Clinical oncology最新文献

英文中文

Two Versus Five-Fraction Magnetic Resonance-Guided Adaptive Radiotherapy with DOminant-TArgeted Boost in Localized Prostate Cancer (DOTA-2): Interim Acute Toxicity Analysis of the Phase II Randomised Trial 二段式与五段式磁共振引导适应放疗对局部前列腺癌（DOTA-2）的优势靶向增强：中期急性毒性分析的II期随机试验。

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-27 DOI: 10.1016/j.clon.2025.104029

R. Romrattaphan, P. Dankulchai, T. Prasartseree, W. Sittiwong, W. Thaweerat, S. Junlabut, S. Nitipitch

Aims

DOminant-TArgeted Boost in Localized Prostate Cancer (DOTA-2) is a phase II randomised controlled trial comparing two ultra-hypofractionated radiotherapy with dominant intraprostatic lesion (DIL) boost: 26 Gy/2F, 32 Gy to DIL vs 36.25 Gy/5F, 40 Gy to DIL, without androgen deprivation therapy (ADT), for prostate cancer.

Materials and methods

Patients with low- to favourable-intermediate-risk prostate cancer were randomly assigned to receive either 2 fractions or 5 fractions. Magnetic resonance-guided adaptive radiotherapy (MRgART) was delivered using the Unity® MR-Linac with the adapt-to-shape workflow for every fraction. The primary endpoint was cumulative grade ≥2 acute genitourinary (GU) and gastrointestinal (GI) toxicity. Secondary endpoints included quality of life in the urinary and sexual domains. An interim analysis of acute GU and GI toxicities was conducted on the first 22 patients from the total planned cohort of 44.

Results

Patients were randomly assigned to either the 2-fraction (N = 10) or 5-fraction stereotactic body radiotherapy (SBRT) (N = 12), stratified by risk group, prostate volume, and DIL location. The median follow-up time was 16 weeks. The cumulative worst acute grade ≥2 GU toxicity was reported in 2/10 (20%) patients in the 2-fraction group vs 4/12 (33.3%) in the 5-fraction group (P = 0.48), with no cases of grade ≥3 acute GU toxicity. No grade ≥2 acute GI toxicity was observed in either arm. The two groups had no significant difference in International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) scores.

Conclusion

Two-fraction SBRT with a DIL boost, delivered using MRgART without ADT, demonstrated acceptable acute GU and GI toxicity in this interim analysis, suggesting the feasibility of continuing the investigation.

目的：局部前列腺癌的显性靶向增强（DOTA-2）是一项II期随机对照试验，比较两种超低分割放疗对显性前列腺内病变（DIL）的增强：26 Gy/2F， 32 Gy对DIL和36.25 Gy/5F， 40 Gy对DIL，不进行雄激素剥夺治疗（ADT），治疗前列腺癌。材料和方法：低至中危前列腺癌患者随机分为2组和5组。磁共振引导的自适应放疗（MRgART）使用Unity®MR-Linac进行，每个部分都具有自适应形状的工作流程。主要终点是累积≥2级急性泌尿生殖系统（GU）和胃肠道（GI）毒性。次要终点包括泌尿和性方面的生活质量。对44例计划队列中的前22例患者进行了急性GU和GI毒性的中期分析。结果：根据危险组、前列腺体积和DIL位置，患者被随机分配到2分位（N = 10）或5分位立体定向放射治疗（SBRT）（N = 12）。中位随访时间为16周。2分组中有2/10（20%）的患者报告了最严重的急性≥2级GU毒性，而5分组中有4/12 (33.3%)(P = 0.48)，没有病例发生≥3级急性GU毒性。两组均未观察到≥2级急性胃肠道毒性。两组在国际前列腺症状评分（IPSS）、国际勃起功能指数（IIEF-5）评分上无显著差异。结论：在这个中期分析中，使用MRgART（不含ADT）进行DIL增强的二组分SBRT显示出可接受的急性GU和GI毒性，表明继续研究的可行性。

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引用次数: 0

Safety and Efficacy of Nivolumab Plus Ipilimumab in Microsatellite Instability-High/Mismatch Repair-Deficient Colorectal Cancer: A Systematic Review Nivolumab联合Ipilimumab治疗微卫星不稳定性高/错配修复缺陷结直肠癌的安全性和有效性：系统综述

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-26 DOI: 10.1016/j.clon.2025.104028

E. Kokori , I.C. Abraham , G. Olatunji , J.E. Aboje , O.A. Akinruli , S.A. Joseph , E.A. Agyemang , C. Ezeano , S.O. Bukky , N. Aderinto , C.E. Agbo

Aims

Colorectal cancer (CRC) remains a significant global health burden, with rising incidence and mortality despite advances in screening and treatment. Microsatellite instability-high (MSI-H) and mismatch repair–deficient (dMMR) CRCs comprise a distinct molecular subtype characterised by a high mutational burden and immunogenicity, rendering them responsive to immune checkpoint inhibitors. The combination of nivolumab (anti–programmed cell death protein 1 [PD-1]) and ipilimumab (anti-CTLA-4) has emerged as a promising therapeutic strategy. This systematic review aims to evaluate the safety and efficacy of nivolumab plus ipilimumab combination therapy in patients with MSI-H/dMMR CRC.

Materials and methods

A literature search was conducted across PubMed, Embase, Cochrane Library, Web of Science, and Scopus up to March 2025. Eligible studies included clinical trials or observational studies that reported efficacy (objective response rate [ORR], progression-free survival [PFS], and overall survival [OS]) and safety outcomes (treatment-related adverse events [TRAEs]) of nivolumab plus ipilimumab combination therapy in MSI-H/dMMR CRC. Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool and the Newcastle-Ottawa Scale.

Results

Six studies (N = 758) were included: four phase II trials, one phase III randomised trial, and one phase II neoadjuvant trial. Participants were predominantly White, with a median age of 56.5–66 years, and most had right-sided tumours. Across studies, nivolumab plus ipilimumab combination therapy demonstrated favourable ORRs (31–69%), durable PFS, and OS benefits, particularly in metastatic settings. Neoadjuvant use also showed a promising pathologic response. TRAEs were generally manageable; grade 3–4 events occurred in 14–35% of patients, commonly diarrhoea, fatigue, and endocrinopathies.

Conclusion

Nivolumab plus ipilimumab is an effective and relatively well-tolerated option for MSI-H/dMMR CRC, offering significant clinical benefit across disease stages. Ongoing trials and longer follow-up are warranted to optimise dosing, identify predictive biomarkers, and refine patient selection.

目的：结直肠癌（CRC）仍然是一个重大的全球健康负担，尽管在筛查和治疗方面取得了进展，但其发病率和死亡率仍在上升。微卫星不稳定性高（MSI-H）和错配修复缺陷（dMMR） crc包括一种独特的分子亚型，其特征是高突变负担和免疫原性，使它们对免疫检查点抑制剂有反应。nivolumab（抗程序性细胞死亡蛋白1 [PD-1]）和ipilimumab（抗ctla -4）的联合治疗已成为一种有前景的治疗策略。本系统综述旨在评估纳武单抗+伊匹单抗联合治疗MSI-H/dMMR CRC患者的安全性和有效性。材料和方法：在PubMed， Embase, Cochrane Library， Web of Science和Scopus上进行了文献检索，截止到2025年3月。符合条件的研究包括临床试验或观察性研究，这些研究报告了nivolumab + ipilimumab联合治疗MSI-H/dMMR CRC的有效性（客观缓解率[ORR]、无进展生存期[PFS]和总生存期[OS]）和安全性（治疗相关不良事件[TRAEs]）。使用Cochrane风险偏倚2 （RoB 2）工具和Newcastle-Ottawa量表评估偏倚风险。结果：纳入6项研究（N = 758）： 4项II期试验，1项III期随机试验和1项II期新辅助试验。参与者主要是白人，中位年龄56.5-66岁，大多数患有右侧肿瘤。在所有研究中，nivolumab + ipilimumab联合治疗显示出良好的orr(31-69%)，持久的PFS和OS益处，特别是在转移性环境中。新辅助治疗也显示出良好的病理反应。贸易逆差总体上是可控的；14-35%的患者发生3-4级事件，通常为腹泻、疲劳和内分泌病变。结论：Nivolumab联合ipilimumab是MSI-H/dMMR CRC的有效且相对耐受性良好的选择，在疾病分期中提供显着的临床益处。正在进行的试验和更长时间的随访是必要的，以优化剂量，确定预测性生物标志物，并完善患者选择。

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引用次数: 0

Re-evaluating the 30 Gy Dose for Chest Wall-Abutting Tumours in Single-Fraction Stereotactic Ablative Radiotherapy : Evidence From a Population-Based Study 重新评估30 Gy剂量对胸壁邻近肿瘤的单次立体定向消融放疗：来自人群研究的证据

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-24 DOI: 10.1016/j.clon.2025.104007

Y. Liu , D. Zhang , S. Tian

引用次数: 0

National Reporting of Bowel Cancer Care by the National Bowel Cancer Audit (NBOCA) Supports Hospital Teams to Improve care and Outcomes 国家肠癌审计（NBOCA）的国家肠癌护理报告支持医院团队改善护理和结果

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-24 DOI: 10.1016/j.clon.2025.104009

NBOCA Project Team, A. Rashid , S. Cook , K. Darley , A. Kuryba , L. Watton , O. Almilaji , N. Fearnhead , M. Braun , J. van der Meulen , K. Walker

引用次数: 0

Intraocular Sarcomas: A Population-based Study 眼内肉瘤：一项基于人群的研究

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-22 DOI: 10.1016/j.clon.2025.104006

P. Loap, Y. Kirova, R. Dendale

引用次数: 0

Royal College of Radiologists Guidance Statements on the Use of Auto-contouring in Radiotherapy 英国皇家放射学会关于在放射治疗中使用自动轮廓的指导声明

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-18 DOI: 10.1016/j.clon.2025.104004

K. Mackay , K. Banfill , D. Bernstein , J. Daniel , P. Diez , S. Gwynne , A. Hoole , R. Jena , T. Marchant , M. Nix , G. Price , M. Teo , I. Boon , S. Hindocha , J. Wang , K. Zucker , A. Taylor

Auto-contouring systems are rapidly becoming more widely used for radiotherapy treatment planning. There is an acknowledged need for formal guidance to help healthcare professionals understand how to safely adopt this technology. The Royal College of Radiologists Artificial Intelligence in Clinical Oncology working group established a multi-disciplinary group of national experts in artificial intelligence and radiotherapy quality assurance (QA). This group has produced consensus recommendations for the safe use of the technology. These include model selection, clinical commissioning, day-to-day QA, and post-implementation monitoring. Other factors such as the impact on the multi-disciplinary team, education, and training are also considered.

The healthcare professional approving auto-contours for use will have overall responsibility, and it is therefore of utmost importance that they have a good understanding of the risks of auto-contouring and how contours should be assessed to mitigate these risks. This guidance aims to enable healthcare professionals acting as operators of a medical device to understand what they need to know about auto-contouring, to facilitate safe adoption of this technology.

自动轮廓系统在放射治疗计划中的应用越来越广泛。人们公认需要正式的指导，以帮助医疗保健专业人员了解如何安全地采用这项技术。英国皇家放射学院临床肿瘤人工智能工作组成立了一个由人工智能和放疗质量保证（QA）方面的国家多学科专家组成的小组。该小组就安全使用该技术提出了共识建议。其中包括模型选择、临床调试、日常质量保证和实施后监测。其他因素，如对多学科团队的影响，教育和培训也被考虑在内。批准使用自动轮廓的医疗保健专业人员将承担全部责任，因此，他们对自动轮廓的风险以及应该如何评估轮廓以减轻这些风险有很好的了解是至关重要的。本指南旨在使作为医疗设备操作员的医疗保健专业人员了解他们需要了解的有关自动轮廓的知识，以促进安全采用此技术。

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引用次数: 0

Phase II Open-Label Randomised Controlled Trial Comparing Oxaliplatin and Cisplatin Based Concurrent Chemoradiotherapy in Locally Advanced Head and Neck Cancers 比较奥沙利铂和顺铂同步放化疗治疗局部晚期头颈癌的II期开放标签随机对照试验

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-18 DOI: 10.1016/j.clon.2025.104005

Y. Yanthan , L. Pandey , A. Pandey , R. Pasricha , D. Joseph , S. Gupta , A. Sehrawat , A. Dhyani , M. Gupta

Aims

Concurrent cisplatin-based chemoradiotherapy (CCRT) is the standard treatment for locally advanced head and neck cancer (LAHNC); however, it also results in substantial treatment-related toxicities. Oxaliplatin has similar radiosensitisation mechanisms to cisplatin and, if found to have equivalent efficacy in LAHNCs, has the potential to replace cisplatin in CCRT protocols.

Materials and methods

This prospective trial compared weekly oxaliplatin 50 mg/m2 to weekly cisplatin 40mg/m² in CCRT protocols for the treatment of non-nasopharyngeal LAHNCs. The primary endpoint was to compare the toxicity profile; secondary endpoints were compliance, locoregional control (LRC), disease-free survival (DFS), and overall survival (OS).

Results

Between January 2019 and June 2020, we randomly assigned 70 LAHNC patients, 35 in each arm, to receive radical CCRT. At a median follow-up of 18 months (range: 3-72), acute toxicities of grade 3 or higher occurred in 31% of patients in the oxaliplatin arm and 77% of patients in the cisplatin arm (P = 0.007). The estimated 3-year LRC, DFS, and OS in the oxaliplatin and cisplatin arms were 32.3% vs 35.9%, 28.7% vs 35.9% and 35.1% vs 37.3%, respectively, while the 5-year LRC, DFS, and OS were 32.3% vs 32.4%, 28.7% vs 28.8%, and 31.2% vs 30.5%, respectively. The absolute differences observed were not statistically significant.

Conclusion

The CCRT with oxaliplatin in non-nasopharyngeal LAHNC exhibits a better toxicity profile and appears comparable to cisplatin in terms of disease control. It may be worthwhile exploring this approach in a larger trial to gather LRC and survival data.

Clinical Trials Registry India

CTRI/2019/01/017198.

目的：同步顺铂化放化疗（CCRT）是局部晚期头颈癌（LAHNC）的标准治疗；然而，它也会导致大量与治疗相关的毒性。奥沙利铂与顺铂具有相似的放射致敏机制，如果发现在LAHNCs中具有相同的疗效，则有可能在CCRT方案中取代顺铂。材料和方法：这项前瞻性试验比较了CCRT方案中每周50 mg/m2的奥沙利铂和每周40mg/m2的顺铂治疗非鼻咽部LAHNCs。主要终点是比较毒性概况；次要终点是依从性、局部区域控制（LRC）、无病生存（DFS）和总生存（OS）。结果：在2019年1月至2020年6月期间，我们随机分配了70例LAHNC患者，每组35例，接受根治性CCRT。中位随访期为18个月（范围：3-72），奥沙利铂组31%的患者出现3级或以上急性毒性，顺铂组77%的患者出现3级或以上急性毒性（P = 0.007）。奥沙利铂和顺铂组的3年LRC、DFS和OS分别为32.3%对35.9%、28.7%对35.9%和35.1%对37.3%，而5年LRC、DFS和OS分别为32.3%对32.4%、28.7%对28.8%和31.2%对30.5%。观察到的绝对差异无统计学意义。结论：奥沙利铂联合CCRT治疗非鼻咽部LAHNC具有更好的毒性，在疾病控制方面与顺铂相当。在更大的试验中探索这种方法来收集LRC和生存数据可能是值得的。临床试验注册印度：CTRI/2019/01/017198。

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引用次数: 0

Clinical Trials in Molecular Radiotherapy: An Overview of the Landscape 分子放射治疗的临床试验：综述

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-16 DOI: 10.1016/j.clon.2025.104003

N. Varmenot , K. Sjögreen Gleisner , J. Taprogge , G.D. Flux

In recent years the treatment of cancer with radioactive drugs, here termed molecular radiotherapy (MRT), has emerged to take a place alongside other treatment modalities, particularly non-radioactive drugs (NRDs) and external beam radiotherapy (EBRT). A purpose-built tool was developed within the Python programming environment to review the evolution of clinical trials performed in the first quarter of the century as recorded by the ClinicalTrials.gov database. It was found that the number of MRT trials registered on ClinicalTrials.gov increased by 15-fold from 6 trials in 2000 to 89 in 2024. The ratio of MRT clinical trials relative to EBRT has remained constant at approximately 1:5. Although the number of MRT trials has remained comparatively low, their frequency in relation to NRD trials has doubled over the 25-year period. All modalities have been investigated in a similar spread of early and late phase trials, with a slightly higher proportion for early phase trials in MRT. The registration of trials has increased for almost all indications, particularly for prostate, neuroendocrine and liver cancers, although the number of trials for lymphoma has declined. The diversity and number of radionuclides involved in MRT clinical trials have increased, with beta-minus emitting radionuclides accounting in 2024 for approximately 89% of studies compared to 11% for alpha-emitters.

近年来，用放射性药物治疗癌症，这里称为分子放射治疗（MRT），已经出现与其他治疗方式，特别是非放射性药物（NRDs）和外束放射治疗（EBRT）一起。我们在Python编程环境中开发了一个专门的工具，用于回顾临床试验在本世纪前25年的发展，这些临床试验记录在ClinicalTrials.gov数据库中。研究发现，在ClinicalTrials.gov上注册的MRT试验数量从2000年的6个增加到2024年的89个，增长了15倍。MRT临床试验相对于EBRT的比例一直保持不变，约为1:5。尽管MRT试验的数量仍然相对较低，但与NRD试验相比，MRT试验的频率在25年期间翻了一番。在早期和晚期试验的相似分布中对所有模式进行了调查，MRT早期试验的比例略高。几乎所有适应症的试验注册数量都有所增加，尤其是前列腺癌、神经内分泌癌和肝癌，尽管淋巴瘤的试验数量有所下降。MRT临床试验中涉及的放射性核素的多样性和数量有所增加，到2024年，β -负排放的放射性核素约占研究的89%，而α -排放的放射性核素仅占11%。

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引用次数: 0

From Numbers to Movement: Making the Toronto Extremity Salvage Score a Living Measure in Soft-tissue Sarcoma Survivorship 从数字到运动：使多伦多肢体挽救评分成为软组织肉瘤生存的生活衡量标准

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-13 DOI: 10.1016/j.clon.2025.104002

S. Haider

引用次数: 0

Access to Stereotactic Radiosurgery Centres Across the United Kingdom—An Investigation of Travel Time 进入全英国立体定向放射外科中心——旅行时间的调查

IF 3 3区医学 Q2 ONCOLOGY

Clinical oncology

Pub Date : 2025-12-12 DOI: 10.1016/j.clon.2025.104000

S.D. Robinson , S. Kingdon , M. Williams

引用次数: 0

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