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A longer and/or better life for the oldest old with glioblastoma. 让患有胶质母细胞瘤的耄耋老人活得更长和/或更好。
IF 2.4 Q2 CLINICAL NEUROLOGY Pub Date : 2024-01-29 eCollection Date: 2024-04-01 DOI: 10.1093/nop/npae007
Katrina Roberto, James R Perry
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引用次数: 0
Diagnosing Pseudoprogression in Glioblastoma: A challenging clinical issue 诊断胶质母细胞瘤的假性进展:一个具有挑战性的临床问题
IF 2.7 Q2 CLINICAL NEUROLOGY Pub Date : 2023-12-13 DOI: 10.1093/nop/npad078
N. Galldiks
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引用次数: 0
Long-Term Neurocognitive and Psychological Outcomes in Meningioma Survivors: Individual Changes Over Time and Radiation Dosimetry 脑膜瘤幸存者的长期神经认知和心理结果:随时间和放射剂量的个体变化
Q2 CLINICAL NEUROLOGY Pub Date : 2023-11-05 DOI: 10.1093/nop/npad072
Angela Sekely, Konstantine K Zakzanis, Donald Mabbott, Derek S Tsang, Paul Kongkham, Gelareh Zadeh, Kim Edelstein
Abstract Background This study investigates long-term changes in neurocognitive performance and psychological symptoms in meningioma survivors, and associations with radiation dose to circumscribed brain regions. Methods We undertook a retrospective study of meningioma survivors who underwent longitudinal clinical neurocognitive assessments. Change in neurocognitive performance or psychological symptoms was assessed using reliable change indices. Radiation dosimetry, if prescribed, was evaluated based on treatment-planning computerized tomography co-registered with contrast-enhanced 3D T1-weighted magnetic resonance imaging. Mixed effects analyses were used to explore whether incidental radiation to brain regions outside the tumor influence neurocognitive and psychological outcomes. Results Most (range=41-93%) survivors demonstrated stable – albeit often below average - neurocognitive and psychological trajectories, although some also exhibited improvements (range=0-31%) or declines (range=0-36%) over time. Higher radiation dose to the parietal-occipital region (partial R2=0.462) and cerebellum (partial R2=0.276) was independently associated with slower visuomotor processing speed. Higher dose to the hippocampi was associated with increases in depression (partial R2=0.367) and trait anxiety (partial R2=0.236). Conclusions Meningioma survivors experience neurocognitive deficits and psychological symptoms many years after diagnosis, and a proportion of them decline over time. This study offers proof of concept that incidental radiation to brain regions beyond the tumor site may contribute to these sequelae. Future investigations should include radiation dosimetry when examining risk factors that contribute to quality of survivorship in this growing population.
背景本研究探讨脑膜瘤幸存者神经认知表现和心理症状的长期变化及其与限定脑区辐射剂量的关系。方法:我们对接受纵向临床神经认知评估的脑膜瘤幸存者进行回顾性研究。使用可靠的变化指数评估神经认知表现或心理症状的变化。如果有处方,则根据治疗计划的计算机断层扫描与对比增强的3D t1加权磁共振成像共同注册来评估辐射剂量。混合效应分析用于探讨肿瘤外脑区偶发辐射是否会影响神经认知和心理结果。大多数(范围=41-93%)幸存者表现出稳定的神经认知和心理轨迹,尽管通常低于平均水平,尽管一些人也表现出改善(范围=0-31%)或下降(范围=0-36%)随着时间的推移。顶枕区(部分R2=0.462)和小脑(部分R2=0.276)较高的辐射剂量与视觉运动加工速度较慢独立相关。高剂量海马与抑郁(偏R2=0.367)和特质焦虑(偏R2=0.236)增加相关。结论脑膜瘤幸存者在诊断多年后出现神经认知缺陷和心理症状,并且随着时间的推移,这些症状的比例下降。这项研究提供了一个概念的证据,即偶然辐射到肿瘤部位以外的大脑区域可能会导致这些后遗症。在这一不断增长的人群中,未来的调查应包括辐射剂量学,以检查影响生存质量的危险因素。
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引用次数: 0
Switch to generic formulation of temozolomide results in statistically significant increase in grade 3 and 4 bone marrow toxicity in glioma patients in the province of Alberta 在阿尔伯塔省,改用替莫唑胺仿制药导致胶质瘤患者3级和4级骨髓毒性显著增加
Q2 CLINICAL NEUROLOGY Pub Date : 2023-10-27 DOI: 10.1093/nop/npad065
Egiroh Omene, Omar Abdel-Rahman, Eugene Batuyong, Samir Patel, Roland Coppens, Jacob Easaw, Kelvin Young
Abstract Background Temozolomide (TMZ) is an oral, systemic chemotherapy used chiefly for treating high grade glioma. Due to the rising costs of systemic chemotherapy, many jurisdictions have replaced brand-name with generic formulations. The aim of this study was to determine whether or not there was difference in the incidence of grade 3 or 4 bone marrow toxicity and median overall survival in patients treated with brand-name vs generic TMZ in the province of Alberta, Canada. The province suspended use of generic TMZ based on preliminary data pointing to excess toxicity. Methods This multicenter, retrospective study included data from patients with newly diagnosed high grade glioma that received treatment with TMZ in Alberta. Multivariate logistic regression analysis was performed to determine association between grade 3 or 4 toxicity to generic vs. brand-name TMZ exposure, ECOG score and age. Kaplan-Meier survival estimates and log-rank testing were used to determine differences in overall survival between the brand-name and generic TMZ cohorts, as well as the cytopenic vs non-cytopenic patients. Furthermore, a screening analysis for grade 3 or 4 bone marrow toxicity was conducted on all de novo glioma patients treated with brand-name TMZ after Alberta preemptively stopped generic TMZ. Results Grade 3 or 4 neutropenia and thrombocytopenia were observed in 15% and 19% of patients treated with generic TMZ (n=156) as compared to 3% and 5% of patients (n=100) treated with brand-name TMZ treated patients; p= 0.003 and 0.001. A trend towards increased median overall survival in GBM patients treated with generic TMZ (13.7 months) versus brand-name (15.8 months, p = 0.178.) was also observed though meeting statistical significance. Based on these results, the province stopped the use of generic TMZ and reverted to the Merck TMZ. An initial review of all new glioma patients (n= 89) treated with Merck TMZ since the province stopped generic drug demonstrated 3.4% and 10.1% grade 3 or 4 neutropenia, and respectively. Conclusions The statistically significant difference in toxicity profile has prompted the province of Alberta to replace generic TMZ for brand-name TMZ in high grade glioma patients pending more detailed analysis. Our study provides evidence supporting the importance of conducting prospective studies on long-term safety for generic chemotherapies.
替莫唑胺(TMZ)是一种口服全身化疗药物,主要用于治疗高度胶质瘤。由于全身化疗费用的上升,许多司法管辖区已经用通用配方取代了品牌。本研究的目的是确定在加拿大阿尔伯塔省,品牌TMZ与通用TMZ治疗的患者在3级或4级骨髓毒性发生率和中位总生存期方面是否存在差异。根据初步数据显示的毒性超标,该省暂停了通用TMZ的使用。方法这项多中心回顾性研究纳入了阿尔伯塔省接受TMZ治疗的新诊断的高度胶质瘤患者的数据。进行多变量logistic回归分析,以确定3级或4级毒性对通用和品牌TMZ暴露,ECOG评分和年龄之间的关系。Kaplan-Meier生存估计和log-rank检验用于确定品牌和通用TMZ队列之间以及细胞减少与非细胞减少患者之间的总生存差异。此外,在Alberta预先停用仿制TMZ后,对所有接受品牌TMZ治疗的新生胶质瘤患者进行了3级或4级骨髓毒性筛选分析。结果3级或4级中性粒细胞减少症和血小板减少症分别在仿制TMZ治疗的患者中占15%和19% (n=156),而在名牌TMZ治疗的患者中占3%和5% (n=100);P = 0.003和0.001。通用TMZ治疗的GBM患者的中位总生存期(13.7个月)比品牌TMZ治疗的中位总生存期(15.8个月,p = 0.178.)也有增加的趋势,但符合统计学意义。基于这些结果,该省停止使用通用TMZ并恢复使用默克TMZ。自该省停用仿制药以来,对所有新发胶质瘤患者(n= 89)的初步审查显示,3级和4级中性粒细胞减少分别为3.4%和10.1%。结论:阿尔伯塔省在高级别胶质瘤患者中,毒性谱的统计学显著差异促使其将仿制TMZ替换为品牌TMZ,等待更详细的分析。我们的研究提供了证据,支持对非专利化疗的长期安全性进行前瞻性研究的重要性。
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引用次数: 0
Impact of CTV margin reduction in glioblastoma patients treated with concurrent chemoradiation 同步放化疗对胶质母细胞瘤患者CTV切缘减少的影响
Q2 CLINICAL NEUROLOGY Pub Date : 2023-10-27 DOI: 10.1093/nop/npad071
Dario Di Perri, David Hofstede, Dianne Hartgerink, Karin Terhaag, Ruud Houben, Alida A Postma, Ann Hoeben, Monique Anten, Linda Ackermans, Inge Compter, Daniëlle B P Eekers
Abstract Background Glioblastoma (GBM) is widely treated using large radiotherapy margins, resulting in substantial irradiation of the surrounding cerebral structures. In this context, the question arises whether these margins could be safely reduced. In 2018, clinical target volume (CTV) expansion was reduced in our institution from 20 to 15 mm around the gross target volume (GTV) (ie, the contrast-enhancing tumor/cavity). We sought to retrospectively analyze the impact of this reduction. Methods All adult patients with GBM treated between January 2015 and December 2020 with concurrent chemoradiation (60Gy/2Gy or 59.4Gy/1.8Gy) were analyzed. Patients treated using a 20 (CTV20, n = 57) or 15 mm (CTV15, n = 56) CTV margin were compared for target volumes, dose parameters to the surrounding organs, pattern of recurrence, and survival outcome. Results Mean GTV was similar in both groups (ie, CTV20: 39.7cm3; CTV15: 37.8cm3; P = .71). Mean CTV and PTV were reduced from 238.9cm3 to 176.7cm3 (P = .001) and from 292.6cm3 to 217.0cm3 (P < .001), for CTV20 and CTV15, respectively. As a result, average brain mean dose (Dmean) was reduced from 25.2Gy to 21.0Gy (P = .002). Significantly lower values were also observed for left hippocampus Dmean, brainstem D0.03cc, cochleas Dmean, and pituitary Dmean. Pattern of recurrence was similar, as well as patient outcome, ie, median progression-free survival was 8.0 and 7.0 months (P = .80), and median overall survival was 11.0 and 14.0 months (P = .61) for CTV20 and CTV15, respectively. Conclusions In GBM patients treated with chemoradiation, reducing the CTV margin from 20 to 15 mm appears to be safe and offers the potential for less treatment toxicity.
摘要背景胶质母细胞瘤(GBM)广泛使用大放射治疗边缘,导致周围大脑结构的大量照射。在这方面,问题是这些差额是否可以安全地减少。2018年,我院临床靶体积(CTV)的扩张范围从总靶体积(GTV)(即增强肿瘤/腔)周围的20毫米缩小到15毫米。我们试图回顾性分析这种减少的影响。方法分析2015年1月至2020年12月期间接受同步放化疗(60Gy/2Gy或59.4Gy/1.8Gy)治疗的所有成年GBM患者。采用20 (CTV20, n = 57)或15 mm (CTV15, n = 56) CTV切缘治疗的患者比较靶体积、对周围器官的剂量参数、复发模式和生存结果。结果两组平均GTV相似(CTV20: 39.7cm3;CTV15: 37.8立方厘米;P = .71)。平均CTV和PTV从238.9cm3降至176.7cm3 (P = 0.001),从292.6cm3降至217.0cm3 (P <.001),分别为CTV20和CTV15。结果脑平均剂量(Dmean)由25.2Gy降至21.0Gy (P = 0.002)。左海马Dmean、脑干D0.03cc、耳蜗Dmean、垂体Dmean均显著降低。复发模式和患者结局相似,即CTV20和CTV15的中位无进展生存期分别为8.0和7.0个月(P = 0.80),中位总生存期分别为11.0和14.0个月(P = 0.61)。结论在接受放化疗的GBM患者中,将CTV边缘从20 mm减少到15 mm似乎是安全的,并且有可能减少治疗毒性。
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引用次数: 0
Time to treat the climate and nature crisis as one indivisible global health emergency 是时候将气候和自然危机视为一个不可分割的全球卫生紧急事件
Q2 CLINICAL NEUROLOGY Pub Date : 2023-10-25 DOI: 10.1093/nop/npad066
Kamran Abbasi, Parveen Ali, Virginia Barbour, Thomas Benfield, Kirsten Bibbins-Domingo, Stephen Hancocks, Richard Horton, Laurie Laybourn-Langton, Robert Mash, Peush Sahni, Wadeia Mohammad Sharief, Paul Yonga, Chris Zielinski
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引用次数: 0
Glioblastoma in the oldest old: clinical characteristics, therapy and outcome in patients aged 80 years and older 老年胶质母细胞瘤:80岁及以上患者的临床特征、治疗和预后
Q2 CLINICAL NEUROLOGY Pub Date : 2023-10-20 DOI: 10.1093/nop/npad070
Christina Stadler, Dorothee Gramatzki, Emilie Le Rhun, Andreas F Hottinger, Thomas Hundsberger, Ulrich Roelcke, Heinz Läubli, Silvia Hofer, Katharina Seystahl, Hans-Georg Wirsching, Michael Weller, Patrick Roth
Abstract Background Incidence rates of glioblastoma in very old patients are rising. The standard of care for this cohort is only partially defined and survival remains poor. The aims of this study were to reveal current practice of tumor-specific therapy and supportive care, and to identify predictors for survival in this cohort. Methods Patients aged 80 years or older at the time of glioblastoma diagnosis were retrospectively identified in six clinical centers in Switzerland and France. Demographics, clinical parameters and survival outcomes were annotated from patient charts. Cox proportional hazards modeling was performed to identify parameters associated with survival. Results Of 107 patients, 45 were diagnosed by biopsy, 30 underwent subtotal resection and 25 had gross total resection. In 7 patients, the extent of resection was not specified. Post-operatively, 34 patients did not receive further tumor-specific treatment. Twelve patients received radiotherapy with concomitant temozolomide, but only 2 patients had maintenance temozolomide therapy. Fourteen patients received temozolomide alone, 35 patients radiotherapy alone, one patient received bevacizumab and one took part in a clinical trial. Median progression-free survival (PFS) was 3.3 months and median overall survival (OS) was 4.2 months. Among patients who received any postoperative treatment, median PFS was 3.9 months and median OS was 7.2 months. Karnofsky performance status (KPS) ≥ 70%, gross total resection and combination therapy were associated with better outcome. The median time spent hospitalized was 30 days, accounting for 23% of the median OS. End of life care was mostly provided by nursing homes (n = 20; 32%) and palliative care wards (n = 16; 26%). Conclusions In this cohort of very old patients diagnosed with glioblastoma, a large proportion was treated with best supportive care. Treatment beyond surgery and, in particular, combined modality treatment were associated with longer OS and may be considered for selected patients even at higher ages.
背景:胶质母细胞瘤在高龄患者中的发病率正在上升。该队列的护理标准仅部分确定,生存率仍然很低。本研究的目的是揭示当前肿瘤特异性治疗和支持性护理的实践,并确定该队列中生存的预测因素。方法回顾性分析瑞士和法国6个临床中心诊断为胶质母细胞瘤时年龄在80岁及以上的患者。人口统计学、临床参数和生存结果从患者图表中标注。采用Cox比例风险模型来确定与生存率相关的参数。结果107例患者中,活检确诊45例,次全切除30例,大体全切除25例。7例患者未明确切除范围。术后34例患者未接受进一步肿瘤特异性治疗。12例患者接受放疗联合替莫唑胺治疗,仅有2例患者接受替莫唑胺维持治疗。14例患者单独接受替莫唑胺治疗,35例患者单独接受放疗,1例患者接受贝伐单抗治疗,1例患者参加临床试验。中位无进展生存期(PFS)为3.3个月,中位总生存期(OS)为4.2个月。在接受任何术后治疗的患者中,中位PFS为3.9个月,中位OS为7.2个月。Karnofsky性能状态(KPS)≥70%,大体全切除和联合治疗的预后较好。中位住院时间为30天,占中位总生存期的23%。临终关怀主要由养老院提供(n = 20;32%)和姑息治疗病房(n = 16;26%)。结论:在这个诊断为胶质母细胞瘤的高龄患者队列中,很大一部分患者接受了最佳支持治疗。手术以外的治疗,特别是联合治疗与更长的生存期相关,甚至可以考虑在更高年龄的特定患者中使用。
{"title":"Glioblastoma in the oldest old: clinical characteristics, therapy and outcome in patients aged 80 years and older","authors":"Christina Stadler, Dorothee Gramatzki, Emilie Le Rhun, Andreas F Hottinger, Thomas Hundsberger, Ulrich Roelcke, Heinz Läubli, Silvia Hofer, Katharina Seystahl, Hans-Georg Wirsching, Michael Weller, Patrick Roth","doi":"10.1093/nop/npad070","DOIUrl":"https://doi.org/10.1093/nop/npad070","url":null,"abstract":"Abstract Background Incidence rates of glioblastoma in very old patients are rising. The standard of care for this cohort is only partially defined and survival remains poor. The aims of this study were to reveal current practice of tumor-specific therapy and supportive care, and to identify predictors for survival in this cohort. Methods Patients aged 80 years or older at the time of glioblastoma diagnosis were retrospectively identified in six clinical centers in Switzerland and France. Demographics, clinical parameters and survival outcomes were annotated from patient charts. Cox proportional hazards modeling was performed to identify parameters associated with survival. Results Of 107 patients, 45 were diagnosed by biopsy, 30 underwent subtotal resection and 25 had gross total resection. In 7 patients, the extent of resection was not specified. Post-operatively, 34 patients did not receive further tumor-specific treatment. Twelve patients received radiotherapy with concomitant temozolomide, but only 2 patients had maintenance temozolomide therapy. Fourteen patients received temozolomide alone, 35 patients radiotherapy alone, one patient received bevacizumab and one took part in a clinical trial. Median progression-free survival (PFS) was 3.3 months and median overall survival (OS) was 4.2 months. Among patients who received any postoperative treatment, median PFS was 3.9 months and median OS was 7.2 months. Karnofsky performance status (KPS) ≥ 70%, gross total resection and combination therapy were associated with better outcome. The median time spent hospitalized was 30 days, accounting for 23% of the median OS. End of life care was mostly provided by nursing homes (n = 20; 32%) and palliative care wards (n = 16; 26%). Conclusions In this cohort of very old patients diagnosed with glioblastoma, a large proportion was treated with best supportive care. Treatment beyond surgery and, in particular, combined modality treatment were associated with longer OS and may be considered for selected patients even at higher ages.","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":"33 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135567806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neuro-oncology clinical trial locations and social vulnerability in the United States 美国神经肿瘤学临床试验地点和社会脆弱性
Q2 CLINICAL NEUROLOGY Pub Date : 2023-10-20 DOI: 10.1093/nop/npad062
Gabriela T Gomez, Brandon E Turner, Kristin J Redmond, Curtiland Deville, Subha Perni
Journal Article Corrected proof Neuro-oncology clinical trial locations and social vulnerability in the United States Get access Gabriela T Gomez, Gabriela T Gomez Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, Maryland, USA https://orcid.org/0000-0002-1761-0070 Search for other works by this author on: Oxford Academic Google Scholar Brandon E Turner, Brandon E Turner Department of Radiation Oncology, Brigham and Women’s Hospital, Boston, Massachusetts, USA Search for other works by this author on: Oxford Academic Google Scholar Kristin J Redmond, Kristin J Redmond Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland, USA Search for other works by this author on: Oxford Academic Google Scholar Curtiland Deville, Jr, Curtiland Deville, Jr Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland, USA Search for other works by this author on: Oxford Academic Google Scholar Subha Perni Subha Perni Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA Corresponding Author: Subha Perni, MD, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Y2.5316, 1515 Holcombe Blvd, Houston TX, 77030, USA (SPerni@mdanderson.org) https://orcid.org/0000-0003-2851-4903 Search for other works by this author on: Oxford Academic Google Scholar Neuro-Oncology Practice, npad062, https://doi.org/10.1093/nop/npad062 Published: 20 October 2023 Article history Corrected and typeset: 20 October 2023 Published: 20 October 2023
期刊文章更正证明美国神经肿瘤学临床试验地点和社会脆弱性获取Gabriela T Gomez, Gabriela T Gomez流行病学系,约翰霍普金斯大学公共卫生学院,巴尔的摩,马里兰州,美国https://orcid.org/0000-0002-1761-0070牛津大学学术bbb学者布兰登·E·特纳,布兰登·E·特纳放射肿瘤科,布莱根妇女医院,波士顿,马萨诸塞州,美国,搜索作者的其他著作:牛津大学学术bb1学者克里斯汀·J·雷德蒙德,克里斯汀·J·雷德蒙德放射肿瘤学和分子辐射科学系,约翰霍普金斯大学,巴尔的摩,马里兰州,美国牛津大学学术谷歌学者Curtiland Deville, Jr, Curtiland Deville, Jr放射肿瘤学和分子放射科学系,约翰霍普金斯大学,巴尔的摩,马里兰州,美国搜索本文作者的其他著作:牛津大学学术谷歌学者Subha Perni Subha Perni放射肿瘤学部门,德克萨斯大学MD安德森癌症中心,休斯顿,德克萨斯州,美国通讯作者:Subha Perni,医学博士,放射肿瘤学部门,德克萨斯大学MD安德森癌症中心,Y2.5316, 1515 Holcombe Blvd, Houston TX, 77030, USA (SPerni@mdanderson.org) https://orcid.org/0000-0003-2851-4903搜索作者的其他作品:Oxford Academic谷歌Scholar neurooncology Practice, npad062, https://doi.org/10.1093/nop/npad062发表:2023年10月20日文章历史校正和排版:2023年10月20日发表:2023年10月20日
{"title":"Neuro-oncology clinical trial locations and social vulnerability in the United States","authors":"Gabriela T Gomez, Brandon E Turner, Kristin J Redmond, Curtiland Deville, Subha Perni","doi":"10.1093/nop/npad062","DOIUrl":"https://doi.org/10.1093/nop/npad062","url":null,"abstract":"Journal Article Corrected proof Neuro-oncology clinical trial locations and social vulnerability in the United States Get access Gabriela T Gomez, Gabriela T Gomez Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, Maryland, USA https://orcid.org/0000-0002-1761-0070 Search for other works by this author on: Oxford Academic Google Scholar Brandon E Turner, Brandon E Turner Department of Radiation Oncology, Brigham and Women’s Hospital, Boston, Massachusetts, USA Search for other works by this author on: Oxford Academic Google Scholar Kristin J Redmond, Kristin J Redmond Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland, USA Search for other works by this author on: Oxford Academic Google Scholar Curtiland Deville, Jr, Curtiland Deville, Jr Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland, USA Search for other works by this author on: Oxford Academic Google Scholar Subha Perni Subha Perni Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA Corresponding Author: Subha Perni, MD, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Y2.5316, 1515 Holcombe Blvd, Houston TX, 77030, USA (SPerni@mdanderson.org) https://orcid.org/0000-0003-2851-4903 Search for other works by this author on: Oxford Academic Google Scholar Neuro-Oncology Practice, npad062, https://doi.org/10.1093/nop/npad062 Published: 20 October 2023 Article history Corrected and typeset: 20 October 2023 Published: 20 October 2023","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":"70 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135567850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Final Report of the Phase II NEXT/CNS-GCT-4 Trial: GemPOx followed by Marrow-ablative Chemotherapy for Recurrent Intracranial Germ Cell Tumors II期NEXT/CNS-GCT-4试验的最终报告:GemPOx后骨髓消融化疗治疗复发性颅内生殖细胞瘤
Q2 CLINICAL NEUROLOGY Pub Date : 2023-10-14 DOI: 10.1093/nop/npad067
Margaret Shatara, Megan Blue, Joseph Stanek, Yin A Liu, Daniel M Prevedello, Pierre Giglio, Vinay K Puduvalli, Sharon L Gardner, Jeffrey C Allen, Kenneth K Wong, Marvin D Nelson, Floyd H Gilles, Roberta H Adams, Jasmine Pauly, Katrina O’Halloran, Ashley S Margol, Girish Dhall, Jonathan L Finlay
Abstract Background Patients with relapsed intracranial germinoma can achieve durable remission with standard chemotherapy regimens and/or re-irradiation; however, innovative therapies are required for patients with relapsed and/or refractory intracranial non-germinomatous germ cell tumors (NGGCTs) due to their poor prognosis. Improved outcomes have been reported using re-induction chemotherapy to achieve minimal residual disease, followed by marrow-ablative chemotherapy (HDCx) with autologous hematopoietic progenitor cell rescue (AuHPCR). We conducted a phase II trial evaluating the response and toxicity of a 3-drug combination developed for recurrent intracranial GCTs (iGCTs) consisting of gemcitabine, paclitaxel and oxaliplatin (GemPOx). Methods Nine patients with confirmed relapsed or refractory intracranial GCT were enrolled after signing informed consent, and received at least two cycles of GemPOx, of which all but one had relapsed or refractory NGGCTs. One patient with progressive disease was found to have pathologically confirmed malignant transformation to pure embryonal rhabdomyosarcoma (without GCT elements), hence was ineligible and not included in the analysis. Patients who experienced sufficient responses proceeded to receive HDCx with AuHPCR. Treatment response was determined based on radiographic tumor assessments and tumor markers. Results Seven patients achieved sufficient response and proceeded with HDCx and AuHPCR, and five subsequently received additional radiotherapy. Two patients developed progressive disease while receiving GemPOx. Myelosuppression and transaminitis were the most common treatment-related adverse events. With a mean follow-up of 44 months, 4 patients (3 NGGCTs, 1 germinoma) are alive without evidence of disease. Conclusion GemPOx demonstrates efficacy in facilitating stem cell mobilization, thus facilitating the feasibility of both HDCx and radiotherapy.
背景复发的颅内生殖细胞瘤患者可以通过标准化疗方案和/或再照射获得持久缓解;然而,由于复发和/或难治性颅内非生发性生殖细胞肿瘤(NGGCTs)预后不良,需要创新的治疗方法。有报道称,使用再诱导化疗来实现最小残留疾病,然后再使用骨髓消融化疗(HDCx)和自体造血祖细胞拯救(AuHPCR)来改善预后。我们进行了一项II期试验,评估由吉西他滨、紫杉醇和奥沙利铂(GemPOx)组成的三药联合治疗复发性颅内gct (igct)的疗效和毒性。方法入选9例确认为复发或难治性颅内GCT的患者,在签署知情同意书后,接受至少2个疗程的GemPOx治疗,其中除1例外均为复发或难治性nggct。1例进展性疾病患者病理证实恶性转化为纯胚胎性横纹肌肉瘤(无GCT元素),因此不符合条件,未纳入分析。有足够反应的患者继续接受AuHPCR的HDCx治疗。治疗效果是根据放射学肿瘤评估和肿瘤标志物来确定的。结果7例患者获得充分缓解,并进行了HDCx和AuHPCR治疗,5例患者随后接受了额外的放疗。两名患者在接受天花治疗时病情进展。骨髓抑制和转氨炎是最常见的治疗相关不良事件。平均随访44个月,4例患者(3例nggct, 1例生殖细胞瘤)存活,无疾病证据。结论GemPOx具有促进干细胞动员的作用,促进了HDCx和放疗的可行性。
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引用次数: 0
Use, Access, and Initial Outcomes of Off-Label Ivosidenib in Patients with IDH1 Mutant Glioma Ivosidenib在IDH1突变型胶质瘤患者中的使用、获取和初步结果
Q2 CLINICAL NEUROLOGY Pub Date : 2023-10-14 DOI: 10.1093/nop/npad068
Katherine B Peters, Candice Alford, Amy Heltemes, Alicia Savelli, Daniel B Landi, Gloria Broadwater, Annick Desjardins, Margaret O Johnson, Justin T Low, Mustafa Khasraw, David M Ashley, Henry S Friedman, Mallika P Patel
Abstract Background Isocitrate dehydrogenase (IDH) is commonly mutated (mIDH) in gliomas, and this mutant enzyme produces the oncometabolite 2-hydroxyglutarate (2HG). 2HG promotes gliomagenesis and is implicated in epileptogenesis. Ivosidenib (IVO), a small molecule oral mIDH1 inhibitor, is FDA-approved for mIDH1 newly diagnosed and relapsed/refractory acute myeloid leukemia. Moreover, IVO has efficacy in clinical trials for recurrent mIDH1 gliomas. Given the lack of targeted treatments for gliomas, we initiated off-label IVO for mIDH glioma patients in October 2020. Methods Retrospectively, we sought to assess early outcomes in our patients and describe their experience on IVO from October 2020 through February 2022. Our objective was to report on the following variables of off-label use of IVO: radiographic response, seizure control, tolerability, and access to the medication. All patients initially received single-agent IVO dosed at 500 mg orally once daily. Results The cohort age range was 21–74 years. Tumor types included astrocytoma (n = 14) and oligodendroglioma (n = 16), with most being grade 2 (n = 21). The best radiographic response in nonenhancing disease (n = 22) was 12 stable diseases, 5 minor responses, 3 partial responses, and 2 progressive diseases. Seizure frequency was stable to improved for most patients (70%, n = 21). IVO was well-tolerated, with the most common toxicities being diarrhea, elevated creatine kinase, and QTc interval prolongation. Most patients (66.7%, n = 20) received drugs via the patient assistance program, with insurance initially covering a third of patients and with ongoing use, later covering 60%. Conclusions Targeted therapies like IVO are options for mIDH glioma patients and can provide positive oncologic and neurological outcomes.
背景异柠檬酸脱氢酶(IDH)在胶质瘤中通常发生突变(mIDH),这种突变酶产生肿瘤代谢物2-羟基戊二酸(2HG)。2HG促进胶质瘤形成,并与癫痫发生有关。Ivosidenib (IVO)是一种小分子口服mIDH1抑制剂,已获fda批准用于治疗mIDH1新诊断和复发/难治性急性髓性白血病。此外,IVO在临床试验中对复发性mIDH1胶质瘤有疗效。鉴于缺乏针对胶质瘤的靶向治疗,我们于2020年10月启动了mIDH胶质瘤患者的标签外IVO。方法回顾性地评估患者的早期结局,并描述他们在2020年10月至2022年2月期间进行IVO的经历。我们的目的是报告IVO说明书外使用的以下变量:影像学反应、癫痫控制、耐受性和药物的可及性。所有患者最初均接受单药IVO治疗,剂量为500mg,每日口服一次。结果队列年龄21 ~ 74岁。肿瘤类型包括星形细胞瘤(n = 14)和少突胶质细胞瘤(n = 16),其中大多数为2级(n = 21)。非增强性疾病的最佳x线反应(n = 22)为稳定疾病12例,轻微反应5例,部分反应3例,进展性疾病2例。大多数患者的癫痫发作频率稳定或改善(70%,n = 21)。IVO耐受性良好,最常见的毒性是腹泻、肌酸激酶升高和QTc间期延长。大多数患者(66.7%,n = 20)通过患者援助计划获得药物,保险最初覆盖三分之一的患者,持续使用,后来覆盖60%。结论IVO等靶向治疗是mIDH胶质瘤患者的选择,可以提供积极的肿瘤学和神经学结果。
{"title":"Use, Access, and Initial Outcomes of Off-Label Ivosidenib in Patients with IDH1 Mutant Glioma","authors":"Katherine B Peters, Candice Alford, Amy Heltemes, Alicia Savelli, Daniel B Landi, Gloria Broadwater, Annick Desjardins, Margaret O Johnson, Justin T Low, Mustafa Khasraw, David M Ashley, Henry S Friedman, Mallika P Patel","doi":"10.1093/nop/npad068","DOIUrl":"https://doi.org/10.1093/nop/npad068","url":null,"abstract":"Abstract Background Isocitrate dehydrogenase (IDH) is commonly mutated (mIDH) in gliomas, and this mutant enzyme produces the oncometabolite 2-hydroxyglutarate (2HG). 2HG promotes gliomagenesis and is implicated in epileptogenesis. Ivosidenib (IVO), a small molecule oral mIDH1 inhibitor, is FDA-approved for mIDH1 newly diagnosed and relapsed/refractory acute myeloid leukemia. Moreover, IVO has efficacy in clinical trials for recurrent mIDH1 gliomas. Given the lack of targeted treatments for gliomas, we initiated off-label IVO for mIDH glioma patients in October 2020. Methods Retrospectively, we sought to assess early outcomes in our patients and describe their experience on IVO from October 2020 through February 2022. Our objective was to report on the following variables of off-label use of IVO: radiographic response, seizure control, tolerability, and access to the medication. All patients initially received single-agent IVO dosed at 500 mg orally once daily. Results The cohort age range was 21–74 years. Tumor types included astrocytoma (n = 14) and oligodendroglioma (n = 16), with most being grade 2 (n = 21). The best radiographic response in nonenhancing disease (n = 22) was 12 stable diseases, 5 minor responses, 3 partial responses, and 2 progressive diseases. Seizure frequency was stable to improved for most patients (70%, n = 21). IVO was well-tolerated, with the most common toxicities being diarrhea, elevated creatine kinase, and QTc interval prolongation. Most patients (66.7%, n = 20) received drugs via the patient assistance program, with insurance initially covering a third of patients and with ongoing use, later covering 60%. Conclusions Targeted therapies like IVO are options for mIDH glioma patients and can provide positive oncologic and neurological outcomes.","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135767397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Neuro-oncology practice
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