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Long-Term outcomes of induction chemotherapy–guided reduced-dose chemoradiotherapy in poor-risk HPV-Positive oropharyngeal Cancer: Results from the sequential quarterback trials 诱导化疗引导下低剂量放化疗治疗低风险hpv阳性口咽癌的长期结局:来自顺序四分卫试验的结果
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-01-20 DOI: 10.1016/j.oraloncology.2026.107858
J.T. Lovett , M.T. Wotman , W.H. Westra , S. Ahn , V. Gupta , R.L. Bakst , Scott Roof , B.A. Miles , E Genden , K. Misiukiewicz , L. Worona , E. Ramos , J. Botzler , T. Chen , M. Posner

Importance

The rising incidence of HPV-positive oropharynx cancer (HPV-OPC) underscores the need for treatment strategies that maintain disease control while minimizing long-term toxicity. This study reports the long-term follow-up of de-escalation in poor prognosis HPV-OPC, providing critical data for future studies.

Objective

To evaluate long-term outcomes in patients with locally advanced HPV-OPC treated with induction chemotherapy (IC) followed by reduced-dose chemoradiation (rdCRT). We hypothesized that de-escalated radiation therapy after IC would be non-inferior to standard-dose CRT (sdCRT).
Design: Two sequential clinical trials; Quarterback (QB) 1: phase III randomized control trial, QB 2: phase II non-randomized trial; patient accrual conducted between December 2012 and February 2022; final data cutoff April 2025. Median follow-up (IQR): 88.5 (64.6–118.2) months.
Setting: Single-institution academic center.
Participants: 62 patients with HPV-OPC were screened. 47 patients received rdCRT after IC and were included in the primary analysis. Key eligibility: smoking history ≤20 pack-years, no active smoking, no distant metastases, molecularly confirmed HPV status.
Interventions: Three cycles of induction TPF (docetaxel, cisplatin, 5-fluorouracil) followed by rdCRT (5600 cGy) with weekly carboplatin in clinical responders; non-responders in both QB trials and responders in the control arm of QB1 received sdCRT (7000 cGy).
Main Outcomes and Measures: Primary endpoints: 3-year locoregional relapse-free survival (LRRFS) and 3-year progression-free survival (PFS). Secondary: overall survival (OS). Tertiary: disease-specific survival.

Results

Among 47 patients treated with rdCRT after IC, the 3-year and 5-year LRRFS were 89.3% and 86.6%. PFS was 87.2% and 84.6% at 3 and 5 years. OS was 91.5% and 89.1% at 3 and 5 years. Six patients (13%) experienced locoregional failure, and two (4%) developed distant metastases. 7/8 treatment failures (87.5%) occurred in patients with extracapsular extension.

Conclusions and Relevance

rdCRT following IC yields durable disease control in poor prognosis HPV-OPC, with outcomes comparable to historical benchmarks. Extended follow-up supports the safety and efficacy of this de-escalation strategy, even in patients with aggressive disease characteristics, but also underscores the need for careful patient selection, particularly in those with extracapsular extension.
重要性:hpv阳性口咽癌(HPV-OPC)发病率的上升强调了在保持疾病控制的同时最小化长期毒性的治疗策略的必要性。本研究报告了不良预后HPV-OPC的降级长期随访,为今后的研究提供了关键数据。目的:评价局部晚期HPV-OPC患者接受诱导化疗(IC)后减少剂量放化疗(rdCRT)的长期预后。我们假设IC后的降级放射治疗不逊于标准剂量CRT (sdCRT)。设计:两项连续临床试验;四分卫(QB) 1: III期随机对照试验,QB 2: II期非随机试验;2012年12月至2022年2月期间进行的患者累积;最终数据截止日期为2025年4月。中位随访(IQR): 88.5(64.6-118.2)个月。设置:单机构学术中心。参与者:筛选了62例HPV-OPC患者。47例患者在IC后接受了rdCRT,并纳入初步分析。关键条件:吸烟史≤20包年,无主动吸烟,无远处转移,分子证实的HPV状态。干预措施:三个周期的TPF诱导(多西紫杉醇、顺铂、5-氟尿嘧啶),随后是rdCRT (5600 cGy),每周卡铂治疗临床应答者;QB试验无应答者和QB1对照组应答者均接受sdCRT (7000 cGy)治疗。主要终点:3年局部无复发生存期(LRRFS)和3年无进展生存期(PFS)。次要指标:总生存期(OS)。第三阶段:疾病特异性生存。结果:在47例IC后接受rdCRT治疗的患者中,3年和5年LRRFS分别为89.3%和86.6%。3年和5年PFS分别为87.2%和84.6%。3年和5年生存率分别为91.5%和89.1%。6名患者(13%)出现局部失败,2名患者(4%)发生远处转移。7/8的治疗失败(87.5%)发生在囊外延伸患者中。结论和相关性:在预后不良的HPV-OPC中,采用IC后的rdCRT可获得持久的疾病控制,其结果与历史基准相当。延长的随访支持这种降压策略的安全性和有效性,即使对具有侵袭性疾病特征的患者也是如此,但也强调需要仔细选择患者,特别是那些囊外延伸的患者。
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引用次数: 0
Prognostic significance of extranodal extension in cervical lymph node metastases of head and neck squamous cell carcinoma: A systematic review and meta-analysis with bibliometric overview 结外延伸在头颈部鳞状细胞癌颈部淋巴结转移中的预后意义:一项系统综述和文献计量学综述的荟萃分析。
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-02-07 DOI: 10.1016/j.oraloncology.2026.107862
Sachender Pal Singh , Supriya Prasad , Purnima Maggi Dean , Asha Lata Kujur , Gagan Jaiswal

Objective

Extranodal extension (ENE) of cervical lymph node metastases is a key prognostic factor in head and neck squamous cell carcinoma (HNSCC). This systematic review and meta-analysis evaluated the survival impact of ENE in HNSCC and identified global research trends relevant to this research field through a complementary bibliometric analysis.

Materials and methods

ScienceDirect, PubMed, and Scopus were systematically searched during 2000–2025. A systematic review and a meta-analysis were conducted in accordance with the PRISMA 2020 guidelines. A Scopus-based bibliometric analysis was conducted using the Biblioshiny package of R to identify and map the publication trends, influential authors, and major institutional contributions between 2010 and 2025.

Results

Of the 839 retrieved records, 711 studies were screened, and 16 studies comprising approximately 3900 patients met all inclusion criteria. The bibliometric analysis of 120 Scopus-indexed publications demonstrated a marked increase in ENE-related research from 2015 onward, driven primarily by institutions in Australia, Taiwan, and South Korea. Keyword mapping indicated expanding intersections of ENE research with radiomics, prognostic modelling, and refinement of staging systems. Meta-analysis confirmed a significant association between ENE and adverse survival outcomes. Subgroup analyses showed consistently poor prognostic implications across both pathologic and radiologic ENE assessments.

Conclusion

ENE in cervical lymph node metastases is an independent and strong predictor of adverse survival in HNSCC. The increasing global attention to ENE highlights its crucial role in multidisciplinary oncologic management. Therefore, standardized pathological and imaging-based assessment of ENE is essential for developing superior prognostic models and optimizing future treatment planning strategies.
目的:颈部淋巴结转移结外延伸(ENE)是头颈部鳞状细胞癌(HNSCC)预后的关键因素。本系统综述和荟萃分析评估了ENE在HNSCC中的生存影响,并通过补充文献计量分析确定了与该研究领域相关的全球研究趋势。材料和方法:在2000-2025年间系统检索了ScienceDirect、PubMed和Scopus。根据PRISMA 2020指南进行了系统评价和荟萃分析。利用R的Biblioshiny软件包进行了基于范围的文献计量分析,以确定和绘制2010年至2025年间的出版趋势、有影响力的作者和主要机构贡献。结果:在839份检索记录中,筛选了711项研究,其中16项研究包括约3900名患者符合所有纳入标准。对120篇scopus索引出版物的文献计量分析表明,自2015年以来,主要由澳大利亚、台湾和韩国的机构推动的ene相关研究显著增加。关键词映射表明ENE研究与放射组学、预后建模和分期系统改进的交叉点正在扩大。荟萃分析证实了ENE与不良生存结果之间的显著关联。亚组分析一致显示病理和放射学ENE评估预后不良。结论:颈淋巴结转移灶的ENE是HNSCC不良生存的一个独立且强有力的预测因子。全球对ENE的关注日益增加,凸显了其在多学科肿瘤学管理中的关键作用。因此,标准化的病理和影像学评估对于建立更好的预后模型和优化未来的治疗计划策略至关重要。
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引用次数: 0
Cervical lymph node metastasis in oral squamous cell carcinoma: From metastatic patterns and risk factors to the development and validation of a predictive model 口腔鳞状细胞癌的颈部淋巴结转移:从转移模式和危险因素到预测模型的发展和验证。
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-01-20 DOI: 10.1016/j.oraloncology.2026.107860
Xiao-Hu Wang , Lei-Ming Cao , Zhao-Qi Zhu , Yao Xiao , Han-Yue Luo , Guang-Rui Wang , Kan Zhou , Yi-Fu Yu , Jun Jia , Bing Liu , Lin-Lin Bu
Cervical lymph node metastasis (CLNM) is the most critical prognostic factor in oral squamous cell carcinoma (OSCC). To facilitate individualized risk assessment, this study aimed to develop and internally validate a novel prediction model. We retrospectively analyzed 3723 patients with OSCC from a single center (2012–2023), with 2792 eligible patients randomly allocated to a training (n = 1954) and a validation set (n = 838). A rigorous variable selection process was employed, where predictors significant in univariable analysis were entered into a multivariable logistic regression model that utilized a stepwise forward and backward elimination procedure to identify the final set of predictors. Six factors were ultimately incorporated into the nomogram: clinical T stage, clinical N stage, histological grade, perineural invasion, time from onset to treatment, and alcohol consumption. The model demonstrated good discrimination in both training (AUC = 0.780) and validation (AUC = 0.744), excellent calibration, and clinical utility. In conclusion, this internally validated nomogram accurately predicts CLNM risk and can aid in tailoring neck management, pending external validation.
宫颈淋巴结转移(CLNM)是口腔鳞状细胞癌(OSCC)最关键的预后因素。为了便于个性化的风险评估,本研究旨在建立一个新的预测模型并进行内部验证。我们回顾性分析了来自单一中心(2012-2023)的3723例OSCC患者,其中2792例符合条件的患者随机分配到训练组(n = 1954)和验证组(n = 838)。采用了严格的变量选择过程,其中在单变量分析中显著的预测因子被输入到多变量逻辑回归模型中,该模型利用逐步向前和向后消除程序来确定最终的预测因子集。六个因素最终被纳入nomogram:临床T分期、临床N分期、组织学分级、神经周围浸润、发病至治疗时间和饮酒。该模型在训练(AUC = 0.780)和验证(AUC = 0.744)上都表现出良好的辨别能力,具有良好的校准性和临床实用性。总之,这个内部验证的nomogram准确地预测了CLNM的风险,可以帮助定制颈部管理,等待外部验证。
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引用次数: 0
Comment on “Risk factors and a risk assessment model for venous thromboembolism in head and neck cancer surgery” 对“头颈部肿瘤手术中静脉血栓栓塞的危险因素及风险评估模型”的评论
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-02-04 DOI: 10.1016/j.oraloncology.2026.107881
Ling Zhang
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引用次数: 0
Tumour microenvironment diversity of HNSCC and the molecular landscape of recurrent disease 恶性鳞状细胞癌肿瘤微环境多样性与复发性疾病的分子景观
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-01-31 DOI: 10.1016/j.oraloncology.2026.107864
Katelyn Steele , Catherine Barnett , Rahul Ladwa , Meg L Donovan , Clara Lawler , Arutha Kulasinghe
Head and neck squamous cell carcinoma (HNSCC) represents a biologically diverse group of malignancies within the upper aerodigestive tract and oral cavity and remains a significant cause of global morbidity and mortality. Increasing evidence highlights that the tumour microenvironment (TME) plays a central role in disease progression and therapeutic response. Distinct immune and stromal profiles have been observed between HPV positive (HPV+) and HPV negative (HPV-) HNSCC, underpinning their differing natural history and responses to immunotherapy. Despite advances, only 15–20% of patients with recurrent or metastatic HNSCC (RMHNSCC) respond to immunotherapy, with no difference in response being seen between HPV+ and HPV- disease. This may reflect the complexity and heterogeneity of the TME. This review explores how emerging spatial omics technologies, combining molecular, and spatial context, are reshaping our understanding of the HNSCC microenvironment, with emphasis on recurrent and/or metastatic disease. By delineating the spatial organisation of immune, stromal, and metabolic features, these approaches provide new insights into mechanisms of treatment resistance, prognostic biomarkers, and therapeutic vulnerabilities. Understanding spatial TME dynamics across HPV-related subtypes may ultimately guide more precise and effective treatment strategies for HNSCC.
头颈部鳞状细胞癌(HNSCC)是一种生物多样性的上消化道和口腔恶性肿瘤,是全球发病率和死亡率的重要原因。越来越多的证据表明,肿瘤微环境(TME)在疾病进展和治疗反应中起着核心作用。在HPV阳性(HPV+)和HPV阴性(HPV-) HNSCC之间观察到不同的免疫和基质特征,支撑了它们不同的自然历史和对免疫治疗的反应。尽管取得了进展,但只有15-20%的复发或转移性HNSCC (RMHNSCC)患者对免疫治疗有反应,HPV+和HPV-疾病之间的反应没有差异。这可能反映了TME的复杂性和异质性。这篇综述探讨了新兴的空间组学技术,结合分子和空间背景,如何重塑我们对HNSCC微环境的理解,重点是复发和/或转移性疾病。通过描述免疫、基质和代谢特征的空间组织,这些方法为治疗耐药、预后生物标志物和治疗脆弱性的机制提供了新的见解。了解hpv相关亚型的TME空间动态可能最终指导更精确和有效的HNSCC治疗策略。
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引用次数: 0
The first report of contralateral parapharyngeal space metastasis of papillary thyroid carcinoma: report of a case 甲状腺乳头状癌对侧咽旁间隙转移1例报告
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-01-30 DOI: 10.1016/j.oraloncology.2026.107865
Nan Wang , Haotian Gao , Shuai-xia Yu , Jiangang Fan , Bin Li , Xiaolong Zhao
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引用次数: 0
Long-term swallowing outcomes following transoral robotic surgery for oropharyngeal cancer – Five years and beyond 口咽癌经口机器人手术后5年及以后的长期吞咽结果。
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-01-31 DOI: 10.1016/j.oraloncology.2026.107876
Bartosz P. Wojtera , Avinash Beharry , Victoria Salati , Karma Lambercy , Nina Wahler , Edouard Romano , Wojciech Golusinski , Christian Simon
Objective: Transoral robotic surgery (TORS), either used alone or combined with radiotherapy, is a common treatment for operable T-stage oropharyngeal squamous cell carcinoma (OPSCC). Due to high survival rates, maintaining quality of life—especially swallowing function—is an important long-term consideration. This study aimed to assess swallowing outcomes five years and beyond following TORS in patients with primary OPSCC.
Methods: “Functional outcome swallowing scale” (FOSS) was used to retrospectively assess long-term dysphagia in 47 OPSCC patients, with a median follow-up of 6.8 years. All patients had a minimum follow-up of five years.
Results: The FOSS scores remained stable at five years compared to 1–4 years post-TORS (all p > 0.99). Furthermore, there were no significant differences in FOSS from 1 to 10 years post-TORS compared to preoperative score. Adjuvant therapy was a univariate predictor of worse swallowing outcomes (OR: 17.46, 95% CrI: 2.94–121.51); however, this effect was limited to the short-term postoperative period (≤ 2 years after TORS). In contrast, subsequent major surgery after TORS and treatment of more advanced tumors (pT2–pT3 vs. pTis–pT1) were associated with persistently worse swallowing outcomes, including long-term follow-up (OR: 23.81, 95% CrI: 4.48–142.59; OR: 15.03, 95% CrI: 3.06–81.45, respectively).
Conclusions: TORS offers excellent and stable long-term swallowing outcomes when used as a single-modality treatment for OPSCC. While outcomes remain satisfactory with additional therapies, swallowing results are influenced by tumor stage, adjuvant treatment, and further major surgery.
目的:经口机器人手术(TORS)无论是单独使用还是联合放疗,都是可手术t期口咽鳞状细胞癌(OPSCC)的常用治疗方法。由于生存率高,维持生活质量,尤其是吞咽功能,是一个重要的长期考虑。本研究旨在评估原发性OPSCC患者接受TORS治疗5年及以后的吞咽结局。方法:采用“功能结局吞咽量表”(FOSS)回顾性评估47例OPSCC患者的长期吞咽困难,中位随访时间为6.8年。所有患者至少随访5年。结果:与tor后1-4年相比,FOSS评分在5年保持稳定(p均为0.99)。此外,与术前评分相比,术后1至10年FOSS评分无显著差异。辅助治疗是吞咽不良结果的单因素预测因子(OR: 17.46, 95% CrI: 2.94-121.51);然而,这种效果仅限于术后短期(TORS后≤2年)。相比之下,TORS后的后续大手术和更晚期肿瘤的治疗(pT2-pT3 vs. pTis-pT1)与持续较差的吞咽结果相关,包括长期随访(OR: 23.81, 95% CrI: 4.48-142.59; OR: 15.03, 95% CrI: 3.06-81.45)。结论:TORS作为OPSCC的单模态治疗具有良好且稳定的长期吞咽效果。虽然附加治疗的结果仍然令人满意,但吞咽结果受肿瘤分期、辅助治疗和进一步的大手术的影响。
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引用次数: 0
Immunotherapy and betel nut-associated oral cavity carcinoma: challenges and opportunities 免疫治疗和槟榔相关的口腔癌:挑战和机遇
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-01-31 DOI: 10.1016/j.oraloncology.2026.107873
William J. Moss , Jonathan West , Peter Brett , Daniel Kwon
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引用次数: 0
Rare laryngeal tumors: A retrospective bicentric study on 74 patients and systematic review 罕见喉部肿瘤:74例双中心回顾性研究及系统回顾。
IF 3.9 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Pub Date : 2026-03-01 Epub Date: 2026-02-04 DOI: 10.1016/j.oraloncology.2026.107852
Francesco Chu , Pietro Benzi , Marta Tagliabue , Chiara Mossinelli , Stefano Filippo Zorzi , Sara Gandini , Marco Romelli , Marta Filauro , Andrea Iandelli , Filippo Marchi , Giorgio Peretti , Mohssen Ansarin

Introduction

Head and neck cancers are the seventh most common malignancy worldwide, with laryngeal cancer (LC) the most prevalent subtype. Although squamous cell carcinoma (SCC) represents 85–90% of LC, rare non-SCC tumors—including laryngeal sarcomas (LS), neuroendocrine carcinomas (LNC), malignant salivary gland tumors (LMSGT), and mucosal melanomas (LMM)—are uncommon but clinically challenging. We combined a bicentric retrospective cohort with a systematic literature review to provide an integrated assessment of these entities.

Methods

Patients with non-SCC malignant laryngeal tumors treated with curative intent at two Italian tertiary centers were retrospectively analyzed. Tumors were classified as LS, LNC, LMSGT, or LMM. Primary endpoints were overall survival (OS), disease specific survival (DSS) and recurrence-free survival (RFS). A systematic review contextualized institutional outcomes.

Results

74 patients were included: 34 LS, 25 LNC, 13 LMSGT, and 2 LMM. Surgery was the primary treatment in 98.6 % of cases. LS and LMSGT demonstrated favorable survival, whereas LNC showed poor outcomes (median OS, 2.89 years) and the highest recurrence rate (72 %). Radical tumor excision achieved effective loco-regional control across histologies. LMM prognosis was dismal, with recurrence in both cases. The literature review revealed marked heterogeneity and wide survival ranges, reflecting rarity and biological diversity.

Conclusion

Rare non-SCC laryngeal tumors comprise heterogeneous and often aggressive diseases with variable prognoses. Despite the absence of standardized management, radical surgery provides effective loco-regional control. Integrating bicentric clinical experience with published evidence highlights the need for multicenter collaboration to optimize treatment strategies and improve outcomes in this rare oncologic setting worldwide today.
头颈癌是全球第七大最常见的恶性肿瘤,喉癌(LC)是最常见的亚型。虽然鳞状细胞癌(SCC)占LC的85-90%,但罕见的非鳞状细胞癌-包括喉肉瘤(LS),神经内分泌癌(LNC),恶性唾液腺肿瘤(LMSGT)和粘膜黑色素瘤(LMM)-并不常见,但临床上具有挑战性。我们将双中心回顾性队列与系统文献综述相结合,对这些实体进行综合评估。方法:回顾性分析意大利两家三级中心治疗的非鳞状细胞癌喉恶性肿瘤患者的疗效。肿瘤分为LS、LNC、LMSGT和LMM。主要终点是总生存期(OS)、疾病特异性生存期(DSS)和无复发生存期(RFS)。一项系统的综述将制度结果置于情境中。结果:74例患者:LS 34例,LNC 25例,LMSGT 13例,LMM 2例。手术是98.6%病例的主要治疗方法。LS和LMSGT表现出良好的生存期,而LNC表现出较差的预后(中位OS, 2.89年)和最高的复发率(72%)。根治性肿瘤切除在组织学上实现了有效的局部区域控制。LMM预后不佳,两例均有复发。文献回顾显示其异质性显著,生存范围广,反映了稀有性和生物多样性。结论:罕见的非鳞状细胞癌喉部肿瘤由异质性和侵袭性疾病组成,预后不一。尽管缺乏规范的管理,根治性手术提供了有效的局部区域控制。将双中心临床经验与已发表的证据相结合,强调了多中心合作的必要性,以优化治疗策略并改善当今全球罕见肿瘤环境的预后。
{"title":"Rare laryngeal tumors: A retrospective bicentric study on 74 patients and systematic review","authors":"Francesco Chu ,&nbsp;Pietro Benzi ,&nbsp;Marta Tagliabue ,&nbsp;Chiara Mossinelli ,&nbsp;Stefano Filippo Zorzi ,&nbsp;Sara Gandini ,&nbsp;Marco Romelli ,&nbsp;Marta Filauro ,&nbsp;Andrea Iandelli ,&nbsp;Filippo Marchi ,&nbsp;Giorgio Peretti ,&nbsp;Mohssen Ansarin","doi":"10.1016/j.oraloncology.2026.107852","DOIUrl":"10.1016/j.oraloncology.2026.107852","url":null,"abstract":"<div><h3>Introduction</h3><div>Head and neck cancers are the seventh most common malignancy worldwide, with laryngeal cancer (LC) the most prevalent subtype. Although squamous cell carcinoma (SCC) represents 85–90% of LC, rare non-SCC tumors—including laryngeal sarcomas (LS), neuroendocrine carcinomas (LNC), malignant salivary gland tumors (LMSGT), and mucosal melanomas (LMM)—are uncommon but clinically challenging. We combined a bicentric retrospective cohort with a systematic literature review to provide an integrated assessment of these entities.</div></div><div><h3>Methods</h3><div>Patients with non-SCC malignant laryngeal tumors treated with curative intent at two Italian tertiary centers were retrospectively analyzed. Tumors were classified as LS, LNC, LMSGT, or LMM. Primary endpoints were overall survival (OS), disease specific survival (DSS) and recurrence-free survival (RFS). A systematic review contextualized institutional outcomes.</div></div><div><h3>Results</h3><div>74 patients were included: 34 LS, 25 LNC, 13 LMSGT, and 2 LMM. Surgery was the primary treatment in 98.6 % of cases. LS and LMSGT demonstrated favorable survival, whereas LNC showed poor outcomes (median OS, 2.89 years) and the highest recurrence rate (72 %). Radical tumor excision achieved effective loco-regional control across histologies. LMM prognosis was dismal, with recurrence in both cases. The literature review revealed marked heterogeneity and wide survival ranges, reflecting rarity and biological diversity.</div></div><div><h3>Conclusion</h3><div>Rare non-SCC laryngeal tumors comprise heterogeneous and often aggressive diseases with variable prognoses. Despite the absence of standardized management, radical surgery provides effective loco-regional control. Integrating bicentric clinical experience with published evidence highlights the need for multicenter collaboration to optimize treatment strategies and improve outcomes in this rare oncologic setting worldwide today.</div></div>","PeriodicalId":19716,"journal":{"name":"Oral oncology","volume":"174 ","pages":"Article 107852"},"PeriodicalIF":3.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146125703","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 : 2026-02-01 Epub 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":"2026-02-01","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}
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Oral oncology
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