Positive Sentinel Lymph Node Research Articles

Significance of Residual Nodal Disease in Clinically Node-Negative Breast Cancer After Neoadjuvant Chemotherapy.

Trials evaluating omission of axillary dissection (ALND) in patients with cN0 breast cancer with positive sentinel lymph nodes (SLNs) haveexcluded neoadjuvant chemotherapy (NACT). It remains unclear whether the data can be extrapolated to cN0 patients undergoing NACT. This study sought to identify factors associated with positive SLNs and additional disease on ALND in cT1-2N0 disease after NACT. The authors queried their database for cT1-2N0 patients treated with NACT followed by SLN biopsy from 1996 to 2022. Physical examination and ultrasound determined clinical nodal status. Multivariable logistic regression identified factors associated with positive SLNs and disease on ALND. Of 1930 patients, 234 (12.1%) had positive SLNs. Positive SLNs were predicted by hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) status (odds ratio [OR] 2.5; p < 0.0001), lobular histology (OR 1.8; p = 0.007), multifocality (OR 2; p = 0.001), grade 1 tumors (OR 2.5; p = 0.002), and cT2 category (OR 1.9; p = 0.004). Of the 234 patients with positive SLNs and known SLN metastasis size, 148 (63.2%) underwent ALND, and 39 (26.4%) had additional positive nodes. Increasing patient age predicted disease on ALND (OR 1.03; p = 0.02). No additional positive nodes on ALND were identified in patients with only isolated tumor cells compared with 12.3% who had micrometastases and 37.6% who had macrometastases (p = 0.01). During a 5-year median follow-up period of the SLN-positive patients, three (1.3%) experienced axillary recurrence and twoof the three underwent ALND at the initial surgerywith no additional positive nodes. In cT1-2N0 breast cancer, HR+/HER2- status, lobular histology, multifocality and cT2 category predicted positive SLNs after NACT. Older age predicted positive nodes on ALND. Patients with positive SLNs had low axillary recurrence rates. These findings support investigation into omission of ALND in cN0 breast cancer and a low volume of SLN disease after NACT.

Lymphatic mapping in second primary or recurrent oral cavity cancer with prior neck treatment: A case series and scoping review

ObjectivesLymphatic mapping is an established technique to map drainage patterns in oral cancer. Its utility in patients who have undergone prior radiation or neck dissection is not well studied. MethodsPatients presenting to a single tertiary cancer center between 2021–2023 for a recurrent/second oral cancer that underwent lymphatic mapping were considered. All patients had a history of a head and neck cancer treated with either radiation or neck dissection. We further conducted a scoping review in MEDLINE, Embase, and Web of Science of lymphatic mapping in oral cancer patients with previous neck treatment. ResultsIn our single center review, a total of 11 patients were included. 73 % received prior radiotherapy and 55 % underwent prior neck dissections for a head and neck cancer. Lymphoscintigraphy-directed neck dissections identified sentinel nodes in 9/11 patients, with only one patient who had positive sentinel node disease. There were no reports of regional recurrence at a median of 10 months follow-up. Our scoping review of 980 studies identified 151 additional patients who underwent sentinel node biopsy for a second oral cancer after previous neck treatment. Overall, the negative predictive value of lymphatic mapping in all studies was 96.7 %. ConclusionLymphatic mapping is feasible in secondary or recurrent oral cavity cancers even in patients with prior radiation or surgical management of the neck. The literature to date demonstrates a negative predictive value of ∼ 97 % for sentinel node mapping and warrants further consideration in the management of salvage oral cancer.

Impact of Clipped Node as a Sentinel Lymph Node on Axillary Staging Following Neoadjuvant Chemotherapy in Clinically Node-Positive Breast Cancer.

Residual disease after neoadjuvant chemotherapy (NAC) is prognostic and informs adjuvant treatment. Targeted axillary dissection (TAD) following NAC has low false-negative rates, facilitating accurate axillary staging. This study evaluates the clipped node status in axillary staging utilizing TAD. Retrospective review identified cN1 breast cancer patients treated with NAC and TAD from July 2013 to June 2023. Nodal ultrasound and biopsy defined cN1 status. Patient, tumor, and treatment characteristics were compared based on clipped node status (sentinel lymph node [SLN] or non-SLN). Multivariate analysis of factors associated with theclipped node as anon-SLN was performed. A total of 680 patients underwent TAD, 94.6% with dual-tracer mapping. In three patients (0.4%), no SLN was identified. The clipped node was a SLN in 610 patients (90%) and non-SLN in 70 (10.3%). When the clipped node was a non-SLN, 42 (60%) were positive for metastasis. In 22 of 42 patients (52%), the clipped non-SLN was the only positive node. The clipped non-SLN cohort had a higher proportion with >3 suspicious nodes at presentation (p = 0.003), fewer SLNs excised (mean 2.2 vs. 3.5, p ≤ 0.001), and fewer positive SLNs (p ≤ 0.001). On multivariate analysis, >3 suspicious nodes on ultrasound (odds ratio 3.0, p = 0.001) and tumor size at presentation (odds ratio 0.9, p = 0.02) were significantly associated with theclipped node as anon-SLN. When the clipped node was a non-SLN, half of the time it was the only positive node and only residual disease on TAD. Given implications for adjuvant therapy, selective clipped node excision is recommended for precise identification of residual disease after NAC.

Are Clinically Node-Negative Patients with a Positive Preoperative Axillary Lymph Node Biopsy Appropriate Candidates for Sentinel Lymph Node Biopsy?

Whether cN0 patients with image-detected nodal metastases are appropriate for sentinel lymph node biopsy (SLNB) or should proceed directly to axillary lymph node dissection (ALND) or neoadjuvant chemotherapy (NAC) is controversial. We sought to determine how often ALND is needed with upfront surgery and to identify factors associated with ≥ 3 positive SLNs after a positive preoperative lymph node (LN) biopsy. Patients with cT1-2N0 breast cancer and a positive LN biopsy treated from 2014 to 2022 were identified from a prospective database. Patients who received NAC were excluded. Clinicopathologic characteristics were compared between women with 1-2 positive SLNs and ≥ 3 positive SLNs. Of 90 eligible patients, 66 (73%) had 1-2 positive SLNs and 24 (27%) had ≥ 3 positive SLNs. The median patient age was 62 years, median tumor size was 2.2 cm, and 16 women (18%) received a mastectomy. There was no difference in body mass index, tumor size, histology, grade, multifocality, presence of lymphovascular invasion, and receptor status between groups. On multivariable analysis, having ≥ 3 positive SLNs was associated with > 1 abnormal LN on preoperative imaging (odds ratio [OR] 4.36, 95% confidence interval [CI] 1.47-14.0; p = 0.01), microscopic extracapsular extension in the SLNs (OR 3.83, 95% CI 1.25-13.7; p = 0.025), and a higher median number of SLNs removed (OR 1.42, 95% CI 1.10-1.88; p = 0.01). More than 70% of women with cT1-2 breast cancer with image-detected nodal metastases had < 3 positive SLNs and did not require ALND. To avoid multiple trips to the operating room, frozen section can be considered in women with multiple abnormal LNs on imaging.

Are Positive Biopsy Margins in Melanoma Significant?: A Cohort Study of Micro- Versus Macroscopic Margin Status and Their Impact on Residual Disease and Survival.

Presence of positive biopsy margins in melanoma can provoke anxiety over potential disease progression from delays to surgical excision, but their impact on outcomes is unknown. We aimed to compare the presence of residual melanoma in the surgical excision specimen and survival between patients with negative, microscopically positive, and macroscopically positive biopsy margins. Patients with cutaneous melanoma who underwent surgical excision over a 13-year period were included. Biopsy characteristics, residual disease in the surgical specimen, and overall and recurrence-free survival were compared between patients with negative, microscopically positive (only scar visible), and macroscopically positive (visible remaining melanoma) biopsy margins. Of 901 patients, 42.4%, 33.3%, and 24.3% had negative, microscopically positive, and macroscopically positive margins, respectively. The incidence of residual invasive melanoma in the surgical specimen varied (P < 0.001), occurring in 5.5%, 17.0%, and 74.9% of patients, respectively. Both microscopically and macroscopically positive margins were associated with residual disease (P < 0.001) but only the latter predicted worse overall (P = 0.013) and recurrence-free survival (P = 0.009). Kaplan-Meier estimated survival was comparable between those with negative and microscopically positive margins, but overall (P = 0.006) and recurrence-free survival (P = 0.004) were significantly worse in the macroscopically positive margin group. These patients had worse prognosis melanoma, with 33.8% being stage III disease, and 23.2% having positive sentinel lymph nodes. Patients and physicians may be reassured in the presence of microscopically positive biopsy margins which arenot associated with worse survival, However, patients with macroscopically positive margins have poorer prognosis and should be treated within an acceptable time frame.

Vital Staining Role in Resection and Reconstruction of Tongue Cancers with Free Flap - A Comparative Study

Abstract Introduction: The purpose of this study is to compare and infer the most suitable dye for visualisation of ipsilateral and contralateral sentinel lymph nodes (SLNs), positive, negative outcomes, sensitivity, their specificities and visualisation of anastomosed blood vessels in microvascular reconstruction of tongue cancers. Materials and Methods: This is a prospective in vivo comparative study involving twenty patients diagnosed with squamous cell carcinoma of the tongue treated with wide excision of primary tongue tumour, modified functional neck dissection and microvascular reconstruction with radial forearm free flap. Consecutive random allocation was done into two groups with ten patients each. Patients were injected with methylene blue as the first group and near-infrared fluorescence indocyanine green (ICG) into the second. The patients were evaluated intraoperatively regarding the better dye in methylene blue and ICG for identification of ipsilateral and contralateral SLNs, their positive, negative outcomes, sensitivity and specificities. Apart from these, in cases of group B, after microvascular transfers, ICG is used for visualisation of anastomosed vessels to prevent abnormal perfusions, leaks and post–flap failures. Descriptive statistics, independent samples t-test, and Chi-square were used for statistical analysis. Results: The present study revealed ICG being the better dye in the parameters mentioned. Discussion: Lymph node yield in neck dissection is a prognostic factor in oral cancers. ICG is inferred as the better dye for identification of SLN with 100% outcomes and in blood vessel visualisation after microvascular free tissue transfers. It is also useful in identifying positive contralateral sentinel nodes, which is helpful in undertaking bilateral neck dissections related to tongue carcinoma.

The impact of Substantial LYMphovascular space invasion on sentinel lymph nodes status and recurrence in Endometrial Cancer patients: SLYM-EC a multicenter retrospective study

IntroductionTo evaluate the prognostic impact of substantial lymph vascular space invasion (LVSI) on the sentinel lymph node involvement and recurrence rate of patients with apparent uterine-confined endometrial cancer. Materials and methodsWe enrolled consecutive patients with apparent confined endometrial cancer who underwent surgical staging with sentinel node mapping from 14 European reference centers. LVSI was analyzed semi-quantitatively, according to a 3-tiered scoring system classified as absent, focal, and substantial. ResultsAmong 2352 eligible patients, 1980 were included in the analysis. Upon final pathology 226 patients (11.4 %) had SLNs involvement. LVSI was diagnosed focal in 152 patients (7.7 %), whereas 357 patients (18.0 %) showed substantial LVSI. Focal or substantial LVSI rate were significantly higher in patients with positive SLNs when compared to patients without SLNs involvement (p < 0.0001). On overall patient-based analysis, the sensitivity, specificity, positive predictive value, and negative predictive value of LVSI for sentinel lymph node metastases were 73 %, 80 %, 32 %, and 96 %, respectively. The 3-year multivariate analysis of recurrence-free survival showed that only the presence of substantial LVSI, and grade 3 disease were associated with relapse. Neither positive sentinel lymph node, deep myometrial infiltration, nor age at surgery were statistically significant. ConclusionsIn patients having undergone sentinel node biopsy, positive LVSI demonstrated moderate sensitivity and reasonable specificity in detecting SLN involvement. LVSI positivity does not correlate with nodal involvement. The presence of substantial LVSI remains a strong independent risk factor for recurrence, indicating a role for potential hematogenous dissemination in patients with early-stage disease.

Sentinel node mapping decreases the risk of failed detection of isolated positive para-aortic lymph node in endometrial cancer

BackgroundIsolated positive para-aortic lymph node metastasis in endometrial cancer is an uncommon event, ranging from 1% to 3%.ObjectiveOur aim was to evaluate the impact of sentinel lymph node (SLN) mapping...

Prediction of non-sentinel lymph node metastases in T1–2 sentinel lymph node-positive breast cancer patients undergoing mastectomy following neoadjuvant therapy

BackgroundAxillary lymph node dissection (ALND) is the standard axillary management for breast cancer patients with positive sentinel lymph node biopsy (SLNB) after neoadjuvant therapy. Nevertheless, when that happens, the frequency of additional positive nodes is not properly evaluated. We aim to develop a prediction model to assess the frequency of additional nodal disease after a positive sentinel lymph node following neoadjuvant therapy.MethodsWe retrospectively analyzed the ultrasound and clinicopathological characteristics of breast cancer patients with 1–3 positive sentinel lymph nodes (SLN) undergoing mastectomy after neoadjuvant therapy (NAT) at our institution, and performed univariate and multivariate logistic analyses to confirm the factors affecting non-SLN metastasis. These factors were included to establish a nomogram, and the area under receiver operating characteristic curve (AUC) and decision curve analysis (DCA) were utilized to assess the validity of this model.ResultsA total of 126 breast cancer patients were ultimately included in our study, 38 (53.5%) patients were diagnosed with non-SLN metastases of all 71 patients in training set. The results of multifactorial logistic analysis suggested that lymph node metastasis ratio (LNR), short axis of lymph node and progesterone receptor (PR) were strongly associated with non-SLN metastasis. We established a nomogram using the above three variables as predictors, which yielded an area under the curve of 0.795, and validated with a favorable AUC of 0.876.ConclusionThe nomogram we constructed can accurately predict the likelihood of non-SLN metastasis in our patients with 1–3 positive SLN after NAT, which may help guide decision making regarding axillary management.

Análisis multicéntrico del manejo quirúrgico y tratamiento adyuvante de los pacientes con melanoma y positividad en la biopsia selectiva del ganglio centinela

ObjectivesTo determine the evolution of the indication for CLND in patients with a positive SLNB, as well as the characteristics associated with its performance. Material and methodsWe conducted a multicenter retrospective observational study with patients with skin melanoma and positive sentinel lymph nodes diagnosed from 2017 through 2022 at 8 Spanish centers and 1 Italian center. ResultsA total of 430 patients were included, 54% men, with 358 (75.1%) aged between 45 and 80 years. A total of 133 cases (31%) exhibited Breslow thickness > 4mm, 206 cases (49.1%) were ulcerated, and in 213 cases (55.7%), lymph node metastasis was > 1mm. Isolated lymphadenectomy or followed by adjuvant therapy was performed in 146 patients (34.1%). After multivariate logistic regression, the factors associated with the performance of CLND were Breslow > 4mm, the acral lentiginous melanoma histological subtype, lymph node metastasis size > 1mm, extracapsular spread, and the participant hospital. Age > 80 years was inversely associated. ConclusionWhile the frequency of CLND in patients with melanoma and positive SLNB has decreased, the indication for systemic adjuvant therapy in these patients has increased. However, CLND is still indicated in patients with high-risk characteristics.

Sentinel lymph node biopsy for early stage vulvar squamous cell carcinoma

Background Patients with regional lymph node involvement from squamous cell carcinoma (SCC) of the vulva have a 48% 5-year relative survival. Recently, sentinel lymph node (SLN) biopsy has become a viable alternative to inguinofemoral lymphadenectomy. We sought to identify risk factors for predicting a positive SLN in patients with vulvar SCC. Methods A retrospective review of 29 patients with vulvar SCC was performed from 2016 to 2021 at a tertiary care center. Clinicopathologic data were collected in addition to SLN status, including number of lymph nodes removed. Results The average depth of invasion was 7.9 mm, average tumor size was 1.8 cm, 3 of 23 patients had perineural invasion, and 4 of 23 patients had lymphovascular invasion. One patient who did not map on lymphoscintigraphy and five patients with recurrent vulvar SCC were excluded from final analysis. The average number of SLNs removed was two. One patient had a positive SLN: the depth of invasion was 17 mm, tumor size was 5.1 cm, and lymphovascular invasion was present. Conclusions Most patients with early stage vulvar SCC had a negative SLN biopsy. Further study is needed to determine the patient subset that could avoid SLN biopsy altogether.

Real-Life Outcomes of Adjuvant Targeted Therapy and Anti-PD1 Agents in Stage III/IV Resected Melanoma.

This study was carried out at the Dermatologic Clinic of the University of Turin, Italy, to assess the effectiveness and safety of adjuvant therapy in patients who received either targeted therapy (TT: dabrafenib + trametinib) or immunotherapy (IT: nivolumab or pembrolizumab) for up to 12 months. A total of 163 patients participated, including 147 with stage III and 19 with stage IV with no evidence of disease. The primary outcomes were relapse-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS). At 48 months, both TT and IT approaches yielded comparable outcomes in terms of RFS (55.6-55.4%, p = 0.532), DMFS (58.2-59.8%, p = 0.761), and OS (62.4-69.5%, p = 0.889). Whilst temporary therapy suspension was more common among TT-treated patients compared to IT-treated individuals, therapy discontinuation due to adverse events occurred at comparable rates in both groups. Predictors of relapse included mitoses, lymphovascular invasion, ulceration, and positive sentinel lymph nodes. Overall, the proportion of BRAF-mutated patients receiving IT stood at 7.4%, lower than what was observed in clinical trials.

Abemaciclib Therapy Using the MonarchE Criteria Results in Large Numbers of Excess Axillary Node Clearances-Time to Pause and Reflect?

The monarchE study added the CDK4/6 inhibitor abemaciclib to the care of women with oestrogen-positive (ER+) breast cancers. Eligibility required meeting monarchE criteria-either >3 positive axillary nodes, or 1-3 positive sentinel nodes (SNB+) with tumour size >50 mm or grade 3 cancers. Women were advised to proceed to completion axillary node clearance (cANC) if size/grade criteria were not fulfilled for >3 positive nodes to be identified. However, cANC is associated with significant morbidity, conflicting with the potential benefits of abemaciclib. We analysed data of 229 consecutive women (2016-2022) with ER+ breast cancer and SNB+ who proceeded to cANC, keeping with contemporary treatment guidelines. We used this cohort to assess numbers that, under national guidance in place currently, would be advised to undergo cANC solely to check eligibility for abemaciclib treatment. Using monarchE criteria, 90 women (39%) would have accessed abemaciclib based on SNB+ and size/grade, without cANC. In total, 139 women would have been advised to proceed to cANC to check eligibility, with only 15/139 (11%) having >3 positive nodes after sentinel node biopsy and cANC. The remaining 124 (89%) would have undergone cANC but remained ineligible for abemaciclib. Size, age, grade, and Ki67 did not predict >3 nodes at cANC. Following cANC, a large majority of women with ER+, <50 mm, and grade 1-2 tumours remain ineligible for abemaciclib yet are subject to significant morbidity including lifelong lymphoedema risk. The monarchE authors state that 15 women need abemaciclib therapy for 1 to clinically benefit. Thus, in our cohort, 139 women undergoing cANC would lead to one woman benefitting.

Treatment Patterns and Outcomes of Stage III Melanoma Patients with Positive Sentinel Lymph Node Biopsy: A Real-Life Experience.

Background: Advancements in managing stage III melanoma have involved the implementation of adjuvant therapies alongside a simultaneous decrease in the utilization of completion lymph node dissection (CLND) following positive sentinel node biopsy (SLNB). Methods: This retrospective study from the University of Turin's Dermatology Clinic analyzed relapse-free survival (RFS) and overall survival (OS) among stage III melanoma patients (n = 157) who underwent CLND after positive SLNB versus those who did not receive such procedure. Results: Patients without CLND had a median RFS of 49 months (95% CI 42-NA), while CLND recipients showed 51 months (95% CI 31-NA) (p = 0.139). The 48-month OS for non-CLND patients was 79.8% (95% CI 58.2-91.0) versus 79.2% (95% CI 67.5-87.0) for CLND recipients (p = 0.463). Adjusted Hazard Ratios through inverse probability treatment weighting revealed the impact of CLND to be insignificant on RFS (aHR 0.90, 95% CI 0.37-2.22) and marginal on OS (aHR 0.41, 95% CI 0.13-1.21). Conversely, adjuvant therapy significantly reduced the risk of relapse (aHR 0.46, 95% CI 0.25-0.84), irrespective of CLND. Conclusions: This study corroborates the growing evidence that CLND after positive SLNB does not enhance RFS or OS, while emphasizing the crucial role of adjuvant therapy, be it immunotherapy or targeted therapy, in reducing the risk of relapse in melanoma patients with positive SLNB.

Optimal management of breast cancer with physical exam negative/radiological abnormal axilla

For breast cancer patients with physical exam node negative but radiological finding node abnormal (cN0/rNa), the NCCN and ASCO guidelines recommend sentinel lymph node biopsy (SLNB) as the first-line axillary staging. However, patients who undergo surgery firstly may be upstaged to pathological II–III status, and these patients happen to be the adaptive population of neoadjuvant therapy (NAT). There is no consensus on the optimal management of cN0/rNa patients. The aim is to explore the optimal management strategy of these patients. We performed a retrospective real-world study of 1414 cN0/rNa patients from June 2014 to October 2022. There were 1003 patients underwent surgery first and 411 patients underwent surgery after NAT. We analyzed the real-world conditions of these patients, compared axilla tumor burden between these two groups. In addition, we compared benefit ratio of axillary surgery and regional nodal irradiation (RNI) de-escalation under the two strategies. Among 1003 patients underwent surgery first, the positive and negative rates of fine needle aspiration (FNA) were 18.5% and 81.5%, respectively. There were 66.1% had ≤ 2 lymph nodes+. There were 40.8% of FNA+ patients could be exempted from ALND underwent surgery first. In 411 patients underwent surgery after NAT, the FNA positive and negative rates were 60.8% and 49.2%, respectively. There were 54.4% of FNA+ patients achieved axilla pathologic complete response (apCR) and could omit ALND after NAT. The apCR was 67.3% in HER2+/TNBC subtypes. According to the NSABP-B51 trial, there were 0 and 54.4% of FNA+ patients could omit RNI among surgery first and after NAT, respectively. Among 1–2 sentinel lymph node (SLN)-positive patients underwent surgery first, with a median follow-up 49 months, there was no difference of survival benefit between SLNB-only and SLNB-ALND. Compared with 1–2 SLN+ patients without RNI, RNI could bring better invasive disease-free survival (97.38% vs. 89.36%, P = 0.046) and breast cancer special survival (100% vs. 94.68%, P = 0.020). It is safe to perform SLNB omitting ALND when detected 1–2 positive SLNs in cN0/rNa patients. Patients with HER2+/TNBC subtypes underwent surgery after NAT had more chance to benefit from dual de-escalation, including axillary surgery and RNI de-escalation.

Individualized prediction of non-sentinel lymph node metastasis in Chinese breast cancer patients with ≥ 3 positive sentinel lymph nodes based on machine-learning algorithms

BackgroundAxillary lymph node dissection (ALND) is a standard procedure for early-stage breast cancer (BC) patients with three or more positive sentinel lymph nodes (SLNs). However, ALND can lead to significant postoperative complications without always providing additional clinical benefits. This study aims to develop machine-learning (ML) models to predict non-sentinel lymph node (non-SLN) metastasis in Chinese BC patients with three or more positive SLNs, potentially allowing the omission of ALND.MethodsData from 2217 BC patients who underwent SLN biopsy at Shantou University Medical College were analyzed, with 634 having positive SLNs. Patients were categorized into those with ≤ 2 positive SLNs and those with ≥ 3 positive SLNs. We applied nine ML algorithms to predict non-SLN metastasis. Model performance was evaluated using ROC curves, precision-recall curves, and calibration curves. Decision Curve Analysis (DCA) assessed the clinical utility of the models.ResultsThe RF model showed superior predictive performance, achieving an AUC of 0.987 in the training set and 0.828 in the validation set. Key predictive features included size of positive SLNs, tumor size, number of SLNs, and ER status. In external validation, the RF model achieved an AUC of 0.870, demonstrating robust predictive capabilities.ConclusionThe developed RF model accurately predicts non-SLN metastasis in BC patients with ≥ 3 positive SLNs, suggesting that ALND might be avoided in selected patients by applying additional axillary radiotherapy. This approach could reduce the incidence of postoperative complications and improve patient quality of life. Further validation in prospective clinical trials is warranted.

A Comprehensive Analysis of Metastatic Disease following Surgery for Clinically Localized Cutaneous Melanoma.

The NCCN considers "baseline staging" (whole body CT or PET scan +/- brain MRI) for all asymptomatic melanoma patients with a positive sentinel lymph node biopsy. The true yield of these workups is unknown. We created cohorts of adult malignant melanoma patients, using the National Cancer Database (2012-2020) to mimic three common scenarios: (1) clinically node negative, with positive sentinel lymph node(s) (SLNB[+]); (2) clinically node negative, with negative sentinel lymph node(s) (SLNB[-]); (3) clinically node positive with confirmed lymph node metastases (cN[+] and pN[+]). Multivariable regression, supervised decision trees, and nomograms were constructed to assess the risk of metastases based on key features. 10,371 patients were SLNB[+], 55,172 were SLNB[-], and 4,012 were cN[+] and pN[+]. The proportion of patients with any metastatic disease (brain metastases) were as follows: SLNB[+]: 1.4% (0.3%); SLNB[-] 0.3% (<0.1%); cN[+] and pN[+] 11.6% (1.6%). On multivariable regression, Breslow depth > 4, ulceration, and lymphovascular invasion were associated with greater risk of metastatic disease. A supervised decision tree for SLNB[+] and SLNB[-] patients found the only groups with >2% risk of metastases were T4 tumors or T2/T3 tumors with ulceration and LVI. Most groups had a negligible risk (<0.1%) of brain metastases. This is the first large analysis to guide the use of imaging for cutaneous melanoma. Among clinically node negative patients, metastatic disease is uncommon and brain metastases are exceedingly rare. Further investigation could promote a tailored approach to metastatic workups guided by individual risk factors.

2380: PMRT improves Disease-Free Survival after Total Mastectomy with 1-3 Positive Sentinel Nodes

2380: PMRT improves Disease-Free Survival after Total Mastectomy with 1-3 Positive Sentinel Nodes

Integrating the melanoma 31-gene expression profile test with clinical and pathologic features can provide personalized precision estimates for sentinel lymph node positivity: an independent performance cohort.

Up to 88% of sentinel lymph node biopsies (SLNBs) are negative. The 31-gene expression profile (31-GEP) test can help identify patients with a low risk of SLN metastasis who can safely forego SLNB. The 31-GEP classifies patients as low (Class 1A), intermediate (Class 1B/2A), or high risk (Class 2B) for recurrence, metastasis, and SLN positivity. The integrated 31-GEP (i31-GEP) combines the 31-GEP risk score with clinicopathologic features using a neural network algorithm to personalize SLN risk prediction. Patients from a single surgical center with 31-GEP results were included (n = 156). An i31-GEP risk prediction < 5% was considered low risk of SLN positivity. Chi-square was used to compare SLN positivity rates between groups. Patients considered low risk by the i31-GEP had a 0% (0/30) SLN positivity rate compared to a 31.9% (30/94, p < 0.001) positivity rate in those with > 10% risk. Using the i31-GEP to guide SLNB decisions could have significantly reduced the number of unnecessary SLNBs by 19.2% (30/156, p < 0.001) for all patients and 33.0% (30/91, p < 0.001) for T1-T2 tumors. Patients with T1-T2 tumors and an i31-GEP-predicted SLN positivity risk > 10% had a similar SLN positivity rate (33.3%) as patients with T3-T4 tumors (31.3%). The i31-GEP identified patients with < 5% risk of SLN positivity who could safely forego SLNB. Combining the 31-GEP with clinicopathologic features for a precise risk estimate can help guide risk-aligned patient care decisions for SLNB to reduce the number of unnecessary SLNBs and increase the SLNB positivity yield if the procedure is performed.

Long-Term Survival Outcomes and Risk Factors for Axillary and Locoregional Recurrence in Japanese Patients with Sentinel Node-Positive Breast Cancer Treated in Accordance with the ACOSOG Z0011 Strategy.

In 2018, we reported the results of a study to assess the feasibility of applying the ACOSOG Z0011 criteria to Japanese patients with early-stage breast cancer (median follow-up, 3 years). Their results over the longer term can now be presented. Risk factors for axillary and locoregional recurrence in Z0011-eligible patients are unknown. Long-term survival outcomes were investigated by analyzing data from patients enrolled in the feasibility study. Data from the feasibility study patients, and from patients eligible for the Z0011 strategy after its introduction into clinical practice, were subjected to multivariate logistic regression analysis to identify risk factors for axillary and locoregional recurrence. Regarding long-term outcomes for the feasibility study patients (n = 189), distant disease-free survival rates at 5 and 7 years were 90.4 ± 2.1% and 85.9 ± 2.6%, respectively, and overall survival rates at 5 and 7 years were 97.3 ± 1.2% and 95.3 ± 1.7%, respectively. Analysis of data from these patients plus the 93 who received Z0011 in clinical practice (total, n = 282) identified the following independent risk factors for axillary recurrence: absence of high axillary tangential irradiation (OR, 5.87 [95% CI, 1.09-31.35], p = 0.04) and number of positive sentinel lymph nodes (OR, 4.65 [95% CI, 1.11-19.48], p = 0.04). Only high Ki67 labeling index (OR, 5.92 [95% CI, 1.31-26.70], p = 0.02) was identified as an independent risk factor for locoregional recurrence. Long-term survival outcome results of the feasibility study show that the Z0011 strategy can be used to treat Japanese patients with early-stage breast cancer. Our findings regarding risk factors suggest that high axillary tangent irradiation is necessary for the prevention of axillary recurrence and that irradiation, including of the regional lymph nodes, should be considered, especially in patients with high Ki67 index values.