Pub Date : 2024-10-16DOI: 10.1007/s11060-024-04835-8
Danielle Terrell, Joseph Camarano, Stephen Whipple, Bharat Guthikonda, Robbie Beyl, W Christopher Newman
Purpose: There has been mounting interest in understanding the impact of financial toxicity (FT) in various cancer types; however, it remains poorly understood and understudied within neuro-oncology-especially as it relates to neurosurgical components of patient care.
Methods: Retrospective, single-center study of patients who underwent craniotomy for resection of glioblastoma from 2020 to 2022. OIBEE™ (Austin, Texas) software was queried to identify the subset of these patients who had a bad debt charged to their account. These patients were deemed to qualify as experiencing FT. Chi Square analysis was conducted between FT and non-FT patient groups. Additionally, survival analyses were performed to determine predictors of progression free and overall survival.
Results: 74 patients were included in this sample. 33/74 (44%) met criteria for FT. The average bad debt amount was $7,476.76 and the median debt amount was $2,015.96, with the average time to financial toxicity after surgery being approximately 127 days. FT patients were significantly younger at diagnosis than those who were not FT (64.6 years- non-FT vs. 59.0 years- FT, p = 0.0344). FT patients were more likely to have undergone subtotal resections rather than a gross total resection compared to non-FT patients (FT GTR 27.3%, non-FT GTR 52.4%, p = 0.028). Hospital length of stay was significantly longer for FT patients compared to non-FT patients (LOS FT 9.5 days, non-FT 6.5 days, p = 0.0312).
Conclusion: Glioblastoma patients are at high risk of experiencing FT with our series showing no significant impact on overall survival. Larger studies are needed to understand the impact of FT on patient outcomes.
目的:人们越来越关注了解财务毒性(FT)对各种癌症类型的影响;然而,在神经肿瘤学领域,人们对财务毒性的了解和研究仍然很少,尤其是与患者护理的神经外科部分有关的财务毒性:对 2020 年至 2022 年期间接受开颅手术切除胶质母细胞瘤的患者进行回顾性单中心研究。通过查询 OIBEE™(德克萨斯州奥斯汀)软件,确定这些患者中哪些人的账户被记入坏账。这些患者被认定为 FT 患者。在 FT 和非 FT 患者组之间进行了 Chi Square 分析。此外,还进行了生存分析,以确定无进展生存期和总生存期的预测因素:74名患者被纳入该样本。33/74(44%)的患者符合 FT 标准。平均坏账金额为 7,476.76 美元,中位数为 2,015.96 美元,术后出现财务毒性的平均时间约为 127 天。与非 FT 患者相比,FT 患者确诊时的年龄明显更小(非 FT 患者 64.6 岁,FT 患者 59.0 岁,P = 0.0344)。与非 FT 患者相比,FT 患者更有可能接受次全切除术,而不是全切除术(FT GTR 27.3%,非 FT GTR 52.4%,p = 0.028)。与非FT患者相比,FT患者的住院时间明显更长(LOS FT 9.5天,非FT 6.5天,p = 0.0312):结论:胶质母细胞瘤患者发生FT的风险很高,但我们的研究结果显示,FT对患者的总生存率没有明显影响。需要进行更大规模的研究,以了解FT对患者预后的影响。
{"title":"Financial toxicity in patients with glioblastoma.","authors":"Danielle Terrell, Joseph Camarano, Stephen Whipple, Bharat Guthikonda, Robbie Beyl, W Christopher Newman","doi":"10.1007/s11060-024-04835-8","DOIUrl":"https://doi.org/10.1007/s11060-024-04835-8","url":null,"abstract":"<p><strong>Purpose: </strong>There has been mounting interest in understanding the impact of financial toxicity (FT) in various cancer types; however, it remains poorly understood and understudied within neuro-oncology-especially as it relates to neurosurgical components of patient care.</p><p><strong>Methods: </strong>Retrospective, single-center study of patients who underwent craniotomy for resection of glioblastoma from 2020 to 2022. OIBEE™ (Austin, Texas) software was queried to identify the subset of these patients who had a bad debt charged to their account. These patients were deemed to qualify as experiencing FT. Chi Square analysis was conducted between FT and non-FT patient groups. Additionally, survival analyses were performed to determine predictors of progression free and overall survival.</p><p><strong>Results: </strong>74 patients were included in this sample. 33/74 (44%) met criteria for FT. The average bad debt amount was $7,476.76 and the median debt amount was $2,015.96, with the average time to financial toxicity after surgery being approximately 127 days. FT patients were significantly younger at diagnosis than those who were not FT (64.6 years- non-FT vs. 59.0 years- FT, p = 0.0344). FT patients were more likely to have undergone subtotal resections rather than a gross total resection compared to non-FT patients (FT GTR 27.3%, non-FT GTR 52.4%, p = 0.028). Hospital length of stay was significantly longer for FT patients compared to non-FT patients (LOS FT 9.5 days, non-FT 6.5 days, p = 0.0312).</p><p><strong>Conclusion: </strong>Glioblastoma patients are at high risk of experiencing FT with our series showing no significant impact on overall survival. Larger studies are needed to understand the impact of FT on patient outcomes.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142467848","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}
Pub Date : 2024-10-15DOI: 10.1007/s11060-024-04848-3
Daniele Armocida, Andrea Bianconi, Giuseppa Zancana, Tingting Jiang, Alessandro Pesce, Fulvio Tartara, Diego Garbossa, Maurizio Salvati, Antonio Santoro, Carlo Serra, Alessandro Frati
Purpose: The goal of glioma surgery is maximal tumor resection associated with minimal post-operative morbidity. Diffusion tensor imaging-tractography/fiber tracking (DTI-FT) is a valuable white-matter (WM) visualization tool for diagnosis and surgical planning. Still, it assumes a descriptive role since the main DTI metrics and parameters showed several limitations in clinical use. New applications and quantitative measurements were recently applied to describe WM architecture that surround the tumor area. The brain adjacent tumor area (BAT) is defined as the region adjacent to the gross tumor volume, which contains signal abnormalities on T2-weighted or FLAIR sequences. The DTI-FT analysis of the BAT can be adopted as predictive values and a guide for safe tumor resection.
Methods: This is an observational prospective study on an extensive series of glioma patients who performed magnetic resonance imaging (MRI) with pre-operative DTI-FT analyzed on the BAT by two different software. We examined DTI parameters of Fractional anisotropy (FA mean, min-max), Mean diffusivity (MD), and the shape-metric "tract irregularity" (TI) grade, comparing it with the surgical series' clinical, radiological, and outcome data.
Results: The population consisted of 118 patients, with a mean age of 60.6 years. 82 patients suffering from high-grade gliomas (69.5%), and 36 from low-grade gliomas (30.5%). A significant inverse relationship exists between the FA mean value and grading (p = 0.001). The relationship appears directly proportional regarding MD values (p = 0.003) and TI values (p = 0.005). FA mean and MD values are susceptible to significant variations with tumor and edema volume (p = 0.05). TI showed an independent relationship with grading regardless of tumor radiological features and dimensions, with a direct relationship with grading, ki67% (p = 0,05), PFS (p < 0.001), and EOR (p < 0.01).
Conclusion: FA, MD, and TI are useful predictive measures of the clinical behavior of glioma, and TI could be helpful for tumor grading identification and surgical planning.
{"title":"DTI fiber-tracking parameters adjacent to gliomas: the role of tract irregularity value in operative planning, resection, and outcome.","authors":"Daniele Armocida, Andrea Bianconi, Giuseppa Zancana, Tingting Jiang, Alessandro Pesce, Fulvio Tartara, Diego Garbossa, Maurizio Salvati, Antonio Santoro, Carlo Serra, Alessandro Frati","doi":"10.1007/s11060-024-04848-3","DOIUrl":"https://doi.org/10.1007/s11060-024-04848-3","url":null,"abstract":"<p><strong>Purpose: </strong>The goal of glioma surgery is maximal tumor resection associated with minimal post-operative morbidity. Diffusion tensor imaging-tractography/fiber tracking (DTI-FT) is a valuable white-matter (WM) visualization tool for diagnosis and surgical planning. Still, it assumes a descriptive role since the main DTI metrics and parameters showed several limitations in clinical use. New applications and quantitative measurements were recently applied to describe WM architecture that surround the tumor area. The brain adjacent tumor area (BAT) is defined as the region adjacent to the gross tumor volume, which contains signal abnormalities on T2-weighted or FLAIR sequences. The DTI-FT analysis of the BAT can be adopted as predictive values and a guide for safe tumor resection.</p><p><strong>Methods: </strong>This is an observational prospective study on an extensive series of glioma patients who performed magnetic resonance imaging (MRI) with pre-operative DTI-FT analyzed on the BAT by two different software. We examined DTI parameters of Fractional anisotropy (FA mean, min-max), Mean diffusivity (MD), and the shape-metric \"tract irregularity\" (TI) grade, comparing it with the surgical series' clinical, radiological, and outcome data.</p><p><strong>Results: </strong>The population consisted of 118 patients, with a mean age of 60.6 years. 82 patients suffering from high-grade gliomas (69.5%), and 36 from low-grade gliomas (30.5%). A significant inverse relationship exists between the FA mean value and grading (p = 0.001). The relationship appears directly proportional regarding MD values (p = 0.003) and TI values (p = 0.005). FA mean and MD values are susceptible to significant variations with tumor and edema volume (p = 0.05). TI showed an independent relationship with grading regardless of tumor radiological features and dimensions, with a direct relationship with grading, ki67% (p = 0,05), PFS (p < 0.001), and EOR (p < 0.01).</p><p><strong>Conclusion: </strong>FA, MD, and TI are useful predictive measures of the clinical behavior of glioma, and TI could be helpful for tumor grading identification and surgical planning.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142467846","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}
Pub Date : 2024-10-14DOI: 10.1007/s11060-024-04845-6
Benjamin R Klein, David J Levi, Ashish H Shah, Michael E Ivan, Allan D Levi
Purpose: This article examines the current state of social media (SoMe) in neuro-oncology and neurosurgical oncology. The goal of this paper is to provide thorough discourse regarding benefits and disadvantages of being a neurosurgical oncologist on SoMe, while discussing the place SoMe will have in cranial tumor-based practices going forward.
Methods: The author's performed a rigorous literature review on the topic. Included information was pertinent to the history of SoMe in neurosurgical oncology and its impact on the field of neuro-oncology. Incorporated as well are the benefits of being a neurosurgical oncologist on SoMe, the drawbacks of participation on SoMe platforms, and knowledge that facilitates discussion about the future of SoMe in neurosurgical oncology.
Results: SoMe plays an important role in neuro-oncology and neurosurgical oncology. SoMe continues to exponentially grow in the healthcare sphere as more providers utilize SoMe platforms. We report objective negative and positive outcomes of SoMe in neurosurgical oncology and neuro-oncology. Here, we summarize these results and provide dialogue describing the effect SoMe is having on the many different aspects of neurosurgical oncology and neuro-oncology.
Conclusion: Although SoMe platforms improve social presence and patient outreach, the use of SoMe can also adversely affect one's career by exposing clinicians to unchecked societal, legal and professional consequences. While using SoMe as a vessel to propagate career initiatives, neurosurgical oncologists should exercise caution with the content they choose to circulate.
目的:本文探讨了社交媒体(SoMe)在神经肿瘤学和神经外科肿瘤学中的应用现状。本文旨在深入探讨作为神经外科肿瘤学家在 SoMe 上的利弊,同时讨论 SoMe 在颅脑肿瘤实践中的未来地位:作者对该主题进行了严格的文献综述。其中包括有关 SoMe 在神经肿瘤外科的历史及其对神经肿瘤学领域的影响的信息。还包括作为神经外科肿瘤学家在SoMe平台上的益处、参与SoMe平台的弊端,以及有助于讨论SoMe在神经外科肿瘤学领域的未来的知识:SoMe在神经肿瘤学和神经外科肿瘤学中发挥着重要作用。随着越来越多的医疗服务提供者使用 SoMe 平台,SoMe 在医疗保健领域继续呈指数级增长。我们报告了 SoMe 在神经肿瘤外科和神经肿瘤学中的客观负面和正面结果。在此,我们总结了这些结果,并提供了对话,描述了SoMe对神经外科肿瘤学和神经肿瘤学许多不同方面的影响:尽管 SoMe 平台提高了社交影响力和患者外展能力,但使用 SoMe 也会使临床医生面临无法控制的社会、法律和专业后果,从而对其职业生涯产生不利影响。神经外科肿瘤学家在使用 SoMe 作为传播职业倡议的渠道时,应谨慎选择传播的内容。
{"title":"Social media \"SoMe\" in neuro-oncology: a review of the literature.","authors":"Benjamin R Klein, David J Levi, Ashish H Shah, Michael E Ivan, Allan D Levi","doi":"10.1007/s11060-024-04845-6","DOIUrl":"https://doi.org/10.1007/s11060-024-04845-6","url":null,"abstract":"<p><strong>Purpose: </strong>This article examines the current state of social media (SoMe) in neuro-oncology and neurosurgical oncology. The goal of this paper is to provide thorough discourse regarding benefits and disadvantages of being a neurosurgical oncologist on SoMe, while discussing the place SoMe will have in cranial tumor-based practices going forward.</p><p><strong>Methods: </strong>The author's performed a rigorous literature review on the topic. Included information was pertinent to the history of SoMe in neurosurgical oncology and its impact on the field of neuro-oncology. Incorporated as well are the benefits of being a neurosurgical oncologist on SoMe, the drawbacks of participation on SoMe platforms, and knowledge that facilitates discussion about the future of SoMe in neurosurgical oncology.</p><p><strong>Results: </strong>SoMe plays an important role in neuro-oncology and neurosurgical oncology. SoMe continues to exponentially grow in the healthcare sphere as more providers utilize SoMe platforms. We report objective negative and positive outcomes of SoMe in neurosurgical oncology and neuro-oncology. Here, we summarize these results and provide dialogue describing the effect SoMe is having on the many different aspects of neurosurgical oncology and neuro-oncology.</p><p><strong>Conclusion: </strong>Although SoMe platforms improve social presence and patient outreach, the use of SoMe can also adversely affect one's career by exposing clinicians to unchecked societal, legal and professional consequences. While using SoMe as a vessel to propagate career initiatives, neurosurgical oncologists should exercise caution with the content they choose to circulate.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142467851","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}
Pub Date : 2024-10-14DOI: 10.1007/s11060-024-04850-9
Melissa M Gardner, Sebastian F Winter, Franziska Stahl, Elizabeth R Gerstner, Helen A Shih, Janet Sherman, Jorg Dietrich, Michael W Parsons
Purpose: Radiation therapy (RT) is an integral treatment component in patients with glioma but associated with neurotoxicity. Proton RT (PRT), as compared with photon RT (XRT), reduces excess radiation to nontarget tissue. We used a retrospective method to evaluate brain imaging metrics of neurotoxicity after treatment with PRT and XRT for glioma.
Methods: We analyzed brain volume change in thirty-four patients with WHO grade 2-3 gliomas treated with either PRT (n = 17) or XRT (n = 17). Both groups were carefully matched by demographic/clinical criteria and assessed longitudinally for two years post-radiotherapy. Brain volume change was measured as ventricular volume expansion in the tumor free hemisphere (contralateral to RT target) as a proxy indicator of brain volume loss. We further assessed the impact of volumetric changes on cognition in PRT patients, who completed neuropsychological testing as part of an outcome study.
Results: We found significant ventricular volume increases in the contralesional hemisphere in both groups at two years post-RT (F(1, 31) = 18.45, p < 0.000, partial η2 = 0.373), with greater volume change observed in XRT (26.55%) vs. PRT (12.03%) (M = 12.03%, SD = 16.26; F(1,31) = 4.26, p = 0.048, partial η2 = 0.121). Although, there was no group-level change on any cognitive test in PRT treated patients, individual changes on cognitive screening, working memory, processing speed and visual memory tasks correlated with contralesional brain volume loss.
Conclusion: This study suggests progressive brain volume loss following cranial irradiation, with greater severity after XRT vs. PRT. Radiation-induced brain volume loss appears to be associated with measurable cognitive changes on an individual level. Prospective studies are warranted to validate these findings and their impacts on long-term cognitive function and quality of life. An improved understanding of the structural and functional consequences of cranial radiation is essential to develop neuroprotective strategies.
{"title":"Brain volume loss after cranial irradiation: a controlled comparison study between photon vs proton radiotherapy for WHO grade 2-3 gliomas.","authors":"Melissa M Gardner, Sebastian F Winter, Franziska Stahl, Elizabeth R Gerstner, Helen A Shih, Janet Sherman, Jorg Dietrich, Michael W Parsons","doi":"10.1007/s11060-024-04850-9","DOIUrl":"https://doi.org/10.1007/s11060-024-04850-9","url":null,"abstract":"<p><strong>Purpose: </strong>Radiation therapy (RT) is an integral treatment component in patients with glioma but associated with neurotoxicity. Proton RT (PRT), as compared with photon RT (XRT), reduces excess radiation to nontarget tissue. We used a retrospective method to evaluate brain imaging metrics of neurotoxicity after treatment with PRT and XRT for glioma.</p><p><strong>Methods: </strong>We analyzed brain volume change in thirty-four patients with WHO grade 2-3 gliomas treated with either PRT (n = 17) or XRT (n = 17). Both groups were carefully matched by demographic/clinical criteria and assessed longitudinally for two years post-radiotherapy. Brain volume change was measured as ventricular volume expansion in the tumor free hemisphere (contralateral to RT target) as a proxy indicator of brain volume loss. We further assessed the impact of volumetric changes on cognition in PRT patients, who completed neuropsychological testing as part of an outcome study.</p><p><strong>Results: </strong>We found significant ventricular volume increases in the contralesional hemisphere in both groups at two years post-RT (F(1, 31) = 18.45, p < 0.000, partial η2 = 0.373), with greater volume change observed in XRT (26.55%) vs. PRT (12.03%) (M = 12.03%, SD = 16.26; F(1,31) = 4.26, p = 0.048, partial η2 = 0.121). Although, there was no group-level change on any cognitive test in PRT treated patients, individual changes on cognitive screening, working memory, processing speed and visual memory tasks correlated with contralesional brain volume loss.</p><p><strong>Conclusion: </strong>This study suggests progressive brain volume loss following cranial irradiation, with greater severity after XRT vs. PRT. Radiation-induced brain volume loss appears to be associated with measurable cognitive changes on an individual level. Prospective studies are warranted to validate these findings and their impacts on long-term cognitive function and quality of life. An improved understanding of the structural and functional consequences of cranial radiation is essential to develop neuroprotective strategies.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142467910","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}
Pub Date : 2024-10-14DOI: 10.1007/s11060-024-04838-5
Kevin Morrow, Andrew Sloan, Jeffrey J Olson, D Ryan Ormond
<p><p>Target population These recommendations apply to adult patients with recurrent WHO grade 2 infiltrative diffuse glioma (oligodendroglioma, astrocytoma).Questions and Recommendations:Imaging Q1: In adult patients with suspected recurrence of histologically proven WHO grade 2 diffuse glioma, do advanced imaging techniques using magnetic resonance spectroscopy, perfusion weighted imaging, diffusion weighted imaging or PET provide superior assessment of tumor recurrence and histologic progression compared to standard MRI neuroimaging?Recommendation Level III: In adult patients with suspected recurrence of histologically proven WHO grade 2 diffuse glioma, advanced imaging techniques using magnetic resonance spectroscopy, perfusion weighted imaging, diffusion weighted imaging or PET are suggested for identification of tumor recurrence or histologic progression.Pathology Q1: In adult patients with suspected recurrence of histologically proven WHO grade 2 diffuse glioma, is molecular testing for IDH-1, IDH-2, and TP53 Mutations and MGMT promotor methylation mutation warranted for predicting survival and formulating treatment recommendations?Recommendation Level III: It is suggested that IDH mutation status be determined for diagnostic purposes. TP53 mutations occur early in WHO grade 2 diffuse glioma pathogenesis, remain stable, and are not suggested as a marker of predisposition to malignant transformation at recurrence or other measures of prognosis. Assessment of MGMT status is suggested as an adjunct to assessing prognosis. Assessment of CDK2NA status is suggested since this is associated with malignant progression of WHO grade 2 diffuse gliomas.Q2: In adult patients with suspected recurrence of histologically proven WHO Grade 2 diffuse glioma, is testing of proliferation indices (MIB-1 and/or BUdR) warranted for predicting survival and formulating treatment recommendations?Recommendation Level III: It is suggested that proliferative indices (MIB-1 or BUdR) be measured in WHO grade 2 diffuse glioma as higher proliferation indices are associated with increased likelihood of recurrence and shorter progression free and overall survival.Chemotherapy Q1: In adult patients with suspected recurrence of histologically proven WHO grade 2 diffuse glioma, does addition of temozolomide (TMZ), other cytotoxic agents or targeted agents to their treatment regimen improve PFS and/or OS?Recommendation Level III: Temozolomide is suggested in the therapy of recurrent WHO grade 2 diffuse glioma as it may improve clinical symptoms. PCV is suggested in the therapy of WHO grade 2 diffuse glioma at recurrence as it may improve clinical symptoms with the strongest evidence being for oligodendrogliomas. TMZ is suggested as the initial choice for recurrent WHO grade 2 diffuse glioma. Carboplatin is not suggested as there is no significant benefit from carboplatin as single agent therapy for recurrent WHO grade 2 diffuse gliomas. There is insufficient evidence to make any
这些建议适用于复发的WHO 2级浸润性弥漫性胶质瘤(少突胶质细胞瘤、星形细胞瘤)的成人患者。问题与建议:影像学问题1:对于组织学证实的WHO 2级弥漫性胶质瘤疑似复发的成人患者,与标准磁共振神经影像学相比,使用磁共振波谱、灌注加权成像、弥散加权成像或正电子发射计算机断层显像的高级影像学技术是否能提供更好的肿瘤复发和组织学进展评估?建议 III 级:对于组织学证实为 WHO 2 级弥漫性胶质瘤疑似复发的成人患者,建议使用磁共振波谱成像、灌注加权成像、弥散加权成像或 PET 等高级成像技术来鉴别肿瘤复发或组织学进展。病理问题 1:对于组织学证实的 WHO 2 级弥漫性胶质瘤疑似复发的成人患者,是否有必要进行 IDH-1、IDH-2 和 TP53 突变以及 MGMT 启动子甲基化突变的分子检测,以预测生存率并制定治疗建议?建议 III 级:建议为诊断目的确定 IDH 突变状态。TP53突变发生在WHO 2级弥漫性胶质瘤发病的早期,并保持稳定,不建议将其作为复发时恶性转化倾向的标志或其他预后指标。建议将 MGMT 状态评估作为评估预后的辅助手段。问题2:对于组织学证实为WHO 2级弥漫性胶质瘤的疑似复发成人患者,是否有必要检测增殖指数(MIB-1和/或BUdR)以预测生存率并制定治疗建议?建议 III 级:建议对 WHO 2 级弥漫性胶质瘤检测增殖指数(MIB-1 或 BUdR),因为增殖指数越高,复发的可能性越大,无进展生存期和总生存期越短。化疗问题1:对于组织学证实的WHO 2级弥漫性胶质瘤疑似复发的成人患者,在治疗方案中添加替莫唑胺(TMZ)、其他细胞毒性药物或靶向药物是否能改善PFS和/或OS?建议等级III:建议在治疗复发的WHO 2级弥漫性胶质瘤时使用替莫唑胺,因为它可以改善临床症状。建议将 PCV 用于治疗复发的 WHO 2 级弥漫性胶质瘤,因为它可以改善临床症状,其中证据最充分的是少突胶质瘤。建议将 TMZ 作为复发的 WHO 2 级弥漫性胶质瘤的初始选择。不建议使用卡铂,因为卡铂作为复发性WHO 2级弥漫性胶质瘤的单药治疗并无明显疗效。放疗问题1:对于组织学证实为WHO 2级弥漫性胶质瘤的疑似复发成人患者,在治疗方案中加入放疗是否能改善PFS和/或OS?建议等级III:如果既往未接受过放疗,建议在复发时进行放疗。问题2:对于既往接受过放疗、组织学证实为WHO 2级弥漫性胶质瘤疑似复发的成人患者,在治疗方案中增加再次放疗或质子治疗是否能改善PFS和/或OS?建议等级III:建议在WHO 2级弥漫性胶质瘤复发的情况下考虑再次放疗,因为它可能会为PFS和OS带来益处。 问题1:对于组织学证实为WHO 2级弥漫性胶质瘤疑似复发的成人患者,手术切除是否能改善PFS和/或OS?目前尚无足够证据就手术治疗的价值或切除范围与复发的WHO 2级弥漫性胶质瘤生存率的关系提出新的具体建议。
{"title":"Congress of Neurological Surgeons systematic review and evidence‑based guidelines on the management of recurrent diffuse low-grade glioma: update.","authors":"Kevin Morrow, Andrew Sloan, Jeffrey J Olson, D Ryan Ormond","doi":"10.1007/s11060-024-04838-5","DOIUrl":"https://doi.org/10.1007/s11060-024-04838-5","url":null,"abstract":"<p><p>Target population These recommendations apply to adult patients with recurrent WHO grade 2 infiltrative diffuse glioma (oligodendroglioma, astrocytoma).Questions and Recommendations:Imaging Q1: In adult patients with suspected recurrence of histologically proven WHO grade 2 diffuse glioma, do advanced imaging techniques using magnetic resonance spectroscopy, perfusion weighted imaging, diffusion weighted imaging or PET provide superior assessment of tumor recurrence and histologic progression compared to standard MRI neuroimaging?Recommendation Level III: In adult patients with suspected recurrence of histologically proven WHO grade 2 diffuse glioma, advanced imaging techniques using magnetic resonance spectroscopy, perfusion weighted imaging, diffusion weighted imaging or PET are suggested for identification of tumor recurrence or histologic progression.Pathology Q1: In adult patients with suspected recurrence of histologically proven WHO grade 2 diffuse glioma, is molecular testing for IDH-1, IDH-2, and TP53 Mutations and MGMT promotor methylation mutation warranted for predicting survival and formulating treatment recommendations?Recommendation Level III: It is suggested that IDH mutation status be determined for diagnostic purposes. TP53 mutations occur early in WHO grade 2 diffuse glioma pathogenesis, remain stable, and are not suggested as a marker of predisposition to malignant transformation at recurrence or other measures of prognosis. Assessment of MGMT status is suggested as an adjunct to assessing prognosis. Assessment of CDK2NA status is suggested since this is associated with malignant progression of WHO grade 2 diffuse gliomas.Q2: In adult patients with suspected recurrence of histologically proven WHO Grade 2 diffuse glioma, is testing of proliferation indices (MIB-1 and/or BUdR) warranted for predicting survival and formulating treatment recommendations?Recommendation Level III: It is suggested that proliferative indices (MIB-1 or BUdR) be measured in WHO grade 2 diffuse glioma as higher proliferation indices are associated with increased likelihood of recurrence and shorter progression free and overall survival.Chemotherapy Q1: In adult patients with suspected recurrence of histologically proven WHO grade 2 diffuse glioma, does addition of temozolomide (TMZ), other cytotoxic agents or targeted agents to their treatment regimen improve PFS and/or OS?Recommendation Level III: Temozolomide is suggested in the therapy of recurrent WHO grade 2 diffuse glioma as it may improve clinical symptoms. PCV is suggested in the therapy of WHO grade 2 diffuse glioma at recurrence as it may improve clinical symptoms with the strongest evidence being for oligodendrogliomas. TMZ is suggested as the initial choice for recurrent WHO grade 2 diffuse glioma. Carboplatin is not suggested as there is no significant benefit from carboplatin as single agent therapy for recurrent WHO grade 2 diffuse gliomas. There is insufficient evidence to make any","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142467912","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}
Pub Date : 2024-10-11DOI: 10.1007/s11060-024-04844-7
Lukasz Przepiorka, Sławomir Kujawski, Katarzyna Wójtowicz, Edyta Maj, Andrzej Marchel, Przemysław Kunert
Purpose: Vestibular schwannomas (VSs) represent the most common cerebellopontine angle tumors, posing a challenge in preserving facial nerve (FN) function during surgery. We employed the Extreme Gradient Boosting machine learning classifier to predict long-term FN outcomes (classified as House-Brackmann grades 1-2 for good outcomes and 3-6 for bad outcomes) after VS surgery.
Methods: In a retrospective analysis of 256 patients, comprehensive pre-, intra-, and post-operative factors were examined. We applied the machine learning (ML) classifier Extreme Gradient Boosting (XGBoost) for the following binary classification: long-term good and bad FN outcome after VS surgery To enhance the interpretability of our model, we utilized an explainable artificial intelligence approach.
Results: Short-term FN function (tau = 0.6) correlated with long-term FN function. The model exhibited an average accuracy of 0.83, a ROC AUC score of 0.91, and Matthew's correlation coefficient score of 0.62. The most influential feature, identified through SHapley Additive exPlanations (SHAP), was short-term FN function. Conversely, large tumor volume and absence of preoperative auditory brainstem responses were associated with unfavorable outcomes.
Conclusions: We introduce an effective ML model for classifying long-term FN outcomes following VS surgery. Short-term FN function was identified as the key predictor of long-term function. This model's excellent ability to differentiate bad and good outcomes makes it useful for evaluating patients and providing recommendations regarding FN dysfunction management.
{"title":"Development and application of explainable artificial intelligence using machine learning classification for long-term facial nerve function after vestibular schwannoma surgery.","authors":"Lukasz Przepiorka, Sławomir Kujawski, Katarzyna Wójtowicz, Edyta Maj, Andrzej Marchel, Przemysław Kunert","doi":"10.1007/s11060-024-04844-7","DOIUrl":"https://doi.org/10.1007/s11060-024-04844-7","url":null,"abstract":"<p><strong>Purpose: </strong>Vestibular schwannomas (VSs) represent the most common cerebellopontine angle tumors, posing a challenge in preserving facial nerve (FN) function during surgery. We employed the Extreme Gradient Boosting machine learning classifier to predict long-term FN outcomes (classified as House-Brackmann grades 1-2 for good outcomes and 3-6 for bad outcomes) after VS surgery.</p><p><strong>Methods: </strong>In a retrospective analysis of 256 patients, comprehensive pre-, intra-, and post-operative factors were examined. We applied the machine learning (ML) classifier Extreme Gradient Boosting (XGBoost) for the following binary classification: long-term good and bad FN outcome after VS surgery To enhance the interpretability of our model, we utilized an explainable artificial intelligence approach.</p><p><strong>Results: </strong>Short-term FN function (tau = 0.6) correlated with long-term FN function. The model exhibited an average accuracy of 0.83, a ROC AUC score of 0.91, and Matthew's correlation coefficient score of 0.62. The most influential feature, identified through SHapley Additive exPlanations (SHAP), was short-term FN function. Conversely, large tumor volume and absence of preoperative auditory brainstem responses were associated with unfavorable outcomes.</p><p><strong>Conclusions: </strong>We introduce an effective ML model for classifying long-term FN outcomes following VS surgery. Short-term FN function was identified as the key predictor of long-term function. This model's excellent ability to differentiate bad and good outcomes makes it useful for evaluating patients and providing recommendations regarding FN dysfunction management.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400438","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}
Background: Glioblastoma's infiltrative growth and heterogeneity are influenced by neural, molecular, genetic, and immunological factors, with the precise origin of these tumors remaining elusive. Neurogenic zones might serve as the tumor stem cells' nest, with tumors in contact with these zones exhibiting worse outcomes and more aggressive growth patterns. This study aimed to determine if these characteristics are reflected in advanced imaging, specifically diffusion and perfusion data.
Methods: In this monocentric retrospective study, 137 glioblastoma therapy-naive patients (IDH-wildtype, grade 4) with advanced preoperative MRI, including perfusion and diffusion imaging, were analyzed. Tumors and neurogenic zones were automatically segmented. Advanced imaging metrics, including cerebral blood volume (CBV) from perfusion imaging, tissue volume mask (TVM), and free water corrected fractional anisotropy (FA-FWE) from diffusion imaging, were extracted.
Results: SVZ infiltration positively correlated with CBV, indicating higher perfusion in tumors. Significant CBV differences were noted between high and low SVZ infiltration cases at specific percentiles. Negative correlation was observed with TVM and positive correlation with FA-FWE, suggesting more infiltrative tumor growth. Significant differences in TVM and FA-FWE values were found between high and low SVZ infiltration cases.
Discussion: Glioblastomas with SVZ infiltration exhibit distinct imaging characteristics, including higher perfusion and lower cell density per voxel, indicating a more infiltrative growth and higher vascularization. Stem cell-like characteristics in SVZ-infiltrating cells could explain the increased infiltration and aggressive behavior. Understanding these imaging and biological correlations could enhance the understanding of glioblastoma evolution.
{"title":"Advanced imaging reveals enhanced malignancy in glioblastomas involving the subventricular zone: evidence of increased infiltrative growth and perfusion.","authors":"Michael Griessmair, Severin Schramm, Julian Ziegenfeuter, Julian Canisius, Kirsten Jung, Claire Delbridge, Friederike Schmidt-Graf, Meike Mitsdoerffer, Claus Zimmer, Bernhard Meyer, Marie-Christin Metz, Benedikt Wiestler","doi":"10.1007/s11060-024-04849-2","DOIUrl":"https://doi.org/10.1007/s11060-024-04849-2","url":null,"abstract":"<p><strong>Background: </strong>Glioblastoma's infiltrative growth and heterogeneity are influenced by neural, molecular, genetic, and immunological factors, with the precise origin of these tumors remaining elusive. Neurogenic zones might serve as the tumor stem cells' nest, with tumors in contact with these zones exhibiting worse outcomes and more aggressive growth patterns. This study aimed to determine if these characteristics are reflected in advanced imaging, specifically diffusion and perfusion data.</p><p><strong>Methods: </strong>In this monocentric retrospective study, 137 glioblastoma therapy-naive patients (IDH-wildtype, grade 4) with advanced preoperative MRI, including perfusion and diffusion imaging, were analyzed. Tumors and neurogenic zones were automatically segmented. Advanced imaging metrics, including cerebral blood volume (CBV) from perfusion imaging, tissue volume mask (TVM), and free water corrected fractional anisotropy (FA-FWE) from diffusion imaging, were extracted.</p><p><strong>Results: </strong>SVZ infiltration positively correlated with CBV, indicating higher perfusion in tumors. Significant CBV differences were noted between high and low SVZ infiltration cases at specific percentiles. Negative correlation was observed with TVM and positive correlation with FA-FWE, suggesting more infiltrative tumor growth. Significant differences in TVM and FA-FWE values were found between high and low SVZ infiltration cases.</p><p><strong>Discussion: </strong>Glioblastomas with SVZ infiltration exhibit distinct imaging characteristics, including higher perfusion and lower cell density per voxel, indicating a more infiltrative growth and higher vascularization. Stem cell-like characteristics in SVZ-infiltrating cells could explain the increased infiltration and aggressive behavior. Understanding these imaging and biological correlations could enhance the understanding of glioblastoma evolution.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400424","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}
Pub Date : 2024-10-10DOI: 10.1007/s11060-024-04784-2
Marcel A Kamp, Larissa Fink, Marie-Therese Forster, Carolin Weiss Lucas, Aaron Lawson McLean, Anna Lawson McLean, Christian Freyschlag, Klaus-Peter Stein, Dorothee Wiewrodt, Felix Muehlensiepen, Florian H Ebner, Marion Rapp, Niklas Thon, Michael Sabel, Nazife Dinc, Christiane von Saß, Marco Stein, Christine Jungk
Objective: Treatment for malignant gliomas involves multiple disciplines, including neurosurgery, radiation therapy, medical and neuro-oncology, and palliative medicine, with function-preserving neurosurgical tumor removal being crucial. However, real-world data on hospital cases, treatment types, especially regarding surgical approaches, and the associated complication and mortality rates in Germany are lacking.
Methods: We analyzed data on hospital cases involving malignant gliomas (ICD-10-GM code C71) from the German §21 Hospital Remuneration Act, provided by the Institute for the Hospital Remuneration System (InEK GmbH), from 2019 to 2022. Our focus was on neuro-oncological operations defined by the German Cancer Society (DKG) and included specific operation and procedure (OPS) codes.
Results: From 2019 to 2022, there were 101,192 hospital cases involving malignant gliomas in Germany. Neurosurgical tumor removal was performed in 27,193 cases (26.9%). Microsurgical techniques were used in 95% of surgeries, intraoperative navigation systems in 84%, fluorescence-guided surgeries in 45.6%, and intraoperative neurophysiological monitoring (IONM) in 46.4%. Surgical or medical complications occurred in 2903 cases (10.7%). The hospital mortality rate was 2.7%. Mortality was significantly higher in patients aged 65 and older (Odds ratio 2.9, p < 0.0001), and lower in cases using fluorescence-guided procedures (Odds ratio 0.8, p = 0.015) and IONM (Odds ratio 0.5, p < 0.0001).
Conclusions: Over the course of 4 years, over 100,000 hospital cases involving adult patients diagnosed with malignant gliomas were treated in Germany, with 27,193 cases undergoing tumor removal using various modern surgical techniques. The hospital mortality rate was 2.7%.
{"title":"In-patient neurosurgical tumor treatments for malignant glioma patients in Germany.","authors":"Marcel A Kamp, Larissa Fink, Marie-Therese Forster, Carolin Weiss Lucas, Aaron Lawson McLean, Anna Lawson McLean, Christian Freyschlag, Klaus-Peter Stein, Dorothee Wiewrodt, Felix Muehlensiepen, Florian H Ebner, Marion Rapp, Niklas Thon, Michael Sabel, Nazife Dinc, Christiane von Saß, Marco Stein, Christine Jungk","doi":"10.1007/s11060-024-04784-2","DOIUrl":"https://doi.org/10.1007/s11060-024-04784-2","url":null,"abstract":"<p><strong>Objective: </strong>Treatment for malignant gliomas involves multiple disciplines, including neurosurgery, radiation therapy, medical and neuro-oncology, and palliative medicine, with function-preserving neurosurgical tumor removal being crucial. However, real-world data on hospital cases, treatment types, especially regarding surgical approaches, and the associated complication and mortality rates in Germany are lacking.</p><p><strong>Methods: </strong>We analyzed data on hospital cases involving malignant gliomas (ICD-10-GM code C71) from the German §21 Hospital Remuneration Act, provided by the Institute for the Hospital Remuneration System (InEK GmbH), from 2019 to 2022. Our focus was on neuro-oncological operations defined by the German Cancer Society (DKG) and included specific operation and procedure (OPS) codes.</p><p><strong>Results: </strong>From 2019 to 2022, there were 101,192 hospital cases involving malignant gliomas in Germany. Neurosurgical tumor removal was performed in 27,193 cases (26.9%). Microsurgical techniques were used in 95% of surgeries, intraoperative navigation systems in 84%, fluorescence-guided surgeries in 45.6%, and intraoperative neurophysiological monitoring (IONM) in 46.4%. Surgical or medical complications occurred in 2903 cases (10.7%). The hospital mortality rate was 2.7%. Mortality was significantly higher in patients aged 65 and older (Odds ratio 2.9, p < 0.0001), and lower in cases using fluorescence-guided procedures (Odds ratio 0.8, p = 0.015) and IONM (Odds ratio 0.5, p < 0.0001).</p><p><strong>Conclusions: </strong>Over the course of 4 years, over 100,000 hospital cases involving adult patients diagnosed with malignant gliomas were treated in Germany, with 27,193 cases undergoing tumor removal using various modern surgical techniques. The hospital mortality rate was 2.7%.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400439","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}
Pub Date : 2024-10-09DOI: 10.1007/s11060-024-04829-6
Jordina Rincon-Torroella, Maureen Rakovec, Anita L Kalluri, Kelly Jiang, Carly Weber-Levine, Megan Parker, Divyaansh Raj, Josh Materi, Sadra Sepehri, Abel Ferres, Karisa C Schreck, Iban Aldecoa, Calixto-Hope G Lucas, Haris I Sair, Kristin J Redmond, Matthias Holdhoff, Jon Weingart, Henry Brem, Josep J González Sánchez, Xiaobu Ye, Chetan Bettegowda
Purpose: Oligodendroglioma is an adult-type diffuse glioma defined by 1p/19q codeletion and IDH1/2 mutation. Treatment includes surgery followed by observation alone in select low-grade tumors, or combination radiation and chemotherapy with procarbazine, lomustine, and vincristine (PCV) or temozolomide (TMZ). While prospective studies investigating treatments for molecularly defined oligodendrogliomas are ongoing, this retrospective study analyzes the relationship between adjuvant regimens and progression-free survival (PFS).
Methods: Adults with IDH-mutant, 1p/19q codeleted oligodendroglioma (WHO grade 2 or 3) who underwent surgery between 2005 and 2021 were identified. Clinical data, disease characteristics, treatment, and outcomes were collected.
Results: A total of 207 patients with grade 2 and 70 with grade 3 oligodendrogliomas were identified. Median (IQR) follow-up was 57 (87) months. Patients with grade 3 tumors who received adjuvant radiation and PCV had longer median PFS (> 110 months) than patients who received radiation and TMZ (52 months, p = 0.008) or no adjuvant chemoradiation (83 months, p = 0.03), which was not seen in grade 2 tumors (p = 0.8). In multivariate analysis, patients who received PCV chemotherapy (Relative Risk [95% CI] = 0.24[0.05-1.08] and radiotherapy (0.46[0.21-1.02]) trended towards longer PFS, independently of grade.
Conclusion: Adjuvant radiation and PCV are associated with improved PFS over radiation with TMZ in patients with grade 3 molecularly defined oligodendrogliomas, and all-grade patients treated with PCV trended towards decreased risk of recurrence and progression. These results highlight the importance of ongoing clinical trials investigating these treatments.
{"title":"Impact of upfront adjuvant chemoradiation on survival in patients with molecularly defined oligodendroglioma: the benefits of PCV over TMZ.","authors":"Jordina Rincon-Torroella, Maureen Rakovec, Anita L Kalluri, Kelly Jiang, Carly Weber-Levine, Megan Parker, Divyaansh Raj, Josh Materi, Sadra Sepehri, Abel Ferres, Karisa C Schreck, Iban Aldecoa, Calixto-Hope G Lucas, Haris I Sair, Kristin J Redmond, Matthias Holdhoff, Jon Weingart, Henry Brem, Josep J González Sánchez, Xiaobu Ye, Chetan Bettegowda","doi":"10.1007/s11060-024-04829-6","DOIUrl":"https://doi.org/10.1007/s11060-024-04829-6","url":null,"abstract":"<p><strong>Purpose: </strong>Oligodendroglioma is an adult-type diffuse glioma defined by 1p/19q codeletion and IDH1/2 mutation. Treatment includes surgery followed by observation alone in select low-grade tumors, or combination radiation and chemotherapy with procarbazine, lomustine, and vincristine (PCV) or temozolomide (TMZ). While prospective studies investigating treatments for molecularly defined oligodendrogliomas are ongoing, this retrospective study analyzes the relationship between adjuvant regimens and progression-free survival (PFS).</p><p><strong>Methods: </strong>Adults with IDH-mutant, 1p/19q codeleted oligodendroglioma (WHO grade 2 or 3) who underwent surgery between 2005 and 2021 were identified. Clinical data, disease characteristics, treatment, and outcomes were collected.</p><p><strong>Results: </strong>A total of 207 patients with grade 2 and 70 with grade 3 oligodendrogliomas were identified. Median (IQR) follow-up was 57 (87) months. Patients with grade 3 tumors who received adjuvant radiation and PCV had longer median PFS (> 110 months) than patients who received radiation and TMZ (52 months, p = 0.008) or no adjuvant chemoradiation (83 months, p = 0.03), which was not seen in grade 2 tumors (p = 0.8). In multivariate analysis, patients who received PCV chemotherapy (Relative Risk [95% CI] = 0.24[0.05-1.08] and radiotherapy (0.46[0.21-1.02]) trended towards longer PFS, independently of grade.</p><p><strong>Conclusion: </strong>Adjuvant radiation and PCV are associated with improved PFS over radiation with TMZ in patients with grade 3 molecularly defined oligodendrogliomas, and all-grade patients treated with PCV trended towards decreased risk of recurrence and progression. These results highlight the importance of ongoing clinical trials investigating these treatments.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142391187","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}
Pub Date : 2024-10-08DOI: 10.1007/s11060-024-04846-5
Mary Jane Lim-Fat, Katrina Roberto, Patrick Y Wen
Biomarker-based clinical trials investigating targeted treatments for brain tumors have surged due to better access to biomarker testing and a deeper grasp of the molecular basis of tumor development. The design of clinical trials is crucial for evaluating safety, confirming effectiveness, and affirming the clinical advantage of novel agents, with the goal of approval by regulatory authorities to expand patient treatment options. Given some challenges unique to brain tumors, early-stage clinical trials for novel targeted agents must integrate pharmacokinetics and tissue-based pharmacodynamic assessments to establish timely go-no-go decisions for larger studies. Surgical window-of-opportunity trials can allow for the comparison of treated and untreated tumor samples, verifying target engagement and its modulatory effects for evidence of biological activity. Due to the challenges of achieving the required sample sizes to power efficacy analyses, later-stage trials of targeted therapies can include basket trials which test one drug on multiple tumor types, while umbrella trials evaluate several biomarkers within a single histology. Platform trials can also be leveraged to investigate multiple biomarker-driven hypotheses within a unified protocol and can incorporate Bayesian algorithms for adaptive randomization. Selecting appropriate endpoints, such as progression-free survival or overall response rate, is crucial and novel response assessment criteria need to be considered in the context of the tumor and therapy being investigated. Lastly, inclusivity in trials is essential to address health disparities and engage diverse patient populations to ensure real-world impact. Future trials should build upon the knowledge gained from both initial achievements and past setbacks in the field.
{"title":"Clinical trial design for novel targeted agents in neuro-oncology.","authors":"Mary Jane Lim-Fat, Katrina Roberto, Patrick Y Wen","doi":"10.1007/s11060-024-04846-5","DOIUrl":"https://doi.org/10.1007/s11060-024-04846-5","url":null,"abstract":"<p><p>Biomarker-based clinical trials investigating targeted treatments for brain tumors have surged due to better access to biomarker testing and a deeper grasp of the molecular basis of tumor development. The design of clinical trials is crucial for evaluating safety, confirming effectiveness, and affirming the clinical advantage of novel agents, with the goal of approval by regulatory authorities to expand patient treatment options. Given some challenges unique to brain tumors, early-stage clinical trials for novel targeted agents must integrate pharmacokinetics and tissue-based pharmacodynamic assessments to establish timely go-no-go decisions for larger studies. Surgical window-of-opportunity trials can allow for the comparison of treated and untreated tumor samples, verifying target engagement and its modulatory effects for evidence of biological activity. Due to the challenges of achieving the required sample sizes to power efficacy analyses, later-stage trials of targeted therapies can include basket trials which test one drug on multiple tumor types, while umbrella trials evaluate several biomarkers within a single histology. Platform trials can also be leveraged to investigate multiple biomarker-driven hypotheses within a unified protocol and can incorporate Bayesian algorithms for adaptive randomization. Selecting appropriate endpoints, such as progression-free survival or overall response rate, is crucial and novel response assessment criteria need to be considered in the context of the tumor and therapy being investigated. Lastly, inclusivity in trials is essential to address health disparities and engage diverse patient populations to ensure real-world impact. Future trials should build upon the knowledge gained from both initial achievements and past setbacks in the field.</p>","PeriodicalId":16425,"journal":{"name":"Journal of Neuro-Oncology","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142391186","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}