首页 > 最新文献

Oral oncology最新文献

英文 中文
Predicting occult lymph node metastasis in level II using preoperative factors 利用术前因素预测II级隐匿淋巴结转移。
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-01-07 DOI: 10.1016/j.oraloncology.2026.107850
Chengwei Xing , Siyuan Xu , Ruiying Liu , Qiuju Wang , Jie Liu

Background

Super-selective neck dissection which declining level II and V for better neck function preservation remains controversial in the treatment of papillary thyroid carcinoma (PTC). This study aims to explore association between occult lymph node metastasis (OLNM) in level II and preoperative clinical characteristics.

Methods

This retrospective study reviewed unilateral cN1b PTC patients who underwent surgery (2000–2017), with clinical lateral neck metastasis limiting in level III and IV. The OLNM in level II was assessed with preoperative clinical characteristics using logistic regression model; its association with pathological nodes distribution was examined with restricted cubic spline; the prognosis value of level II OLNM was evaluated using Kaplan–Meier method and Cox regression model.

Results

A total of 640 patients (mean [SD] age, 41[11.3] years; 440[68.8 %] female individuals; 307[48.0 %] with OLNM in level II) were analyzed. Primary tumor size (>1.5 cm, OR, 1.625[1.174–2.252]; P = 0.003) and clinical positive lymph nodes (multiple, OR, 4.241 [2.283–8.506]; P < 0.001) are associated with elevated risk of level II OLNM. A non-linear relationship was found between level II OLNM and metastatic lymph nodes number in levels III and IV. No significant difference in all-site recurrence-free survival (RFS) or regional RFS was found between patients with or without level II OLNM, even after adjusting other potential risk factors.

Conclusion

The primary tumor size and metastatic burden in adjacent cervical compartments are associated with risk of level II OLNM, super-selective neck dissection could be considered in patients with small primary tumor cancer and low metastatic burden.
背景:在甲状腺乳头状癌(PTC)的治疗中,为了更好地保留颈部功能而降低II级和V级的超选择性颈部清扫术仍然存在争议。本研究旨在探讨II级隐匿淋巴结转移(OLNM)与术前临床特征的关系。方法:本回顾性研究回顾了2000-2017年接受手术的单侧cN1b PTC患者,临床侧颈转移仅限于III级和IV级。II级的OLNM采用logistic回归模型评估术前临床特征;用受限三次样条分析其与病理淋巴结分布的关系;采用Kaplan-Meier法和Cox回归模型评价II级OLNM的预后价值。结果:共分析640例患者(平均[SD]年龄41[11.3]岁,女性440例[68.8%],II级OLNM 307例[48.0%])。原发肿瘤大小(>1.5 cm, OR, 1.625[1.174-2.252]; P = 0.003)和临床阳性淋巴结(多个,OR, 4.241 [2.283-8.506]); P结论:相邻颈间室原发肿瘤大小和转移负担与II级OLNM发生风险相关,原发肿瘤小、转移负担低的患者可考虑超选择性颈部清扫。
{"title":"Predicting occult lymph node metastasis in level II using preoperative factors","authors":"Chengwei Xing ,&nbsp;Siyuan Xu ,&nbsp;Ruiying Liu ,&nbsp;Qiuju Wang ,&nbsp;Jie Liu","doi":"10.1016/j.oraloncology.2026.107850","DOIUrl":"10.1016/j.oraloncology.2026.107850","url":null,"abstract":"<div><h3>Background</h3><div>Super-selective neck dissection which declining level II and V for better neck function preservation remains controversial in the treatment of papillary thyroid carcinoma (PTC). This study aims to explore association between occult lymph node metastasis (OLNM) in level II and preoperative clinical characteristics.</div></div><div><h3>Methods</h3><div>This retrospective study reviewed unilateral cN1b PTC patients who underwent surgery (2000–2017), with clinical lateral neck metastasis limiting in level III and IV. The OLNM in level II was assessed with preoperative clinical characteristics using logistic regression model; its association with pathological nodes distribution was examined with restricted cubic spline; the prognosis value of level II OLNM was evaluated using Kaplan–Meier method and Cox regression model.</div></div><div><h3>Results</h3><div>A total of 640 patients (mean [SD] age, 41[11.3] years; 440[68.8 %] female individuals; 307[48.0 %] with OLNM in level II) were analyzed. Primary tumor size (&gt;1.5 cm, OR, 1.625[1.174–2.252]; P = 0.003) and clinical positive lymph nodes (multiple, OR, 4.241 [2.283–8.506]; P &lt; 0.001) are associated with elevated risk of level II OLNM. A non-linear relationship was found between level II OLNM and metastatic lymph nodes number in levels III and IV. No significant difference in all-site recurrence-free survival (RFS) or regional RFS was found between patients with or without level II OLNM, even after adjusting other potential risk factors.</div></div><div><h3>Conclusion</h3><div>The primary tumor size and metastatic burden in adjacent cervical compartments are associated with risk of level II OLNM, super-selective neck dissection could be considered in patients with small primary tumor cancer and low metastatic burden.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107850"},"PeriodicalIF":3.9,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Establishment of novel stable human sinonasal NUT carcinoma cell lines 稳定的新型人鼻窦NUT癌细胞系的建立。
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-01-03 DOI: 10.1016/j.oraloncology.2025.107828
Yoko Takahashi , Diana Bell , Arnoldo Corona , Shirely Y Su , Renata Ferrarotto , Brandon Gunn , Franco DeMonte , Shaan Raza , Ehab Y Hanna

Purpose

NUT carcinoma is a rare and aggressive malignancy defined by NUTM1 gene rearrangements, with no standard treatment approaches and limited preclinical models, especially for tumors arising in the sinonasal tract. We aimed to establish and characterize novel, stable sinonasal NUT carcinoma cell lines derived from the primary disease site to contribute to therapeutic development.

Experimental design

Tumor specimens from a sinonasal NUT carcinoma patient were cultured to establish two cell lines, MDA-NUT87 and MDA-NUT88. Cytogenetic analysis, immunohistochemistry, RT-PCR, and Sanger sequencing confirmed the presence of the BRD4::NUTM1 fusion. Sensitivity to a BET inhibitor, OTX-015, was assessed via dose–response assays. In vivo tumorigenicity was evaluated using subcutaneous xenografts in nude mice.

Results

MDA-NUT87 and MDA-NUT88 maintained stable morphology and harbored the characteristic t(15;19) translocation and BRD4::NUTM1 (exon 11: exon 2) fusion. The cells expressed nuclear NUT protein and responded to OTX-015 with IC50 values in the low nanomolar range. Tumorigenicity was observed in vivo, albeit with modest efficiency, suggesting a contributing role of the tumor microenvironment in disease progression.

Conclusions

MDA-NUT87 and MDA-NUT88 are the first stable human sinonasal NUT carcinoma cell lines established from the primary tumor site. They preserve the hallmark genetic and phenotypic characteristics of NUT carcinoma and show sensitivity to BET inhibition. These models represent valuable tools for mechanistic studies and high-throughput drug screening in sinonasal NUT carcinoma.
目的:NUT癌是一种罕见的侵袭性恶性肿瘤,由NUTM1基因重排定义,没有标准的治疗方法和有限的临床前模型,特别是发生在鼻窦的肿瘤。我们的目的是建立和表征来自原发疾病部位的新型、稳定的鼻窦NUT癌细胞系,以促进治疗发展。实验设计:培养1例鼻窦NUT癌患者肿瘤标本,建立MDA-NUT87和MDA-NUT88两个细胞系。细胞遗传学分析、免疫组织化学、RT-PCR和Sanger测序证实了BRD4::NUTM1融合的存在。通过剂量-反应试验评估对BET抑制剂OTX-015的敏感性。用裸鼠皮下异种移植物评估体内致瘤性。结果:MDA-NUT87和MDA-NUT88形态保持稳定,具有t(15;19)易位和BRD4::NUTM1(外显子11:外显子2)融合的特征。细胞表达核NUT蛋白,对OTX-015有反应,IC50值在低纳摩尔范围内。在体内观察到致瘤性,尽管效率不高,但表明肿瘤微环境在疾病进展中起着重要作用。结论:MDA-NUT87和MDA-NUT88是第一个从原发肿瘤部位建立的稳定的人鼻窦NUT癌细胞系。它们保留了NUT癌的标志性遗传和表型特征,并表现出对BET抑制的敏感性。这些模型为鼻窦NUT癌的机制研究和高通量药物筛选提供了有价值的工具。
{"title":"Establishment of novel stable human sinonasal NUT carcinoma cell lines","authors":"Yoko Takahashi ,&nbsp;Diana Bell ,&nbsp;Arnoldo Corona ,&nbsp;Shirely Y Su ,&nbsp;Renata Ferrarotto ,&nbsp;Brandon Gunn ,&nbsp;Franco DeMonte ,&nbsp;Shaan Raza ,&nbsp;Ehab Y Hanna","doi":"10.1016/j.oraloncology.2025.107828","DOIUrl":"10.1016/j.oraloncology.2025.107828","url":null,"abstract":"<div><h3>Purpose</h3><div>NUT carcinoma is a rare and aggressive malignancy defined by <em>NUTM1</em> gene rearrangements, with no standard treatment approaches and limited preclinical models, especially for tumors arising in the sinonasal tract. We aimed to establish and characterize novel, stable sinonasal NUT carcinoma cell lines derived from the primary disease site to contribute to therapeutic development.</div></div><div><h3>Experimental design</h3><div>Tumor specimens from a sinonasal NUT carcinoma patient were cultured to establish two cell lines, MDA-NUT87 and MDA-NUT88. Cytogenetic analysis, immunohistochemistry, RT-PCR, and Sanger sequencing confirmed the presence of the <em>BRD4::NUTM1</em> fusion. Sensitivity to a BET inhibitor, OTX-015, was assessed via dose–response assays. In vivo tumorigenicity was evaluated using subcutaneous xenografts in nude mice.</div></div><div><h3>Results</h3><div>MDA-NUT87 and MDA-NUT88 maintained stable morphology and harbored the characteristic t(15;19) translocation and <em>BRD4::NUTM1</em> (exon 11: exon 2) fusion. The cells expressed nuclear NUT protein and responded to OTX-015 with IC<sub>50</sub> values in the low nanomolar range. Tumorigenicity was observed in vivo, albeit with modest efficiency, suggesting a contributing role of the tumor microenvironment in disease progression.</div></div><div><h3>Conclusions</h3><div>MDA-NUT87 and MDA-NUT88 are the first stable human sinonasal NUT carcinoma cell lines established from the primary tumor site. They preserve the hallmark genetic and phenotypic characteristics of NUT carcinoma and show sensitivity to BET inhibition. These models represent valuable tools for mechanistic studies and high-throughput drug screening in sinonasal NUT carcinoma.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107828"},"PeriodicalIF":3.9,"publicationDate":"2026-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145900772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Harnessing TP53 mutational status to enhance prognostic precision and therapeutic effectiveness in head and neck squamous cell carcinoma 利用TP53突变状态提高头颈部鳞状细胞癌的预后准确性和治疗效果
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-01-02 DOI: 10.1016/j.oraloncology.2025.107846
Angeliki Margoni , Kostas A. Papavassiliou , Athanasios G. Papavassiliou
{"title":"Harnessing TP53 mutational status to enhance prognostic precision and therapeutic effectiveness in head and neck squamous cell carcinoma","authors":"Angeliki Margoni ,&nbsp;Kostas A. Papavassiliou ,&nbsp;Athanasios G. Papavassiliou","doi":"10.1016/j.oraloncology.2025.107846","DOIUrl":"10.1016/j.oraloncology.2025.107846","url":null,"abstract":"","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107846"},"PeriodicalIF":3.9,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145885900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Positron emission tomography-based intratumoral spatial diversity for prognosis in nasopharyngeal carcinoma 基于正电子发射层析成像的肿瘤内空间多样性对鼻咽癌预后的影响
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-01-01 DOI: 10.1016/j.oraloncology.2025.107845
Shuxian Niu , Jianming Ding , Hanshen Chen , Zeyu Zhu , Xiyi Liao , Huiling Hong , Chuanben Chen , Jiyang Dong , Zhaodong Fei

Background

This study aimed to develop a radiomics-based framework for quantifying intratumoral heterogeneity (ITH) in nasopharyngeal carcinoma (NPC) using three-dimensional tumor subregions. The goal was to enhance conventional clinical risk stratification and investigate the biological basis of ITH.

Methods

This multicenter retrospective study included PET scans from 760 treatment-naïve NPC patients. Radiomics features were extracted from the whole tumor (WT), and the intratumoral spatial diversity score (ITSDS) was simultaneously quantified through subregion analysis. After a multi-step feature selection process, both WT and ITH models were developed. Finally, a nomogram was constructed by integrating ITSDS with clinical factors. All models were evaluated using the C-index, AUC, and calibration curves, and their performance was interpreted using SHAP. Additionally, the biological characteristics of the ITH model were analyzed using tissue proteomics.

Results

The training, internal validation, and external validation cohorts included 480, 235, and 45 patients, respectively. The ITH model showed superior C-indexes of 0.852, 0.792, and 0.757 compared to the clinical and WT models. The nomogram demonstrated the best prognostic value, with C-indexes of 0.864, 0.817, and 0.772 in the three cohorts, respectively. The nomogram effectively classified patients into risk groups for progression-free survival (P < 0.01). Tissue proteomic analysis revealed upregulated ciliary movement, a more complex tumor microenvironment, and impaired immune function in the high-ITH group.

Conclusion

The nomogram integrating ITSDS biomarkers with clinical factors improved risk stratification accuracy and created a clinically translatable framework for NPC. This approach potentially offers mechanistic insights into ITH and holds promise for advancing precision oncology.
本研究旨在建立一个基于放射组学的框架,利用三维肿瘤亚区来量化鼻咽癌(NPC)的肿瘤内异质性(ITH)。目的是加强常规临床风险分层和探讨ITH的生物学基础。方法本多中心回顾性研究包括760例treatment-naïve NPC患者的PET扫描。从整个肿瘤(WT)中提取放射组学特征,并通过分区域分析同时量化肿瘤内空间多样性评分(ITSDS)。经过多步特征选择过程,开发了WT和ITH模型。最后,将ITSDS与临床因素相结合,构建nomogram。使用c指数、AUC和校准曲线对所有模型进行评估,并使用SHAP对其性能进行解释。此外,利用组织蛋白质组学分析ITH模型的生物学特性。结果培训队列、内部验证队列和外部验证队列分别包括480例、235例和45例患者。与临床模型和WT模型相比,ITH模型的c指数分别为0.852、0.792和0.757。nomogram显示了最佳的预后价值,3个队列的c指数分别为0.864、0.817和0.772。nomogram无进展生存图(P < 0.01)有效地将患者分为危险组。组织蛋白质组学分析显示,高ith组纤毛运动上调,肿瘤微环境更复杂,免疫功能受损。结论结合ITSDS生物标志物与临床因素的nomogram风险分层方法提高了风险分层的准确性,为鼻咽癌的临床诊断提供了一个可翻译的框架。这种方法为ITH提供了潜在的机制见解,并有望推进精准肿瘤学。
{"title":"Positron emission tomography-based intratumoral spatial diversity for prognosis in nasopharyngeal carcinoma","authors":"Shuxian Niu ,&nbsp;Jianming Ding ,&nbsp;Hanshen Chen ,&nbsp;Zeyu Zhu ,&nbsp;Xiyi Liao ,&nbsp;Huiling Hong ,&nbsp;Chuanben Chen ,&nbsp;Jiyang Dong ,&nbsp;Zhaodong Fei","doi":"10.1016/j.oraloncology.2025.107845","DOIUrl":"10.1016/j.oraloncology.2025.107845","url":null,"abstract":"<div><h3>Background</h3><div>This study aimed to develop a radiomics-based framework for quantifying intratumoral heterogeneity (ITH) in nasopharyngeal carcinoma (NPC) using three-dimensional tumor subregions. The goal was to enhance conventional clinical risk stratification and investigate the biological basis of ITH.</div></div><div><h3>Methods</h3><div>This multicenter retrospective study included PET scans from 760 treatment-naïve NPC patients. Radiomics features were extracted from the whole tumor (WT), and the intratumoral spatial diversity score (ITSDS) was simultaneously quantified through subregion analysis. After a multi-step feature selection process, both WT and ITH models were developed. Finally, a nomogram was constructed by integrating ITSDS with clinical factors. All models were evaluated using the C-index, AUC, and calibration curves, and their performance was interpreted using SHAP. Additionally, the biological characteristics of the ITH model were analyzed using tissue proteomics.</div></div><div><h3>Results</h3><div>The training, internal validation, and external validation cohorts included 480, 235, and 45 patients, respectively. The ITH model showed superior C-indexes of 0.852, 0.792, and 0.757 compared to the clinical and WT models. The nomogram demonstrated the best prognostic value, with C-indexes of 0.864, 0.817, and 0.772 in the three cohorts, respectively. The nomogram effectively classified patients into risk groups for progression-free survival (P &lt; 0.01). Tissue proteomic analysis revealed upregulated ciliary movement, a more complex tumor microenvironment, and impaired immune function in the high-ITH group.</div></div><div><h3>Conclusion</h3><div>The nomogram integrating ITSDS biomarkers with clinical factors improved risk stratification accuracy and created a clinically translatable framework for NPC. This approach potentially offers mechanistic insights into ITH and holds promise for advancing precision oncology.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107845"},"PeriodicalIF":3.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145885904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Development and validation of a risk nomogram for predicting central lymph node metastasis in papillary thyroid microcarcinoma 预测甲状腺乳头状微癌中央淋巴结转移的风险图的建立和验证
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2025-12-31 DOI: 10.1016/j.oraloncology.2025.107842
Weidong Zhang, Xianjiang Wu, Yingchun Wang, Qi Le, Yue Xie, Kejie Yu

Background

The global incidence of papillary thyroid microcarcinoma (PTMC) continues to rise, and the optimal management strategy remains controversial due to its generally favorable prognosis. Central lymph node metastasis (CLNM) is an important predictor of recurrence and survival and therefore plays a critical role in guiding therapeutic decision-making. This study aimed to develop and validate a nomogram to preoperatively predict the risk of CLNM in PTMC patients.

Methods

Patients from ward A (n = 877) were assigned to the training cohort, and those from ward B (n = 637) formed the validation cohort. Clinical characteristics and ultrasonographic variables were evaluated. Univariate and multivariate logistic regression analyses were performed to identify independent predictors of CLNM, which were subsequently incorporated into a predictive nomogram. Model performance was assessed using receiver operating characteristic (ROC) analysis, calibration curves, and decision curve analysis (DCA).

Results

Univariate analysis identified gender, age, maximum tumor diameter (MTD), multifocality, calcification and capsule status as significantly associated with CLNM (P < 0.05). Multivariate logistic regression analysis revealed gender, age, MTD, multifocality, and capsule status as independent predictors. The nomogram demonstrated good discriminative ability, with an area under the curve (AUC) of 0.724 in the training cohort and 0.708 in the validation cohort. Calibration curves showed excellent agreement between predicted and observed outcomes, and DCA confirmed favorable clinical utility.

Conclusion

We successfully developed and validated a clinically applicable nomogram that integrates preoperative clinical and ultrasonographic features to predict CLNM in PTMC patients. This model may assist clinicians in tailoring surgical strategies and optimizing individualized management.
背景:甲状腺乳头状微癌(PTMC)的全球发病率持续上升,由于其普遍预后良好,最佳治疗策略仍存在争议。中央淋巴结转移(CLNM)是复发和生存的重要预测因素,因此在指导治疗决策中起着关键作用。本研究旨在开发和验证一种nomogram方法,用于术前预测PTMC患者发生CLNM的风险。方法将A病区877例患者纳入训练队列,B病区637例患者纳入验证队列。评估临床特征和超声指标。进行单变量和多变量逻辑回归分析以确定CLNM的独立预测因子,随后将其纳入预测nomogram。采用受试者工作特征(ROC)分析、校准曲线和决策曲线分析(DCA)评估模型的性能。结果单因素分析发现,性别、年龄、最大肿瘤直径(MTD)、多灶性、钙化和被囊状态与CLNM显著相关(P < 0.05)。多因素logistic回归分析显示,性别、年龄、MTD、多病灶和胶囊状态是独立的预测因素。nomogram具有较好的判别能力,训练组和验证组的曲线下面积(AUC)分别为0.724和0.708。校准曲线显示预测结果和观察结果非常吻合,DCA证实了良好的临床应用。结论我们成功开发并验证了一种临床适用的nomogram,该nomogram结合了术前临床和超声特征来预测PTMC患者的CLNM。该模型可以帮助临床医生定制手术策略和优化个性化管理。
{"title":"Development and validation of a risk nomogram for predicting central lymph node metastasis in papillary thyroid microcarcinoma","authors":"Weidong Zhang,&nbsp;Xianjiang Wu,&nbsp;Yingchun Wang,&nbsp;Qi Le,&nbsp;Yue Xie,&nbsp;Kejie Yu","doi":"10.1016/j.oraloncology.2025.107842","DOIUrl":"10.1016/j.oraloncology.2025.107842","url":null,"abstract":"<div><h3>Background</h3><div>The global incidence of papillary thyroid microcarcinoma (PTMC) continues to rise, and the optimal management strategy remains controversial due to its generally favorable prognosis. Central lymph node metastasis (CLNM) is an important predictor of recurrence and survival and therefore plays a critical role in guiding therapeutic decision-making. This study aimed to develop and validate a nomogram to preoperatively predict the risk of CLNM in PTMC patients.</div></div><div><h3>Methods</h3><div>Patients from ward A (n = 877) were assigned to the training cohort, and those from ward B (n = 637) formed the validation cohort. Clinical characteristics and ultrasonographic variables were evaluated. Univariate and multivariate logistic regression analyses were performed to identify independent predictors of CLNM, which were subsequently incorporated into a predictive nomogram. Model performance was assessed using receiver operating characteristic (ROC) analysis, calibration curves, and decision curve analysis (DCA).</div></div><div><h3>Results</h3><div>Univariate analysis identified gender, age, maximum tumor diameter (MTD), multifocality, calcification and capsule status as significantly associated with CLNM (P &lt; 0.05). Multivariate logistic regression analysis revealed gender, age, MTD, multifocality, and capsule status as independent predictors. The nomogram demonstrated good discriminative ability, with an area under the curve (AUC) of 0.724 in the training cohort and 0.708 in the validation cohort. Calibration curves showed excellent agreement between predicted and observed outcomes, and DCA confirmed favorable clinical utility.</div></div><div><h3>Conclusion</h3><div>We successfully developed and validated a clinically applicable nomogram that integrates preoperative clinical and ultrasonographic features to predict CLNM in PTMC patients. This model may assist clinicians in tailoring surgical strategies and optimizing individualized management.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107842"},"PeriodicalIF":3.9,"publicationDate":"2025-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145885899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Exercise and quality of life in head and neck squamous cell carcinoma patients receiving neoadjuvant immuno-chemotherapy: A randomized, open-labeled phase II trial 接受新辅助免疫化疗的头颈部鳞状细胞癌患者的运动和生活质量:一项随机、开放标记的II期试验
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2025-12-31 DOI: 10.1016/j.oraloncology.2025.107844
Guoming Xiao , Li Ning , Lihui Chen , Shu Zhang , Yingle Chen , Yanfeng Chen

Background

Head and neck squamous cell carcinoma (HNSCC) significantly impairs patients’ quality of life (QoL). While neoadjuvant immuno-chemotherapy offers potential survival benefits, it is associated with substantial treatment-related toxicities, including fatigue, sleep disturbances, and functional decline. Exercise therapy has shown promise in improving QoL in other cancers, but its role in HNSCC patients receiving neoadjuvant therapy remains underexplored.

Methods

This single-center, open-label, randomized phase II trial enrolled 114 HNSCC patients undergoing neoadjuvant immuno-chemotherapy. Participants were randomized 1:1 to an exercise group (personalized breathing and aerobic exercise program) or a control group (routine care). Outcomes were assessed using the BFI-C, EORTC QLQ-C30, QLQ-H&N35, and PSQI at baseline, after 2 cycles, and after 3 cycles of therapy.

Results

The exercise group demonstrated significantly lower fatigue scores (BFI) after 2 and 3 cycles compared to controls (P < 0.05). Sleep quality (PSQI) improved significantly in the exercise group and worsened in the control group. The exercise group also showed better outcomes in physical functioning, fatigue and insomnia.

Conclusion

Exercise therapy is feasible and effective in reducing fatigue and improving sleep quality in HNSCC patients receiving neoadjuvant immuno-chemotherapy. Early integration of exercise may mitigate treatment-related symptoms and improve tolerance and overall QoL.
背景头颈部鳞状细胞癌(HNSCC)显著降低患者的生活质量(QoL)。虽然新辅助免疫化疗提供了潜在的生存益处,但它与大量治疗相关的毒性相关,包括疲劳、睡眠障碍和功能下降。运动疗法已显示出改善其他癌症患者生活质量的希望,但其在接受新辅助治疗的HNSCC患者中的作用仍未得到充分探讨。方法:该单中心、开放标签、随机II期试验纳入114例接受新辅助免疫化疗的HNSCC患者。参与者按1:1随机分为运动组(个性化呼吸和有氧运动计划)或对照组(常规护理)。采用基线时、治疗2个周期后和治疗3个周期后的BFI-C、EORTC QLQ-C30、qlq - hn35和PSQI进行结果评估。结果运动组在2、3个周期后的疲劳评分(BFI)明显低于对照组(P < 0.05)。睡眠质量(PSQI)在运动组显著改善,而在对照组恶化。锻炼组在身体机能、疲劳和失眠方面也表现出更好的结果。结论运动疗法对HNSCC新辅助免疫化疗患者减轻疲劳、改善睡眠质量是可行和有效的。早期整合运动可以减轻治疗相关症状,提高耐受性和总体生活质量。
{"title":"Exercise and quality of life in head and neck squamous cell carcinoma patients receiving neoadjuvant immuno-chemotherapy: A randomized, open-labeled phase II trial","authors":"Guoming Xiao ,&nbsp;Li Ning ,&nbsp;Lihui Chen ,&nbsp;Shu Zhang ,&nbsp;Yingle Chen ,&nbsp;Yanfeng Chen","doi":"10.1016/j.oraloncology.2025.107844","DOIUrl":"10.1016/j.oraloncology.2025.107844","url":null,"abstract":"<div><h3>Background</h3><div>Head and neck squamous cell carcinoma (HNSCC) significantly impairs patients’ quality of life (QoL). While neoadjuvant immuno-chemotherapy offers potential survival benefits, it is associated with substantial treatment-related toxicities, including fatigue, sleep disturbances, and functional decline. Exercise therapy has shown promise in improving QoL in other cancers, but its role in HNSCC patients receiving neoadjuvant therapy remains underexplored.</div></div><div><h3>Methods</h3><div>This single-center, open-label, randomized phase II trial enrolled 114 HNSCC patients undergoing neoadjuvant immuno-chemotherapy. Participants were randomized 1:1 to an exercise group (personalized breathing and aerobic exercise program) or a control group (routine care). Outcomes were assessed using the BFI-C, EORTC QLQ-C30, QLQ-H&amp;N35, and PSQI at baseline, after 2 cycles, and after 3 cycles of therapy.</div></div><div><h3>Results</h3><div>The exercise group demonstrated significantly lower fatigue scores (BFI) after 2 and 3 cycles compared to controls (P &lt; 0.05). Sleep quality (PSQI) improved significantly in the exercise group and worsened in the control group. The exercise group also showed better outcomes in physical functioning, fatigue and insomnia.</div></div><div><h3>Conclusion</h3><div>Exercise therapy is feasible and effective in reducing fatigue and improving sleep quality in HNSCC patients receiving neoadjuvant immuno-chemotherapy. Early integration of exercise may mitigate treatment-related symptoms and improve tolerance and overall QoL.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107844"},"PeriodicalIF":3.9,"publicationDate":"2025-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145885901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Head and neck cancer trends in Denmark: A nationwide, 40-Year data analysis 丹麦头颈癌趋势:全国40年数据分析
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2025-12-30 DOI: 10.1016/j.oraloncology.2025.107843
Kathrine K. Jakobsen , Jacob H. Rasmussen , Jacob Melchiors , Tina K. Agander , Christian von Buchwald , Christian Grønhøj

Background and purpose

Head and neck cancers (HNCs) encompass various malignancies with variation in anatomical site, histology, and survival outcomes. This study aims to describe HNC incidence and survival trends in Denmark from 1980 to 2021.

Patients/material and methods

This retrospective, cohort study used data from the Danish Cancer Registry and the Central Population Register to include all HNC cases in the upper aerodigestive tract from 1980 to 2021. Incidence rates were age-adjusted and survival analyzed as relative survival rates compared to the general population. Average Annual Percent Change (AAPC) in incidence was calculated using linear regression models.

Results

A total of 36,626 HNC cases were included. The age-adjusted incidence rate (AAIR) increased significantly from 7.1 in 1980 to 12.5 per 100,000 in 2021. From 2015 to 2021, oropharyngeal cancer was the most common HNC. Further, oropharyngeal cancer demonstrated the highest 5-year relative survival of 70.1 % [95 % CI: 67.9–72.4]. Hypopharyngeal cancer had the lowest survival (26.8 % [95 % CI: 25.1 to 28.7]). Overall, the 5-year relative survival improved during the study period from 46.9 % [95 % CI: 44.7–49.2] in 1980–1984 to 65.2 % [95 % CI: 63.8 to 66.6] in 2015–2019.

Interpretation

Our study showed a continued increase in incidence for HNC alongside an improvement in survival. The survival varied notably across different tumor subsite. Continued research is essential to address these variations and improve outcomes across cancer subsites. Exploring opportunities for treatment de-escalation to mitigate the toxicity associated with current therapies is essential to optimizing long-term quality of life for survivors.
背景和目的:头颈癌(HNCs)包括各种不同的恶性肿瘤,在解剖部位、组织学和生存结果上都有差异。本研究旨在描述1980年至2021年丹麦HNC发病率和生存趋势。患者/材料和方法:这项回顾性队列研究使用了丹麦癌症登记处和中央人口登记处的数据,包括1980年至2021年期间所有上气消化道HNC病例。对发病率进行年龄调整,并将生存率作为与一般人群相比的相对生存率进行分析。采用线性回归模型计算发病率的年均百分率变化(AAPC)。结果:共纳入HNC病例36626例。年龄调整后的发病率(AAIR)从1980年的7.1 / 10万显著增加到2021年的12.5 / 10万。2015 - 2021年,口咽癌是最常见的HNC。此外,口咽癌的5年相对生存率最高,为70.1% [95% CI: 67.9-72.4]。下咽癌的生存率最低(26.8% [95% CI: 25.1 ~ 28.7])。总体而言,研究期间的5年相对生存率从1980-1984年的46.9% [95% CI: 44.7-49.2]提高到2015-2019年的65.2% [95% CI: 63.8 - 66.6]。解释:我们的研究显示,HNC的发病率在持续增加的同时,生存率也在提高。不同肿瘤亚区生存率差异显著。持续的研究对于解决这些差异和改善癌症亚位点的结果至关重要。探索治疗降级的机会,以减轻与当前治疗相关的毒性,对于优化幸存者的长期生活质量至关重要。
{"title":"Head and neck cancer trends in Denmark: A nationwide, 40-Year data analysis","authors":"Kathrine K. Jakobsen ,&nbsp;Jacob H. Rasmussen ,&nbsp;Jacob Melchiors ,&nbsp;Tina K. Agander ,&nbsp;Christian von Buchwald ,&nbsp;Christian Grønhøj","doi":"10.1016/j.oraloncology.2025.107843","DOIUrl":"10.1016/j.oraloncology.2025.107843","url":null,"abstract":"<div><h3>Background and purpose</h3><div>Head and neck cancers (HNCs) encompass various malignancies with variation in anatomical site, histology, and survival outcomes. This study aims to describe HNC incidence and survival trends in Denmark from 1980 to 2021.</div></div><div><h3>Patients/material and methods</h3><div>This retrospective, cohort study used data from the Danish Cancer Registry and the Central Population Register to include all HNC cases in the upper aerodigestive tract from 1980 to 2021. Incidence rates were age-adjusted and survival analyzed as relative survival rates compared to the general population. Average Annual Percent Change (AAPC) in incidence was calculated using linear regression models.</div></div><div><h3>Results</h3><div>A total of 36,626 HNC cases were included. The age-adjusted incidence rate (AAIR) increased significantly from 7.1 in 1980 to 12.5 per 100,000 in 2021. From 2015 to 2021, oropharyngeal cancer was the most common HNC. Further, oropharyngeal cancer demonstrated the highest 5-year relative survival of 70.1 % [95 % CI: 67.9–72.4]. Hypopharyngeal cancer had the lowest survival (26.8 % [95 % CI: 25.1 to 28.7]). Overall, the 5-year relative survival improved during the study period from 46.9 % [95 % CI: 44.7–49.2] in 1980–1984 to 65.2 % [95 % CI: 63.8 to 66.6] in 2015–2019.</div></div><div><h3>Interpretation</h3><div>Our study showed a continued increase in incidence for HNC alongside an improvement in survival. The survival varied notably across different tumor subsite. Continued research is essential to address these variations and improve outcomes across cancer subsites. Exploring opportunities for treatment de-escalation to mitigate the toxicity associated with current therapies is essential to optimizing long-term quality of life for survivors.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107843"},"PeriodicalIF":3.9,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145878732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Prevalence, risk Factors, and quality of life in patients with head and neck lymphedema following treatment for head and neck Cancer: The HeNLy-1 study 头颈癌治疗后头颈淋巴水肿患者的患病率、危险因素和生活质量:HeNLy-1研究
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2025-12-27 DOI: 10.1016/j.oraloncology.2025.107838
Shivakumar Thiagarajan , T Rukmangathan , Drub Sharma , Aniket Kakade , Arun Balaji , Marri Rebeka , Vanita Noronha , Kumar Prabhash , Sarbani Ghosh-Laskar , Gouri Pantvaidya

Background

Patients treated for head & neck cancer (HNC) are at risk of developing head and neck lymphedema (HNL) that may impact their functions and quality of life (QoL). This study aimed to assess the prevalence of HNL, its risk factors, and evaluate its impact on QoL.

Methods

In this observational (cross-sectional) study, we included adult HNC patients who had completed definitive treatment at least 6 months prior and who had received some part of their treatment at our institute. The external lymphedema was rated using the MD Anderson Cancer Centre (MDACC) HNL rating system, and internal lymphedema using Patterson’s scale. Health-related QoL was assessed using the University of Washington quality of life questionnaire.

Results

A total of 421 were enrolled, with a median duration post-treatment of 19 months. HNL was present in 190 patients (45.1 %), either internal or external lymphedema or both. Most of them had stage 1a HNL. Factors that predisposed to the development of HNL were age (>47 years) [p = 0.002, 1.993(1.279–2.935)], tobacco use [p = 0.025, 1.864(1.081–3.214)], and the type of treatment received, especially those who received definitive chemoradiotherapy [p < 0.001,9.750(4.063–23.395)]. Patients with HNL, especially internal lymphedema, reported significantly more QoL impairments, particularly related to swallowing, chewing, xerostomia, taste and mood.

Conclusion

HNL was present in 45.1% of the patients in our cohort, predominantly stage 1a. Age, tobacco use, and treatment received predisposed the patient to develop HNL. Patients with internal lymphedema particularly had swallowing-related QoL issues.
背景头颈癌(HNC)患者有发生头颈淋巴水肿(HNL)的风险,这可能影响他们的功能和生活质量(QoL)。本研究旨在评估HNL的患病率,其危险因素,并评估其对生活质量的影响。方法在这项观察性(横断面)研究中,我们纳入了至少6个月前完成最终治疗并在我们研究所接受部分治疗的成年HNC患者。外部淋巴水肿使用MD安德森癌症中心(MDACC) HNL评分系统进行评分,内部淋巴水肿使用帕特森量表。使用华盛顿大学生活质量问卷评估与健康相关的生活质量。结果共纳入421例,治疗后中位持续时间为19个月。190例(45.1%)患者存在HNL,内部或外部淋巴水肿或两者兼而有之。他们大多数是1a期HNL。易患HNL的因素为年龄(47岁)[p = 0.002, 1.993(1.277 ~ 2.935)]、吸烟情况[p = 0.025, 1.864(1.081 ~ 3.214)]、治疗方式,特别是明确接受放化疗的患者[p <; 0.001,9.750(4.063 ~ 23.395)]。HNL患者,特别是内淋巴水肿患者,报告的生活质量受损明显更多,特别是与吞咽、咀嚼、口干、味觉和情绪有关。结论在我们的队列中,45.1%的患者存在hnl,主要是1a期。年龄、吸烟和接受的治疗使患者易患HNL。患有内淋巴水肿的患者尤其存在吞咽相关的生活质量问题。
{"title":"Prevalence, risk Factors, and quality of life in patients with head and neck lymphedema following treatment for head and neck Cancer: The HeNLy-1 study","authors":"Shivakumar Thiagarajan ,&nbsp;T Rukmangathan ,&nbsp;Drub Sharma ,&nbsp;Aniket Kakade ,&nbsp;Arun Balaji ,&nbsp;Marri Rebeka ,&nbsp;Vanita Noronha ,&nbsp;Kumar Prabhash ,&nbsp;Sarbani Ghosh-Laskar ,&nbsp;Gouri Pantvaidya","doi":"10.1016/j.oraloncology.2025.107838","DOIUrl":"10.1016/j.oraloncology.2025.107838","url":null,"abstract":"<div><h3>Background</h3><div>Patients treated for head &amp; neck cancer (HNC) are at risk of developing head and neck lymphedema (HNL) that may impact their functions and quality of life (QoL). This study aimed to assess the prevalence of HNL, its risk factors, and evaluate its impact on QoL.</div></div><div><h3>Methods</h3><div>In this observational (cross-sectional) study, we included adult HNC patients who had completed definitive treatment at least 6 months prior and who had received some part of their treatment at our institute. The external lymphedema was rated using the MD Anderson Cancer Centre (MDACC) HNL rating system, and internal lymphedema using Patterson’s scale. Health-related QoL was assessed using the University of Washington quality of life questionnaire.</div></div><div><h3>Results</h3><div>A total of 421 were enrolled, with a median duration post-treatment of 19 months. HNL was present in 190 patients (45.1 %), either internal or external lymphedema or both. Most of them had stage 1a HNL. Factors that predisposed to the development of HNL were age (&gt;47 years) [p = 0.002, 1.993(1.279–2.935)], tobacco use [p = 0.025, 1.864(1.081–3.214)], and the type of treatment received, especially those who received definitive chemoradiotherapy [p &lt; 0.001,9.750(4.063–23.395)]. Patients with HNL, especially internal lymphedema, reported significantly more QoL impairments, particularly related to swallowing, chewing, xerostomia, taste and mood.</div></div><div><h3>Conclusion</h3><div>HNL was present in 45.1% of the patients in our cohort, predominantly stage 1a. Age, tobacco use, and treatment received predisposed the patient to develop HNL. Patients with internal lymphedema particularly had swallowing-related QoL issues.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107838"},"PeriodicalIF":3.9,"publicationDate":"2025-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145842678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Safety reporting in head and neck squamous cell carcinoma clinical Trials: A comparative analysis of ClinicalTrials.gov data and published research 头颈部鳞状细胞癌临床试验的安全性报告:ClinicalTrials.gov数据和已发表研究的比较分析
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2025-12-26 DOI: 10.1016/j.oraloncology.2025.107840
Mahad Chaudhry , Annes Elfar , Kaylyn Rowsey , Andrew Neel , Adam Khan , Ty Lutze , David Wenger , Matt Vassar

Introduction

Head and Neck Squamous Cell Carcinoma (HNSCC) is a debilitating malignancy that requires a multimodal approach in treatment, which is associated with a considerable burden of adverse events (AE). Since the 2007 FDA Amendments Act (FDAAA 801) mandates comprehensive AE reporting on ClinicalTrials.gov, the consistency of these data with corresponding peer‑reviewed publications remains unclear. This study examines the consistency of AE reporting between ClinicalTrials.gov and peer-reviewed publications for HNSCC randomized clinical trials (RCTs) conducted post-FDAAA implementation.

Materials and Methods

We retrospectively analyzed AE reporting on Phase II-IV HNSCC RCTs registered on clinicaltrials.gov between September 27, 2009, and January 15, 2025. Data was extracted on participant counts and total events for serious adverse events (SAEs), other adverse events (OAEs), all-cause mortality (ACM), and treatment discontinuation. Discrepancies were defined as any mismatch in counts or reporting. Chi-square and Mann-Whitney U tests assessed differences in reporting frequencies and publication delays between trial and publication data.

Results

Overall, 60 trials met inclusion criteria. All 60/60 (100 %) trials reported participants affected by SAEs versus 43/60 (71.7 %) publications (p < 0.05), of which 33/43 (76.7 %) showed discrepant counts. Likewise, 60/60 (100 %) trials versus 22/60 (36.7 %) publications reported participants affected by OAEs (p < 0.05), with 18/22 (81.8 %) mismatches. Among 24/24 (100 %) trials completed post‑2017, ACM was reported on ClinicalTrials.gov versus 15/24 (62.5 %) publications, and 22/24 (91.7 %) of those pairs differed. Participant discontinuations due to AEs appeared in 17/60 (28.3 %) registries versus 39/60 (65.0 %) publications (p < 0.05); of the 15/17 (88.2 %) with both sources reporting, 9/15 (60.0 %) had discordant counts.

Conclusion

Substantial inconsistencies in AE, mortality, and discontinuation reporting persist between ClinicalTrials.gov and peer‑reviewed publications of HNSCC RCTs. To uphold transparency and patient safety, enhanced technical safeguards on registry platforms and stricter journal policies, such as mandatory discrepancy checklists, are urgently needed.
头颈部鳞状细胞癌(HNSCC)是一种使人衰弱的恶性肿瘤,需要多模式的治疗方法,这与相当大的不良事件(AE)负担有关。由于2007年FDA修订法案(FDAAA 801)要求在ClinicalTrials.gov上发布全面的AE报告,这些数据与相应的同行评审出版物的一致性仍然不清楚。本研究检验了在fdaaa实施后进行的HNSCC随机临床试验(rct)中,ClinicalTrials.gov和同行评审出版物之间AE报告的一致性。材料和方法我们回顾性分析2009年9月27日至2025年1月15日在clinicaltrials.gov上注册的II-IV期HNSCC随机对照试验的AE报告。提取了参与者数量和严重不良事件(sae)、其他不良事件(oae)、全因死亡率(ACM)和停止治疗的总事件的数据。差异被定义为计数或报告中的任何不匹配。卡方检验和Mann-Whitney U检验评估了试验和发表数据之间报告频率和发表延迟的差异。结果总共有60项试验符合纳入标准。所有60/60(100%)的试验报告了受试者受SAEs影响,而43/60(71.7%)的出版物(p < 0.05),其中33/43(76.7%)显示计数差异。同样,60/60(100%)的试验和22/60(36.7%)的出版物报告参与者受到oae的影响(p < 0.05),其中18/22(81.8%)不匹配。在2017年后完成的24/24(100%)项试验中,ACM在ClinicalTrials.gov上发表,而15/24(62.5%)项发表,其中22/24(91.7%)对不同。17/60(28.3%)的研究报告中出现了因不良事件导致的受试者终止研究,而39/60(65.0%)的研究报告中出现了因不良事件导致的受试者终止研究(p < 0.05);在有两个来源报告的15/17例(88.2%)中,9/15例(60.0%)计数不一致。结论:在临床试验网站和同行评审的HNSCC随机对照试验出版物之间,AE、死亡率和停药报告存在实质性的不一致。为了维护透明度和患者安全,迫切需要加强注册平台的技术保障和更严格的期刊政策,例如强制性差异核对表。
{"title":"Safety reporting in head and neck squamous cell carcinoma clinical Trials: A comparative analysis of ClinicalTrials.gov data and published research","authors":"Mahad Chaudhry ,&nbsp;Annes Elfar ,&nbsp;Kaylyn Rowsey ,&nbsp;Andrew Neel ,&nbsp;Adam Khan ,&nbsp;Ty Lutze ,&nbsp;David Wenger ,&nbsp;Matt Vassar","doi":"10.1016/j.oraloncology.2025.107840","DOIUrl":"10.1016/j.oraloncology.2025.107840","url":null,"abstract":"<div><h3>Introduction</h3><div>Head and Neck Squamous Cell Carcinoma (HNSCC) is a debilitating malignancy that requires a multimodal approach in treatment, which is associated with a considerable burden of adverse events (AE). Since the 2007 FDA Amendments Act (FDAAA 801) mandates comprehensive AE reporting on ClinicalTrials.gov, the consistency of these data with corresponding peer‑reviewed publications remains unclear. This study examines the consistency of AE reporting between ClinicalTrials.gov and peer-reviewed publications for HNSCC randomized clinical trials (RCTs) conducted post-FDAAA implementation.</div></div><div><h3>Materials and Methods</h3><div>We retrospectively analyzed AE reporting on Phase II-IV HNSCC RCTs registered on clinicaltrials.gov between September 27, 2009, and January 15, 2025. Data was extracted on participant counts and total events for serious adverse events (SAEs), other adverse events (OAEs), all-cause mortality (ACM), and treatment discontinuation. Discrepancies were defined as any mismatch in counts or reporting. Chi-square and Mann-Whitney U tests assessed differences in reporting frequencies and publication delays between trial and publication data.</div></div><div><h3>Results</h3><div>Overall, 60 trials met inclusion criteria. All 60/60 (100 %) trials reported participants affected by SAEs versus 43/60 (71.7 %) publications (p &lt; 0.05), of which 33/43 (76.7 %) showed discrepant counts. Likewise, 60/60 (100 %) trials versus 22/60 (36.7 %) publications reported participants affected by OAEs (p &lt; 0.05), with 18/22 (81.8 %) mismatches. Among 24/24 (100 %) trials completed post‑2017, ACM was reported on ClinicalTrials.gov versus 15/24 (62.5 %) publications, and 22/24 (91.7 %) of those pairs differed. Participant discontinuations due to AEs appeared in 17/60 (28.3 %) registries versus 39/60 (65.0 %) publications (p &lt; 0.05); of the 15/17 (88.2 %) with both sources reporting, 9/15 (60.0 %) had discordant counts.</div></div><div><h3>Conclusion</h3><div>Substantial inconsistencies in AE, mortality, and discontinuation reporting persist between ClinicalTrials.gov and peer‑reviewed publications of HNSCC RCTs. To uphold transparency and patient safety, enhanced technical safeguards on registry platforms and stricter journal policies, such as mandatory discrepancy checklists, are urgently needed.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107840"},"PeriodicalIF":3.9,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145841963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
European surgical guidelines: transoral robotic surgery for head and neck cancers 欧洲外科指南:头颈部癌症的经口机器人手术
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2025-12-26 DOI: 10.1016/j.oraloncology.2025.107826
Jérôme R. Lechien , Vinidh Paleri , Robin Baudouin , Aina Brunet , Carlos M. Chiesa-Estomba , Erika Crosetti , Andrea De Vito , Giovanni Cammaroto , Armando De Virgilio , Nicolas Fakhry , Wojciech Golusinski , Heikki Irjala , Stefan Lang , C.Rene Leemans , Sylvain Moriniere , Alberto M. Saibene , Claudio Sampieri , Somiah Siddiq , Vincent Vander Poorten , David Viros Porcuna , Stéphane Hans

Background

Substantial heterogeneity in practice exists across centers regarding the indications and perioperative care for patients undergoing transoral robotic surgery (TORS) for head and neck cancer. This consensus paper aims to propose a European surgical practice guideline in this setting.

Methods

Twenty-two experts from European and International scientific societies participated in a modified Delphi process for rating and validating statements about indications, contraindications, surgical outcomes, and pre- and postoperative care associated with TORS for head and neck cancer care. Consensus was deemed to have been achieved when two-thirds of experts agreed or strongly agreed with the statement; those with fewer than one-third agreement were improved and resubmitted for voting until final validation or rejection.

Results

Of the initial 41 statements, 38 reached consensus after three voting rounds. Statements propose recommendations for the preoperative assessment (n = 7), indications and contraindications for TORS in oropharyngeal, laryngeal, and hypopharyngeal primaries (n = 10), surgical outcomes to be reported (n = 7), postoperative care (n = 8), and clinical research (n = 6). TORS is appropriate for small, accessible oropharyngeal and supraglottic tumors with favorable exposure. The contraindications set out in detail for oropharyngeal, laryngeal and hypopharyngeal lesions will assist in decision-making, especially when presented with a controversial clinical scenario. Standardized reporting of surgical, functional, and oncological outcomes, including swallowing, voice quality, and survival rates, is essential for evidence-based practice. TORS represents a promising avenue for therapeutic de-escalation in HPV-positive oropharyngeal cancers.

Conclusion

The European TORS surgical consensus provides clinical recommendations for the indications, contraindications, surgical and perioperative care for TORS management of head and neck malignancies.
背景:在实践中,各中心对于头颈癌患者接受经口机器人手术(TORS)的适应证和围手术期护理存在很大的异质性。本共识文件旨在提出在这种情况下的欧洲外科实践指南。方法来自欧洲和国际科学学会的22位专家参与了一项改进的德尔菲过程,对TORS治疗头颈癌的适应症、禁忌症、手术结果以及术前和术后护理相关的声明进行评级和验证。当三分之二的专家同意或强烈同意该声明时,即视为达成共识;少于三分之一的同意被改进并重新提交投票,直到最终生效或被否决。结果在最初的41项声明中,经过三轮投票,38项声明达成共识。陈述提出了以下建议:术前评估(n = 7),口咽、喉部和下咽原发手术TORS的适应症和禁忌症(n = 10),手术结果报告(n = 7),术后护理(n = 8)和临床研究(n = 6)。tor适用于小的,可接近的口咽和声门上肿瘤,有良好的暴露。详细列出口咽、喉部和下咽病变的禁忌症将有助于决策,特别是当出现有争议的临床情况时。标准化报告手术、功能和肿瘤结果,包括吞咽、语音质量和生存率,对循证实践至关重要。TORS代表了hpv阳性口咽癌治疗降级的有希望的途径。结论欧洲TORS手术共识为TORS治疗头颈部恶性肿瘤的适应症、禁忌症、手术及围手术期护理提供了临床建议。
{"title":"European surgical guidelines: transoral robotic surgery for head and neck cancers","authors":"Jérôme R. Lechien ,&nbsp;Vinidh Paleri ,&nbsp;Robin Baudouin ,&nbsp;Aina Brunet ,&nbsp;Carlos M. Chiesa-Estomba ,&nbsp;Erika Crosetti ,&nbsp;Andrea De Vito ,&nbsp;Giovanni Cammaroto ,&nbsp;Armando De Virgilio ,&nbsp;Nicolas Fakhry ,&nbsp;Wojciech Golusinski ,&nbsp;Heikki Irjala ,&nbsp;Stefan Lang ,&nbsp;C.Rene Leemans ,&nbsp;Sylvain Moriniere ,&nbsp;Alberto M. Saibene ,&nbsp;Claudio Sampieri ,&nbsp;Somiah Siddiq ,&nbsp;Vincent Vander Poorten ,&nbsp;David Viros Porcuna ,&nbsp;Stéphane Hans","doi":"10.1016/j.oraloncology.2025.107826","DOIUrl":"10.1016/j.oraloncology.2025.107826","url":null,"abstract":"<div><h3>Background</h3><div>Substantial heterogeneity in practice exists across centers regarding the indications and perioperative care for patients undergoing transoral robotic surgery (TORS) for head and neck cancer. This consensus paper aims to propose a European surgical practice guideline in this setting.</div></div><div><h3>Methods</h3><div>Twenty-two experts from European and International scientific societies participated in a modified Delphi process for rating and validating statements about indications, contraindications, surgical outcomes, and pre- and postoperative care associated with TORS for head and neck cancer care. Consensus was deemed to have been achieved when two-thirds of experts agreed or strongly agreed with the statement; those with fewer than one-third agreement were improved and resubmitted for voting until final validation or rejection.</div></div><div><h3>Results</h3><div>Of the initial 41 statements, 38 reached consensus after three voting rounds. Statements propose recommendations for the preoperative assessment (n = 7), indications and contraindications for TORS in oropharyngeal, laryngeal, and hypopharyngeal primaries (n = 10), surgical outcomes to be reported (n = 7), postoperative care (n = 8), and clinical research (n = 6). TORS is appropriate for small, accessible oropharyngeal and supraglottic tumors with favorable exposure. The contraindications set out in detail for oropharyngeal, laryngeal and hypopharyngeal lesions will assist in decision-making, especially when presented with a controversial clinical scenario. Standardized reporting of surgical, functional, and oncological outcomes, including swallowing, voice quality, and survival rates, is essential for evidence-based practice. TORS represents a promising avenue for therapeutic de-escalation in HPV-positive oropharyngeal cancers.</div></div><div><h3>Conclusion</h3><div>The European TORS surgical consensus provides clinical recommendations for the indications, contraindications, surgical and perioperative care for TORS management of head and neck malignancies.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"173 ","pages":"Article 107826"},"PeriodicalIF":3.9,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145841964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
期刊
Oral oncology
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1