Axillary Sentinel Lymph Node Research Articles

Indocyanine Green Marking of Axillary Sentinel Lymph Nodes in Early Breast Cancer

AbstractAxillary sentinel lymph node excision (SLNE) in breast cancer patients with clinically node-negative disease may be carried out using different tracers. The standard tracer is technetium colloid (99mTc). Indocyanine green (ICG) can be used as an alternative. This study aimed to evaluate the clinical usefulness of this fluorescent dye in a standardized setting.A prospective, single-center cohort study carried out at the University Gynecological Hospital of Rostock from September 2023 to May 2024 carried out sentinel lymph node marking using only ICG in patients with breast malignancies. The ICG injection was administered immediately after the induction of anesthesia. Detection of the sentinel lymph node (SLN) was done using a laparoscopy system suitable for ICG. The aim was to determine the detection rate (DR) for SLNs marked exclusively using ICG and to record any complications. The costs of using ICG to mark SLNs were compared with those for 99mTc marking.During the study period, contraindications against marking with ICG were ascertained for five (3.8%) of 132 patients with planned SLNE. A total of 100 SLNEs were carried out after ICG marking in patients who met the inclusion criteria in the context of the study. A median of two SLNs were resected. The detection rate (DR) for SLNs was 98.0%. SLNs were identified in all obese patients. No serious systemic side effects occurred following ICG injection. Transient skin discoloration in the area around the injection site were observed in eight patients. The direct cost of ICG marking was 62.73 Euros, which was 170.36 Euros lower than the cost of 99mTc marking.The detection rate of axillary SLNs marked using ICG is high and the method is cost-effective, has few side effects and can also be used in obese patients. Contraindications against the administration of ICG are rare. Marking with ICG is a good alternative to the 99mTc method and offers advantages in terms of costs, logistics, no exposure to radiation, and patient comfort.

Exploring methylene blue as an effective alternative to radiotracer for sentinel lymph node biopsy in early breast cancer in resource-limited settings

Background: Sentinel lymph node biopsy is the recommended approach in the evaluation of axilla during breast cancer surgery. This study evaluated the results of patients who underwent methylene blue sentinel lymph node biopsy. Methods: The study included 35 female patients with T1, T2 and T3 tumours. 5 ml of 1% methylene blue was injected into the periareolar region. The axillary sentinel lymph node was found and removed, and axillary dissection was performed. The sentinel lymph node and axillary dissection specimen were histopathologically examined, and the results were compared. Results: The sentinel lymph node was found in 33 (90%) patients. There were no complications associated with the use of methylene blue dye. Methylene blue-stained sentinel nodes were histologically negative for malignancy in 42% and positive in 58% of patients. Corresponding to sentinel nodes, the final axillary staging was negative in 60% and positive in 40% of patients. On diagnostic accuracy parameters, the sensitivity of the methylene blue method in early breast cancer (cT1-3N0M0) patients was 90.47%, and the specificity was 100%. The PPV of the technique under study was found to be 100% and NPV was 85.71%. The accuracy rate was 93%, and the false negative rate was identified as 9.5%. Conclusions: Sentinel lymph node biopsy by methylene blue is a method that can be applied with high accuracy. Methylene blue can be considered as an alternative to radio colloid dye in sentinel lymph node biopsy in a limited resource setting.

Non-Palpable Breast Cancer: A Targeting Challenge–Comparison of Radio-Guided vs. Wire-Guided Localization Techniques

Background: The incidence of non-palpable breast cancer is increasing due to widespread screening and neo-adjuvant therapies. Among the available tumor localization techniques, radio-guided occult lesion localization (ROLL) has largely replaced wire-guided localization (WGL). The aim of this study was to compare the ROLL and WGL techniques in terms of the effectiveness of isotopic marking of axillary sentinel lymph nodes and to assess patient perspectives along with surgeon and radiologist preferences. Methods: A single-center, prospective, randomized study enrolled 110 patients with non-palpable breast lesions (56 ROLL, 54 WGL). Breast type, tumor volume, location, histological and radiological features, and localization/surgical duration were evaluated in the context of sentinel lymph node marking using isotope (technetium-99m-labeled human serum albumin) and blue dye. Statistical analysis was performed with significance set at p < 0.05 and strong significance at p < 0.01. Results: A single-center, prospective, randomized study enrolled 110 patients with non-palpable breast lesions (56 ROLL, 54 WGL). Breast type, tumor volume, location, histological and radiological features, and localization/surgical duration were evaluated in the context of sentinel lymph node marking using isotope (technetium-99m-labeled human serum albumin) and blue dye. Statistical analysis was performed with significance set at p < 0.05 and strong significance at p < 0.01. Conclusions: While ROLL provided advantages in terms of patient comfort and logistical simplicity, WGL was superior for axillary sentinel lymph node marking, particularly in inner quadrant tumors, suggesting that WGL may be preferred in these cases.

An associate of suspicious axillary node and sentinel node in breast cancer to minimizing axillary surgery, prospective cohort study

Background: Arm morbidity and postoperative complications following sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) are common problems in patients with breast cancer. The de-escalating axillary surgery is increasing; however, there is a lack of patients with suspicious nodes. This study aimed to reduce the need for SLNB in suspicious lymph node cases. Methods: A prospective cohort study of women with invasive breast cancer who underwent surgery between January 2021 and December 2022. The study included two cohorts: Cohort A comprised patients with stage cT1-2N0-1M0 cancer who planned upfront surgery, while Cohort B included patients with stages cT1-4N2M0, cT3-4N1M0, or cT1-2N0-1M0 who received neoadjuvant systemic treatment. During the study, a clip was inserted into the suspicious lymph node on imaging to determine whether it could serve as a sentinel node and potentially replace SLNB or reduce the need for axillary surgery. Result: In cohort A, twenty-two surgeries were performed, while in cohort B, seven surgeries were performed. The median follow-up time was 15 months. In cohort A, 71% of the patients had cN0 disease, while 28% had cN1 disease. A suspicious node correlated to a sentinel node was noted in 66.67% of cohort A. The false-negative rate (FNR) was 14.28%. However, when the clip node removal procedure was performed instead of the sentinel node procedure, the FNR was 10%. Conclusion: In early breast cancer, suspicious nodes in imaging studies could not currently represent sentinel lymph nodes, and the FNR was still high. Nevertheless, more studies with larger populations will provide a better understanding due to the limited number of patients.

Collateralization of the upper extremity lymphatic system after axillary lymph node dissection.

Lymphatic drainage from the arm may be altered after axillary lymph node dissection (ALND). Understanding these alterations is important as they may change standard surgical and radiation treatment in recurrent breast cancer or upper extremity skin cancers, including melanoma. Utilizing a single-institution planar and single photon emission computed tomography/computed tomography lymphoscintigraphy database, we identified patients with a diagnosis of upper extremity cutaneous melanoma from 2008 to 2023 who previously underwent ALND for cancer treatment and did not develop upper extremity cancer-related lymphedema. ALND patients were matched to control patients presenting with cutaneous melanomas at the same anatomic sites. Sentinel lymph nodes (SLNs) were compared between both groups. Of 3628 upper extremity melanoma cutaneous patients, 934 met inclusion criteria, including 22 ALND and 912 control patients. Level I axillary SLN drainage was observed in 98% of controls and 27% of ALND patients (p < 0.001). Level II axillary SLN drainage was observed in 3% of controls and 27% of ALND patients (p < 0.001). Level III axillary SLN drainage was observed in 1% of controls and 32% of ALND patients (p < 0.001). Epitrochlear SLN drainage was observed in 9% of controls and 32% of ALND patients, respectively (p < 0.046). Brachial SLN drainage was observed in 4% of controls and 23% of ALND patients (p < 0.001). Distinct changes in functional lymphatic drainage were seen between the arms of patients who previously underwent ALND versus control patients. Levels II and III axillary, epitrochlear, and brachial nodes are possible sites of metastatic disease that should be considered in patients with a prior ALND.

Relation Between Characteristics of Indocyanine Green Lymphography and Development of Breast Cancer-Related Lymphedema.

Background: Breast cancer-related lymphedema (BCRL) is a disabling and frequently occurring condition after treatment for breast cancer. Studying lymph anatomy by means of indocyanine green (ICG) lymphography is a promising tool to help better understand BCRL. The aim of this study is to investigate the relation between ICG lymphography characteristics and the risk of developing BCRL. Methods and Results: Patients scheduled for breast surgery with either unilateral axillary lymph node dissection or sentinel lymph node biopsy between November 2017 and May 2019 were included. Patients were assessed at baseline and up to 36 months postsurgery. BCRL was defined as an increase of ≥5% relative arm volume difference compared with the presurgical difference. In total, 128 patients were included. During 36 months of follow-up, 45 patients (35.2%) developed BCRL. The number of lymph vessels before surgery was not a statistically significant risk factor for developing BCRL (p = 0.8485). However, an increase in the number of lymph vessels compared with baseline was a significant protective factor for developing BCRL (odds ratio = 0.8). An increase of one lymph vessel corresponds to a 19% relative risk reduction of developing BCRL. The presence of lymph nodes at baseline and the change in the presence of lymph nodes compared with baseline were no predictors for the development of BCRL (p = 0.0986 and p = 0.8910, respectively). Conclusions: An increase in the number of lymph vessels visualized by ICG lymphography compared with baseline is a protective factor for developing BCRL. Therapies with the ability to increase the number of lymph vessels can thus possibly decrease the risk of developing BCRL.

Viability of Whole-Slide Imaging for Intraoperative Touch Imprint Cytological Diagnosis of Axillary Sentinel Lymph Nodes in Breast Cancer Patients.

Whole-slide imaging (WSI) is a promising tool in pathology. However, the use of WSI in cytopathology has lagged behind that in histology. We aimed to evaluate the utility of WSI for the intraoperative touch imprint cytological diagnosis of axillary sentinel lymph nodes (SLNs) in breast cancer patients. Glass slides from touch imprint cytology of 480 axillary SLNs were scanned using two different WSI scanners. The intra- and interobserver concordance, accuracy, possible reasons for misdiagnosis, scanning time, and review time for three cytopathologists were compared between WSI and light microscopy (LM). A total of 4320 diagnoses were obtained. There was substantial to strong intraobserver concordance when comparing reads among paired LM slides and WSI digital slides (κ coefficient ranged from 0.63 to 0.88, and concordance rates ranged from 94.58% to 98.33%). Substantial to strong interobserver agreement was also observed among the three cytopathologists (κ coefficient ranged from 0.67 to 0.85, and concordance rates ranged from 95.42% to 97.92%). The accuracy of LM was slightly higher (average of 98.06%) than that of WSI (averages of 96.81% and 97.78%). The majority of misdiagnoses were false negative diagnoses due to the following top three causes: few cancer cells, confusing cancer cells with histiocytes, and confusing cancer cells with lymphocytes. This study is the first to address the feasibility of WSI in touch imprint cytology. The use of WSI for intraoperative touch imprint cytological diagnosis of SLNs is a practical option when experienced staff are not available on-site.

An interactive 3D atlas of sentinel lymph nodes in breast cancer developed using SPECT/CT

BackgroundThe identification and assessment of sentinel lymph nodes (SLNs) in breast cancer is important for optimised patient management. The aim of this study was to develop an interactive 3D breast SLN atlas and to perform statistical analyses of lymphatic drainage patterns and tumour prevalence.MethodsA total of 861 early-stage breast cancer patients who underwent preoperative lymphoscintigraphy and SPECT/CT were included. Lymphatic drainage and tumour prevalence statistics were computed using Bayesian inference, non-parametric bootstrapping, and regression techniques. Image registration of SPECT/CT to a reference patient CT was carried out on 350 patients, and SLN positions transformed relative to the reference CT. The reference CT was segmented to visualise bones and muscles, and SLN distributions compared with the European Society for Therapeutic Radiology and Oncology (ESTRO) clinical target volumes (CTVs). The SLN atlas and statistical analyses were integrated into a graphical user interface (GUI).ResultsDirect lymphatic drainage to the axilla level I (anterior) node field was most common (77.2%), followed by the internal mammary node field (30.4%). Tumour prevalence was highest in the upper outer breast quadrant (22.9%) followed by the retroareolar region (12.8%). The 3D atlas had 765 SLNs from 335 patients, with 33.3–66.7% of axillary SLNs and 25.4% of internal mammary SLNs covered by ESTRO CTVs.ConclusionThe interactive 3D atlas effectively displays breast SLN distribution and statistics for a large patient cohort. The atlas is freely available to download and is a valuable educational resource that could be used in future to guide treatment.

Quality assessment of radiotherapy in the prospective randomized SENOMAC trial

Background and purposeRecommendations for regional radiotherapy (RT) of sentinel lymph node (SLN)-positive breast cancer are debated. We here report a RT quality assessment of the SENOMAC trial. Materials and MethodsThe SENOMAC trial randomized clinically node-negative breast cancer patients with 1–2 SLN macrometastases to completion axillary lymph node dissection (cALND) or SLN biopsy only between 2015–2021. Adjuvant RT followed national guidelines. RT plans for patients included in Sweden and Denmark until June 2019 were collected (N = 1176) and compared to case report forms (CRF). Dose to level I (N = 270) and the humeral head (N = 321) was analyzed in detail. ResultsCRF-data and RT plans agreed in 99.3 % (breast/chest wall) and in 96.6 % of patients (regional RT). Congruence for whether level I was an intended RT target was lower (78 %). In accordance with Danish national guidelines, level I was more often an intended target in the SLN biopsy only arm (N = 334/611, 55 %,) than in the cALND arm (N = 174/565, 31 %,). When an intended target, level I received prescribed dose to 100 % (IQR 98–100 %) of the volume. However, even when not an intended target, full dose was delivered to > 80 % of level I (IQR 75–90 %). The intentional inclusion of level I in the target volume more than doubled the dose received by ≥ 50 % of the humeral head. ConclusionCongruence between CRF data and RT plans was excellent. Level I received a high dose coverage even when not intentionally included in the target. Including level I in target significantly increased dose to the humeral head.

Revealing undetected axillary sentinel node in neoadjuvant chemotherapy treated breast cancer

Revealing undetected axillary sentinel node in neoadjuvant chemotherapy treated breast cancer

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

BackgroundTargeted 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.MethodsWe 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).ResultsA 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).ConclusionThese 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 PO5-02-12: 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.

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.

The Role of Axillary Lymph Node Dissection versus Sentinel Lymph Node Dissection in Breast Cancer Patients with Clinical N2b-N3c Disease Who Receive Adjuvant Radiotherapy.

For breast cancer with advanced regional lymph node involvement, axillary lymph node dissection (ALND) remains the standard of care for staging and treating the axilla despite the presence of undissected lymph nodes. The benefit of ALND in this setting is unknown. We sought to describe national patterns of care of axillary surgery and its association with overall survival (OS) among women with cN2b-N3c breast cancer who receive adjuvant radiotherapy. We identified female patients with cN2b-N3c breast cancer from 2012 to 2017 from the National Cancer Database. Clinical and demographic information were analyzed using Wilcoxon rank sum and χ2 tests. Predictors of receipt of ALND and predictors of death were identified with multivariable logistic regression modeling. Inverse probability of treatment weighting was implemented to adjust for differences in treatment cohorts. The Kaplan-Meier method was used to evaluate OS. We identified 7167 patients. Of these, 922 (13%) received SLNB and 6254 (87%) received ALND; 7% were cN2b, 19% cN3a, 24% cN3b, 19% cN3c, and 31% cN3, not otherwise specified. Predictors of receipt of ALND were age 50-69 years [odds ratio (OR) 1.3, p < 0.01], cN3a (OR 7.6, p < 0.01), cN3b (OR 2.8, p < 0.01), and cN3c (OR 4.2, p < 0.01). Predictors of death included cN3c (OR 1.9, p < 0.01), age 70-90 years (OR 1.5, p = 0.01), and positive surgical margins (OR 1.5, p < 0.01). After cohort balancing, ALND was not associated with improved OS when compared with SLNB (HR 0.99, p = 0.91). ALND in patients with advanced nodal disease was not associated with improved survival compared with SLNB for women who receive adjuvant radiotherapy.

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.

Sentinel lymph node identification using NIR-II ultrabright Raman nanotags on preclinical models

Surface-enhanced Raman spectroscopy (SERS) nanotags have garnered much attention as promising bioimaging contrast agent with ultrahigh sensitivity, but their clinical translation faces challenges including biological and laser safety. As breast sentinel lymph node (SLN) imaging agents, SERS nanotags used by local injection and only accumulation in SLNs, which were removed during surgery, greatly reduce biological safety concerns. But their clinical translation lacks pilot demonstration on large animals close to humans. The laser safety requires irradiance below the maximum permissible exposure threshold, which is currently not achievable in most SERS applications. Here we report the invention of the core-shell SERS nanotags with ultrahigh brightness (1 pM limit of detection) at the second near-infrared (NIR-II) window for SLN identification on pre-clinical animal models including rabbits and non-human primate. We for the first time realize the intraoperative SERS-guided SLN navigation under a clinically safe laser (1.73 J/cm2) and identify multiple axillary SLNs on a non-human primate. No evidence of biosafety issues was observed in systematic examinations of these nanotags. Our study unveils the potential of NIR-II SERS nanotags as appropriate SLN tracers, making significant advances toward the accurate positioning of lesions using the SERS-based tracer technique.

Carbon nanoparticles versus patent blue dye for detection of sentinel lymph node in patients with early breast cancer

Background Sentinel lymph nodes biopsy (SLNB) has replaced axillary lymph node dissection (ALND) in a considerable percentage of patients with early-stage breast cancer which was a great advance in preventing many surgical complications and enhancing their health welfare. Although there are different sentinel lymph nodes (SLNs) tracers with different identification rates, there is no agreement about the idealistic method. Aim The study was designed to compare carbon nanoparticles and patent blue v dye regarding SLNs detection rate, number of SLNs, time of detection, metastatic SLNs, cost, and safety in patients with early breast cancer and clinically node-negative axilla. Patients and methods A total of 40 patients with axillary lymph node-negative early-stage breast cancer patients were divided into two groups and subjected to carbon nanoparticles and patent blue V dye in group A and group B, respectively. Patients who were pregnant or lactating had node-positive axilla (N1-3) or metastatic breast cancer (M1) or had neoadjuvant chemotherapy were excluded. Results The mean age was 48.3±9.5 and 47 ±8.9, while the mean BMI of 33.3±4.8 and 32.834±4.862, the SLN detection rates were 95% and 90% in groups A and B, respectively. A total of 128 sentinel lymph nodes (SLNs) were removed from patients in the two groups (65 with Carbon Nanoparticles and 63 with patent blue dye). The mean number of SLNs was 3.4±0.7 (range, 2–5) and 3.5±1.2 (range, 2–7), mean time of SLNs detection was 13.5±4.5 (range, 7–22) and 12.7± 3.6 (range, 7–18 min) between group A and B, respectively. Conclusion There is no significant difference between carbon nanoparticles and patent blue dye regarding axillary SLNs in early breast cancer regarding identification rate, number of SLNs, time of detection, metastatic SLNs, cost, and safety with slight preference to carbon nanoparticles regarding postoperative skin staining and Egyptian market availability.