Results Of Sentinel Lymph Node Biopsy Research Articles

Abstract P3-05-56: The clinical impact of preoperatively needle-aspiration biopsy for axillary lymph nodes in T1-T2 breast cancer patients with axillary lymph node metastasis

Abstract Introduction: More than half of the results of axillary lymph node dissection followed by metastasis in sentinel lymph node(SLN) biopsy are negative. For deescalating axillary surgery, it is necessary to predict the non-SLN metastasis state, where metastasis was confirmed in the SLN biopsy. Method: Breast cancer patients with T1 and T2 stage were retrospectively reviewed from January 2008 to December 2016. A total of 818 patients underwent surgery as the primary treatment and the result of SLN biopsy was positive for metastasis. Patients who skipped SLN biopsy procedure and were proven metastatic axillary lymph nodes by needle-aspiration biopsy (NAB) were excluded. SLN was defined as lymph nodes detected by the dual method with hot-uptake by radioisotope and dyed by blue dye, or lymph nodes with palpable or suspected metastatic findings during SLN biopsy. Clinicopathological factors including and extra-nodal invasiveness were analyzed. Result: The median follow-up period was 73 months. Non-SLN metastasis was significantly seen in patients with older than 50 years, positive node metastases by preoperative NAB, high T stage, and extra-nodal invasion. In subgroup analysis, patients who underwent total mastectomy had the similar patterns of the increased risk of having non-SLN. Poor overall survival was observed in the patients with the presence of non-SLN metastasis. Conclusion: We confirmed predictive factors with a high probability of non-SLN metastasis. Axillary lymph node dissection cannot be overlooked in the patients proven the metastatic result of preoperative NAB. Citation Format: Jee Hyun Ahn, Suk Jun Lee, Jieon Go, Hyung Seok Park, Jee Ye Kim, Seung Il Kim, Byeong Woo Park, Seho Park. The clinical impact of preoperatively needle-aspiration biopsy for axillary lymph nodes in T1-T2 breast cancer patients with axillary lymph node metastasis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-05-56.

Representativeness of initial skin biopsies showing pure desmoplastic melanoma: implications for management

Desmoplastic melanoma (DM) is an uncommon subtype of melanoma with distinct clinicopathological features. It is classified into pure desmoplastic melanoma (PDM) when the proportion of desmoplastic melanoma is ≥90% of the dermally-invasive component, and mixed desmoplastic melanoma (MDM) when the proportion of desmoplastic melanoma is <90%. Studies have reported a lower sentinel lymph node biopsy (SLNB)-positivity rate in PDM compared to MDM and non-DM. As a result, some have recommended not performing SLNB in PDM patients. When PDM is identified in a partial biopsy of a melanoma, there is a risk that sampling bias may under-recognise MDM, but to the best of our knowledge this has not been previously assessed or quantified. The aim of this study was to assess the concordance of the proportion of desmoplastic melanoma in an initial partial biopsy of PDM with the proportion in the entire tumour following complete excision, in patients with cutaneous melanoma. A secondary aim was to determine how frequently this potentially resulted in a patient not receiving a SLNB. Seventy-eight cases of cutaneous melanoma were identified from the Melanoma Institute Australia (MIA) database and 23 cases from the Memorial Sloan Kettering Cancer Centre (MSKCC), where an initial biopsy contained PDM and a subsequent wide excision had residual invasive melanoma. Clinicopathological features were analysed in all patients, including whether a SLNB was performed, the results of SLNB, and any subsequent recurrence. Ninety percent (91/101) of cases were still classified as PDM in the complete wide excision specimen while 10% (10/101) of cases were reclassified as MDM, which was a significant change in classification of final desmoplastic melanoma subtype (p<0.001). The proportion of desmoplastic melanoma was also significantly different between the initial and excisional biopsies (p=0.004). Forty-eight (48/101) patients had a SLNB, of which two (4.5%) were positive for metastatic melanoma; both cases were PDM in the excision specimen. Of the 10 cases demonstrating MDM in the excision specimen, the initial biopsy was a punch biopsy in six cases, shave biopsy in two cases and subcutaneous tissue was sampled in two patients (one punch biopsy, one incisional biopsy). Four of these 10 patients underwent SLNB which was negative in all cases. Twenty-two patients developed recurrence in the follow-up period (median 30 months, range 1-192 months), three with MDM in their excision specimen. One patient did not have a SLNB and developed regional lymph node recurrence. In this study there was a 10% risk that the percentage of desmoplastic melanoma in an initial biopsy of PDM was not representative of the entire lesion, resulting in reclassification as MDM in the excision specimen. If a SLNB is not performed in such cases, a positive SLNB may be missed (one patient in our study) which could impact treatment options for the patient. We recommend caution in not offering a SLNB in the setting of an initial biopsy of PDM if the biopsy is small compared with the overall lesion. If a SLNB is not procured at the time of wide excision in such cases, the SLNs should still be mapped by lymphoscintigraphy to facilitate careful follow up and to enable earlier detection and treatment of nodal disease.

Alternatives and reduced need for sentinel lymph node biopsy (SLNB) staging for melanoma

Sentinel lymph node biopsy (SLNB) has been introduced in the 1990s to identify patients who might benefit from completion lymph node dissection. Neither SLNB nor CLND improved survival, but SLNB staging did provide the best staging, above Breslow thickness and ulceration. The SLN status and SLN tumour burden were used in all trials until date looking at modern adjuvant systemic therapy with immune checkpoint inhibition (ICI) or targeted therapies (TT). Adjuvant ICI and TT are shifting towards stage II melanoma. The question is whether there is still role for SLNB in melanoma, in this day and age, and if so, how does the future look for SLNB staging? The SLN status and SLN tumour burden might be useful for a consultation to discuss the number needed to treat in a risk/benefit discussion. For stage IIB/C patients, it seems likely, however, that patients will forego a nuclear scan followed by the risk of surgical intervention and morbidity associated with SLNB if they opt to receive adjuvant therapy regardless of the SLNB result. For stage I/IIA, it is still required to detect high-risk patients who might benefit from adjuvant therapy. However, biomarkers are emerging, such as gene expression profilers (GEP), immunohistological signatures and liquid biopsies with ctDNA. There still is a role for SLNB staging in melanoma today, but we expect that the availability of therapeutic option independent of SLNB status as well as emergence of validated biomarkers to predict risk will reduce the need for SLNB staging in the upcoming decade to the point it will no longer be used.

The Integrated 31-Gene Expression Profile Test (i31-GEP) for Cutaneous Melanoma Outperforms the CP-GEP at Identifying Patients who can Forego Sentinel Lymph Node Biopsy when Applying NCCN Guidelines

Introduction: Eighty-eight percent of patients who receive a sentinel lymph node biopsy (SLNB) receive a negative result. Current guidelines suggest avoiding SLNB if the risk of positivity is &lt;5%. A low threshold for performing SLNB indicates worry about missing positive nodes but results in many unnecessary biopsies. The integrated 31-gene expression profile (i31-GEP) test combines the 31-GEP with Breslow thickness, age, ulceration, and mitotic rate using a validated neural network algorithm to identify patients with &lt;5% risk by reporting a precise, individualized likelihood score. Using logistic regression, a separate GEP (8 genes plus Breslow thickness and age; CP-GEP) also aims to identify patients who can forego SLNB by binning patients into low- and high-risk categories. This study compared the i31-GEP for SLNB with the CP-GEP to identify patients who can safely forego SLNB. Methods: This study evaluated the genes, gene pathways, and relative contribution of the two gene signatures relative to clinical and pathologic factors and further analyzed patients with T1b-T2 tumors from previously published studies in U.S. cohorts for the i31-GEP (n=763) and CP-GEP (n=153). A ratio of true-to-false-negative i31-GEP for SLNB and CP-GEP test results was compared to the guideline-established ratio of 19 negatives to one missed positive (19:1) if foregoing SLNB using a 5% risk threshold. Results: The i31-GEP had a 30:1 true-to-false-negative ratio, compared to 15:1 using CP-GEP. In T1b tumors, the i31-GEP ratio increased to 35:1 compared to 14:1 using CP-GEP. Limitations: Retrospective design, which could lead to bias. Patients included in both analyses were primarily from institutional surgical centers, and referral bias may not make the result generalizable. Conclusion: Only the i31-GEP provided benefit over guideline-established care for identifying patients with low risk of SLN positivity.

Identification of the lymph node metastasis-related automated breast volume scanning features for predicting axillary lymph node tumor burden of invasive breast cancer via a clinical prediction model.

Breast cancer has become the malignant tumor with the highest incidence in women. Axillary lymph node dissection (ALND) is an effective method of maintaining regional control; however, it is associated with a significant risk of complications. Meanwhile, whether the patients need ALND or not is according to sentinel lymph node biopsy (SLNB). However, the false-negative results of SLNB had been reported. Automated breast volume scanning (ABVS) is a routine examination in breast cancer. A real-world cohort consisting of 245 breast cancer patients who underwent ABVS examination were enrolled, including 251 tumor lesions. The ABVS manifestations were analyzed with the SLNB results, and the ALND results for selecting the lymph node metastasis were related to ABVS features. Finally, a nomogram was used to construct a breast cancer axillary lymph node tumor burden prediction model. Breast cancer patients with a molecular subtype of luminal B type, a maximum lesion diameter of ≥5 cm, tumor invasion of the Cooper’s ligament, and tumor invasion of the nipple had heavy lymph node tumor burden. Molecular classification, tumor size, and Cooper’s ligament status were used to construct a clinical prediction model of axillary lymph node tumor burden. The consistency indexes (or AUC) of the training cohort and the validation cohort were 0.743 and 0.711, respectively, which was close to SLNB (0.768). The best cutoff value of the ABVS nomogram was 81.146 points. After combination with ABVS features and SLNB, the AUC of the prediction model was 0.889, and the best cutoff value was 178.965 points. The calibration curve showed that the constructed nomogram clinical prediction model and the real results were highly consistent. The clinical prediction model constructed using molecular classification, tumor size, and Cooper’s ligament status can effectively predict the probability of heavy axillary lymph node tumor burden, which can be the significant supplement to the SLNB. Therefore, this model may be used for individual decision-making in the diagnosis and treatments of breast cancer.

ASO Visual Abstract: How Often Do Sentinel Lymph Node Biopsy Results Affect Adjuvant Therapy Decisions Among Postmenopausal Women with Early-Stage HR+/HER2- Breast Cancer in the Post-RxPONDER Era?

ASO Visual Abstract: How Often Do Sentinel Lymph Node Biopsy Results Affect Adjuvant Therapy Decisions Among Postmenopausal Women with Early-Stage HR+/HER2- Breast Cancer in the Post-RxPONDER Era?

How Often Do Sentinel Lymph Node Biopsy Results Affect Adjuvant Therapy Decisions Among Postmenopausal Women with Early-Stage HR+/HER2- Breast Cancer in the Post-RxPONDER Era?

The RxPONDER trial reported no benefit to chemotherapy among postmenopausal patients with HR+/HER2- tumors, one to three positive nodes, and low recurrence scores, questioning the role of axillary staging in this population. Here, we evaluate the impact of sentinel lymph node biopsy (SLNB) results on adjuvant therapy decisions in postmenopausal women with HR+/HER2- breast cancer. Postmenopausal women with cT1-2N0, HR+/HER2- breast cancer treated with lumpectomy and SLNB from 2012 to 2018 were identified. Receipt of nodal irradiation, indication for axillary lymph node dissection (ALND) and chemotherapy, and partial breast irradiation (PBI) eligibility were reviewed with pre- and post-SLNB results. A total of 1786 women were identified: median age 62 years, 84% with pT1 tumors, and 16% with pT2-3 tumors. Of those, 85% (n = 1525) remained pN0, 14% (n = 244) were pN1, and 1% (n = 17) were pN2-3. A total of 20 (1%) patients had > 2 positive SLNs, necessitating ALND. Pre-SLNB, 1478 women were considered PBI eligible; post-SLNB, 227 (13%) converted to PBI ineligible. In total, 58 patients with positive nodes received nodal irradiation, representing 3% of the entire cohort and 22% of pN+ patients. Overall, 1401 patients had an Oncotype DX recurrence score available, including 1273 patients with pN0 stage and 128 with pN1, with 173 (14%) and 16 (13%), respectively, having a recurrence score > 25, warranting chemotherapy. While few cN0 postmenopausal women with HR+/HER2- tumors had nodal pathology that warranted ALND, receipt of nodal irradiation, or indicated need for chemotherapy, in 13%, SLNB would have an impact on consideration for PBI. Among patients eligible for PBI, findings from SLNB may help refine selection among postmenopausal women with this tumor profile.

Investigate the accuracy and economic value of the upstaging prediction model for ductal carcinoma in situ.

e12577 Background: The current study aims to define the “high-risk upstaging model” in ductal carcinoma in situ (DCIS) and investigate its accuracy in order to suggest the most precise application of sentinel lymph node biopsy (SLNB). Methods: PubMed, EMBASE, and Cochrane library databases were searched. Prospective and retrospective cohort studies that evaluated the pathological outcomes of SLNB and the upstaging rate in women with DCIS were included. We analyzed factors that potentially indicate nodal involvement risk and combine the significant ones into “high-risk upstaging model”. Consecutively, we conducted a retrospective study by applying our model and NCCN guideline model into DCIS patients extracted from hospital database. Both the excess treatment rate and incomplete treatment rate of SLNB were analyzed. The diagnostic performance of the model in predicting upstaging risk was evaluated with receiver operating characteristic (ROC) curve. Results: We retrieved 43 prospective and 69 retrospective studies including 44,001 DCIS patients. The upstaging rate was significantly higher in patients with estrogen receptor-negative status, palpable mass, tumor size &gt; 2 cm on imaging, and high-nuclear grade and those who received a preoperative diagnosis through core needle biopsy. We then collected 168 DCIS patients who entered in Shuang-Ho hospital from February 2017 to August 2021. Ninety-six patients who didn’t upstage in final pathology have received extra SLNB and two patients who upstaged in final pathology did not receive SLNB in primary surgery. The areas under the ROC curve of the model developed by multivariable logistic regression for predicting upstaging risk in the NCCN guideline group and “high-risk upstaging model” group were 0.642 and 0.706, the sensitivity at 66.0% and 83.0%, and the specificities at 62.5% and 49.2%, respectively. Conclusions: “High-risk upstaging model” shows higher areas under the ROC curve and sensitivity as well compared with current NCCN guideline. Our prediction model can provide surgeons with a more accurate and specific indications of SLNB in DCIS.

Abstract P1-01-06: Predictor of sentinel node positivity in screen-detected invasive breast cancer

Abstract Introduction: Sentinel lymph node biopsy represents the standard of care for staging axilla in breast cancer patients who are clinically node negative. ACOSOG Z11 trial results questioned the importance of low burden nodal disease. Results from the SOUND trial on omission of axillary surgery in selected patients with early stage breast cancer are still awaited. Breast screening programs aim to detect cancers at an early stage and are expected to have low burden of nodal disease. The aim of our study was to determine predictors of sentinel node biopsy positivity in invasive breast cancers detected on screening mammography. Methods: This retrospective study included patients with node negative invasive breast cancer detected on screening mammogram performed between April 2018 and March 2020 and subsequently underwent curative surgery including sentinel node biopsy at breast care unit of Castle Hill Hospital, Cottingham, U.K. We looked at patient’s clinical, radiological and pre-operative pathological features and correlated them with histological results of sentinel node biopsy. Statistical analysis of the data was performed using SPSS version 22 and p-value of 0.05 was considered significant. Results: We identified 304 patients who met inclusion criteria. The mean age of these patients was 62.71 ± 7.2 years (range 47-78 years). Majority (88%) of women were postmenopausal. Overall, the sentinel node positivity rate was 11.76%. Women over the age of 55 years were less likely to be node positive compared to younger women (9.9% vs 22%, p=0.016). Tumours less than 10mm in size had node positive rate of 5.5% compared to tumour larger than 21mm (25%, p = 0.000). In comparison to grade 2and grade 3 tumours, grade 1 tumours had lower node positivity rate, (5% vs 14.4%) but the difference did not reach statistical significance (p= 0.073). All women with tubular and mucinous histological subtypes (n=13) were node negative. All women with grade 1 tumours less than 10mm in size (n=48) had a negative sentinel node biopsy compared to women with grade 2 tumors more than 20mm (9/32=28% positivity rate) and p-value of 0.000. There was no association between oestrogen, progesterone and HER2 receptor status with sentinel lymph node positivity rate. Conclusion: In selected screen detected patients including those above the age of 55 years, having grade 1 cancer, and less than 10 mm size on pre-treatment imaging, there might be scope for omission of axillary surgery. Citation Format: Raouef Ahmed Bichoo, Mohammed Bilal Elahi, Dorin Dumitru, Naila Bint Ihsan, Eiman Khalifa, Masuma Sarker, Tapan K Mahapatra, Brendan Paul Wooler, Peter Kneeshaw, Kartikae Grover. Predictor of sentinel node positivity in screen-detected invasive breast cancer [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 P1-01-06.

Abstract OT1-04-02: The NAUTILUS trial (No Axillary sUrgical Treatment In clinically Lymph node negative patients after UltraSonography): A prospective multicenter randomized phase III trial (NCT04303715)

Abstract Background. Sentinel lymph node biopsy (SLNB) is currently the standard axillary staging procedure for clinically node-negative breast cancer. According to the ACOSOG Z0011 trial, axillary lymph node dissection (ALND) is now often omitted for clinically node-negative cT1-2 breast cancer patients undergoing breast-conserving surgery even if 1 or 2 metastatic lymph nodes (LN) are identified. It was shown that radiotherapy contributes to regional control of the axilla non-inferior to ALND even in the presence of metastatic LNs. Furthermore, LN metastasis has a limited role in planning adjuvant systemic therapy for hormone receptor-negative breast cancers, and also for hormone receptor-positive, HER2-negative breast cancer with increased use of genomic assays. SLNB is not without complications and omitting axillary staging operation could improve quality of life. Trial Design. In this multicenter, phase III randomized controlled trial including 9 study sites in South Korea, we plan to 1:1 randomize 1734 patients to either omit SLNB (Arm 1) or receive SLNB (Arm 2). Additional ALND can be performed according to the discretion of the surgeon according to the SLNB results. All patients must receive whole-breast irradiation ± tumor bed boost. The recommended upper margin of the radiation field is within 2cm of the humeral head. ClinicalTrials.gov identifier: NCT04303715. Eligibility. Inclusion criteria: women ≥19 years; cT1-2N0M0 unilateral invasive breast carcinoma; all molecular subtypes; clinically and radiologically tumor size ≤ 5cm; clinically- and ultrasonogram-negative axillary lymph nodes, or no tumor on core needle biopsy or fine needle aspiration cytology in case of suspicious lymph nodes; candidate for breast-conserving surgery with no restriction to radiotherapy and adequate systemic therapy. Exclusion criteria: history of any malignancy within 5 years (exception: thyroid cancer and well-treated skin cancer except melanoma); bilateral breast cancer; neoadjuvant chemotherapy; candidate for total mastectomy; male breast cancer. Specific Aims. Primary objective is to test the hypothesis that omitting SLNB for breast cancer is non-inferior to axillary staging operation in terms of 5-year disease-free survival. Secondary objectives are to compare overall survival, distant metastasis-free survival, locoregional recurrence, quality of life assessment, and DFS and axillary recurrence according to molecular subtypes. Statistical Methods. With an expected 5-year DFS of 86% for Arm 2, Arm 1(SLNB omission) will be assessed with a non-inferiority limit of 5% and hazard ratio of 1.4, power 80%, and significance level of 5%, where 224 events are required. The calculated sample size is 780 per study arm, resulting in a total of 1,734 patients assuming a 10% drop-out rate. Present Accrual and Target Accrual. The first patient was randomized on September 15, 2020. As of July 9, 2021, 480 patients have been randomized. Target accrual of 1734 patients is expected to be complete by April 2023, with the primary endpoint analysis expected in 2028. Citation Format: Han-Byoel Lee, Ji Gwang Jung, Jung Min Chang, Ji Hyun Chang, Woo Kyung Moon, Kyung Hwan Shin, Il Yong Chung, Seok Jin Nam, Eun-Kyu Kim, Seeyoun Lee, Seho Park, Woo Sung Lim, Yongsik Jung, Wonshik Han. The NAUTILUS trial (No Axillary sUrgical Treatment In clinically Lymph node negative patients after UltraSonography): A prospective multicenter randomized phase III trial (NCT04303715) [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 OT1-04-02.

Surgical Management of Axilla of Triple-Negative Breast Cancer in the Z1071 Era: A Propensity Score-Matched Analysis of the National Cancer Database.

The role of sentinel lymph node biopsy (SLNB) in triple-negative breast cancer (TNBC) patients who present with clinical N1 (cN1) disease and undergo complete clinical response (cCR) to neoadjuvant systemic therapy (NAST) remains unclear. We aimed to study the outcomes of SLNB versus axillary lymph node dissection (ALND) in this setting. Patients with cN1 TNBC who showed cCR to NAST were selected from the National Cancer Database (NCDB), and propensity score matched 1:1 between SLNB and ALND in all-comers, ypN0, and ypN1 subgroups. Overall survival (OS) was compared using the Kaplan-Meier method. Cox regression was used to identify predictors of OS. Of the 2953 patients selected. 1062 (36.0%) underwent SLNB and 1891 (64.0%) underwent ALND. There was a chronological increase in national SLNB utilization (from 20% in 2012 to 46% in 2017). One thousand three patients were propensity matched between SLNB and ALND, and no OS difference was noted (81.73 ± 1.04 vs. 80.07 ± 0.70 months; p = 0.127). In the ypN0 subgroup, 884 pairs were matched and no significant OS difference was found (85.29 ± 0.84 vs. 82.60 ± 0.68 months; p = 0.638). In ypN+ patients, 129 pairs were matched and demonstrated a trend toward decreased OS with SLNB (64.37 ± 3.12 vs. 72.45 ± 72.45; p = 0.085). Cox regression identified age, inner tumors, advanced T stage, partial/no in-breast response, and nodal status as unfavorable predictors of OS. Definitive axillary surgical procedure was not a predictor in the final model. SLNB and ALND appear to yield comparable OS in cN1 TNBC patients who demonstrate cCR to NAST. Caution should be exercised in ypN1 patients as worse OS could be associated with SLNB.

Dermal invasion matters in breast cancer sentinel lymph node biopsy results

The aim of this study was to evaluate whether cancer invasion of the dermis could hamper drainage of the radiotracer in breast cancer patients who were undergoing a Sentinel Lymph Node Biopsy (SLNB) procedure. Ten patients who presented with T1-T2 breast cancer with dermal invasion alone as confirmed by a punch biopsy of skin were evaluated. For the SLNB procedure, a lymphoscintigraphy was performed 2 hours after intratumoral administration of 2 mCi (74 MBq) of 99mTc nanocolloid. The sentinel lymph nodes (SLN) were evaluated for the presence of tumor cells by hematoxylin-eosin staining and, when negative, by immunocytochemistry using anti-cytokeratin antibody (CAM 5.2). No migration of radiotracer was found in three patients, and one patient had a false negative SLN, so altogether the technique failed in four patients (40%). Axillary nodes proved to be positive in seven patients (70%).The high rate of failure in the lymphatic mapping and the high proportion of axillary positivity suggest a causal relationship with the invasion of the dermis, with possible implications for the validity of the SLNB procedure.

Outcomes of Sentinel Lymph Node Biopsy for Primary Cutaneous Squamous Cell Carcinoma of the Head and Neck.

Limited data exist on sentinel lymph node biopsy (SLNB) for cutaneous squamous cell carcinoma (cSCC) of the head and neck. To review the results of SLNB for patients with cSCC of the head and neck at the authors' institution. A retrospective review was completed for patients who underwent SLNB for cSCC of the head and neck over 19 years. Patient demographics, immune status, tumor stage, total patients with positive SLNB, local recurrence, nodal recurrence, in-transit metastasis, and disease-specific death were recorded. Sixty patients underwent lymphoscintigraphy, and an SLN was identified in 58 patients. The mean follow-up was 3.2 years (range, 15 days-16 years). Four patients (6.9%) had a positive SLNB. All were Brigham and Women's Hospital (BWH) stage T2b tumors. Three of these patients were immunosuppressed, 3 patients underwent neck dissection, and 2 patients received adjuvant radiation. None developed local or regional recurrence. Of the 53 patients with a negative SLNB, there were 4 local recurrences, 2 in-transit metastases, and no nodal recurrences. Immunosuppressed patients with tumors BWH stage T2b or greater may be a reasonable cohort to focus future prospective studies on the utility of SLNB in cSCC of the head and neck.

Waiving Subsequent Complete Lymph Node Dissection in Melanoma Patients with Positive Sentinel Lymph Node Does Not Result in Worse Outcome on 20-Year Analysis.

Simple SummaryThe aim of the present study was to investigate long-term outcomes of melanoma patients who had micrometastasis on sentinel lymph node (SLN) biopsy. We focused on the comparison between melanoma patients with and without complete lymph node dissection (CLND) following a positive SLN biopsy result. Patients without CLND did not significantly differ from patients with CLND in regard to age, gender, tumor thickness, tumor ulceration, capsule infiltration of SLN, and invasion level of SLN. On 10-year analysis, we did not observe a significantly increased risk for melanoma relapse or melanoma-specific death in patients who did not undergo CLND after the detection of micrometastases on SLN biopsy. On 20-year analysis, again, the patients without CLND had no significantly increased risk of melanoma relapse and worse melanoma-specific survival. Hence, our 10-year survival data confirm the current notion that waiving CLND in SLN-positive patients does not result in clinical disadvantages with respect to melanoma-specific survival. For the first time, we demonstrate on 20-year survival analysis that relapse rates and melanoma-specific survival does not significantly differ between patients with or without CLND on long-term follow-up.Complete lymph node dissection (CLND) following positive sentinel lymph node (SLN) biopsy has been the standard of care for decades. We aimed to study melanoma patients with an emphasis on the outcome of patients with versus without CLND following positive SLN biopsy. SLN-positive patients with or without CLND were compared regarding important prognostic clinical and histological characteristics. Ten-year and 20-year survival curves for melanoma relapse and melanoma-specific survival (MSS) were determined by the Kaplan-Meier method and Cox proportional-hazards regression. We studied 258 patients who had micrometastases in their SLN biopsy. CLND was performed in 209 of 258 patients (81%). Hence, in 49 of 258 patients (19%) with SLN micrometastases, CLND was not performed. These patients did not significantly (p > 0.05) differ from patients with CLND in regard to age, gender, tumor thickness, tumor ulceration, capsule infiltration of SLN, or invasion level of SLN. On 10-year analysis, we did not observe a significantly increased risk for melanoma relapse and worse in MSS in patients who did not undergo CLND (hazard ratio: 1.1 (95% CI 0.67 to 1.7) and 1.1 (95% CI 0.67 to 1.9), respectively). On 20-year survival analysis, we confirmed that the risk of melanoma relapse and impaired MSS does not significantly increase in patients without CLND (hazard ratio: 1.2 (95% CI 0.8 to 1.9) and 1.3 (95% CI 0.8 to 2.3), respectively). On 10-year as well as 20-year multivariable follow-up analysis (including several important prognostic factors), Cox proportional-hazards regression showed that the status of CLND did not remain in the regression model (p > 0.1). Our 10-year data give conclusive support to previous investigations indicating that waiving CLND in patients with SLN micrometastases does not affect MSS. More importantly, our long-term follow-up data confirm for the first time the 10-year survival data of previous investigations.

283 Neutrophil/lymphocyte ratio as a predictor of lymph node metastasis in extramammary Paget disease: A retrospective study

To prevent further development of extramammary Paget’s disease (EMPD), it is critical to detect lymph node metastasis at an early stage. Therefore, biomarkers that predict the risk of lymph node metastasis are required. In the present retrospective study, we evaluated the potential of neutrophil- to-lymphocyte ratio (NLR) in peripheral blood samples as a biomarker for the risk of lymph node metastasis in EMPD. This study involved 137 EMPD patients who underwent sentinel lymph node biopsy (SLNB) at our hospital from March 2003 to March 2020. The χ2 test, Mann-Whitney U test, logistic regression analysis and Kruskal-Wallis test were used to analyze the correlations between NLR and clinical features/laboratory findings and between SLNB positivity and clinical features/ laboratory findings. Receiver-operator curves were constructed using the DeLong model to define the optimal NLR cutoff value. The NLR cutoff value was defined as 3.0. The high NLR group had 30 patients whose NLRs exceeded 3 (NLR > 3), and 23% of the patients showed sentinel lymph node metastasis (SLNM). The low NLR group had 107 patients whose NLRs were no more than 3 (NLR ≤ 3), and 8% of the patients had SLNM. The rate of SLNM was significantly higher in the high NLR group than in the low NLR group (χ2 test; P = .0245). The odds ratio of SLNM for patients with NLR greater than 3 was 3.311 (95% confidence interval [CI], 1.117 to 9.804; P = .0380) compared with patients with NLR of 3 or less. Then, we classified the patients into 2 groups by SLNB results. Sixteen of the 137 patients (11.7%) showed SLNM. In the logistic regression analysis of 5 variables in 137 patients (Table II) and six variables including carcinoembryonic antigen (CEA) in 55 patients for SLNB positivity, only NLR was found to be significantly associated with SLNB positivity. Here we reported NLR might be a significant predictor for LNM in EMPD patients, providing us with a clue for determining which of them could benefit from SLNB.

Lymphatic drainage map of the head and neck skin squamous cell carcinoma detected by sentinel lymph node biopsy.

Squamous cell carcinoma of the skin often affects the scalp and neck region and has a potential for complex lymphatic metastases. The aim of this study was to examine the pattern of lymphatic drainage that would enable better insight and prediction of lymphatic metastasis of head and neck squamous cell carcinoma (HNSCC) in relation to the anatomical localization of the primary process. A prospective analysis included 64 patients who underwent sentinel lymph node (SLN) biopsy. The biopsy was performed in patients with high-risk cutaneous head and neck squamous cell carcinoma between 2006 and 2010. SLNs in tumors of the forehead, temporal region, lateral cheek, and auricle were found in the cervical region at level II and parotid lymph nodes (p<0.001). In tumors of the nose, periorbital region, and postauricular tumors, SLNs were found in parotid lymph nodes (p<0.001), in tumors of the medial cheek in level I cervical lymph nodes and parotid lymph nodes (p=0.003). In tumors of the neck, SLNs were detected in the cervical region at level IV, whereas in tumors of the posterior scalp they were found in the occipital region (p<0.001). The results of SLN biopsy in high-risk cutaneous HNSCCs show the regularity of metastasis based on which a lymphatic drainage map can be constructed and thus potential metastatic sites depending on the primary tumor localization predicted.

Accuracy of Preoperative Ultrasound-Guided Axillary Lymph Node Core Needle Biopsy to Predict Axillary Lymph Node Involvement in Breast Cancer

Background: Breast cancer operative management consists of breast surgery and axillary lymph node (ALN) assessment. ALN status is an important prognostic factor and determinant of breast cancer treatment. Objective: To investigate preoperative ultrasound-guided axillary lymph node core needle biopsy (USACNB) accuracy in predicting ALN involvement for breast cancer. Materials and Methods: This retrospective cohort study took place between February 2014 and May 2019. One hundred nine consecutive operable breast cancer patients with suspicious ALN involvement were assessed using preoperative USACNB and subsequent breast cancer surgery. Exclusion criteria were insufficient ALN tissue from USACNB for interpretation, previous breast or axillary surgery on the same side. Patients with preoperative histopathology results proving of metastasis underwent ALN dissection (ALND) while those with negative results had sentinel lymph node biopsy (SLNB). When SLNB was positive, ALND was then performed. Preoperative USACNB accuracy was analyzed using SLNB or ALND pathological results as standard tests. Results: The sensitivity, specificity, PPV, and NPV of preoperative USACNB in evaluating ALN involvement was 87.5%, 100%, 100%, and 80.4%, respectively, with an accuracy of 91.7%. Conclusion: Preoperative USACNB shows high diagnostic accuracy in ALN metastasis, but its NPV remains too low to completely rule out ALN involvement. Standard SLNB is still necessary in cases of negative USACNB. Keywords: Breast cancer; Ultrasound guided core needle biopsy; Axillary lymph node

Volar location and degree of pigmentation are associated with poor survival and first metastasis pattern in acral melanoma

The risk factors affecting acral melanoma metastasis and prognosis remain unclear. The study included 168 patients with invasive acral melanoma who were followed for ≥3years. We evaluated patient demographics, stages, clinicopathological features, anatomic site of melanoma including nail versus volar surface, and degree of melanoma pigmentations, sentinel lymph node biopsy results, and the first metastasis sites. Of the 168 patients (mean age 64.5years; 52.4% male), 43 (25.6%) had invasive melanoma without metastasis, 113 (67.3%) had invasive melanoma with a first lymph node metastasis, and 12 (7.1%) had invasive melanoma with invasive melanoma with a first distant metastasis. Advanced T stage, high mitotic rate, ulceration, and the degree of pigmentation were significant risk factors for metastasis. Amelanotic and mild pigmentation of acral melanoma was associated with first distant metastasis, whereas heavy pigmentation was associated with first lymph node metastasis. Advanced TNM stages, high mitotic rate, volar location (hazard ratio=2.24, 95% confidence interval 1.18-4.26), and low-pigmentation (hazard ratio=2.02, 95% confidence interval 1.17-3.49) were associated with melanoma-specific mortality.

Comparison of survival outcomes for axillary surgery extent based on intraoperative sentinel lymph node biopsy result after neoadjuvant chemotherapy for breast cancer.

To investigate the survival difference between limited axillary surgery and full axillary lymph node dissection (ALND) in patients with 1-3 positive sentinel lymph node biopsies (SLNBs) after neoadjuvant chemotherapy (NAC). We retrospectively analyzed data from 676 patients who underwent surgery between 2007 and 2017 with cT1-4, cN0-3, cM0 breast cancer at the time of diagnosis and 1-3 positive SLNBs after NAC. The patients received either SLNB only or completed level I or II ALND based on SLNB results. After propensity score matching, 483 patients who had undergone SLNB only (n = 188) and ALND (n = 295) were included. We examined overall survival, axillary recurrence-free survival, regional recurrence-free survival, and distant metastasis-free survival and compared them between the subgroups. At a median follow-up of 59.4months, no significant statistical difference was observed in overall survival, axillary recurrence-free survival, regional recurrence-free survival, and distant metastasis-free survival between SLNB only and ALND. No significant differences were observed in the 5-year axillary recurrence-free survival (93.1% vs. 94.0%, hazard ratio [HR] = 0.94, 95% confidence interval [CI] = 0.43-2.05, p = 0.876) and 5-year overall survival (97.7% vs. 97.3%, HR = 1.65, 95% CI = 0.58-4.65, p = 0.347) between the two groups. Our analysis suggests that SLNB alone may be a possible option for patients with 1-3 sentinel node-positive breast cancer following NAC without significant compromise of recurrence or overall survival.

Abstract PD4-03: Can genomic profiling eliminate the need for SLNB in ER positive, T1-2 breast cancer?

Abstract Background: As tumor biology has taken precedence over anatomic staging, NCCN guidelines now allow for genomic profiling to make adjuvant treatment recommendations for Nmi-N1 breast cancer (BC). This makes nodal status, determined by sentinel lymph node biopsy (SLNB), less influential. Although generally safe, SLNB adds an incision, operative time, monetary costs, and carries risks of chronic paresthesia (9%) or lymphedema (2-6%). We hypothesized that, if ultrasound (US) excludes occult nodal metastasis and genomic profiling is used in making chemotherapy recommendations for N0-N1 disease, SLNB will be the sole indicator of a need for chemotherapy in &amp;lt;5% of patients. Methods: This was a retrospective data and tissue analysis of patients treated at our breast center (11/2011 – 12/2015). Postmenopausal women with ER positive, HER2 negative, pT1-2 BC with non-suspicious axillary US who underwent SLNB without preoperative chemotherapy were included. For each patient, we compared recommended adjuvant therapy (per NCCN guidelines) based on SLNB results, versus the recommendation had SLNB been negative. For N0-N1 cases, we used Oncotype DX Breast Recurrence Score® test to determine chemotherapy. For Nmi-N1 cases, chemotherapy was considered for Recurrence Score® (RS) 18-25 and recommended for RS &amp;gt; 25. When not in the electronic medical record (EMR), RS result was obtained from stored specimens, with patient consent. Patients without a RS result were excluded from the chemotherapy outcomes analysis. Results: Of 217 included patients, nodal status was as follows: N0, n=184 (85%); Nmi-N1, n=29 (13%); N2-3, n=4 (2%). Therefore, in 85% of patients SLNB did not influence any adjuvant treatment recommendation. In 4.1% of patients, SLNB resulted in a recommendation for axillary lymph node dissection (Table). In 15.2% of patients (n=33), SLNB resulted in a consideration (13.4%) or recommendation for (1.8%) nodal irradiation. RS result was available in 147 patients (68% of cohort). However, only 8 of those with unknown RS result (4% of cohort) were node-positive; for node-negative patients, RS would not affect any study outcome (change in treatment based on SLNB). Among patients with RS result, based on actual SLNB result, chemotherapy was recommended or considered in 30 patients. In 23 of these, chemotherapy would have been recommended regardless of SLNB result based on RS &amp;gt; 25. Therefore, SLNB made a difference in whether to recommend or consider chemotherapy in 4.7% of patients (7/147). Conclusions: SLNB changed the recommendation whether to receive chemotherapy (no to yes, or no to consider) in only 4.7% of patients. More often, SLNB influenced the chemotherapy regimen recommended (2nd vs. 3rd generation), or local therapy recommendations. With increasing role for genomic profiling, the role of SLNB in determining adjuvant therapy is diminishing. When chemotherapy would not be considered, omission of SLNB may be considered in postmenopausal patients with ER positive, T1-2 BC and negative axillary US. If genomic profiling were performed prior to surgery, the results could change surgical management. In women with RS 0-11, SLNB is highly unlikely to alter the recommendation against chemotherapy. In women with RS &amp;gt; 25, chemotherapy is recommended regardless of SLN status, but a positive SLN would affect the regimen recommended. SLNB is most influential in patients with RS 18-25. Use of genomic profiling preoperatively to tailor whether SLNB is performed should be prospectively validated. Table. Comparison of adjuvant treatment recommendations based on SLNB result vs. presumed negative SLNBBased on presumed negative SLNBBased on actual SLNB result% for whom SLNB would change treatment recommendation8Axillary lymph node dissection recommended1094.1% (9/217)Nodal irradiation recommended2041.8% (4/217)Nodal irradiation considered302913.4% (29/217)Chemotherapy recommended423240.6% (1/147)Chemotherapy considered5064.1% (6/147)Third-generation chemotherapy recommended6064.1% (6/147)Third-generation chemotherapy considered7064.1% (6/147)1)For &amp;gt;2 positive SLN, or gross extranodal extension (ENE). Since surgeon determination of gross ENE was not consistently available, &amp;gt; 2 mm of ENE on pathology was used to defined “gross” extension. 2)For N2-3 disease 3)For Nmi-N1 disease 4)For RS &amp;gt; 25, or N2-3 5)For Nmi-N1 disease, with RS 18-25 6)For Nmi-N1 disease with RS &amp;gt; 25; or N2-3; this group is a subset of those for whom chemotherapy would be recommended 7)For Nmi-N1 disease with RS 18-25; this group is a subset of those for whom chemotherapy would be recommended 8)Patients without Recurrence Score result were excluded from analysis of chemotherapy outcomes; fractions are included to show the denominator used for each calculation. Citation Format: Rubie Sue Jackson, Elaine Lee, Carol Tweed, Charles Mylander, Laura Martino, Martin Rosman, Kip Waite, Nicholas Huerta, Lorraine Tafra. Can genomic profiling eliminate the need for SLNB in ER positive, T1-2 breast cancer? [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 PD4-03.