Sentinel Node Staging Research Articles

Sentinel Lymph Node Staging in Early-Stage Cervical Cancer: A Comprehensive Review.

Cervical cancer (CC) continues to be a significant global public health concern, even with preventive measures in place. In women with early-stage CC, the status of lymph nodes is of paramount importance, not only for the final prognosis but also for determining the best therapeutic strategy. According to main international guidelines, pelvic full lymphadenectomy (PLND) is recommended for lymph node staging. However, in these early stages of CC, sentinel lymph node biopsy (SLNB) has emerged as a precise technique for evaluating lymph node involvement, improving its morbidity profile. We performed a literature review through PubMed articles about progress on the application of SLNB in women with early-stage CC focusing on the comparison with PET/CT and PLND in terms of oncological outcomes and diagnostic accuracy. While the superiority of SLNB is clear compared to radiologic modalities, it demonstrates no clear oncologic inferiority over PLND, given the higher detection rate of positive lymph nodes and predominance of no lymph node recurrences. However, due to a lack of prospective evidence, particularly concerning long-term oncological safety, SLNB is not the current gold standard. With careful patient selection and adherence to straightforward protocols, a low false-negative rate can be ensured. The aim of the ongoing prospective trials is to address these issues.

Comparison of Different Techniques for the Assessment of Sentinel Lymph Node Biopsy in Melanoma: A Systematic Review.

The gold standard for sentinel lymph node staging in melanoma is the use of the combined technique of radioisotope plus blue dye. New techniques and alternative methods have been proposed, with the promise of achieving comparable efficacy. We then carried out a literature search. We conducted a literature search using the "sentinel lymph node biopsy" and "melanoma" keywords, then selected the case-control studies (the quality of which was assessed using the STROBE criteria). Twelve studies of 13,017 were selected, concerning the identification rate of indocyanine green fluorescence and indocyanine green-99mtc-nanocolloid techniques. We have found a comparable identification rate between the various techniques, even if given the small population present for some techniques, the results did not reach statistical significance. The use of new techniques in sentinel lymph node detection promises results comparable to the gold standard techniques, but further studies are needed to validate these methods in the context of melanoma surgery.

Sentinel Lymph Node Mapping and Staging Surgery via Gasless Transvaginal Natural Orifice Transluminal Endoscopic Surgery: A Case Report of Patient with Endometrial Cancer Patient and Comorbid Rheumatic Heart Disease

Patient: Female, 43-year-old Final Diagnosis: The stage 1A endometrioid adenocarcinoma and RHD pathology, including the cardiac function of class II, severe MS, and pulmonary hypertension Symptoms: Irregular vaginal bleeding for more than 1 month Medication:— Clinical Procedure: — Specialty: Surgery Objective: Unusual or unexpected effect of treatment Background: Conventional laparoscopic surgery and transvaginal natural orifice transluminal endoscopic surgery (vNOTES) both use CO2 pneumoperitoneum to expose the surgical space. However, CO2 pneumoperitoneum is undoubtedly dangerous for patients with rheumatic heart disease (RHD) and can cause cardiopulmonary impairments. Therefore, we selected the sentinel lymph node (SLN) mapping strategy to guide the staging surgery via gasless vNOTES for an endometrial cancer (EC)-patient with comorbid RHD. Here, we discuss whether our selected surgical method was safe and feasible for this patient.Case Report:A 43-year-old woman with a history of RHD, severe mitral regurgitation, and pulmonary hypertension for more than 30 years received diagnostic curettage for irregular vaginal bleeding for more than 1 month. Pathological examinations revealed the occurrence of highly differentiated intrauterine endometrioid adenocarcinoma. She was admitted to the gynecological ward of our hospital for further surgery. We performed EC staging surgery with SLN mapping via gasless vNOTES and adopted a series of effective measures to solve the intraoperative complications of surgical space exposure. Surgery was successful. The patient recovered well and was discharged 5 days after surgery. She has been followed up in the gynecological clinic for nearly 1 year. At the time of this report, she had good recovery, no recurrence and metastasis, and normal tumor markers.Conclusions:For EC patients with comorbid RHD pathology, application of staging surgery with SLN mapping via gasless vNOTES was shown to be safe and feasible. This approach is expected to be highly effective for patients with contraindications to CO2 pneumoperitoneum laparoscopy.

Imaging Cancer in Pregnancy.

Pregnancy-associated cancer (PAC) is defined as cancer that is detected during pregnancy and up to 1 year postpartum. Although rare (~1:1000 pregnancies), PAC is increasing owing to postponed childbearing and advanced maternal age at conception. Cancer-related symptoms masked by physiologic gestational changes may delay diagnosis. Imaging, clinical management, and treatment require a carefully choreographed multidisciplinary team approach. The risk-benefit of every imaging modality, the strategies to balance the safety of mother and fetus, and the support of the patient and family at every step are crucial. US and MRI are preferred imaging modalities that lack ionizing radiation. Radiation dose concerns should be addressed, noting that most imaging examinations (including mammography, radiography, CT, and technetium 99m-labeled sulfur colloid sentinel lymph node staging) are performed at radiation levels below thresholds at which deterministic side effects are seen. Dose estimates should be provided after each examination. The use of iodinated intravenous contrast material is safe during pregnancy, but gadolinium-based contrast material should be avoided. Accurate diagnosis and staging combined with gestational age affect decisions about surgery and chemotherapy. Whole-body MRI with diffusion-weighted sequences is ideal to screen for primary and metastatic sites, determine disease stage, identify biopsy targets, and guide further cancer site-specific imaging. The authors provide an update of the imaging triage, safety considerations, cancer-specific imaging, and treatment options for cancer in pregnancy. An invited commentary by Silverstein and Van Loon is available online. Online supplemental material is available for this article. ©RSNA, 2022.

Anatomical breast imaging-derived parameters do not provide incremental information in prediction of nonvisualization of sentinel lymph nodes on lymphoscintigraphy.

ObjectiveAccurate sentinel lymph node (SLN) staging is essential for both prognosis and treatment in patients with breast cancer. However, the preoperative lymphoscintigraphy may fail to visualize the SLN. The aim of this retrospective study was to investigate whether parameters derived from anatomical breast imaging can predict SLN nonvisualization on lymphoscintigraphy.MethodsFor this retrospective study, all data of mammography, breast MRI, and lymphoscintigraphy of SLN procedures from January 2016 to April 2021 were collected and reviewed from the Amsterdam UMC database.ResultsA total of 758 breast cancer patients were included in this study. SLN nonvisualization on planar lymphoscintigraphy at 2-h postinjection (pi) was 29.7% and was reduced after a second injection to 7.5% at late lymphoscintigraphy 4-h pi. Multivariable analysis showed that age ≥ 70 years (P = 0.019; OR, 1.82; 95% CI, 1.10–3.01), BMI ≥ 30 kg/m2 (P = 0.031; OR, 1.59; 95% CI, 1.04–2.43), and nonpalpable tumors (P = 0.034; OR, 1.54; 95% CI, 1.03–2.04) were independent predictors of SLN nonvisualization. Differences in tumor size, Breast Imaging-Reporting and Data System classification, or breast density were not significantly associated with SLN nonvisualization.ConclusionThis study shows that, by using a multivariable analysis, risk factors for SLN nonvisualization in breast cancer patients during preoperative lymphoscintigraphy at 2-h pi are age ≥ 70 years, BMI ≥ 30 kg/m2, and nonpalpable tumors. Parameters derived from mammography or breast MRI, however, are not useful to predict SLN nonvisualization on lymphoscintigraphy.

Sentinel lymph node biopsy in patients with clinical stage IIB/C cutaneous melanoma: A national cohort study

Approval of adjuvant anti-programmed cell death protein 1 therapy for pathologic stage IIB/C cutaneous melanoma has led some to question the role of sentinel lymph node (SLN) biopsy in the clinical stage IIB/C disease. To determine the prognostic significance of SLN staging on disease-specific survival (DSS) for clinical stage IIB/C primary cutaneous melanoma in the preimmunotherapy era. A retrospective cohort study was performed evaluating patients who underwent excision of clinical stage IIB/C cutaneous melanoma using the Surveillance, Epidemiology, and End Results database (2004-2011). Patients who did and did not undergo SLN biopsy were compared using propensity matching, and among those who underwent SLN biopsy, matched patients were further stratified by SLN status (SLN positive [SLN+] or SLN negative [SLN-]). Of the 8562 patients evaluated, 6021 (70.3%) underwent SLN biopsy. SLN positivity was associated with significantly reduced 5-year DSS among matched patients who underwent SLN biopsy (47.1% SLN+vs 75.5% SLN-; P<.001). Five-year DSS remained significantly different across matched T-stages: T3b (54.2% SLN+vs 64.8% SLN-; P=.004), T4a (55.5% SLN+vs 71.6% SLN-; P=.001), and T4b (38.6% SLN+vs 60.9% SLN-; P<.001). Retrospective study. For patients with clinical stage IIB/C cutaneous melanoma, SLN status provides essential prognostic information.

PN0(i+) and pN1mi Breast Cancer: Treatment and Outcomes in Comparison With pN0 and pN1a in the Modern Era

Locoregional recurrence risk and the role of locoregional radiation therapy (LRRT) in pN0(i+) and pN1mi breast cancer are unclear. This study compares locoregional relapse-free survival (LRRFS) in patients with pN0(i+) and pN1mi relative to pN0 and pN1a disease and evaluates LRRFS according to locoregional treatment. We studied 10,271 patients referred between 2006 and 2011 with newly diagnosed pT1-T2, pN0, pN0(i+), pN1mi, or pN1a, M0 breast cancer. Outcomes were 10-year Kaplan-Meier LRRFS, relapse-free survival (RFS), distant relapse-free survival, and breast cancer-specific survival. Multivariable analysis of LRRFS and RFS was performed in pN0(i+) and pN1mi cohorts. Median follow-up was 9.3 years. In patients with pN0 (n = 7492), pN0(i+) (n = 305), pN1mi (n = 619), and pN1a (n = 1855) disease, LRRT was used in 1.1%, 24.3%, 45.7%, and 71.1%, respectively. Ten-year outcomes were LRRFS 96%, 92%, 97%, and 96% (P < .001), distant RFS 94%, 91%, 90%, and 84% (P < .001), and breast cancer-specific survival 95%, 90%, 93%, and 87% (P < .001), respectively. Ten-year LRRFS for patients treated with breast-conserving surgery alone, with breast RT, and with LRRT were 81%, 93%, and 91% for patients with pN0(i+) (P = .16) and 94%, 96%, and 100% for patients with pN1mi (P = .02), respectively. Among patients treated with mastectomy, 10-year LRRFS with surgery alone and with LRRT were 93% and 100% for patients with pN0(i+) (P = .12) and 95% and 99% for patients with pN1mi (P = .09). On multivariable analysis of patients with pN0(i+) and pN1mi, systemic therapy was associated with improved LRRFS in patients with pN0(i+) (hazard ratio [HR], 0.2; [0.06-0.6]; P = .005) and patients with pN1mi (HR, 0.1; [0.03-0.5]; P = .006). In patients with pN1mi, LRRT was associated with a trend toward increased LRRFS (HR, 0.2; [0.03-1.1]; P = .07). LRRT was not significantly associated with improved RFS in pN0(i+) or pN1mi disease. In the era of sentinel node staging and modern systemic therapy, patients with pN0(i+) and PN1mi treated with LRRT experienced 10-year LRR risks ≤10% after breast-conserving surgery or mastectomy and RT. LRRT was associated with a trend toward increased LRRFS in pN1mi but not pN0(i+) disease.

Abstract GS4-05: Preservation of axillary lymph nodes compared to complete dissection in T1-T2 breast cancer patients presenting 1-2 metastatic sentinel lymph nodes. A multicenter randomized clinical trial. Sinodar One

Abstract Introduction: Sentinel lymph node (SLN) staging is currently used to avoid complete axillary lymph node dissection (ALND) in breast cancer (BC) patients. The SLN is the only site of axillary metastasis (MTS) in ≥60% of cases. Recently, a randomized controlled trial (Z0011) comparing SLN biopsy (SLNB) alone with SLNB followed by ALND in patients with 1-2 SLNs+ demonstrated no significant statistical difference in relapse and overall survival (OS) rates among the two different groups. However, this study had some limitations: small tumor size (≤2cm in 70% of cases), frequent presence of only microMTS in SLN (40%), prevalent use of “whole breast” adjuvant radiotherapy (&amp;gt;90%). Given these considerations, the SINODAR-ONE study started in April 2015. Objectives: The aims are to assess whether ALND omission in BC patients with 1-2 SLNs+ is associated with worse survival and/or increased rate of regional/distant relapse. Thus evaluating whether SLNB is or is not inferior to ALND. Primary endpoint is OS. Secondary endpoints are disease-free survival (DFS) referring to distant MTS and loco-regional recurrence. Methods: Patients received either mastectomy or conservative surgery plus radiotherapy. They all underwent SLNB and were randomly divided into two arms of treatment: standard (SLNB plus ALND) or experimental treatment (only SLNB). According to multidisciplinary evaluation, patients could undergo additional adjuvant radiotherapy, chemo- and/or hormonal therapy, or no further therapy. Eligibility criteria: age 40-75 years; primary invasive T1-T2 tumor; axillary nodes cN0; no more than 2 macro-metastatic SLNs; no distant MTS; no neo-adjuvant therapy; no previous invasive BC. Exclusion criteria: in situ, inflammatory, contralateral BC; micro-metastatic SLNs; pregnancy or breast feeding; comorbidity impeding adjuvant therapy. All analyses were performed both on all patients according to the Intention-To-Treat principle and excluding those patients who did not receive the axillary treatment randomly assigned. Statistical analysis: OS and DFS were calculated using the Kaplan-Meier Product Limit Estimator and differences between arms were assessed with the log-rank test. Results: The enrollment of patients ended in April 2020 with a total of 889 cases (443: standard arm; 446: experimental arm). In April 2021, we conducted a preliminary analysis on 889 patients. We found the two groups homogeneous for epidemiologic characteristics (age and menopausal status), tumor characteristics (tumor size, pTNM, immunohistochemistry, histology, grading, vascular and lymphatic invasion), and adjuvant therapies. The majority of patients (77.2%) received breast conserving surgery, while 22.8% of patients underwent mastectomy. A median of 2 SLNs were removed in both arms. Overall, only 3 micro-metastatic SNLs were found (1 in the standard arm and 2 in the experimental arm). Conclusion: In sum, OS rate is 99.1% and 99.3% in the standard and experimental arm, respectively; DFS rate is 96.8% and 95.9% in the standard and experimental arm, respectively. After a median follow-up of 36 months, there has been only one axillary recurrence in the experimental arm. Additionally, we found seven distant relapses in both arms; four and three deaths in the standard and experimental arm, respectively. Citation Format: Damiano Gentile, Wolfgang Gatzemeier, Erika Barbieri, Andrea Sagona, Alberto Bottini, Valentina Errico, Alberto Testori, Marta Scorsetti, Giuseppe Canavese, Corrado Tinterri. Preservation of axillary lymph nodes compared to complete dissection in T1-T2 breast cancer patients presenting 1-2 metastatic sentinel lymph nodes. A multicenter randomized clinical trial. Sinodar One [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr GS4-05.

Sentinel lymph node localization and staging with a low-dose of superparamagnetic iron oxide (SPIO) enhanced MRI and magnetometer in patients with cutaneous melanoma of the extremity - The MAGMEN feasibility study

BackgroundIn patients with melanoma, sentinel lymph node (SLN) status is pivotal for treatment decisions. Current routine for SLN detection combines Technetium99m (Tc99) lymphoscintigraphy and blue dye (BD). The primary aim of this study was to examine the feasibility of using a low dose of superparamagnetic iron oxide (SPIO) injected intracutaneously to detect and identify the SLN, and the secondary aim was to investigate if a low dose of SPIO would enable a preoperative MRI-evaluation of SLN status. MethodsPatients with melanoma of the extremities were eligible. Before surgery, a baseline MRI of the nodal basin was followed by an injection of a low dose (0.02–0.5 mL) of SPIO and then a second MRI (SPIO-MRI). Tc99 and BD was used in parallel and all nodes with a superparamagnetic and/or radioactive signal were harvested and analyzed. ResultsFifteen patients were included and the SLNB procedure was successful in all patients (27 SLNs removed). All superparamagnetic SLNs were visualized by MRI corresponding to the same nodes on scintigraphy. Micrometastatic deposits were identified in four SLNs taken from three patients, and SPIO-MRI correctly predicted two of the metastases. There was an association between MRI artefacts in the lymph node and the dose SPIO given. DiscussionIt is feasible to detect SLN in patients with melanoma using a low dose of SPIO injected intracutaneously compared with the standard dual technique. A low dose of SPIO reduces the lymph node MRI artefacts, opening up for a non-invasive assessment of SLN status in patients with cancer.

High-resolution three-dimensional imaging for precise staging in melanoma

IntroductionMany cancer guidelines include sentinel lymph node (SLN) staging to identify microscopic metastatic disease. Current SLN analysis of melanoma patients is effective but has the substantial drawback that only a small representative portion of the node is sampled, whereas most of the tissue is discarded. This might explain the high clinical false-negative rate of current SLN diagnosis in melanoma. Furthermore, the quantitative assessment of metastatic load and microanatomical localisation might yield prognosis with higher precision. Thus, methods to analyse entire SLNs with cellular resolution apart from tedious sequential physical sectioning are required. Patients and methodsEleven melanoma patients eligible to undergo SLN biopsy were included in this prospective study. SLNs were fixed, optically cleared, whole-mount stained and imaged using light sheet fluorescence microscopy (LSFM). Subsequently, compatible and unbiased gold standard histopathological assessment allowed regular patient staging. This enabled intrasample comparison of LSFM and histological findings. In addition, the development of an algorithm, RAYhance, enabled easy-to-handle display of LSFM data in a browsable histologic slide-like fashion. ResultsWe comprehensively quantify total tumour volume while simultaneously visualising cellular and anatomical hallmarks of the associated SLN architecture. In a first-in-human study of 21 SLN of melanoma patients, LSFM not only confirmed all metastases identified by routine histopathological assessment but also additionally revealed metastases not detected by routine histology alone. This already led to additional therapeutic options for one patient. ConclusionOur three-dimensional digital pathology approach can increase sensitivity and accuracy of SLN metastasis detection and potentially alleviate the need for conventional histopathological assessment in the future. German clinical trials register(DRKS00015737).

Sentinel Lymph Node Staging with Indocyanine Green for Patients with Cervical Cancer: The Safety and Feasibility of Open Approach Using SPY-PHI Technique.

(1) Background: Sentinel lymph node staging (SLN) with indocyanine green (ICG) in cervical cancer is the standard of care in most national and international guidelines. However, the vast majority of relevant studies about the safety and feasibility of this method are conducted on minimally invasive surgery; (2) Methods: This study is a retrospective analysis of a retrospective collected database of 76 consecutive patients with cervical cancers, who were operated laparoscopically (50%), or laparotomy (50%). Sentinel nodes were defined as the ICG-positive pelvic nodes in the first and second echelons. False negative cases were defined as positive non-sentinel lymph nodes despite successful sentinel mapping or failed mapping bilaterally by per-patient assessment or unilaterally by pelvic sidewall assessment; (3) Results: Regardless of the approach (open or laparoscopic), the SLN technique achieved a total sensitivity, specificity, and negative predictive value (NPV) of 94.7%, 98.6%, and 94.7%, respectively in the entire sample. The bilateral detection rate was as high as 93.4% with identical results in both approaches. The sensitivity and NPV for SNL in open surgery was found to be similar to minimal access surgery; (4) Conclusions: ICG and SPY-PHI technique is a reliable tool to detect sentinel lymph nodes in cervical cancer during laparotomy.

The 10-year results after national introduction of pelvic lymph node staging in Danish intermediate-risk endometrial cancer patients not given postoperative radiotherapy

The 10-year results after national introduction of pelvic lymph node staging in Danish intermediate-risk endometrial cancer patients not given postoperative radiotherapy. Gitte Ørtoft; Claus Høgdall; Estrid S Hansen; Margit Dueholm. ObjectiveTo prepare for the national introduction of sentinel node staging, we evaluated the consequences of the previous national decision to introduce lymph node staging in intermediate-risk endometrial cancer patients (grade 1/2 with > 50% or grade 3 with < 50% myometrial invasion) by determining the number of patients upstaged by lymphadenectomy and whether upstaging affected the survival and recurrence patterns of non-staged patients and patients with and without lymph node metastases. Study DesignIn a national cohort study, 2005–12, 1294 stage I–IV patients who should have been offered lymphadenectomy were progressively registered. The number of patients upstaged by lymphadenectomy, 10-year survivals were evaluated by Kaplan–Meier analysis and adjusted Cox regression. ResultsThis study demonstrates that it takes time to introduce lymphadenectomy at a national level, as indicated by the increasing number of cases staged per year, from 12% in 2005 to 74% in 2012. Pelvic lymphadenectomy was performed in 43.8% (567/1294) and lymph node metastases were found in 13.6% (77/567). As 54 patients had further dissemination outside the uterine body, only 23 patients (6%) were upstaged from stage I to IIIC. Compared to lymph node-negative patients, the 77 patients with lymph node metastasis had significantly lower overall, (55% versus 68%), disease-specific (64% versus 86%), and progression-free survival (51% versus 77%), mainly due to non-local recurrences including a high number of paraaortic recurrences. In 873 final stage I intermediate-risk patients, 10-year survival and recurrence rates were not significantly lower in non-staged as compared to lymph node-negative patients (overall survival 62% versus 70%: disease-specific survival: 90% versus 90%, progression-free survival: 81% vs 83%), probably due to the low number of patients upstaged from stage I to stage IIIC. ConclusionLymph node metastases were present in 13.6% of patients with intermediate-risk who underwent pelvic lympadenectomy, and these patients had a lower 10-year survival than lymph node-negative patients. Because lymphadenectomy upstaged only 6% from stage I to stage IIIC, survival and recurrence rates were not significantly compromised in non-staged as compared to lymph node-negative intermediate-risk stage I patients. Sentinel node staging has now been implemented in Danish intermediate-risk endometrial cancer patients.

Risk factors for nonvisualization of the sentinel lymph node on lymphoscintigraphy in breast cancer patients

BackgroundAccurate sentinel lymph node (SLN) staging is essential for both prognosis and treatment in patients with breast cancer. However, the preoperative lymphoscintigraphy may fail to visualize the SLN in some patients. The purpose of this retrospective study was to identify risk factors associated with SLN nonvisualization on lymphoscintigraphy. For this single-center retrospective study, all data of lymphoscintigraphy of SLN procedures from March 2011 to April 2021 were collected and reviewed from the Amsterdam UMC database.ResultsA total of 1886 SLN procedures were included in this study. The SLN nonvisualization rate was 25.1% on lymphoscintigraphy at 4 h post-injection. The SLN nonvisualization rate decreased to 9.4% after reinjection. Multivariable analysis showed that age ≥ 70 years (P < 0.001; OR: 2.27; 95% CI: 1.46–3.53), BMI ≥ 30 kg/m2 (P = 0.031; OR: 1.48; 95% CI: 1.04–2.12) and nonpalpable tumors (P = 0.004; OR: 1.54; 95% CI: 1.15–2.07) were independent predictors of SLN nonvisualization. Tumor location, brand of radiopharmaceutical, injected dose and volume, experience of preparer and administrator were not associated with SLN nonvisualization. None of the patient, tumor or tracer characteristics were associated with SLN nonvisualization after radiotracer reinjection.ConclusionsThis study shows that risk factors for SLN nonvisualization in breast cancer patients during preoperative lymphoscintigraphy are age ≥ 70 years, BMI ≥ 30 kg/m2 and nonpalpable tumors. Our results support the notion that SLN lymphoscintigraphy is a very robust technique that does not depend on the experience of the preparer or administrator of the radiotracer.

107 COVID 19 - Developing A Second Brain for Axillary Conservation During the Pandemic By Extrapolating Evidence On Technical Trends Of Sentinel Node Staging Of Axilla Into A Streamlined Recommendation

IntroductionAxillary conservation is the way forward after game changing trials like ACOSOG Z0011, surrogate trials like IBCSG,AMAROS, ALMANAC, on-going POSNOC, and newbie ATNEC have decreased the need to fiddle with the axilla. Current standard is the utilisation of double technique with radioisotope and blue dye to decrease false negative rates for true sentinel node retrieval.MethodLiterature search on the topic in the last two decades.ResultsThe search yielded 197 publications which were subjected to a meticulous review.ConclusionsSingle agent radioisotope is recommended in palpable and good biology breast tumours. Use of single agent blue dye can be standardised in axillary tail tumours. It is also recommended when isotope mapping is logistically not feasible or during pandemics like COVID 19 where looming infrastructure challenges are prevalent. Dual agent technique should be considered in previously treated breast and axilla, neoadjuvant chemotherapy cohort, bad tumour biology, high BMI and macromastia groups for true nodal retrieval. Optimal number of nodes taken out should not be more than three (n = 3). Lower axillary sampling of not more than 3 nodes is recommended for troubleshooting. Magnetic tracing can be used as an adjunct to either single agent (RI/BD) technique when there is failure to localise the sentinel node.

Abstract PD4-01: Preservation of axillary lymph nodes compared to complete dissection in T1-T2 breast cancer patients presenting 1-2 metastatic sentinel lymph nodes : A multicenter randomized clinical trial. Sinodar One.

Abstract Introduction: Sentinel lymph node (SLN) staging is currently used to avoid complete axillary lymph node dissection (ALND) in breast cancer (BC) patients. The SLN is the only site of axillary metastasis (MTS) in ≤60% of cases. Recently, a randomized controlled trial (Z0011) comparing SLN biopsy (SLNB) alone with SLNB followed by ALND in patients with 1-2 SLNs+ demonstrated no significant statistical difference in relapse and overall survival rates among the two different groups. However, this study had some limitations: small tumor size (≤2cm in 70% of cases), frequent presence of only microMTS in SLN (40%), prevalent use of “whole breast” adjuvant radiotherapy (&amp;gt;90%). Given these considerations, the SINODAR-ONE study started in April 2015.Objectives: The aims are to assess whether ALND omission in BC patients with 1-2 SLNs+ is associated with worse survival and/or increased rate of regional/distant relapse. Thus evaluating whether SLNB is or is not inferior to ALND. Primary endpoint is overall survival (OS). Secondary endpoints are disease-free survival (DFS) referring to distant MTS and loco-regional recurrence. Methods: Patients receive either mastectomy or conservative surgery plus radiotherapy. They all undergo SLNB and are randomly divided into two arms of treatment: standard (SLNB plus ALND) or experimental treatment (only SLNB). According to multidisciplinary evaluation, patients may undergo additional adjuvant radiotherapy, chemo- and/or hormonal therapy , or no further therapy. Eligibility criteria: age 40-75 years; primary invasive T1-T2 tumor; axillary nodes clinically N0; no more than 2 macro-metastatic SLNs; no distant MTS; no neo-adjuvant therapy; no previous invasive BC; signed informed consent. Exclusion criteria: in situ, inflammatory, contralateral BC; micro-metastic SLNs; pregnancy or breast feeding; comorbidity impeding adjuvant therapy. All analyses are performed both on all patients according to the Intention-To-Treat principle and excluding those patients who did not receive the axillary treatment randomly assigned. Statistical analysis: OS and DFS are calculated using the Kaplan-Meier Product Limit Estimator and differences between arms are assessed with the log-rank test. Results: The enrollment of patients ended in April 2020 with a total of 889 cases (443: standard arm; 446: experimental arm). In June 2020, we conducted an ad interim analysis on 889 patients. We found the two groups homogeneous for epidemiologic characteristics (age and menopausal status), tumor characteristics (tumor size, pTNM, immunohistochemistry, histology, grading, vascular and lymphatic invasion), adjuvant therapies and surgery on T. In particular we have performed a 23,1% of mastectomies in the standard arm and 20,1% in the experimental arm. We found a median of 2 sentinel lymph nodes removed in both arms and 1 non-sentinel positive lymph node in the experimental arm, and only 3 micro-metastases (1 in the standard arm and 2 in the experimental arm). Conclusion: In sum, with a median follow-up of 30 months, there have been no axillary recurrence in both arms. In the standard arm we found 8 total events (2 deaths and 6 distant relapses) and in in the experimental arm 6 events (1 death and 5 distant relapses), with a projected 5-years cumulative incidence of 6,5% in standard arm and 4,85% in the experimental arm. Citation Format: Corrado Tinterri, Emilia Marrazzo, Chiara Anghelone, Erika Barbieri, Andrea Sagona, Alberto Bottini, Arianna Rubino, Damiano Gentile, Wolfgang Gatzemeier, Valentina Errico, Alberto Testori, Giuseppe Canavese. Preservation of axillary lymph nodes compared to complete dissection in T1-T2 breast cancer patients presenting 1-2 metastatic sentinel lymph nodes : A multicenter randomized clinical trial. Sinodar One. [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD4-01.

Abstract PS1-62: Two decades of experience with sentinel node staging of axilla - is false negative no longer a worry?

Abstract Aim: To review current literature and standard practices in various techniques of sentinel node biopsy for staging the axilla for treating early breast cancer. The purpose is to provide evidence based recommendation as guidance platform for optimal true sentinel node retrieval irrespective of surgeon expertise. Background: Axillary conservation is the way forward after game changing trials like ACOSOG Z0011, surrogate trials like IBCSG,AMAROS, ALMANAC, ongoing POSNOC, and newbie ATNEC have progressively or plan to decrease the need to unnecessarily fiddle with the axilla thereby increasing the chances of arm related and other morbidities. Axillary sentinel node biopsy entails retrieval of first draining lymph node in the breast-axilla pathway to plan treatment in breast cancer by appropriate staging of axilla. Current standard is the utilisation of double agent technique with radioactive isotope and blue dye injection to decrease false negative rates for true sentinel node retrieval. Novel techniques like magnetic and infrared tracing are still being investigated for validation. Method: PMC, Medline, EMBASE, PubMed and Cochrane library searched for clinical trials, randomised trials, systematic reviews and meta-analysis on techniques of axillary sentinel node biopsy in early breast cancer. This covered the last 25 years literature on the topic. Results: The search yielded 197 publications which were subjected to a meticulous review and narrowed to a select pertinent body of evidence to extrapolate suggested guidance rationally, the bibliography of which is provided at the end. Conclusion: Single agent preferably radioisotope for lymphatic mapping is recommended in palpable and good biology tumours. Use of single agent blue dye can be standardised in axillary tail tumours. It is also recommended as being effective when isotope mapping is logistically not feasible or during pandemics like COVID 19 where looming infrastructure challenges are prevalent. Dual agent technique should be considered in previously treated breast and axilla, neoadjuvant chemotherapy cohort, bad tumour biology, high BMI and macromastia groups for true nodal retrieval. Optimal number of nodes taken out should not be more than three (n=3). Lower axillary sampling of not more than 3 nodes is recommended for troubleshooting with any localising agent technique. Triple site injection at peri-tumoural, subcutaneous and sub areolar regions and larger volume of blue dye agent injection of up to 8mls increases the localisation success in the dual technique group for lymphatic mapping. Magnetic tracing can be used as an adjunct to either single agent radioactive isotope or blue dye (RI/BD) technique when there is failure to localise the sentinel node. Citation Format: Tahera Arif, Mohammed Shamim Absar. Two decades of experience with sentinel node staging of axilla - is false negative no longer a worry? [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS1-62.

Non-radical primary diagnostic biopsies affect survival in cutaneous head and neck melanoma

Background It is unclear if a non-radical diagnostic biopsy entails a higher risk for metastasis and poorer survival for patients with cutaneous head and neck melanoma (cHNM). Aims/objectives To assess whether or not initial diagnostic biopsy modality and radicality (clear, positive, or narrow histopathological margins) influence recurrence and survival in patients with cHNM. Materials and methods Histopathological radicality of initial diagnostic biopsies and outcome for 368 consecutive cHNM patients, clinically asymptomatic of metastatic disease and referred to a tertiary care academic center for sentinel lymph node staging from 2004 through 2018, were retrospectively analyzed. Results Patients with positive (n = 133) or narrow (0.1–0.5 mm) (n = 34) histopathological margins had significantly worse loco-regional (p=.004) and distant control (p=.004) as well as lower overall (p=.017) and melanoma specific (p=.0002) survival than 201 patients with clear margins. Multivariate analysis indicated positive or narrow histopathological margins as independent negative prognostic factors for melanoma specific survival (HR 2.16, p=.015), together with deeper Breslow (HR 1.17, p=.00001) and ulceration (HR 2.49, p=.003). Conclusions and significance Non-radical primary diagnostic biopsies increase the risk for metastatic disease and impair survival in cHNM. Accordingly, radical melanoma diagnostic procedures should be encouraged in the head and neck region when possible.

Does the result of the sentinel lymph node in breast cancer differ depending on the method of the intra-operative assessment used?

Background: Sentinel lymph node biopsy (SLNB) has been considered the preferred diagnostic procedure for sentinel lymph node (SLN) staging. There are two main techniques for intra-operative SLN analysis based on intraoperative histological (H&E) or molecular (OSNA) examination.The aim of our work is to understand the differences in the outcomes according to the use of one method versus the other.

Performance of Indocyanine-Green Imaging for Sentinel Lymph Node Mapping and Lymph Node Metastasis in Esophageal Cancer: Systematic Review and Meta-Analysis.

Lymphatic mapping with indocyanine-green (ICG) and near-infrared light fluorescent imaging is widely used for sentinel lymph node staging in different types of cancer but is not fully accepted for all procedures because studies have reported heterogeneous results. This study aimed to assess the detection rate (DR) of ICG imaging for sentinel lymph node mapping (SLNM) and lymph node metastases (LNMs) in esophageal cancer. A systematic search was performed to identify relevant studies examining the use of ICG imaging for SLNM in patients with esophageal cancer. Extracted results were pooled in a single-proportion meta-analysis, with a random-effects model, presented as forest plots. Six studies were included in the analysis. The ICG DR for SLNM was 89% [95% confidence interval (CI) 71%-96%]. The pooled sensitivity and specificity values for the detection of LNMs were 84% (95% CI 64%-94%) and 15% (95% CI 3%-45%), respectively. A trend towards a lower DR was found with increasing mean latency time between ICG injection and SLNM. ICG imaging is a technique that potentially could improve lymph node yield excision and, as a consequence, improve the detection of lymph node metastases.

Two decades of experience with Sentinel node staging of axilla – is false negative no longer a worry?

Background: Axillary conservation is the way forward after game changing trials like ACOSOG Z0011, surrogate trials like IBCSG,AMAROS, ALMANAC, on-going POSNOC, and newbie ATNEC have decreased the need to fiddle with the axilla. Current standard is the utilisation of double technique with radioisotope and blue dye to decrease false negative rates for true sentinel node retrieval.