast cancer. Patients with pathologic evidence of nodal metastasis scheduled for upfront surgery typically also undergo axillary lymph node dissection (ALND). Although SLNB is the gold standard method for detecting nodal metastasis, axillary lymph node fine-needle aspiration biopsy (FNAB) utility has not been thoroughly explored. Ultrasound-guided axillary lymph node FNAB samples along with concurrent ipsilateral breast tissue samples were searched and reviewed. The control group included histologic findings of axillary dissection or intraoperative SLNB results. A total of 354 axillary lymph node FNAB samples with matched histology were included. Of these, 187 (52.8%) were positive for metastatic carcinoma of breast origin; 143 (40.4%) were negative for metastasis; 12 (3.4%) showed atypical cells; six (1.7%) were suspicious for metastasis; and six (1.7%) were nondiagnostic because of a lack of lymphoid tissue and malignant cells. Of the 143 negative FNAB samples, 22 (15.4%) were positive on either intraoperative SLNB or ALND. When only the positive and negative FNAB samples were accounted for (n=330; 93.2%), overall diagnostic sensitivity and specificity were 89.4% and 99.2%, respectively. Although axillary SLNB is the standard procedure for detecting nodal metastasis of breast origin, axillary lymph node FNAB appears to be a suitable alternative in a significant proportion of patients. A standard SLNB should be performed in cases of negative axillary lymph node FNAB findings, particularly nodes with abnormal imaging findings.

Is it the Type of Axillary Surgery or the Number of Removed Lymph Nodes That Increases the Risk of Breast Cancer Related Lymphedema (BCRL)? Results from a Prospective Screening Trial

Axillary surgery has been identified as the main risk factor for BCRL regardless the delivery of regional nodal radiation (RLNR). Yet it remains unknown if it is the type of axillary surgery or the number of removed lymph nodes (LN) that increases BCRL risks. Between 2008 and 2021, 3,350 patients (pts) who received surgery for breast cancer were enrolled in a lymphedema screening trial. Patients with bilateral breast cancer or without axillary surgery were excluded. Perometry was used to assess limb volume preoperatively in all patients. BCRL was defined as a ≥10% relative arm-volume increase arising >3 months postoperatively. The cohort was divided by axillary surgery type: axillary lymph node dissection (ALND) and sentinel lymph node biopsy (SLNB). Radiation was delivered using 3D conformal technique and RLNR was defined as the usage of anterior supraclavicular field. No hypofractionation was used and doses ranged between 50 and 50.4 Gy in 25-28 fractions. Multivariable Cox proportional hazard models compared the cumulative incidence of BCRL and local failure between different patient groups. After applying inclusion criteria, 2,623 pts were available with overall median follow-up s of 6.1 years. Of the entire cohort, 709 (27%) had ALND with a median of 16 LN removed, while 1,914 (73%) received SLNB only with a median of 2 LN removed. The median number of malignant LN and patients receiving RLNR was higher in ALND group compared to SLNB only group. Frequency distribution analysis showed that the main overlap between ALND and SLNB only groups happen in the range of 3-11 LN removed. Therefore, the primary analysis focused only on pts with 3-11 LN across both groups (n = 690: ALND n = 140, SLNB n = 550). The multivariable model adjusted for BMI, RLNR, age and breast surgery showed that in this group with 3-11 LN removed in both cohorts, ALND remained significantly associated with BCRL (HR: 4.2, p<0.0001). Separate analyses for the entire SLNB only group and ALND groups were conducted to evaluate if the BCRL risk increases per each removed LN within the same axillary surgery group. The multivariable analysis for SLNB only pts(N = 1,914) showed that for each LN removed the risk of BCRL did not increase significantly (HR:1.06, p = 0.3), similarly for ALND group (N = 709) for each LN removed (HR:1.02, p = 0.08). For pts with pathologic N2-N3 disease and clinical node negative without neoadjuvant chemotherapy receiving ALND, the number of LN removed did not significantly improve neither Local control (HR:1.02, p = 0.8) nor distant disease survival (HR:1.01, p = 0.6). ALND procedure per se is the main risk factor for BCRL not the number of LNs removed. For high-risk pts with >N2 disease, aggressive ALND did not improve tumor outcome. De-escalation with targeted axillary sampling followed by RLNR should be evaluated. Future lymphedema research should account for type of axillary surgery instead of number of LNs removed as a factor. (NCT01521741).

Novel model based on ultrasound predict axillary lymph node metastasis in breast cancer

BackgroundWhether there is axillary lymph node metastasis is crucial for formulating the treatment plan for breast cancer. Currently, invasive methods are still used for preoperative evaluation of lymph nodes. If non-invasive preoperative evaluation can be achieved, it will effectively improve the treatment plan.ObjectiveConstructed a predict model based on ultrasound examination, which forest axillary lymph node metastasis in breast cancer, and validated this model.MethodPatients admitted to Xiamen First Hospital from April 2018 to August 2021 with complete case data were included in this study. Patients who had undergone breast cancer resection and axillary lymph node dissection or sentinel lymph node biopsy were divided into a training and validation cohort in a 7:3 ratio. In the training cohort, patients were divided into metastatic and non-metastatic groups based on whether axillary lymph nodes had metastasis. The parameters of the two groups were compared, and statistically significant parameters were included in multivariate analysis. Then, a Nomogram model was constructed, named Lymph metastasis predict model (LMPM). Calibration curves, receiver operating curve (ROC), and decision curve analysis (DCA) were plotted between the training and validation cohort, calculate the risk score of each patient, identify the optimal cutoff value, and test the predictive efficacy of LMPM.ResultTwo hundred seventy-three patients were enrolled in final study, the average age 49.7 ± 8.7, training cohort included 191 patients, the diameter of breast cancer, the lymph node peak systolic flow velocity (LNPS) and the cortex area hilum ratio (CH) of lymph node were exist significant difference in metastatic and non-metastatic group. Multivariate analysis showed cancer diameter, LNPS and CH included in LMPM, the cutoff value was 95, the calibration curve, ROC, DCA in training and validation cohort show satisfactory result.ConclusionThe predict model-LMPM, can predict axillary lymph node metastasis in breast cancer, which is useful for developing personalized treatment plans. However, further validation of the model is required by incorporating a larger number of patients.

ASO Visual Abstract: The Use of Wearable Activity Monitors to Measure the Upper Limb Physical Activity After Axillary Lymph Node Dissection and Sentinel Lymph Node Biopsy.

ASO Visual Abstract: The Use of Wearable Activity Monitors to Measure the Upper Limb Physical Activity After Axillary Lymph Node Dissection and Sentinel Lymph Node Biopsy.

The Use of Wearable Activity Monitors to Measure Upper Limb Physical Activity After Axillary Lymph Node Dissection and Sentinel Lymph Node Biopsy

BackgroundWe suspect that morbidity from both sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND) has been inadequately evaluated to date. Current methodologies are subjective and susceptible to bias. Objective assessment using wearable activity monitors (WAMs) would allow quantitative analysis of recovery by measuring physical activity (PA) and could provide evidence for axillary de-escalation.Patients and MethodsA prospective, single center, observational study was conducted from February 2020 to May 2022. Consecutive patients undergoing breast and/or reconstructive surgery and axillary surgeries were identified from the operating schedules. Patients wore WAMs for an average of 3 days prior to surgery and up to 2 weeks following surgery. In total, 56 patients with breast cancer were recruited, of whom 35 underwent SLNB and 21 ALND.ResultsPatients who underwent ALND experienced significantly worse PA compared with those who underwent SLNB in week 2 (median 66.4% versus 72.7%, p = 0.015). Subgroup analysis revealed significantly lower PA in simple mastectomy (Mx)-ALND versus Mx-SLNB (median 90.3% versus 70.5%, p = 0.015) in week 2. The PA for SLNB did not return to baseline at 2 weeks after surgery.ConclusionsCompared with SLNB, ALND results in a lower PA level in week 2. The findings also indicate that SLNB has a protracted effect on PA levels, which extend to 2 weeks postoperatively. Monitoring recovery objectively following breast cancer surgery provides patients and surgeons with more information regarding the predicted outcomes of their surgery, which can drive the development of a personalized rehabilitation program.

Multimodal laparoscopic coincidence gamma imaging system for near-infrared fluorescence guided surgery: a preclinical study.

Minimally invasive surgery has advantages in terms of quality of life and patient outcomes. Recently, near-infrared (NIR) fluorescence guided surgery has widely used for preclinical and clinical trials. However, NIR fluorescence has a maximum penetration capability of 10mm. Radiographic imaging can be a solution to overcome the depth issue of NIR fluorescence. For this reason, the performance of the multimodal imaging system, which integrates annihilation gamma (511keV) rays, NIR fluorescence, and color images, was evaluated. The multimodal imaging system consisted of a laparoscopic module, containing an internal detector for annihilation gamma events and cameras for optical imaging, and a flat module for coincidence detection with the internal detector. The acquired images were integrated by an algorithm with post image processing and registration. To evaluate the performance of the proposed multimodal imaging system, the images of a resolution target, a square bar target filled with a fluorescence dye, and a sodium-22 point source were analyzed. A preclinical test for axillary sentinel lymph node (SLN) biopsy with a rat model was conducted. The spatial resolution of color images was equivalent to 4 lp/mm. The modulation transfer function of NIR fluorescence at 1 lp/mm was 0.83. The 511keV gamma sensitivity and spatial resolution of the point source were 0.54cps/kBq and 2.1mm, respectively. The image of 511keV gamma rays showed almost the same intensity regardless of the thickness of the tissue phantom. In the preclinical test, an integrated image of the SLN sample of the rat model was obtained with the proposed multimodal imaging system. With the proposed laparoscopic system, a merged image of the sample was obtained with the rat model. The annihilation gamma rays showed penetration capability with the tissue-mimicking phantom superior to that of NIR fluorescence.