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Design and conduct of theranostic trials in neuro-oncology: Challenges and opportunities. 设计和开展神经肿瘤学治疗试验:挑战与机遇。
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-05 DOI: 10.1093/neuonc/noae162
Patrick Y Wen, Matthias Preusser, Nathalie L Albert

Theranostics is a new treatment modality integrating molecular imaging with targeted radionuclide therapy. Theranostic agents have received regulatory approval for some systemic cancers and have therapeutic potential in neuro-oncology. As clinical trials are developed to evaluate the efficacy of theranostic agents in brain tumors, specific considerations will have to be considered, taking into account lessons learned from previous studies examining other treatment modalities in neuro-oncology. These include the need for molecular imaging or surgical window-of-opportunity studies to confirm adequate passage across the blood-brain barrier, optimizing eligibility criteria and selection of the most appropriate response criteria and endpoints to address issues such as pseudoprogression. This review will discuss some of the issues that should be considered when designing clinical trials for theranostic agents.

Theranostics 是一种将分子成像与放射性核素靶向治疗相结合的新型治疗模式。一些全身性癌症的治疗药物已获得监管部门的批准,在神经肿瘤学方面也具有治疗潜力。在开展临床试验以评估治疗放射治疗药物对脑肿瘤的疗效时,必须考虑到具体的注意事项,并吸取之前研究神经肿瘤学其他治疗方式的经验教训。这些因素包括需要进行分子成像或手术机会窗研究,以确认药物充分通过血脑屏障;优化资格标准;选择最合适的反应标准和终点,以解决假性进展等问题。本综述将讨论在设计治疗药物临床试验时应考虑的一些问题。
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引用次数: 0
Genome-wide polygenic risk scores predict risk of glioma and molecular subtypes. 全基因组多基因风险评分预测胶质瘤风险和分子亚型。
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae112
Taishi Nakase, Geno A Guerra, Quinn T Ostrom, Tian Ge, Beatrice S Melin, Margaret Wrensch, John K Wiencke, Robert B Jenkins, Jeanette E Eckel-Passow, Melissa L Bondy, Stephen S Francis, Linda Kachuri

Background: Polygenic risk scores (PRS) aggregate the contribution of many risk variants to provide a personalized genetic susceptibility profile. Since sample sizes of glioma genome-wide association studies (GWAS) remain modest, there is a need to efficiently capture genetic risk using available data.

Methods: We applied a method based on continuous shrinkage priors (PRS-CS) to model the joint effects of over 1 million common variants on disease risk and compared this to an approach (PRS-CT) that only selects a limited set of independent variants that reach genome-wide significance (P < 5 × 10-8). PRS models were trained using GWAS stratified by histological (10 346 cases and 14 687 controls) and molecular subtype (2632 cases and 2445 controls), and validated in 2 independent cohorts.

Results: PRS-CS was generally more predictive than PRS-CT with a median increase in explained variance (R2) of 24% (interquartile range = 11-30%) across glioma subtypes. Improvements were pronounced for glioblastoma (GBM), with PRS-CS yielding larger odds ratios (OR) per standard deviation (SD) (OR = 1.93, P = 2.0 × 10-54 vs. OR = 1.83, P = 9.4 × 10-50) and higher explained variance (R2 = 2.82% vs. R2 = 2.56%). Individuals in the 80th percentile of the PRS-CS distribution had a significantly higher risk of GBM (0.107%) at age 60 compared to those with average PRS (0.046%, P = 2.4 × 10-12). Lifetime absolute risk reached 1.18% for glioma and 0.76% for IDH wildtype tumors for individuals in the 95th PRS percentile. PRS-CS augmented the classification of IDH mutation status in cases when added to demographic factors (AUC = 0.839 vs. AUC = 0.895, PΔAUC = 6.8 × 10-9).

Conclusions: Genome-wide PRS has the potential to enhance the detection of high-risk individuals and help distinguish between prognostic glioma subtypes.

背景:多基因风险评分(PRS多基因风险评分(PRS)综合了许多风险变异的贡献,提供了个性化的遗传易感性特征。由于胶质瘤全基因组关联研究(GWAS)的样本量仍然不大,因此需要利用现有数据有效捕捉遗传风险:方法:我们采用了一种基于连续收缩先验(PRS-CS)的方法来模拟 100 多万个常见变异对疾病风险的联合影响,并将其与只选择达到全基因组显著性(PResults:在各种胶质瘤亚型中,PRS-CS 的预测性普遍高于 PRS-CT,解释方差 (R2) 的中位数增加了 24%(四分位间范围=11-30%)。PRS-CS对胶质母细胞瘤(GBM)的预测效果显著,每标准差的几率比(OR)更大(OR=1.93,P=2.0×10-54 vs. OR=1.83,P=9.4×10-50),解释方差(R2=2.82% vs. R2=2.56%)更高。PRS-CS分布第80百分位数的人与PRS平均值(0.046%,P=2.4×10-12)的人相比,60岁时罹患GBM的风险(0.107%)明显更高。PRS百分位数第95位的人患胶质瘤的终生绝对风险为1.18%,患IDH野生型肿瘤的终生绝对风险为0.76%。当加入人口统计学因素时,PRS-CS增强了病例中IDH突变状态的分类(AUC=0.839 vs. AUC=0.895,PΔAUC=6.8×10-9):结论:全基因组PRS有望提高高危人群的检测率,并有助于区分预后良好的胶质瘤亚型。
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引用次数: 0
Temozolomide use in elderly patients with MGMT promoter unmethylated glioblastoma: Is it finally time to dismount a dead horse? 在MGMT启动子未甲基化胶质母细胞瘤老年患者中使用替莫唑胺:终于到了死马当活马医的时候了吗?
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae143
Ugur T Sener, Erik P Sulman, Jann N Sarkaria
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引用次数: 0
Digital "flipbooks" for enhanced visual assessment of simple and complex brain tumors. 用于增强简单和复杂脑肿瘤视觉评估的数字 "活页"。
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae097
Nicholas S Cho, Viên Lam Le, Francesco Sanvito, Sonoko Oshima, Jayla Harper, Saewon Chun, Catalina Raymond, Albert Lai, Phioanh L Nghiemphu, Jingwen Yao, Richard Everson, Noriko Salamon, Timothy F Cloughesy, Benjamin M Ellingson

Typical longitudinal radiographic assessment of brain tumors relies on side-by-side qualitative visualization of serial magnetic resonance images (MRIs) aided by quantitative measurements of tumor size. However, when assessing slowly growing tumors and/or complex tumors, side-by-side visualization and quantification may be difficult or unreliable. Whole-brain, patient-specific "digital flipbooks" of longitudinal scans are a potential method to augment radiographic side-by-side reads in clinical settings by enhancing the visual perception of changes in tumor size, mass effect, and infiltration across multiple slices over time. In this approach, co-registered, consecutive MRI scans are displayed in a slide deck, where one slide displays multiple brain slices of a single timepoint in an array (eg, 3 × 5 "mosaic" view of slices). The flipbooks are viewed similarly to an animated flipbook of cartoons/photos so that subtle radiographic changes are visualized via perceived motion when scrolling through the slides. Importantly, flipbooks can be created easily with free, open-source software. This article describes the step-by-step methodology for creating flipbooks and discusses clinical scenarios for which flipbooks are particularly useful. Example flipbooks are provided in Supplementary Material.

脑肿瘤的典型纵向放射学评估依赖于序列磁共振成像(MRI)的并排定性观察和肿瘤大小的定量测量。然而,在评估生长缓慢的肿瘤和/或复杂肿瘤时,并排观察和量化可能会很困难或不可靠。针对患者的全脑纵向扫描 "数字翻转本 "是一种潜在的方法,可增强临床环境中的放射并排阅读,提高对肿瘤大小、肿块效应和浸润随时间在多个切片上的变化的视觉感知。在这种方法中,共登记的连续磁共振成像扫描以幻灯片的形式显示,其中一张幻灯片以阵列形式显示单个时间点的多个脑切片(如 3x5 的 "马赛克 "切片视图)。翻页书的观看方式类似于动画片/照片的翻页书,因此在滚动浏览幻灯片时,可以通过感知到的运动来直观地看到细微的放射学变化。重要的是,翻页书可以通过免费的开源软件轻松制作。本文介绍了制作翻页手册的逐步方法,并讨论了翻页手册特别有用的临床场景。在线补充材料中提供了翻页图书示例。
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引用次数: 0
Tools and toys beyond RANO 2.0: Digital flipbooks to monitor brain tumor growth dynamics? RANO 2.0 之外的工具和玩具:监测脑肿瘤生长动态的数字翻书?
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae141
Emilie Le Rhun, Michael Weller
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引用次数: 0
Response to the letter by Wang et al.: Selumetinib for plexiform neurofibroma: Advances and ongoing challenges. 回应 Wang 等人的信:赛鲁米替尼治疗丛状神经纤维瘤:进展与持续挑战。
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae181
Beom Hee Lee, Hyery Kim, Hee Mang Yoon
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引用次数: 0
Leptomeningeal metastases from solid tumors: A Society for Neuro-Oncology and American Society of Clinical Oncology consensus review on clinical management and future directions. 实体瘤的脑膜转移:关于临床管理和未来方向的 SNO 和 ASCO 共识综述。
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae103
Jessica A Wilcox, Ugonma N Chukwueke, Myung-Ju Ahn, Ayal A Aizer, Tejus A Bale, Dieta Brandsma, Priscilla K Brastianos, Susan Chang, Mariza Daras, Peter Forsyth, Livia Garzia, Michael Glantz, Isabella C Glitza Oliva, Priya Kumthekar, Emilie Le Rhun, Seema Nagpal, Barbara O'Brien, Elena Pentsova, Eudocia Quant Lee, Jan Remsik, Roberta Rudà, Inna Smalley, Michael D Taylor, Michael Weller, Jeffrey Wefel, Jonathan T Yang, Robert J Young, Patrick Y Wen, Adrienne A Boire

Leptomeningeal metastases (LM) are increasingly becoming recognized as a treatable, yet generally incurable, complication of advanced cancer. As modern cancer therapeutics have prolonged the lives of patients with metastatic cancer, specifically in patients with parenchymal brain metastases, treatment options, and clinical research protocols for patients with LM from solid tumors have similarly evolved to improve survival within specific populations. Recent expansions in clinical investigation, early diagnosis, and drug development have given rise to new unanswered questions. These include leptomeningeal metastasis biology and preferred animal modeling, epidemiology in the modern cancer population, ensuring validation and accessibility of newer leptomeningeal metastasis diagnostics, best clinical practices with multimodality treatment options, clinical trial design and standardization of response assessments, and avenues worthy of further research. An international group of multi-disciplinary experts in the research and management of LM, supported by the Society for Neuro-Oncology and American Society of Clinical Oncology, were assembled to reach a consensus opinion on these pressing topics and provide a roadmap for future directions. Our hope is that these recommendations will accelerate collaboration and progress in the field of LM and serve as a platform for further discussion and patient advocacy.

人们日益认识到,脑膜转移是晚期癌症的一种可治疗但通常无法治愈的并发症。随着现代癌症疗法延长了转移性癌症患者的生命,特别是脑实质转移患者的生命,针对实体瘤脑膜转移患者的治疗方案和临床研究方案也同样得到了发展,以提高特定人群的生存率。近来,临床研究、早期诊断和药物开发领域的扩展引发了新的未解之谜。这些问题包括脑膜转移生物学和首选动物模型、现代癌症人群的流行病学、确保更新的脑膜转移诊断方法的有效性和可及性、多模式治疗方案的最佳临床实践、临床试验设计和反应评估的标准化,以及值得进一步研究的途径。在神经肿瘤学会(Society for Neuro-Oncology)和美国临床肿瘤学会(American Society of Clinical Oncology)的支持下,研究和治疗脑转移瘤的多学科专家组成了一个国际小组,就这些紧迫的课题达成了共识,并为未来的发展方向提供了路线图。我们希望这些建议能加快脑膜外转移领域的合作与进步,并为进一步的讨论和患者权益维护提供一个平台。
{"title":"Leptomeningeal metastases from solid tumors: A Society for Neuro-Oncology and American Society of Clinical Oncology consensus review on clinical management and future directions.","authors":"Jessica A Wilcox, Ugonma N Chukwueke, Myung-Ju Ahn, Ayal A Aizer, Tejus A Bale, Dieta Brandsma, Priscilla K Brastianos, Susan Chang, Mariza Daras, Peter Forsyth, Livia Garzia, Michael Glantz, Isabella C Glitza Oliva, Priya Kumthekar, Emilie Le Rhun, Seema Nagpal, Barbara O'Brien, Elena Pentsova, Eudocia Quant Lee, Jan Remsik, Roberta Rudà, Inna Smalley, Michael D Taylor, Michael Weller, Jeffrey Wefel, Jonathan T Yang, Robert J Young, Patrick Y Wen, Adrienne A Boire","doi":"10.1093/neuonc/noae103","DOIUrl":"10.1093/neuonc/noae103","url":null,"abstract":"<p><p>Leptomeningeal metastases (LM) are increasingly becoming recognized as a treatable, yet generally incurable, complication of advanced cancer. As modern cancer therapeutics have prolonged the lives of patients with metastatic cancer, specifically in patients with parenchymal brain metastases, treatment options, and clinical research protocols for patients with LM from solid tumors have similarly evolved to improve survival within specific populations. Recent expansions in clinical investigation, early diagnosis, and drug development have given rise to new unanswered questions. These include leptomeningeal metastasis biology and preferred animal modeling, epidemiology in the modern cancer population, ensuring validation and accessibility of newer leptomeningeal metastasis diagnostics, best clinical practices with multimodality treatment options, clinical trial design and standardization of response assessments, and avenues worthy of further research. An international group of multi-disciplinary experts in the research and management of LM, supported by the Society for Neuro-Oncology and American Society of Clinical Oncology, were assembled to reach a consensus opinion on these pressing topics and provide a roadmap for future directions. Our hope is that these recommendations will accelerate collaboration and progress in the field of LM and serve as a platform for further discussion and patient advocacy.</p>","PeriodicalId":19377,"journal":{"name":"Neuro-oncology","volume":" ","pages":"1781-1804"},"PeriodicalIF":16.4,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11449070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141432455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The biological significance of tumor grade, age, enhancement, and extent of resection in IDH-mutant gliomas: How should they inform treatment decisions in the era of IDH inhibitors? IDH突变胶质瘤的肿瘤分级、年龄、增强程度和切除范围的生物学意义:在IDH抑制剂时代,它们应如何指导治疗决策?特邀评论。
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae107
Martin J van den Bent, Pim J French, Daniel Brat, Joerg C Tonn, Mehdi Touat, Benjamin M Ellingson, Robert J Young, Johan Pallud, Andreas von Deimling, Felix Sahm, Dominique Figarella Branger, Raymond Y Huang, Michael Weller, Ingo K Mellinghoff, Tim F Cloughsey, Jason T Huse, Kenneth Aldape, Guido Reifenberger, Gilbert Youssef, Philipp Karschnia, Houtan Noushmehr, Katherine B Peters, Francois Ducray, Matthias Preusser, Patrick Y Wen

The 2016 and 2021 World Health Organization 2021 Classification of central nervous system tumors have resulted in a major improvement in the classification of isocitrate dehydrogenase (IDH)-mutant gliomas. With more effective treatments many patients experience prolonged survival. However, treatment guidelines are often still based on information from historical series comprising both patients with IDH wild-type and IDH-mutant tumors. They provide recommendations for radiotherapy and chemotherapy for so-called high-risk patients, usually based on residual tumor after surgery and age over 40. More up-to-date studies give a better insight into clinical, radiological, and molecular factors associated with the outcome of patients with IDH-mutant glioma. These insights should be used today for risk stratification and for treatment decisions. In many patients with IDH-mutant grades 2 and 3 glioma, if carefully monitored postponing radiotherapy and chemotherapy is safe, and will not jeopardize the overall outcome of patients. With the INDIGO trial showing patient benefit from the IDH inhibitor vorasidenib, there is a sizable population in which it seems reasonable to try this class of agents before recommending radio-chemotherapy with its delayed adverse event profile affecting quality of survival. Ongoing trials should help to further identify the patients that are benefiting from this treatment.

世界卫生组织(WHO)2016 年和 2021 年的中枢神经系统(CNS)肿瘤分类对 IDH 突变胶质瘤的分类进行了重大改进。通过更有效的治疗,许多患者的生存期得以延长。然而,治疗指南通常仍基于由 IDHwt 和 IDH 突变肿瘤患者组成的历史系列资料。这些指南为所谓的高危患者提供放疗和化疗建议,通常以术后肿瘤残留和年龄超过 40 岁为依据。更多的最新研究使人们对与 IDH 突变胶质瘤患者预后相关的临床、放射学和分子因素有了更深入的了解。如今,这些见解应被用于风险分层和治疗决策。对于许多IDH突变的2级和3级胶质瘤患者来说,如果仔细监测,推迟放疗和化疗是安全的,也不会影响患者的总体预后。INDIGO试验显示,IDH抑制剂vorasidenib可使患者获益,因此,在推荐放化疗之前,先试用此类药物似乎是合理的,因为放化疗的延迟不良反应会影响患者的生存质量。正在进行的试验应有助于进一步确定哪些患者可从这种治疗中获益。
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引用次数: 0
Meningioma: International Consortium on Meningiomas consensus review on scientific advances and treatment paradigms for clinicians, researchers, and patients. 脑膜瘤:国际脑膜瘤联盟 (ICOM) 为临床医生、研究人员和患者提供的有关科学进展和治疗范例的共识综述。
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae082
Justin Z Wang, Alexander P Landry, David R Raleigh, Felix Sahm, Kyle M Walsh, Roland Goldbrunner, Leeor S Yefet, Jörg C Tonn, Chloe Gui, Quinn T Ostrom, Jill Barnholtz-Sloan, Arie Perry, Yosef Ellenbogen, C Oliver Hanemann, Gerhard Jungwirth, Michael D Jenkinson, Ghazaleh Tabatabai, Tiit I Mathiesen, Michael W McDermott, Marcos Tatagiba, Christian la Fougère, Sybren L N Maas, Norbert Galldiks, Nathalie L Albert, Priscilla K Brastianos, Felix Ehret, Giuseppe Minniti, Katrin Lamszus, Franz L Ricklefs, Jens Schittenhelm, Katharine J Drummond, Ian F Dunn, Omar N Pathmanaban, Aaron A Cohen-Gadol, Erik P Sulman, Emeline Tabouret, Emelie Le Rhun, Christian Mawrin, Jennifer Moliterno, Michael Weller, Wenya Linda Bi, Andrew Gao, Stephen Yip, Maximilian Niyazi, Kenneth Aldape, Patrick Y Wen, Susan Short, Matthias Preusser, Farshad Nassiri, Gelareh Zadeh

Meningiomas are the most common primary intracranial tumors in adults and are increasing in incidence due to the aging population and increased access to neuroimaging. While most exhibit nonmalignant behavior, a subset of meningiomas are biologically aggressive and are associated with treatment resistance, resulting in significant neurologic morbidity and even mortality. In recent years, meaningful advances in our understanding of the biology of these tumors have led to the incorporation of molecular biomarkers into their grading and prognostication. However, unlike other central nervous system (CNS) tumors, a unified molecular taxonomy for meningiomas has not yet been established and remains an overarching goal of the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy-Not Official World Health Organization (cIMPACT-NOW) working group. Additionally, clinical equipoise still remains on how specific meningioma cases and patient populations should be optimally managed. To address these existing gaps, members of the International Consortium on Meningiomas including field-leading experts, have prepared this comprehensive consensus narrative review directed toward clinicians, researchers, and patients. Included in this manuscript are detailed overviews of proposed molecular classifications, novel biomarkers, contemporary treatment strategies, trials on systemic therapies, health-related quality-of-life studies, and management strategies for unique meningioma patient populations. In each section, we discuss the current state of knowledge as well as ongoing clinical and research challenges to road map future directions for further investigation.

脑膜瘤是成人最常见的原发性颅内肿瘤,随着人口老龄化和神经影像学技术的发展,其发病率也在不断上升。虽然大多数脑膜瘤表现为非恶性,但也有一部分脑膜瘤具有生物侵袭性,会导致严重的神经系统发病率和死亡率。近年来,我们对脑膜瘤生物学特性的认识取得了重大进展,并将分子生物标志物纳入了脑膜瘤的分级和预后评估中。然而,与其他中枢神经系统肿瘤不同的是,脑膜瘤尚未建立统一的分子分类法,这仍是中枢神经系统肿瘤分类-非官方世卫组织(cIMPACT-NOW)工作组的首要目标。在如何对特定脑膜瘤病例和患者群体进行最佳管理方面,临床上也仍存在分歧。为了弥补这些现有的不足,国际脑膜瘤联盟(ICOM)的成员,包括该领域的权威专家,针对临床医生、研究人员和患者编写了一份全面的共识叙述性综述。本手稿详细概述了拟议的分子分类、新型生物标记物、当代治疗策略、系统疗法试验、与健康相关的生活质量研究以及针对特殊脑膜瘤患者群体的管理策略。在每一部分中,我们都讨论了当前的知识水平以及正在面临的临床和研究挑战,为未来的进一步研究指明了方向。
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引用次数: 0
Corrigendum to: LY6K promotes glioblastoma tumorigenicity via CAV-1-mediated ERK1/2 signaling enhancement. 更正:LY6K通过CAV-1介导的ERK1/2信号增强促进胶质母细胞瘤的致瘤性
IF 16.4 1区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-10-03 DOI: 10.1093/neuonc/noae151
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引用次数: 0
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Neuro-oncology
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