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Standards for Publishing in JAMA Otolaryngology-Head & Neck Surgery. JAMA耳鼻咽喉头颈外科杂志出版标准。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-02-05 DOI: 10.1001/jamaoto.2025.5346
Jay F Piccirillo
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引用次数: 0
Thyroidectomy Outcomes in Older Adults: A Systematic Review and Meta-Analysis. 老年人甲状腺切除术的结果:系统回顾和荟萃分析。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-02-05 DOI: 10.1001/jamaoto.2025.5345
Ahmed Ghani, Abdullah R Ayesh, Harisanth Rajaram, Sherwin M Ganegoda, Marios Alogakos, Alma Sato, Karl Hage, Christian A Than, Hayato Nakanishi, Joyce Shin, Gustavo Romero-Velez

Importance: A greater proportion of older patients (age ≥65 years) are undergoing thyroidectomy amidst an aging population. Given the elusive results in the literature, clarifying whether older patients face different thyroidectomy safety profiles is crucial for optimizing risk assessment and patient counseling.

Objective: To evaluate the association between older age (age ≥65 years) and thyroidectomy safety by comparing endocrine-related complications, including recurrent laryngeal nerve injury, hypocalcemia, hematoma, and mortality in older compared with younger patients.

Data sources: Ovid MEDLINE, CINAHL, Ovid Embase, and the Cochrane Library were systematically searched from inception to May 29, 2025; only English-language studies were included.

Study selection: Cohort studies comparing thyroidectomy outcomes between older and younger patients and reporting endocrine-related complications were included. Two independent reviewers screened abstracts and full texts. Of 3192 studies identified, 11 met inclusion criteria.

Data extraction and synthesis: Two independent reviewers extracted data following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Risk of bias across studies was evaluated using the ROBINS-I (Risk of Bias in Nonrandomized Studies of Interventions) tool. Random-effects models were used to pool data.

Main outcomes and measures: Incidence of recurrent laryngeal nerve injury, hypocalcemia, and hematoma; odds ratios (ORs) with 95% CIs were calculated.

Results: The analysis included 11 studies with a total of 427 886 patients of whom 104 232 (24.4%) were older adults (≥65 years). Older adults had greater odds of overall recurrent laryngeal nerve injury (2.3% vs 1.0%; OR, 1.58; 95% CI, 1.15-2.16; I2 = 76%), hematoma (2.4% vs 1.0%; OR, 2.32; 95% CI, 1.70-3.16; I2 = 0%), and mortality at last follow-up (0.3% vs 0.01%; OR, 11.09; 95% CI, 1.77-69.52; I2 = 90%) compared with younger patients. However, rates of overall hypocalcemia (OR, 0.80; 95% CI, 0.61-1.05; I2 = 71%) and wound complications (OR, 1.38; 95% CI, 0.92-2.06; I2 = 0%) were similar.

Conclusions and relevance: This systematic review and meta-analysis found that thyroidectomy is safe in older patients, with only small absolute increases in recurrent laryngeal nerve injury, hematoma, and mortality despite statistical significance. These findings support individualized counseling and perioperative planning while acknowledging the overall safety of thyroidectomy in this population.

重要性:在老龄化人口中,接受甲状腺切除术的老年患者(年龄≥65岁)的比例更高。鉴于文献中难以捉摸的结果,阐明老年患者是否面临不同的甲状腺切除术安全性对优化风险评估和患者咨询至关重要。目的:通过比较老年人与年轻患者的内分泌相关并发症,包括喉返神经损伤、低钙血症、血肿和死亡率,评估老年人(≥65岁)与甲状腺切除术安全性之间的关系。数据来源:Ovid MEDLINE, CINAHL, Ovid Embase和Cochrane图书馆从成立到2025年5月29日进行系统检索;仅包括英语研究。研究选择:纳入比较老年和年轻患者甲状腺切除术结果和报告内分泌相关并发症的队列研究。两名独立审稿人对摘要和全文进行了筛选。在确定的3192项研究中,有11项符合纳入标准。数据提取和综合:两名独立审稿人按照PRISMA(系统评价和荟萃分析首选报告项目)指南提取数据。使用ROBINS-I(非随机干预研究的偏倚风险)工具评估各研究的偏倚风险。随机效应模型用于汇集数据。主要观察指标:喉返神经损伤、低血钙、血肿发生率;计算95% ci的优势比(ORs)。结果:该分析包括11项研究,共427 886例患者,其中104 232例(24.4%)为老年人(≥65岁)。与年轻患者相比,老年人总体喉返神经损伤(2.3% vs 1.0%; OR, 1.58; 95% CI, 1.15-2.16; I2 = 76%)、血肿(2.4% vs 1.0%; OR, 2.32; 95% CI, 1.70-3.16; I2 = 0%)和最后随访死亡率(0.3% vs 0.01%; OR, 11.09; 95% CI, 1.77-69.52; I2 = 90%)的几率更高。然而,总体低钙血症发生率(OR, 0.80; 95% CI, 0.61-1.05; I2 = 71%)和伤口并发症发生率(OR, 1.38; 95% CI, 0.92-2.06; I2 = 0%)相似。结论和相关性:本系统综述和荟萃分析发现,甲状腺切除术对老年患者是安全的,尽管有统计学意义,但喉返神经损伤、血肿和死亡率只有小幅绝对增加。这些发现支持个体化咨询和围手术期计划,同时承认甲状腺切除术在这一人群中的总体安全性。
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引用次数: 0
Social Media and Disease Recognition. 社会媒体和疾病识别。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-02-05 DOI: 10.1001/jamaoto.2025.5216
Rachel B Kutler, Hayley L Born
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引用次数: 0
Antigua. 安提瓜岛。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-02-05 DOI: 10.1001/jamaoto.2025.5340
James Berry
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引用次数: 0
Large Language Models and Otolaryngology: A Review. 大语言模型与耳鼻喉科学:综述。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-02-05 DOI: 10.1001/jamaoto.2025.5335
James W Bao, Mona N Jawad, Cole Pavelchek, William J B Powell, Inez Y Oh, Aditi Gupta, Matthew A Shew

Importance: Large language models (LLMs), a rapidly advancing domain of artificial intelligence (AI), are poised to transform administrative, clinical, and research paradigms. Although adoption across medicine has accelerated, otolaryngology represents only a fraction of this progress compared with other specialties. This review highlights the advantages of LLMs and innovations from other fields to provide otolaryngologists with a foundation for advancing these technologies. Given the unique reliance of otolaryngology on multimodal data (text, imaging, electrophysiology, and video) and its symptom-driven complexity, LLMs represent a powerful but underused tool for advancing patient care.

Observations: LLMs efficiently combine the strengths of deep learning and natural language processing, enabling revolutionary language abilities. Most otolaryngology research has focused narrowly on question-answering tasks with limited clinical integration. In contrast, other specialties have demonstrated broad methodological applications, including (1) converting unstructured data (eg, notes, reports) into structured variables; (2) automated phenotyping and subphenotyping to advance precision medicine; (3) streamlining administrative tasks; (4) developing domain-specific decision support tools; and (5) using multimodal language models that integrate text with images. Importantly, LLMs are accessible and adaptable, requiring far less labeled data than traditional machine learning models, enabling broader applications to researchers. Yet, in otolaryngology, most studies remain limited to feasibility evaluations with closed-source models, constraining their clinical utility and translational potential.

Conclusions and relevance: LLMs hold significant promise to enhance biomedical research and patient care. Otolaryngology, with its rich clinical, functional, and multimodal data, is well positioned to benefit from these tools. However, progress requires moving beyond feasibility studies toward clinical trial-like validation and implementation research. Future efforts should prioritize open-source model development, domain-specific fine-tuning, secure multi-institutional deployment, and legal oversight to ensure transparency, reproducibility, and generalizability. By aligning with advancements in other specialties, otolaryngology can leverage its unique resources to pioneer responsible LLM applications that improve efficiency, augment decision support, and transform patient outcomes.

重要性:大型语言模型(llm)是人工智能(AI)快速发展的领域,有望改变行政、临床和研究范式。尽管在医学领域的应用加快了,但与其他专业相比,耳鼻喉科只代表了这一进步的一小部分。本文综述了llm的优势和其他领域的创新,为耳鼻喉科医生提供了进一步发展这些技术的基础。考虑到耳鼻喉科对多模态数据(文本、成像、电生理和视频)的独特依赖及其症状驱动的复杂性,llm代表了一个强大但未充分利用的工具来推进患者护理。观察:llm有效地结合了深度学习和自然语言处理的优势,实现了革命性的语言能力。大多数耳鼻喉科研究都集中在有限的临床整合的问答任务上。相比之下,其他专业已经展示了广泛的方法应用,包括(1)将非结构化数据(例如,笔记,报告)转换为结构化变量;(2)自动化表型和亚表型,推进精准医疗;(三)精简行政管理;(4)开发特定领域的决策支持工具;(5)采用文本与图像相结合的多模态语言模型。重要的是,llm具有可访问性和适应性,与传统的机器学习模型相比,需要的标记数据要少得多,从而可以为研究人员提供更广泛的应用。然而,在耳鼻喉科,大多数研究仍然局限于封闭源模型的可行性评估,限制了它们的临床应用和转化潜力。结论和相关性:法学硕士在加强生物医学研究和患者护理方面具有重要的前景。耳鼻喉科具有丰富的临床、功能和多模式数据,可以很好地从这些工具中受益。然而,进展需要从可行性研究转向类似临床试验的验证和实施研究。未来的工作应该优先考虑开源模型开发、特定领域的微调、安全的多机构部署和法律监督,以确保透明度、可再现性和通用性。通过与其他专业的进步保持一致,耳鼻喉科可以利用其独特的资源开拓负责任的法学硕士应用,提高效率,增强决策支持,并改变患者的治疗结果。
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引用次数: 0
Clinical Severity Staging System and Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. 阻塞性睡眠呼吸暂停的临床严重程度分期系统及对舌下神经刺激的反应。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-02-05 DOI: 10.1001/jamaoto.2025.4851
Jenny Ji, Hannah Z Wang, Ryan S Jackson, Miranda R Lindburg, Dorina Kallogjeri, Eric C Landsness, Jay F Piccirillo

Importance: While hypoglossal nerve stimulators (HGNS) have been shown to be associated with reduced apnea-hypopnea index (AHI) scores in many continuous positive airway pressure-intolerant patients with obstructive sleep apnea (OSA), it is not effective for all patients, and it is unclear who would benefit most.

Objective: To explore baseline factors associated with response to HGNS and create a prognostic stratification system.

Design, setting, and participants: This retrospective cohort study included patients with OSA who underwent implant with an HGNS from April 2019 to October 2023 at a single tertiary care center and received a postimplant sleep study. During that time, 194 patients underwent HGNS implant. Data were analyzed from February 2024 to April 2024.

Intervention or exposure: HGNS implant and sleep study.

Main outcomes and measures: Response according to the modified Sher criteria (>50% reduction in AHI score and AHI <15 postimplant).

Results: Among the 119 patients included, the median (range) age was 63 (33-79) years, and 36 (30%) were female. Of the 119 included, 83 (70%) were responders. Neck size, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), AHI score, and comorbidity burden were associated with response and used to create a 4-category clinical severity staging system. Patients with small necks (≤14 inches for women or ≤16 inches for men), a BMI of less than 30, and an AHI score of 30 or less had the highest response rate (11 [91%]). Patients with large necks (>14 inches for women or >16 inches for men), a BMI of 30 or greater, an AHI score of 30 or greater, and comorbidities had the lowest response rate (16 [38%]). The staging system had moderate discriminative power, with a C statistic of 0.68 (95% CI, 0.57-0.78).

Conclusions and relevance: The results of this cohort study suggest that neck size, BMI, AHI score, and comorbidity burden are 4 clinically relevant and easily obtainable values that are associated with response to HGNS. While this staging system may help physicians identify patients who are most likely to benefit from implant, these results need to be validated in a separate cohort.

重要性:虽然舌下神经刺激剂(HGNS)已被证明与许多持续气道正压不耐受的阻塞性睡眠呼吸暂停(OSA)患者的呼吸暂停低通气指数(AHI)评分降低相关,但它并非对所有患者都有效,而且尚不清楚谁将受益最多。目的:探讨与HGNS反应相关的基线因素,并建立预后分层系统。设计、环境和参与者:本回顾性队列研究包括2019年4月至2023年10月在单一三级护理中心接受HGNS植入的OSA患者,并接受植入后睡眠研究。在此期间,194例患者接受了HGNS植入。数据分析时间为2024年2月至2024年4月。干预或暴露:HGNS植入和睡眠研究。主要结局和措施:符合修改后的Sher标准(AHI评分降低50%);AHI结果:纳入的119例患者中位(范围)年龄为63(33-79)岁,其中36例(30%)为女性。在纳入的119例患者中,83例(70%)有应答。颈部大小、体重指数(BMI;计算方法为体重(公斤)除以身高(米)的平方)、AHI评分和合并症负担与反应相关,并用于创建4类临床严重程度分期系统。颈部较小(女性≤14英寸或男性≤16英寸)、BMI小于30、AHI评分小于30的患者有效率最高(11[91%])。颈部较大(女性>14英寸或男性>16英寸)、BMI≥30、AHI评分≥30、合并症患者的缓解率最低(16例[38%])。分期系统具有中等判别能力,C统计量为0.68 (95% CI, 0.57-0.78)。结论和相关性:该队列研究的结果表明,颈部大小、BMI、AHI评分和合并症负担是与HGNS反应相关的4个临床相关且易于获得的值。虽然这种分期系统可以帮助医生确定最有可能从植入物中获益的患者,但这些结果需要在单独的队列中进行验证。
{"title":"Clinical Severity Staging System and Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea.","authors":"Jenny Ji, Hannah Z Wang, Ryan S Jackson, Miranda R Lindburg, Dorina Kallogjeri, Eric C Landsness, Jay F Piccirillo","doi":"10.1001/jamaoto.2025.4851","DOIUrl":"10.1001/jamaoto.2025.4851","url":null,"abstract":"<p><strong>Importance: </strong>While hypoglossal nerve stimulators (HGNS) have been shown to be associated with reduced apnea-hypopnea index (AHI) scores in many continuous positive airway pressure-intolerant patients with obstructive sleep apnea (OSA), it is not effective for all patients, and it is unclear who would benefit most.</p><p><strong>Objective: </strong>To explore baseline factors associated with response to HGNS and create a prognostic stratification system.</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study included patients with OSA who underwent implant with an HGNS from April 2019 to October 2023 at a single tertiary care center and received a postimplant sleep study. During that time, 194 patients underwent HGNS implant. Data were analyzed from February 2024 to April 2024.</p><p><strong>Intervention or exposure: </strong>HGNS implant and sleep study.</p><p><strong>Main outcomes and measures: </strong>Response according to the modified Sher criteria (>50% reduction in AHI score and AHI <15 postimplant).</p><p><strong>Results: </strong>Among the 119 patients included, the median (range) age was 63 (33-79) years, and 36 (30%) were female. Of the 119 included, 83 (70%) were responders. Neck size, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), AHI score, and comorbidity burden were associated with response and used to create a 4-category clinical severity staging system. Patients with small necks (≤14 inches for women or ≤16 inches for men), a BMI of less than 30, and an AHI score of 30 or less had the highest response rate (11 [91%]). Patients with large necks (>14 inches for women or >16 inches for men), a BMI of 30 or greater, an AHI score of 30 or greater, and comorbidities had the lowest response rate (16 [38%]). The staging system had moderate discriminative power, with a C statistic of 0.68 (95% CI, 0.57-0.78).</p><p><strong>Conclusions and relevance: </strong>The results of this cohort study suggest that neck size, BMI, AHI score, and comorbidity burden are 4 clinically relevant and easily obtainable values that are associated with response to HGNS. While this staging system may help physicians identify patients who are most likely to benefit from implant, these results need to be validated in a separate cohort.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12878641/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hypotensive Agents for Controlled Hypotension in Endoscopic Sinus Surgery: A Systematic Review and Network Meta-Analysis. 内窥镜鼻窦手术控制降压的降压药:系统回顾和网络荟萃分析。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-29 DOI: 10.1001/jamaoto.2025.5222
Abdelrahman Saeed, Omar Saeed, Mohamedhen Vall Nounou, Edward D McCoul, Qasi Najah, Sara Saleh, Osama Barakat, Ahmed Wahhab, Longgang Yu, Muhammed Elhadi

Importance: Excessive bleeding during endoscopic sinus surgery (ESS) impairs visualization and increases complications. Controlled hypotension is widely used; however, comparative effectiveness of available pharmacological agents remains uncertain.

Objective: To compare the effectiveness and safety of hypotensive drugs for reduced bleeding in ESS.

Data sources: PubMed, Scopus, Web of Science, and Cochrane databases were searched from inception to December 2024, and updated to include studies up to May 2025.

Study selection: Randomized clinical trials of patients undergoing ESS and receiving dexmedetomidine, clonidine, esmolol, labetalol, bisoprolol, metoprolol, diltiazem, nifedipine, or verapamil vs placebo. A total of 1258 records were screened.

Data extraction and synthesis: Data were extracted and assessed using the Cochrane risk of bias tool. Certainty was rated using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework. A random-effects meta-analysis was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement guidelines.

Main outcomes and measures: Surgical bleeding score, intraoperative mean arterial pressure (MAP), and mean intraoperative heart rate. Secondary outcomes included blood loss, surgery duration, and emergence time.

Results: The analysis included 52 randomized clinical trials involving 3526 participants; of these, 43 studies contributed to the network analysis. Several agents were associated with reduced bleeding vs placebo: diltiazem (mean difference [MD], -1.25; 95% CI, -2.13 to -0.37), esmolol (MD, -1.16; 95% CI, -1.80 to -0.51), dexmedetomidine (MD, -1.09; 95% CI, -1.48 to -0.70), labetalol (MD, -1.00; 95% CI, -1.58 to -0.42), and clonidine (MD, -0.69; 95% CI, -1.23 to -0.16). Dexmedetomidine was associated with the most reduced MAP (MD, -30.30 mm Hg; 95% CI, -47.91 to -12.69), followed by clonidine (MD, -28.61; 95% CI, -53.11 to -4.11), esmolol (MD, -27.62; 95% CI, -49.73 to -5.51), and labetalol (MD, -26.54; 95% CI, -47.20 to -5.87). At 60 minutes, bisoprolol (MD, -58.30; 95% CI, -67.50 to -49.10 beats per minute [bpm]), verapamil (MD, -49.90; 95% CI, -58.98 to -40.82 bpm), and labetalol (MD, -43.89; 95% CI, -54.59 to -33.18 bpm) produced the largest heart rate reductions. Esmolol (MD, -3.67; 95% CI, -4.21 to -3.13 minutes) and labetalol (MD, -3.64; 95% CI, -4.79 to -2.49 minutes) shortened emergence time.

Conclusions and relevance: In this systematic review and network meta-analysis, controlled hypotension improved surgical field quality in ESS with comparable safety. Diltiazem, esmolol, dexmedetomidine, labetalol, and clonidine were effective; dexmedetomidine was associated with reduced MAP the most, and esmolol favored recovery.

重要性:内窥镜鼻窦手术(ESS)中出血过多会损害可视化并增加并发症。控制性低血压被广泛应用;然而,现有药物的相对有效性仍然不确定。目的:比较降压药减少ESS出血的有效性和安全性。数据来源:PubMed, Scopus, Web of Science和Cochrane数据库从成立到2024年12月进行了搜索,并更新到2025年5月。研究选择:接受ESS并接受右美托咪定、氯定、艾司洛尔、拉贝他洛尔、比索洛尔、美托洛尔、地尔硫卓、硝苯地平或维拉帕米与安慰剂的随机临床试验。总共筛选了1258条记录。数据提取和综合:使用Cochrane偏倚风险工具提取和评估数据。使用GRADE(建议评估、发展和评估分级)框架对确定性进行评级。随机效应荟萃分析按照PRISMA(系统评价和荟萃分析首选报告项目)声明指南进行。主要观察指标:手术出血评分、术中平均动脉压(MAP)、术中平均心率。次要结局包括出血量、手术时间和急救时间。结果:分析纳入52项随机临床试验,涉及3526名受试者;其中,43项研究对网络分析做出了贡献。与安慰剂相比,几种药物与减少出血相关:地尔硫卓(平均差[MD], -1.25; 95% CI, -2.13至-0.37)、艾司洛尔(MD, -1.16; 95% CI, -1.80至-0.51)、右美托咪定(MD, -1.09; 95% CI, -1.48至-0.70)、拉贝他洛尔(MD, -1.00; 95% CI, -1.58至-0.42)和克拉定(MD, -0.69; 95% CI, -1.23至-0.16)。右美托咪定与MAP降低最多相关(MD, -30.30 mm Hg; 95% CI, -47.91至-12.69),其次是cola (MD, -28.61; 95% CI, -53.11至-4.11)、esmolol (MD, -27.62; 95% CI, -49.73至-5.51)和labetalol (MD, -26.54; 95% CI, -47.20至-5.87)。在60分钟时,比索洛尔(MD, -58.30; 95% CI, -67.50至-49.10次/分钟[bpm])、维拉帕米(MD, -49.90; 95% CI, -58.98至-40.82 bpm)和拉贝他洛尔(MD, -43.89; 95% CI, -54.59至-33.18 bpm)产生最大的心率降低。艾司洛尔(MD, -3.67; 95% CI, -4.21 ~ -3.13分钟)和拉贝洛尔(MD, -3.64; 95% CI, -4.79 ~ -2.49分钟)缩短急救时间。结论和相关性:在本系统综述和网络荟萃分析中,控制性低血压改善了ESS手术野质量,且安全性相当。地尔硫卓、艾司洛尔、右美托咪定、拉贝他洛尔和可乐定有效;右美托咪定与MAP减少相关最多,而艾司洛尔有利于恢复。
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引用次数: 0
Accuracy of Sentinel Lymph Node Biopsy to Predict Nodal Metastasis in Head and Neck Merkel Cell Carcinoma. 前哨淋巴结活检预测头颈部默克尔细胞癌淋巴结转移的准确性。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-29 DOI: 10.1001/jamaoto.2025.5211
Stephanie Y Wang, Gavin Turner, Karla L Valdes-Morales, Emily R Hunter, Mimi Kim, Van Anh Tran, Kyle Polen, Dylan Haynes, Christopher J Miller, Jeremy R Etzkorn, Joseph F Sobanko, Joanna L Walker, Junqian Zhang, Robert M Brody, Steven B Cannady, Karthik Rajasekaran, D Gregory Farwell, John T Miura, Giorgos C Karakousis, John R Lukens, Ravi K Amaravadi, Lynn M Schuchter, Tara C Mitchell, H William Higgins, Ryan M Carey

Importance: Merkel cell carcinoma (MCC) is a rare neuroendocrine malignant neoplasm often affecting the head and neck. Sentinel lymph node biopsy (SLNB) is routinely performed; however, the accuracy and reliability of SLNB for head and neck MCC remains unknown.

Objective: To determine the accuracy of SLNB in head and neck MCC and inform pre- and post-SLNB risk stratification.

Design, setting, and participants: This was a single-center cohort study of patients with clinically node-negative head and neck MCC who underwent SLNB from January 2006 to January 2025; median (IQR) follow-up was 1.9 (0.8-4.6) years. Data analysis was conducted from April to November 2025.

Interventions: SLNB outcome and nodal disease status.

Main outcomes and measures: SLNB accuracy measured by sensitivity, negative predictive value (NPV), and false negative (FN) rate. FN SLNB was defined as regional nodal recurrence at the first site of recurrence after a negative SLNB without concurrent local or in-transit recurrence. Factors associated with failed SLNB (defined as nonvisualization on lymphoscintigraphy, inability to identify the sentinel lymph node intraoperatively, or absence of nodal tissue in the pathology specimen) were evaluated using effect-size measures. Cox proportional hazards model identified factors associated with nodal disease, comparing patients who developed nodal disease (identified by SLNB or subsequent clinical and/or imaging evaluation) with those who did not develop nodal disease during follow-up.

Results: Of 86 participants (mean [SD] age, 75.6 [9.6] years; 36 female [41.9%] and 50 male [58.1%] individuals) with clinically node-negative head and neck MCC, 69 (80.2%) underwent SLNB. Occult nodal disease was identified in 19 participants (27.5%). SLNB sensitivity was 52.6% (10 of 19 patients), NPV was 88.6% (31 of 35 patients), and FN rate was 26.7% (4 of 15 patients). SLNB failed in 29.0% (20 of 69 patients), with tumor location, female sex, and older age having medium to large effect on SLNB failure. Lymphovascular invasion, infiltrative growth pattern, and tumor size had the largest effect size on nodal disease with Cox analysis.

Conclusions and relevance: In this large single-site cohort study, SLNB remained a useful tool in head and neck MCC, identifying more than half of occult nodal disease. Given reduced performance in this region, patients with failed SLNB or negative SLNB plus high-risk features may benefit from tailored management, including intensified therapy and surveillance.

重要性:默克尔细胞癌(MCC)是一种罕见的神经内分泌恶性肿瘤,常累及头颈部。前哨淋巴结活检(SLNB)是常规检查;然而,SLNB对头颈部MCC的准确性和可靠性尚不清楚。目的:确定SLNB在头颈部MCC中的准确性,为SLNB前后的风险分层提供依据。设计、环境和参与者:这是一项单中心队列研究,研究对象为2006年1月至2025年1月接受SLNB治疗的临床淋巴结阴性头颈部MCC患者;中位(IQR)随访时间为1.9(0.8-4.6)年。数据分析时间为2025年4月至11月。干预措施:SLNB结果和淋巴结疾病状态。主要结局和测量指标:SLNB准确性(灵敏度)、阴性预测值(NPV)和假阴性(FN)率。FN SLNB被定义为阴性SLNB后第一个复发部位的区域性淋巴结复发,没有并发局部或途中复发。与SLNB失败相关的因素(定义为淋巴显像未显示,术中无法识别前哨淋巴结,或病理标本中没有淋巴结组织)使用效应大小测量进行评估。Cox比例风险模型确定了与淋巴结疾病相关的因素,比较了在随访期间发生淋巴结疾病(通过SLNB或随后的临床和/或影像学评估确定)的患者与未发生淋巴结疾病的患者。结果:86例临床淋巴结阴性头颈部MCC患者(平均[SD]年龄75.6[9.6]岁,女性36例[41.9%],男性50例[58.1%])中,69例(80.2%)接受了SLNB。19名参与者(27.5%)发现隐匿性淋巴结疾病。SLNB敏感性为52.6% (10 / 19),NPV为88.6% (31 / 35),FN率为26.7%(4 / 15)。69例患者中有20例(29.0%)SLNB失败,肿瘤位置、女性、年龄对SLNB失败有中等到较大的影响。经Cox分析,淋巴血管浸润、浸润性生长模式和肿瘤大小对淋巴结疾病的影响最大。结论和相关性:在这项大型单点队列研究中,SLNB仍然是头颈部MCC的有用工具,可识别一半以上的隐匿性淋巴结疾病。鉴于该区域的表现下降,SLNB失败或SLNB阴性加上高风险特征的患者可能受益于量身定制的管理,包括强化治疗和监测。
{"title":"Accuracy of Sentinel Lymph Node Biopsy to Predict Nodal Metastasis in Head and Neck Merkel Cell Carcinoma.","authors":"Stephanie Y Wang, Gavin Turner, Karla L Valdes-Morales, Emily R Hunter, Mimi Kim, Van Anh Tran, Kyle Polen, Dylan Haynes, Christopher J Miller, Jeremy R Etzkorn, Joseph F Sobanko, Joanna L Walker, Junqian Zhang, Robert M Brody, Steven B Cannady, Karthik Rajasekaran, D Gregory Farwell, John T Miura, Giorgos C Karakousis, John R Lukens, Ravi K Amaravadi, Lynn M Schuchter, Tara C Mitchell, H William Higgins, Ryan M Carey","doi":"10.1001/jamaoto.2025.5211","DOIUrl":"10.1001/jamaoto.2025.5211","url":null,"abstract":"<p><strong>Importance: </strong>Merkel cell carcinoma (MCC) is a rare neuroendocrine malignant neoplasm often affecting the head and neck. Sentinel lymph node biopsy (SLNB) is routinely performed; however, the accuracy and reliability of SLNB for head and neck MCC remains unknown.</p><p><strong>Objective: </strong>To determine the accuracy of SLNB in head and neck MCC and inform pre- and post-SLNB risk stratification.</p><p><strong>Design, setting, and participants: </strong>This was a single-center cohort study of patients with clinically node-negative head and neck MCC who underwent SLNB from January 2006 to January 2025; median (IQR) follow-up was 1.9 (0.8-4.6) years. Data analysis was conducted from April to November 2025.</p><p><strong>Interventions: </strong>SLNB outcome and nodal disease status.</p><p><strong>Main outcomes and measures: </strong>SLNB accuracy measured by sensitivity, negative predictive value (NPV), and false negative (FN) rate. FN SLNB was defined as regional nodal recurrence at the first site of recurrence after a negative SLNB without concurrent local or in-transit recurrence. Factors associated with failed SLNB (defined as nonvisualization on lymphoscintigraphy, inability to identify the sentinel lymph node intraoperatively, or absence of nodal tissue in the pathology specimen) were evaluated using effect-size measures. Cox proportional hazards model identified factors associated with nodal disease, comparing patients who developed nodal disease (identified by SLNB or subsequent clinical and/or imaging evaluation) with those who did not develop nodal disease during follow-up.</p><p><strong>Results: </strong>Of 86 participants (mean [SD] age, 75.6 [9.6] years; 36 female [41.9%] and 50 male [58.1%] individuals) with clinically node-negative head and neck MCC, 69 (80.2%) underwent SLNB. Occult nodal disease was identified in 19 participants (27.5%). SLNB sensitivity was 52.6% (10 of 19 patients), NPV was 88.6% (31 of 35 patients), and FN rate was 26.7% (4 of 15 patients). SLNB failed in 29.0% (20 of 69 patients), with tumor location, female sex, and older age having medium to large effect on SLNB failure. Lymphovascular invasion, infiltrative growth pattern, and tumor size had the largest effect size on nodal disease with Cox analysis.</p><p><strong>Conclusions and relevance: </strong>In this large single-site cohort study, SLNB remained a useful tool in head and neck MCC, identifying more than half of occult nodal disease. Given reduced performance in this region, patients with failed SLNB or negative SLNB plus high-risk features may benefit from tailored management, including intensified therapy and surveillance.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12856741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146085929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Beyond the Usual Fashion-Rethinking the Operative Report. 超越常规——对执行报告的反思。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-29 DOI: 10.1001/jamaoto.2025.4987
Edward D McCoul
{"title":"Beyond the Usual Fashion-Rethinking the Operative Report.","authors":"Edward D McCoul","doi":"10.1001/jamaoto.2025.4987","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.4987","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146085950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Intratumoral Radioenhancer Nanoparticle NBTXR3 Followed by Radiotherapy in Head and Neck Cancer: A Phase 1 Dose-Expansion Nonrandomized Clinical Trial. 肿瘤内放疗增强剂纳米颗粒NBTXR3放疗头颈癌:一项1期剂量扩展非随机临床试验
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-29 DOI: 10.1001/jamaoto.2025.4939
Christophe Le Tourneau, Xavier Liem, France Nguyen, Simon Deraedt, Sébastien Salas, Valentin Calugaru, Maria Plana Serrahima, Stéphanie Wong Hee Kam, Caroline Hoffmann, Maria Lesnik, Pierre Blanchard, Gilles Poissonnet, Alexandre Bozec, Esma Saada-Bouzid, Franck Jégoux, Joël Castelli, Kiran Devisetty, Yann Lelonge, Eric Jadaud, Laetitia Houdas, Anais Debard, Omar I Vivar, Laetitia Finzi, Alessandra Serra, Isabel Linares, Carlos Arranz Obispo, Juliette Thariat, Audrey Rambeau, Nicolas Fakhry, Laure Santini, Jordi Giralt, Irene Braña García, Manuel Sáez Barba, Philippe Gorphe, Frigyes Helfferich, Adrienn Herczeg, Zsuzsanna Papai, Jacek Fijuth, Zoltán Takácsi-Nagy
<p><strong>Importance: </strong>Intratumoral delivery of NBTXR3 radioenhancer followed by radiation therapy (RT) previously demonstrated safety and feasibility in cisplatin-ineligible and cetuximab-ineligible patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in a dose-escalation phase 1 study.</p><p><strong>Objective: </strong>To evaluate safety and preliminary efficacy of NBTXR3 followed by RT in patients with locally advanced HNSCC ineligible to receive concurrent systemic therapy.</p><p><strong>Design, setting, and participants: </strong>This single-arm, phase 1 dose-expansion nonrandomized clinical trial was conducted across 20 centers in Europe between March 4, 2019, and January 10, 2022. Patients were ineligible for cisplatin and cetuximab per investigator's judgement and had unresectable T3-4 or overall stage III/IVA HNSCC (per the American Joint Committee on Cancer Staging Manual, eighth edition) of the oral cavity or oropharynx. Data were analyzed from July to August 2023.</p><p><strong>Interventions: </strong>Patients received a single intratumoral administration of NBTXR3 in the primary tumor at the recommended dose of 22% of estimated tumor volume (ETV) followed by RT (70 Gy over 35 fractions).</p><p><strong>Main outcomes and measures: </strong>Primary outcomes were safety and efficacy assessed by the objective response rate (ORR) of the NBTXR3-injected primary tumor. Other outcomes included ORR of all lesions (injected primary tumor and noninjected involved lymph nodes), progression-free survival, and overall survival.</p><p><strong>Results: </strong>Of the 56 patients treated, the median (range) age was 72 (44-89) years, 40 (71%) were men, 34 (61%) were 70 years and older, and 36 (64%) had a substantial burden of comorbidities (age-adjusted Charlson Comorbidity Index score of 4 or greater). Median (range) follow-up was 33.0 (0.7-44.6) months. NBTXR3-related treatment-emergent adverse events occurred in 9 patients (16%), of which 6 (11%) were grade 3 or higher, the most frequent being stomatitis (2 [4%]). Objective tumor response was assessed in 44 patients, as 12 patients were unable to complete RT or did not have posttreatment tumor assessment. In this evaluable patient population, the ORR of the injected primary tumor and ORR of all lesions were 82% (95% CI, 67-92) and 80% (95% CI, 65-90), respectively. Among all 56 treated patients, the median progression-free survival was 11.4 months (95% CI, 6.7 to not reached), and the median overall survival was 18.1 months (95% CI, 9.7 to not reached).</p><p><strong>Conclusions and relevance: </strong>This dose-expansion phase 1 nonrandomized clinical trial demonstrated that intratumoral NBTXR3 followed by RT in a high-risk patient population unable to receive cisplatin or cetuximab was feasible and had a preliminary efficacy signal that supports a benefit-risk profile being evaluated in an ongoing randomized phase III trial.</p><p><strong>Trial registration: </str
重要性:在一项剂量递增的1期研究中,在不适合顺铂和西妥昔单抗治疗的局部晚期头颈部鳞状细胞癌(HNSCC)患者中,瘤内给予NBTXR3放射增强剂后进行放射治疗(RT)已经证明了安全性和可行性。目的:评价NBTXR3联合RT治疗局部晚期HNSCC不适合同时接受全身治疗的患者的安全性和初步疗效。设计、环境和参与者:这项单臂、一期剂量扩张非随机临床试验于2019年3月4日至2022年1月10日在欧洲的20个中心进行。根据研究者的判断,患者不适合顺铂和西妥昔单抗,并且口腔或口咽的T3-4期或III/IVA期HNSCC(根据美国癌症分期手册联合委员会,第八版)不可切除。数据分析时间为2023年7月至8月。干预措施:患者在原发肿瘤中接受单次瘤内给药,推荐剂量为估计肿瘤体积(ETV)的22%,然后接受RT (70 Gy / 35份)。主要结局和指标:主要结局以nbtxr3注射原发肿瘤的客观缓解率(ORR)评价安全性和有效性。其他结果包括所有病变(注射原发肿瘤和非注射受累淋巴结)的ORR、无进展生存期和总生存期。结果:56例接受治疗的患者中位(范围)年龄为72岁(44-89岁),40例(71%)为男性,34例(61%)为70岁及以上,36例(64%)有严重的合并症负担(年龄调整的Charlson共病指数评分为4或更高)。中位(范围)随访时间为33.0(0.7-44.6)个月。9例(16%)患者发生nbtxr3相关治疗不良事件,其中6例(11%)为3级及以上,最常见的是口炎(2例[4%])。目的:对44例患者的肿瘤反应进行评估,其中12例患者无法完成RT或未进行治疗后肿瘤评估。在这个可评估的患者群体中,注射原发肿瘤的ORR和所有病变的ORR分别为82% (95% CI, 67-92)和80% (95% CI, 65-90)。在所有56例接受治疗的患者中,中位无进展生存期为11.4个月(95% CI, 6.7至未达到),中位总生存期为18.1个月(95% CI, 9.7至未达到)。结论和相关性:这项剂量扩大的1期非随机临床试验表明,在无法接受顺铂或西妥昔单抗的高风险患者群体中,瘤内NBTXR3随后进行RT治疗是可行的,并且具有初步的疗效信号,支持正在进行的随机III期试验评估的获益-风险特征。试验注册:ClinicalTrials.gov标识符:NCT01946867。
{"title":"Intratumoral Radioenhancer Nanoparticle NBTXR3 Followed by Radiotherapy in Head and Neck Cancer: A Phase 1 Dose-Expansion Nonrandomized Clinical Trial.","authors":"Christophe Le Tourneau, Xavier Liem, France Nguyen, Simon Deraedt, Sébastien Salas, Valentin Calugaru, Maria Plana Serrahima, Stéphanie Wong Hee Kam, Caroline Hoffmann, Maria Lesnik, Pierre Blanchard, Gilles Poissonnet, Alexandre Bozec, Esma Saada-Bouzid, Franck Jégoux, Joël Castelli, Kiran Devisetty, Yann Lelonge, Eric Jadaud, Laetitia Houdas, Anais Debard, Omar I Vivar, Laetitia Finzi, Alessandra Serra, Isabel Linares, Carlos Arranz Obispo, Juliette Thariat, Audrey Rambeau, Nicolas Fakhry, Laure Santini, Jordi Giralt, Irene Braña García, Manuel Sáez Barba, Philippe Gorphe, Frigyes Helfferich, Adrienn Herczeg, Zsuzsanna Papai, Jacek Fijuth, Zoltán Takácsi-Nagy","doi":"10.1001/jamaoto.2025.4939","DOIUrl":"10.1001/jamaoto.2025.4939","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Intratumoral delivery of NBTXR3 radioenhancer followed by radiation therapy (RT) previously demonstrated safety and feasibility in cisplatin-ineligible and cetuximab-ineligible patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in a dose-escalation phase 1 study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate safety and preliminary efficacy of NBTXR3 followed by RT in patients with locally advanced HNSCC ineligible to receive concurrent systemic therapy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This single-arm, phase 1 dose-expansion nonrandomized clinical trial was conducted across 20 centers in Europe between March 4, 2019, and January 10, 2022. Patients were ineligible for cisplatin and cetuximab per investigator's judgement and had unresectable T3-4 or overall stage III/IVA HNSCC (per the American Joint Committee on Cancer Staging Manual, eighth edition) of the oral cavity or oropharynx. Data were analyzed from July to August 2023.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;Patients received a single intratumoral administration of NBTXR3 in the primary tumor at the recommended dose of 22% of estimated tumor volume (ETV) followed by RT (70 Gy over 35 fractions).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;Primary outcomes were safety and efficacy assessed by the objective response rate (ORR) of the NBTXR3-injected primary tumor. Other outcomes included ORR of all lesions (injected primary tumor and noninjected involved lymph nodes), progression-free survival, and overall survival.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 56 patients treated, the median (range) age was 72 (44-89) years, 40 (71%) were men, 34 (61%) were 70 years and older, and 36 (64%) had a substantial burden of comorbidities (age-adjusted Charlson Comorbidity Index score of 4 or greater). Median (range) follow-up was 33.0 (0.7-44.6) months. NBTXR3-related treatment-emergent adverse events occurred in 9 patients (16%), of which 6 (11%) were grade 3 or higher, the most frequent being stomatitis (2 [4%]). Objective tumor response was assessed in 44 patients, as 12 patients were unable to complete RT or did not have posttreatment tumor assessment. In this evaluable patient population, the ORR of the injected primary tumor and ORR of all lesions were 82% (95% CI, 67-92) and 80% (95% CI, 65-90), respectively. Among all 56 treated patients, the median progression-free survival was 11.4 months (95% CI, 6.7 to not reached), and the median overall survival was 18.1 months (95% CI, 9.7 to not reached).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;This dose-expansion phase 1 nonrandomized clinical trial demonstrated that intratumoral NBTXR3 followed by RT in a high-risk patient population unable to receive cisplatin or cetuximab was feasible and had a preliminary efficacy signal that supports a benefit-risk profile being evaluated in an ongoing randomized phase III trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/str","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12856740/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146085944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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JAMA otolaryngology-- head & neck surgery
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