tbuckley/cabot-search huggingface dataset:
Identification and validation of a serum microRNA panel for detection of early-stage breast cancer.
Authors: Ruiyang Zou, Lihan Zhou, Sau Yeen Loke, Heng-Phon Too, Ann Lee
Journal: Journal of Clinical Oncology (2019)

3051 Background: The implementation of mammogram-based screening has significantly improved the early detection of breast cancer in the west. However, the use of screening mammography is less prevalent in Asia partly due to social and cultural reasons. The aim of this study was to determine if a serum microRNA (miRNA) panel could be used as biomarkers to assist in the early detection of breast cancer. Methods: We conducted a multi-center, multi-ethnic study to identify and validate miRNA biomarkers for the early detection of breast cancer. A total of 1070 subjects including 550 breast cancer cases (predominantly stage 1 and 2) and 520 matched controls from 6 independent sources were included in this study. Among these, there were 768 American and European subjects recruited by biobanks and 302 Singaporean Asian Subjects recruited at the National Cancer Centre Singapore and the National University Hospital. The study was conducted in 3 phases. First, 119 European Caucasian serum samples (Discovery Cohort) were interrogated to identify differentially expressed miRNAs between early-stage breast cancer cases and matched controls, among 520 circulating miRNA candidates by quantitative RT-PCR using MiRXES assays. The remaining 951 subjects from 5 independent sources were assigned into two groups for biomarker optimization/algorithm development (Optimization Cohort, n = 451) and validation (Validation Cohort, n = 500). Results: Among the 520 circulating miRNAs measured, 241 were quantified in absolute copy numbers for 119 subjects in the Discovery Cohort. Thirty-two candidate miRNAs were identified. These miRNAs consistently showed differential expression between cancer and control subjects in the Optimization Cohort. A multi-variant panel of 8 miRNAs and an algorithm was developed using the combined Discovery and Optimization Cohorts, with an AUC of &gt; 0.90. When validated in the independent Validation Cohort, the panel demonstrated an AUC of &gt; 0.85. Conclusions: We developed and validated a serum miRNA panel that is both sensitive (~70%) and specific (~90%) in detecting early-stage breast cancer.
Impact of rates of referral and systemic therapy on 1-year outcomes in metastatic NSCLC: A real-world population based study.
Authors: Adam Michael Fundytus, Yunting Fu, Lorraine Shack, Truong-Minh Pham, Winson Y. Cheung
Journal: Journal of Clinical Oncology (2019)

e18238 Background: EGFR/ALK inhibitors and immunotherapy represent promising treatments for metastatic NSCLC, but patients must be referred to a cancer center (CC) to be considered for these treatments. Local referral rates to a CC for advanced pancreatic cancer are only 51%. We hypothesized that rates of referral for stage IV NSCLC are also low, thereby affecting survival. Methods: Using linked data from the provincial cancer registry, oncology specific EMR, administrative claims and vital statistics, we identified all patients diagnosed with stage IV NSCLC from 2009 to 2016 in Alberta, Canada. Demographics, Charlson Comorbidity Index (CCI), method of diagnosis, year of diagnosis and site of metastasis were compared between patients referred vs not referred (NR) to a CC and between those who received systemic therapy (ST) vs those who did not. A multivariable piecewise constant hazard model was constructed to estimate the hazard ratio (HR) of death in the 1 st year. Results: We identified 9717 stage IV NSCLC patients among whom 65.8% and 34.2% were diagnosed pre and post 2012. In this cohort, 6907 (71%) were seen at a CC. Factors which predict referral to a cancer center are: dx by cytology (OR 6.81, 95% CI: 5.99-7.75; p &lt; 0.001) or histology (OR 6.29, 95% CI: 5.40-7.34; p &lt; 0.001) vs radiologic dx; Age &lt; 70 (OR 1.87, 95% CI: 1.69-2.07; p &lt; 0.001); dx after 2012 (OR 1.52, 95% Cl 1.36-1.70; p &lt; 0.001) and CCI≤1 (OR 1.50, 95% Cl 1.34-1.68; p &lt; 0.001). ST was administered to 2057(21.2%). Factors that predict ST are: dx by cytology (OR 6.48, 95% CI: 5.18-8.11; p &lt; 0.001) or histology (OR 6.35.18 , 95% CI: 5.02-8.04; p &lt; 0.001); Age &lt; 70 (OR 2.55, 95% Cl 2.33-2.82; p &lt; 0.001); CCI≤1 (OR 1.56, 95% Cl 1.39-1.76; p &lt; 0.001); dx after 2012 (OR 1.28, 95% CI: 1.16-1.41 and female gender (OR 1.18 , 95% CI: 1.07-1.29; p &lt; 0.001; p &lt; 0.001). Within the 1 st year post dx, HR for mortality was lower both in patients referred to a CC vs NR (HR 0.3, 95%CI .28-0.31, p &lt; 0.0001) and patients receiving ST vs no ST (HR 0.3, 95% CI .28-0.32, p &lt; 0.0001). Conclusions: Close to 1 in 3 patients with stage IV NSCLC were not referred to a CC even though referral and receipt of ST were associated with a significantly lower risk of death in the 1 st year following diagnosis. Clear delineation and wide dissemination of appropriate referral pathways are needed to improve outcomes, especially among older patients.
TCF-1 limits the formation of Tc17 cells via repression of the MAF–RORγt axis
Authors: Lisa A. Mielke, Yang Liao, Ella Bridie Clemens, Matthew A. Firth, Brigette Duckworth, Qiutong Huang, Francisca F. Almeida, Michael Chopin, Hui-Fern Koay, Carolyn A. Bell, Soroor Hediyeh-Zadeh, Simone L. Park, Dinesh Raghu, Jarny Choi, Tracy L. Putoczki, Philip D. Hodgkin, Ashley E. Franks, Laura K. Mackay, Dale I. Godfrey, Melissa J. Davis, Hai-Hui Xue, Vanessa L. Bryant, Katherine Kedzierska, Wei Shi, Gabrielle T. Belz
Journal: The Journal of Experimental Medicine (2019)

Interleukin (IL)-17–producing CD8+ T (Tc17) cells have emerged as key players in host-microbiota interactions, infection, and cancer. The factors that drive their development, in contrast to interferon (IFN)-γ–producing effector CD8+ T cells, are not clear. Here we demonstrate that the transcription factor TCF-1 (Tcf7) regulates CD8+ T cell fate decisions in double-positive (DP) thymocytes through the sequential suppression of MAF and RORγt, in parallel with TCF-1–driven modulation of chromatin state. Ablation of TCF-1 resulted in enhanced Tc17 cell development and exposed a gene set signature to drive tissue repair and lipid metabolism, which was distinct from other CD8+ T cell subsets. IL-17–producing CD8+ T cells isolated from healthy humans were also distinct from CD8+IL-17− T cells and enriched in pathways driven by MAF and RORγt. Overall, our study reveals how TCF-1 exerts central control of T cell differentiation in the thymus by normally repressing Tc17 differentiation and promoting an effector fate outcome.
Tumor mutational burden identifies chemorefractory gastric cancer with overall survival advantage after receiving toripalimab, a PD-1 antibody.
Authors: Rui-Hua Xu, Feng Wang, Xiao-Li Wei, Fenghua Wang, Nong Xu, Lin Shen, Guanghai Dai, Xianglin Yuan, Ye Chen, Shujun Yang, Jianhua Shi, Xi-Chun Hu, Xiaoyan Lin, Qingyuan Zhang, Ji Feng Feng, Yi Ba, Yunpeng Liu, Hai Wu, Hui Feng, Sheng Yao
Journal: Journal of Clinical Oncology (2019)

4021 Background: Tumor mutational burden (TMB) is correlated with enhanced objective response rate (ORR) and progression-free survival for certain cancers receiving immunotherapy. This study aimed to investigate the safety and activity of toripalimab, a humanized PD-1 antibody, in advanced gastric cancer (AGC), and the efficacy predictive value of biomarkers including TMB and PD-L1. Methods: This study was a part of phase Ib/II trial evaluating the safety and activity of toripalimab as a single agent therapy or in combination with chemotherapy in chemo-refractory or treatment-naïve AGC, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and neck squamous cell carcinoma. This report focused on the chemo-refractory AGC cohort receiving toripalimab (3 mg/Kg d1, Q2W) as a single agent therapy. Primary endpoint was ORR. Biomarkers including tumor PD-L1 expression, TMB, microsatellite instability (MSI) and Epstein-Barr virus (EBV) infection status were evaluated for their correlation with clinical efficacy as preplanned. Tumor PD-L1 expression was assessed with the SP142 immunohistochemistry assay, and the other biomarkers were assessed with whole exome sequencing based on tumor samples. Results: There were 58 subjects included in this cohort. The ORR was 12.1% and the disease control rate was 39.7%. Only 1 subject was MSI-H and achieved partial response. One out of 4 EBV positive subjects achieved partial response. Significant higher ORR was observed in subjects with positive PD-L1 expression (ORR 37.5%, 3/8) or TMB ≥12 Mutations/Mb (ORR 33.3%, 4/8) than those with negative PD-L1 expression (ORR 8.5%) or TMB &lt; 12 Mutations/Mb (ORR 7.0%). The TMB-high subgroup showed significant superior OS than the TMB-low subgroup (HR = 0.48 [96% CI 0.24 to 0.96], p = 0.038), while PD-L1 expression status failed to differentiate OS. Conclusions: Toripalimab demonstrated promising anti-tumor activity in chemo-refractory AGC patients. TMB might serve as a better predictive marker for OS than PD-L1 expression for chemo-refractory AGC patients receiving PD-1 blockade immunotherapy. Clinical trial information: NCT02915432.
A landscape of circulating tumor DNA in esophageal adenocarcinoma and squamous cell carcinoma.
Authors: Kabir Mody, Rami Manochakian, Daniel H. Ahn, Ali Roberts, Rebecca Nagy, Richard B. Lanman, Pashtoon Murtaza Kasi
Journal: Journal of Clinical Oncology (2019)

4070 Background: Esophageal cancer (EC) is a lethal malignancy with limited treatment options. Genomic analyses have led to the elucidation of numerous dysregulated genes in esophageal adenocarcinoma (AC) and squamous cell carcinoma (SCC), and the potential for advancement of targeted therapies in this disease. Data regarding circulating tumor DNA (ctDNA) plasma analysis in EC in real-world clinical practice is limited. Methods: We performed ctDNA next-generation sequencing (NGS) analysis in patients (pts) with EC (January 2015- February 2018). ctDNA analysis was performed using Guardant 360 (Guardant Health, CA) which detects single nucleotide variants and insertion/deletion mutations, and specific amplifications and fusions, in up to 73 different genes. The mutant allele fraction (MAF) for detected alterations was calculated relative to wild type in ctDNA. Therapeutic relevance was defined as alterations within OncoKB levels 1-3B and R1. Results: Among 450 pts, 487 total samples were analyzed (77% AC, 31% SCC). ctDNA NGS revealed at least one genomic alteration (excluding variants of uncertain significance and synonymous mutations) in 81% of pts (90% AC, 88% SCC). Median number of alterations per AC patient was 4 [range, 1-59] and a median MAF of 0.84% (range, 0.02% - 83.7%); SCC was 5 [range, 1-26], with a median MAF of 0.99% (range, 0.01% - 85.2%). The total number of unique alterations was 1,162. The most commonly altered genes in AC: TP53 (70%), KRAS (20%), ERBB2 (18%), EGFR (16%), PIK3CA (16%); in SCC: TP53 (88%), PIK3CA (24%), CCND1 (23%), KRAS (21%), EGFR 15%). Therapeutically relevant alterations will be described. Conclusions: ctDNA plasma profiling of pts with EC is a feasible alternative and non-invasive method to gather comprehensive genomic data. Further large comparison studies to assess landscape of genomic alterations observed through ctDNA versus tissue-based assays, in addition to studies of targeted therapy outcomes based on ctDNA-detected alterations, are needed.
Circulating cell-free DNA (cfDNA) levels and fragmentation pattern can distinguish nonmuscle invasive (NMI) from muscle-invasive (MI) and metastatic (met) bladder cancer (BC).
Authors: Jaleh Fallah, Shinjini Ganguly, Hong Li, Wei (Auston) Wei, Aysegul Balyimez, Thirunavukkarasu Sitalaximi, C. Marcela Diaz-Montero, Patricia A. Rayman, Marcelo Lamenza, Priscilla Dann, Donna Company, Rahul D. Tendulkar, Mohamed Abazeed, Jorge A. Garcia, Moshe Chaim Ornstein, Brian I. Rini, Byron H Lee, Petros Grivas, Omar Y. Mian
Journal: Journal of Clinical Oncology (2019)

4523 Background: Occult MI and met BC may be under-staged. Circulating cfDNA may be a dynamic, low-cost and minimally invasive biomarker. We evaluated correlations between total circulating cfDNA and presence of MIBC and met BC. We hypothesized that the relative abundance of circulating low molecular weight cfDNA would correlate with BC stage. Methods: Peripheral blood from pts with BC was collected in Streck BCT tubes and processed to obtain cf nucleic acid extracts. Total cfDNA quantity (ng/ml) was assessed by fluorimetry. cfDNA fragment size was measured by Bioanalyzer DNA analysis. Wilcoxon rank sum test and Fisher’s Exact test were used to compare cfDNA quantity and fragmentation pattern among pts with NMIBC, MIBC, met BC. Results: Blood was obtained from 58 pts with BC (20% women, 34% never smokers, median age 71 (29-89). There was no significant difference in cfDNA between MIBC and met BC, however, it was significantly lower in pts with NMIBC vs MIBC and met BC (table). The concentration of low molecular weight fragments (LMW-frags) (100 - 400) base pairs and the ratio of LMW-Frag to cfDNA were significantly different between pts with NMIBC and pts with MIBC or met BC (table). Using median values as the cutoff, there was a significantly higher proportion of pts with cfDNA &gt; 7 ng/ml and LMW-frags &gt; 1.6 ng/mL, in MIBC &amp; met BC vs NMIBC (p &lt; 0.001). The % of pts with LMW-frags to cfDNA &gt; 30%, was significantly different among NMIBC, MIBC and met BC groups: 16%, 53%, 78%, respectively (p &lt; 0.001). Conclusions: This exploratory study suggests that cfDNA levels may correlate with BC stage. Measuring the relative abundance of LMW-frags with the expected size of cf DNA can enhance the specificity of cfDNA analysis for distinction between MIBC and met BC. Further studies are needed to confirm findings and define the optimal cut-points for optimal BC staging. [Table: see text]
SOPHIA primary analysis: A phase 3 (P3) study of margetuximab (M) + chemotherapy (C) versus trastuzumab (T) + C in patients (pts) with HER2+ metastatic (met) breast cancer (MBC) after prior anti-HER2 therapies (Tx).
Authors: Hope S. Rugo, Seock-Ah Im, Gail Lynn Shaw Wright, Santiago Escriva-de-Romani, Michelino DeLaurentiis, Javier Cortes, Shakeela Wazeen Bahadur, Barbara B. Haley, Raul H. Oyola, David A. Riseberg, Antonino Musolino, Fatima Cardoso, Giuseppe Curigliano, Peter A. Kaufman, Mark D. Pegram, Sutton Edlich, Sam Hong, Edwin P. Rock, William John Gradishar
Journal: Journal of Clinical Oncology (2019)

1000 Background: Pretreated HER2+ MBC lacks a defined standard of care, although T is commonly used. M has similar HER2 binding and antiproliferative effects as T. By contrast, M’s Fc region is engineered to increase affinity for both alleles of the activating Fc receptor (FcR), CD16A, and decrease affinity for the inhibitory FcR, CD32B. The low affinity CD16A-158F allele (~85% of population) has been associated with diminished clinical response to T. In a Phase 1 trial, M demonstrated acceptable safety, anti-tumor activity, and evidence of HER2-specific antibody and T-cell responses. Methods: SOPHIA (NCT02492711), a randomized, open-label P3 trial, enrolled pts with HER2+ MBC after pertuzumab and 1–3 lines of prior Tx for MBC. Pts were randomized 1:1 to M (15 mg/kg IV q3w + C) or T (6 [8 for loading dose] mg/kg IV q3w + C), stratified by met sites (≤2, &gt; 2), lines of Tx for met disease (≤2, &gt; 2), and C choice (standard dose capecitabine, eribulin, gemcitabine, or vinorelbine). Primary endpoints are central blinded PFS and OS, assessed sequentially using the stratified log-rank test. Objective response rate (ORR) was a secondary endpoint. 257 PFS events were required to provide 90% power to show PFS superiority at 2-sided α = 0.05. Results: Intent-to-treat analysis (536 pts: M 266; T 270) occurred after 265 PFS events. M prolonged PFS over T (median 5.8 vs 4.9 mo, hazard ratio [HR], 0.76; 95% CI, 0.59–0.98; P= 0.033). Treatment effects were more pronounced in pts with CD16A genotypes containing a 158F allele (median PFS 6.9 vs 5.1 mo, HR, 0.68; 95% CI, 0.52–0.90; P= 0.005). In 524 pts with baseline measurable disease (M 262; T 262), ORR was higher with M (22%; 95% CI, 17.3-27.7%) vs T (16%; 95% CI 11.8-21.0%). Safety profiles were comparable in 529 pts who received study therapy. Grade ≥3 AEs and serious AEs occurred in 138 (52%) and 39 (15%) vs 128 (48%) and 46 (17%) pts on M vs T, respectively. PFS data cutoff: 10/10/18. Conclusions: In combination with chemotherapy in pretreated HER2+ MBC, M improves PFS over T with comparable safety. CD16A genotyping suggests a differential benefit in patients with a 158F allele. OS data are maturing. Clinical trial information: NCT02492711.
Proximity to oil refineries and risk of cancer: A population-based analysis.
Authors: Stephen B. Williams, Yong Shan, Usama Jazzar, Preston Kerr, Ikenna Okereke, V. Suzanne Klimberg, Douglas S. Tyler, Nagireddy Putluri, David S Lopez, John D Prochaska, Cornelis Elferink, Jacques G. Baillargeon, Yong-Fang Kuo, Hemalkumar B Mehta
Journal: Journal of Clinical Oncology (2020)

e13586 Background: Proximity to oil refineries and cancer incidence is largely unknown. We sought to compare the incidence of cancer (bladder, breast, colon, lung, lymphoma, and prostate) according to proximity to an oil refinery in the State of Texas. Methods: A total of 6,302,265 persons aged ≥20 years from January 1, 2001 through December 31, 2014 were identified. We used zero-inflated Poisson regression models to examine the association of proximity to an oil refinery with cancer incidence. Results: We observed that proximity to an oil refinery was associated with a significantly increased risk of incident cancer diagnosis across all cancer types. For example, persons residing within 0-10 (Risk Ratio (RR) 1.16, 95% Confidence Interval (CI) 1.13-1.19) and 11-20 (RR 1.08, 95% CI 1.05-1.11) miles were significantly more likely to be diagnosed with lymphoma than individuals who lived within 21-30 miles from an oil refinery. We also observed differences in stage of cancer at diagnosis according to proximity to an oil refinery. We also found persons residing within 0-10 miles were more likely to be diagnosed with distant metastasis and/or systemic disease than people residing 21-30 miles from an oil refinery. The greatest risk of distant disease was observed in patients diagnosed with bladder cancer living within 0-10 vs. 21-30 miles (RR 1.33, 95% CI 1.06-1.68), respectively. Conclusions: Proximity to an oil refinery was associated with an increased risk of multiple cancer types. We also observed significantly increased risk of regional and distant/metastatic disease according to proximity to an oil refinery.
HFE-COMPOUND HETEROZYGOTES WITH SERUM FERRITIN < 1000 UG/L AT AGE 65 ARE NOT AT INCREASED RISK OF HEMOCHROMATOSIS COMPARED TO HFE WILD-TYPE CONTROLS
Authors: Lyle C. Gurrin, Nadine Bertalli, Gregory W. Dalton, Nicholas Osborne, Clare C. Constantine, Dallas English, Dorota M. Gertig, Martin Delatycki, John L. Hopper, Graham Giles, Gregory J. Anderson, John K. Olynyk, Lawrie W. Powell, Katrina J. Allen
Journal: Hepatology (2008)
Correlation of radiosensitivity of lung carcinoma to CD137L endogenous expression levels.
Authors: Swati Girdhani, Andrew Rodriguez, Rajiv Dua, Renate Parry
Journal: Journal of Clinical Oncology (2019)

e14229 Background: Radiation therapy is a cornerstone in the management of cancer. Preclinical and clinical evidence indicate the therapeutic efficacy of radiation therapy can be augmented by immunomodulatory antibodies against targets such as CD137 and PD-1/PD-L1. Despite evidence of synergy, the mechanistic basis has yet to be fully explored. In this study, we investigated how the expression of CD137, CD137L, PD-1, and PD-L1 correlates with radiosensitivity and proliferation of lung tumor cell lines treated with radiation as well as anti-PD-L1 and agonist anti-CD137 antibodies. Methods: Expression of CD137, CD137L and PD-L1 was measured by RT-qPCR in eight NSCLC cell lines (HCC827, HCC2935, H358, H460, A549, H596, H1650, H520) treated with radiation in doses of 0-8 Gy. Clonogenic assays for radiosensitivity and the CyQUANT assay for cell proliferation were performed after treatment with radiation in combination with anti-PD-L1 (0.01-10µg/ml) and agonist anti-CD137 (0.01-10µg/ml) antibodies. Results: Out of the eight cell lines tested, four were found to be radioresistant – H460, A549, HCC827 and H358 had SF2 (survival at 2 Gy) = 0.76, 0.70, 0.67 and 0.62, respectively – two were moderately sensitive – H520 and HCC2935 (SF2 = 0.54 and 0.40) and two were sensitive to radiation – H596 and H1650 (SF2 = 0.38 and 0.27). Expression analysis by RT-qPCR showed high endogenous expression of CD137L in three out of four radioresistant cell lines while the fourth, H358, had low endogenous expression of CD137L but upon irradiation showed more than a 3-fold induction of CD137L expression. PD-L1 expression levels measured by RT-qPCR did not correlate with radiosensitivity. In vitro cell proliferation was found to be inhibited by 48-68% in all eight NSCLC cell lines after 4 Gy radiation, but combination with anti-PD-L1 and agonist anti-CD-137 antibodies did not contribute additional toxicity. Conclusions: Our results demonstrate that CD137L expression on NSCLC cell lines correlates with radioresistance. Further, addition of anti-PD-L1 and agonist anti-CD137 antibodies to radiation showed little synergistic effect in vitro on tumor cell proliferation. Additional studies to address the synergistic effect of radiation and immunomodulation on tumor cells co-cultured with immune cells is ongoing.
Neck Dissections Based on Sentinel Lymph Node Navigation Versus Elective Neck Dissections in Early Oral Cancers: A Randomized, Multicenter, and Noninferiority Trial
Authors: Yasuhisa Hasegawa, Kiyoaki Tsukahara, Seiichi Yoshimoto, Kouki Miura, Junkichi Yokoyama, Shigeru Hirano, Hirokazu Uemura, Masashi Sugasawa, Tomokazu Yoshizaki, Akihiro Homma, Kazuaki Chikamatsu, Mikio Suzuki, Akihiro Shiotani, Takashi Matsuzuka, Naoyuki Kohno, Masakazu Miyazaki, Isao Oze, Keitaro Matsuo, Shigeru Kosuda, Yasushi Yatabe
Journal: Journal of Clinical Oncology (2021)

PURPOSE This study aimed to compare patients with early oral cavity squamous cell carcinoma (OCSCC) (tumor category [T] 1-2, node-negative, and no distant metastasis) treated with traditional elective neck dissection (ND) with those managed by sentinel lymph node biopsy (SLNB) using survival and neck function and complications as end points. METHODS Sixteen institutions in Japan participated in the study (trial registration number: UMIN000006510). Patients of age ≥ 18 years with histologically confirmed, previously untreated OCSCC (Union for International Cancer Control TNM Classification of Malignant Tumors 7th edition T1-2, node-negative no distant metastasis), with ≥ 4 mm (T1) depth of invasion, were randomly assigned to undergo standard selective ND (ND group; n = 137) or SLNB-navigated ND (SLNB group; n = 134). The primary end point was the 3-year overall survival rate, with a 12% noninferiority margin; secondary end points included postoperative neck functionality and complications and 3-year disease-free survival. Sentinel lymph nodes underwent intraoperative multislice frozen section analyses for the diagnosis. Patients with positive sentinel lymph nodes underwent either one-stage or second-look ND. RESULTS Pathologic metastasis-positive nodes were observed in 24.8% (34 of 137) and 33.6% (46 of 134) of patients in the ND and SLNB groups, respectively ( P = .190). The 3-year overall survival in the SLNB group (87.9%; lower limit of one-sided 95% CI, 82.4) was noninferior to that in the ND group (86.6%; lower limit 95% CI, 80.9; P for noninferiority &lt; .001). The 3-year disease-free survival rate was 78.7% (lower limit 95% CI, 72.1) and 81.3% (75.0) in the SLNB and ND groups, respectively ( P for noninferiority &lt; .001). The scores of neck functionality in the SLNB group were significantly better than those in the ND group. CONCLUSION SLNB-navigated ND may replace elective ND without a survival disadvantage and reduce postoperative neck disability in patients with early-stage OCSCC.