Alexandre Boutet, Mikail Malik, A. Yang, J. Germann, Samuel S Haile, Hyo Jin Son, Artur Vetkas, V. Pai, Warren P Mason, Gelareh Zadeh, Daniel M Mandell
The diagnosis of leptomeningeal metastatic disease has major prognostic and therapeutic implications. We report 13 patients with a radiologically distinct kind of focal, enhancing leptomeningeal lesion on brain MRI that mimics leptomeningeal metastatic disease. These patients were assessed at University Health Network (Toronto, Canada) between January 2001 and December 2023. Median age was 68 years (range, 55–78 years) and 10 patients were women. All patients had brain MRI including contrast-enhanced T2-weighted fluid attenuation inversion recovery (FLAIR) and T1-weighted spin echo sequences. MRI in all 13 patients showed a focal enhancing lesion located along the leptomeningeal surface of the brain. The MRI exams were reported as possible or likely leptomeningeal metastatic disease for the majority (9/13) of patients. Each lesion was curvilinear rather than sheet-like, and some lesions consisted of multiple connected/branching curvilinear structures with the appearance of abnormal vessels. Some lesions had a visible connection with a nearby cortical vein. The lesions were distinct from normal blood vessels. Follow-up contrast-enhanced brain MRI for 8/13 (62%) patients at a median of 3.9 years (IQR 2.4–6.6 years) showed all lesions were unchanged over time. Another 2/13 (15%) patients had clinical and CT brain follow-up after one year with no evidence of metastatic disease. We describe a distinct kind of focal, enhancing leptomeningeal lesion on brain MRI that mimics metastatic disease. These lesions are likely a type of low-flow vascular anomaly. Their curvilinear/branching shape and intense enhancement particularly on T2-weighted FLAIR images distinguishes these lesions from tumor.
{"title":"Focal Leptomeningeal Vascular Anomalies on Brain MRI: A Mimic of Leptomeningeal Metastatic Disease","authors":"Alexandre Boutet, Mikail Malik, A. Yang, J. Germann, Samuel S Haile, Hyo Jin Son, Artur Vetkas, V. Pai, Warren P Mason, Gelareh Zadeh, Daniel M Mandell","doi":"10.1093/nop/npae050","DOIUrl":"https://doi.org/10.1093/nop/npae050","url":null,"abstract":"\u0000 \u0000 \u0000 The diagnosis of leptomeningeal metastatic disease has major prognostic and therapeutic implications. We report 13 patients with a radiologically distinct kind of focal, enhancing leptomeningeal lesion on brain MRI that mimics leptomeningeal metastatic disease.\u0000 \u0000 \u0000 \u0000 These patients were assessed at University Health Network (Toronto, Canada) between January 2001 and December 2023.\u0000 \u0000 \u0000 \u0000 Median age was 68 years (range, 55–78 years) and 10 patients were women. All patients had brain MRI including contrast-enhanced T2-weighted fluid attenuation inversion recovery (FLAIR) and T1-weighted spin echo sequences. MRI in all 13 patients showed a focal enhancing lesion located along the leptomeningeal surface of the brain. The MRI exams were reported as possible or likely leptomeningeal metastatic disease for the majority (9/13) of patients. Each lesion was curvilinear rather than sheet-like, and some lesions consisted of multiple connected/branching curvilinear structures with the appearance of abnormal vessels. Some lesions had a visible connection with a nearby cortical vein. The lesions were distinct from normal blood vessels. Follow-up contrast-enhanced brain MRI for 8/13 (62%) patients at a median of 3.9 years (IQR 2.4–6.6 years) showed all lesions were unchanged over time. Another 2/13 (15%) patients had clinical and CT brain follow-up after one year with no evidence of metastatic disease.\u0000 \u0000 \u0000 \u0000 We describe a distinct kind of focal, enhancing leptomeningeal lesion on brain MRI that mimics metastatic disease. These lesions are likely a type of low-flow vascular anomaly. Their curvilinear/branching shape and intense enhancement particularly on T2-weighted FLAIR images distinguishes these lesions from tumor.\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141373504","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}
Danielle A Bazer, Anna Kolchinski, N. Bush, Jennifer L Clarke, Stephen J Bagley, K. Schreck
Combined BRAF and MEK inhibition is effective for some BRAFV600E altered gliomas, a cancer for which there are few effective therapies. While recent clinical trials demonstrate objective response rates of 30-40%, tolerable adverse event rates are 70-90% and 12-15% patients stop therapy for toxicity. There are no clear guidelines regarding timing and re-initiation of BRAF-targeted therapies following drug holidays. Here, we describe four patients with rapid disease progression during periods of treatment interruption. All patients experienced response upon resumption of targeted therapy. This is a multi-institutional, retrospective review of 4 patients. Three patients were diagnosed with BRAFV600E mutated anaplastic pleomorphic xanthoastrocytoma (aPXA) and one with epithelioid glioblastoma. The age range was 32 to 46; three patients were female and one patient was male. All patients were initially treated with radiation and were subsequently treated with BRAF/MEK inhibitors after disease progression. All patients with aPXA required the targeted therapy to be held due to toxicity and one patient held the therapy prior to transitioning to a novel BRAF-targeted agent. All patients were restarted on BRAF/MEK inhibitors after a drug holiday. Three patients required a dose reduction and all improved clinically following reinitiation. Clinical and radiographic progression may occur rapidly upon holding BRAF-targeted therapy, warranting judicious dose-reductions and minimization of drug holidays
{"title":"No drug holidays in BRAFV600E glioma patients: an argument for dose reduction of targeted therapies","authors":"Danielle A Bazer, Anna Kolchinski, N. Bush, Jennifer L Clarke, Stephen J Bagley, K. Schreck","doi":"10.1093/nop/npae046","DOIUrl":"https://doi.org/10.1093/nop/npae046","url":null,"abstract":"\u0000 \u0000 \u0000 Combined BRAF and MEK inhibition is effective for some BRAFV600E altered gliomas, a cancer for which there are few effective therapies. While recent clinical trials demonstrate objective response rates of 30-40%, tolerable adverse event rates are 70-90% and 12-15% patients stop therapy for toxicity. There are no clear guidelines regarding timing and re-initiation of BRAF-targeted therapies following drug holidays. Here, we describe four patients with rapid disease progression during periods of treatment interruption. All patients experienced response upon resumption of targeted therapy.\u0000 \u0000 \u0000 \u0000 This is a multi-institutional, retrospective review of 4 patients.\u0000 \u0000 \u0000 \u0000 Three patients were diagnosed with BRAFV600E mutated anaplastic pleomorphic xanthoastrocytoma (aPXA) and one with epithelioid glioblastoma. The age range was 32 to 46; three patients were female and one patient was male. All patients were initially treated with radiation and were subsequently treated with BRAF/MEK inhibitors after disease progression. All patients with aPXA required the targeted therapy to be held due to toxicity and one patient held the therapy prior to transitioning to a novel BRAF-targeted agent. All patients were restarted on BRAF/MEK inhibitors after a drug holiday. Three patients required a dose reduction and all improved clinically following reinitiation.\u0000 \u0000 \u0000 \u0000 Clinical and radiographic progression may occur rapidly upon holding BRAF-targeted therapy, warranting judicious dose-reductions and minimization of drug holidays\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141100875","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}
{"title":"Platform trials for rare cancers—A complex innovation to accelerate knowledge","authors":"Peter Hau, Michael C Frühwald","doi":"10.1093/nop/npae035","DOIUrl":"https://doi.org/10.1093/nop/npae035","url":null,"abstract":"","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141102499","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}
O. Näslund, Stina Jakobsson, E. Thurin, T. Skoglund, Jenny Pettersson-Segerlind, B. Brynedal, A. Jakola, Jiri Bartek
Asymptomatic patients with meningiomas are increasingly detected, where management can be challenging in terms of surgery versus watchful waiting. Health-related quality of life (HRQoL) is an important factor in clinical decision making, albeit not greatly studied in this patient group. The aim of this paper is to map the HRQoL among patients with surgically removed asymptomatic meningioma as compared to the general population. Patients with first time surgically treated asymptomatic meningioma between 2007 and 2013 were identified. Patients were invited 2017 to answer a survey regarding different aspects of quality of life, using EuroQoL (EQ)-5D-3L, perceived health, lifestyle, and occupancy. Data from electronic patient records was obtained. The patients were matched based on age and gender with data from the Stockholm Region Public Health Cohort database. There was no difference in EQ-5D-3L or visual analogue scale (VAS) between the patients and their matched controls. Patients and controls experienced ill health to the same extent, but patients felt to a greater extent that this impacted their way of life. In 36% of patients, preoperative occupation was not resumed, mostly due to cognitive symptoms. Additionally, the study suggested social detachment in this cohort, as significantly more patients were living alone and had less emotional support compared to controls. Although surgically treated patients with asymptomatic intracranial meningioma have similar overall HRQoL compared to the general population, surgery has an impact on return to work and cognitive function.
{"title":"Health-related Quality of Life in surgically treated asymptomatic meningioma patients: a population-based matched cohort study","authors":"O. Näslund, Stina Jakobsson, E. Thurin, T. Skoglund, Jenny Pettersson-Segerlind, B. Brynedal, A. Jakola, Jiri Bartek","doi":"10.1093/nop/npae047","DOIUrl":"https://doi.org/10.1093/nop/npae047","url":null,"abstract":"\u0000 \u0000 \u0000 Asymptomatic patients with meningiomas are increasingly detected, where management can be challenging in terms of surgery versus watchful waiting. Health-related quality of life (HRQoL) is an important factor in clinical decision making, albeit not greatly studied in this patient group. The aim of this paper is to map the HRQoL among patients with surgically removed asymptomatic meningioma as compared to the general population.\u0000 \u0000 \u0000 \u0000 Patients with first time surgically treated asymptomatic meningioma between 2007 and 2013 were identified. Patients were invited 2017 to answer a survey regarding different aspects of quality of life, using EuroQoL (EQ)-5D-3L, perceived health, lifestyle, and occupancy. Data from electronic patient records was obtained. The patients were matched based on age and gender with data from the Stockholm Region Public Health Cohort database.\u0000 \u0000 \u0000 \u0000 There was no difference in EQ-5D-3L or visual analogue scale (VAS) between the patients and their matched controls. Patients and controls experienced ill health to the same extent, but patients felt to a greater extent that this impacted their way of life. In 36% of patients, preoperative occupation was not resumed, mostly due to cognitive symptoms. Additionally, the study suggested social detachment in this cohort, as significantly more patients were living alone and had less emotional support compared to controls.\u0000 \u0000 \u0000 \u0000 Although surgically treated patients with asymptomatic intracranial meningioma have similar overall HRQoL compared to the general population, surgery has an impact on return to work and cognitive function.\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141100837","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}
Maeve M Pascoe, Alex R. Wollet, Julianie De La Cruz Minyety, Elizabeth Vera, Hope Miller, O. Celiku, H. Leeper, Kelly Fernandez, Jennifer Reyes, Demarrius Young, Alvina A. Acquaye-Mallory, Kendra A. Adegbesan, L. Boris, E. Burton, Claudia P Chambers, Anna Choi, E. Grajkowska, Tricia F. Kunst, Jason Levine, M. Panzer, M. Penas-Prado, V. Pillai, L. Polskin, Jing Wu, Mark R Gilbert, T. Mendoza, Amanda L King, Dorela D. Shuboni-Mulligan, Terri S Armstrong
Sleep-wake disturbances are common and disabling in primary brain tumor (PBT) patients but studies exploring longitudinal data are limited. This study investigates the feasibility and relationship between longitudinal patient-reported outcomes (PROs) and physiologic data collected via smart wearables. Fifty-four PBT patients ≥18 years wore Fitbit smart-wearable devices for 4 weeks, which captured physiologic sleep measures (e.g., total sleep time, wake after sleep onset (WASO)). They completed PROs (Sleep Hygiene Index, PROMIS Sleep-Related Impairment (SRI) and Sleep Disturbance (SD), Morningness-Eveningness Questionnaire (MEQ)) at baseline and 4 weeks. Smart wearable use feasibility (enrollment/attrition, data missingness), clinical characteristics, test consistency, PROs severity, and relationships between PROs and physiologic sleep measures were assessed. The majority (72%) wore their Fitbit for the entire study duration with 89% missing <3 days, no participant withdrawals, and 100% PRO completion. PROMIS SRI/SD and MEQ were all consistent/reliable (Cronbach’s alpha 0.74-0.92). Chronotype breakdown showed 39% morning, 56% intermediate, and only 6% evening types. Moderate-severe SD & SRI were reported in 13% and 17% at baseline, and with significant improvement in SD at 4 weeks (p=0.014). Fitbit-recorded measures showed a correlation at week 4 between WASO and SD (r=0.35, p=0.009) but not with SRI (r=0.24, p=0.08). Collecting sleep data with Fitbits is feasible, PROs are consistent/reliable, >10% of participants had SD and SRI that improved with smart wearable use, and SD was associated with WASO. The skewed chronotype distribution, risk and impact of sleep fragmentation mechanisms warrant further investigation.
{"title":"Assessing Sleep in Primary Brain Tumor Patients using Smart Wearables and Patient-Reported Data: Feasibility and Interim Analysis of an Observational Study","authors":"Maeve M Pascoe, Alex R. Wollet, Julianie De La Cruz Minyety, Elizabeth Vera, Hope Miller, O. Celiku, H. Leeper, Kelly Fernandez, Jennifer Reyes, Demarrius Young, Alvina A. Acquaye-Mallory, Kendra A. Adegbesan, L. Boris, E. Burton, Claudia P Chambers, Anna Choi, E. Grajkowska, Tricia F. Kunst, Jason Levine, M. Panzer, M. Penas-Prado, V. Pillai, L. Polskin, Jing Wu, Mark R Gilbert, T. Mendoza, Amanda L King, Dorela D. Shuboni-Mulligan, Terri S Armstrong","doi":"10.1093/nop/npae048","DOIUrl":"https://doi.org/10.1093/nop/npae048","url":null,"abstract":"\u0000 \u0000 \u0000 Sleep-wake disturbances are common and disabling in primary brain tumor (PBT) patients but studies exploring longitudinal data are limited. This study investigates the feasibility and relationship between longitudinal patient-reported outcomes (PROs) and physiologic data collected via smart wearables.\u0000 \u0000 \u0000 \u0000 Fifty-four PBT patients ≥18 years wore Fitbit smart-wearable devices for 4 weeks, which captured physiologic sleep measures (e.g., total sleep time, wake after sleep onset (WASO)). They completed PROs (Sleep Hygiene Index, PROMIS Sleep-Related Impairment (SRI) and Sleep Disturbance (SD), Morningness-Eveningness Questionnaire (MEQ)) at baseline and 4 weeks. Smart wearable use feasibility (enrollment/attrition, data missingness), clinical characteristics, test consistency, PROs severity, and relationships between PROs and physiologic sleep measures were assessed.\u0000 \u0000 \u0000 \u0000 The majority (72%) wore their Fitbit for the entire study duration with 89% missing <3 days, no participant withdrawals, and 100% PRO completion. PROMIS SRI/SD and MEQ were all consistent/reliable (Cronbach’s alpha 0.74-0.92). Chronotype breakdown showed 39% morning, 56% intermediate, and only 6% evening types. Moderate-severe SD & SRI were reported in 13% and 17% at baseline, and with significant improvement in SD at 4 weeks (p=0.014). Fitbit-recorded measures showed a correlation at week 4 between WASO and SD (r=0.35, p=0.009) but not with SRI (r=0.24, p=0.08).\u0000 \u0000 \u0000 \u0000 Collecting sleep data with Fitbits is feasible, PROs are consistent/reliable, >10% of participants had SD and SRI that improved with smart wearable use, and SD was associated with WASO. The skewed chronotype distribution, risk and impact of sleep fragmentation mechanisms warrant further investigation.\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141100680","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}
V. Di Nunno, L. Gatto, Marta Aprile, S. Bartolini, A. Tosoni, Enrico Franceschi
Within socio-economic variables, economic income has been associated with the prognosis of patients with glioblastoma. However, studies investigating this issue provided conflicting results We carried out a systematic review and meta-analysis of studies investigating the correlation between economic income and survival in patients with glioblastoma. The inverse variance technique for HR assessment has been employed reporting the random effect model. We included 12 studies for a total of 143303 GBM patients (67463 with high economic income, and 25679 with low economic income). In the overall analysis, lower economic income resulted in poorer survival (pooled HR 1.09, 95%CI, 1.02-1.17, I2=64%). Variables like the type of Health Care System (public, private, or mixed) and the time in which patients have been treated (pre or post-EORTC-NCIC trial 22981/26981, CE.3 protocol advent) did not modify survival on pooled analysis. Economic conditions and income influence the prognosis of patients with glioblastoma. A better understanding of the modifiable barriers leading to treatment disparities in more disadvantaged patients is warranted to make equal oncological care.
{"title":"Economic Income And Survival In Patients Affected By Glioblastoma: A Systematic Review And Meta-Analysis","authors":"V. Di Nunno, L. Gatto, Marta Aprile, S. Bartolini, A. Tosoni, Enrico Franceschi","doi":"10.1093/nop/npae045","DOIUrl":"https://doi.org/10.1093/nop/npae045","url":null,"abstract":"\u0000 \u0000 \u0000 Within socio-economic variables, economic income has been associated with the prognosis of patients with glioblastoma. However, studies investigating this issue provided conflicting results\u0000 \u0000 \u0000 \u0000 We carried out a systematic review and meta-analysis of studies investigating the correlation between economic income and survival in patients with glioblastoma. The inverse variance technique for HR assessment has been employed reporting the random effect model.\u0000 \u0000 \u0000 \u0000 We included 12 studies for a total of 143303 GBM patients (67463 with high economic income, and 25679 with low economic income). In the overall analysis, lower economic income resulted in poorer survival (pooled HR 1.09, 95%CI, 1.02-1.17, I2=64%). Variables like the type of Health Care System (public, private, or mixed) and the time in which patients have been treated (pre or post-EORTC-NCIC trial 22981/26981, CE.3 protocol advent) did not modify survival on pooled analysis.\u0000 \u0000 \u0000 \u0000 Economic conditions and income influence the prognosis of patients with glioblastoma. A better understanding of the modifiable barriers leading to treatment disparities in more disadvantaged patients is warranted to make equal oncological care.\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140990262","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}
Mr Joshua S Suppree, Miss Sophia Hart, Sumirat M. Keshwara, Miss Sandhya Trichinopoly Krishna, Conor S Gillespie, G. Richardson, M. Mustafa, Conor L Mallucci, Barry Pizer, James Hayden, A. Islim, Michael D Jenkinson, Mr Christopher P Millward
It is of vital importance to comprehensively and transparently report clinical trial activity. The SPIRIT 2013 and CONSORT 2010 statements exist to define items to be reported in clinical trial protocols and randomized controlled trials, respectively. The aim of this methodological review was to assess the reporting quality of pediatric neuro-oncology trial protocols and trial result articles. Published trial protocols and phase II/III trial result articles relating to pediatric brain tumours (published after the introduction of the SPIRIT 2013 statement), were identified through searches of 4 electronic bibliographic databases. The reporting quality of included trial protocols and result articles was assessed against the aforementioned statements. In addition, the CONSORT-A checklist was used to assess the abstracts of trial result articles. Percentage adherence was calculated for each article. 9 trial protocols, 68 phase II trials, and 8 phase III trial results articles were included. Mean adherence of trial protocols to the SPIRIT statement was 76.8% (SD: 0.09). Mean adherence of trial abstracts to CONSORT-A was 67.4% (SD: 0.13) for phase II abstracts and 47.5% (SD: 0.09) for phase III abstracts. Adherence of trial result articles to CONSORT was 71.3% (SD: 0.10) for phase II trials and 70.3% (SD: 0.13) for phase III trials. The reporting quality of pediatric neuro-oncology trial protocols and trial result articles requires improvement, particularly in the areas of randomization and blinding. This is consistent with our previously published findings following similar assessment of reporting quality for adult neuro-oncology trial protocols and result articles.
{"title":"Assessing the reporting quality of pediatric neuro-oncology protocols, abstracts and trials:Adherence to the SPIRIT and CONSORT statements","authors":"Mr Joshua S Suppree, Miss Sophia Hart, Sumirat M. Keshwara, Miss Sandhya Trichinopoly Krishna, Conor S Gillespie, G. Richardson, M. Mustafa, Conor L Mallucci, Barry Pizer, James Hayden, A. Islim, Michael D Jenkinson, Mr Christopher P Millward","doi":"10.1093/nop/npae042","DOIUrl":"https://doi.org/10.1093/nop/npae042","url":null,"abstract":"\u0000 \u0000 \u0000 It is of vital importance to comprehensively and transparently report clinical trial activity. The SPIRIT 2013 and CONSORT 2010 statements exist to define items to be reported in clinical trial protocols and randomized controlled trials, respectively. The aim of this methodological review was to assess the reporting quality of pediatric neuro-oncology trial protocols and trial result articles.\u0000 \u0000 \u0000 \u0000 Published trial protocols and phase II/III trial result articles relating to pediatric brain tumours (published after the introduction of the SPIRIT 2013 statement), were identified through searches of 4 electronic bibliographic databases. The reporting quality of included trial protocols and result articles was assessed against the aforementioned statements. In addition, the CONSORT-A checklist was used to assess the abstracts of trial result articles. Percentage adherence was calculated for each article.\u0000 \u0000 \u0000 \u0000 9 trial protocols, 68 phase II trials, and 8 phase III trial results articles were included. Mean adherence of trial protocols to the SPIRIT statement was 76.8% (SD: 0.09). Mean adherence of trial abstracts to CONSORT-A was 67.4% (SD: 0.13) for phase II abstracts and 47.5% (SD: 0.09) for phase III abstracts. Adherence of trial result articles to CONSORT was 71.3% (SD: 0.10) for phase II trials and 70.3% (SD: 0.13) for phase III trials.\u0000 \u0000 \u0000 \u0000 The reporting quality of pediatric neuro-oncology trial protocols and trial result articles requires improvement, particularly in the areas of randomization and blinding. This is consistent with our previously published findings following similar assessment of reporting quality for adult neuro-oncology trial protocols and result articles.\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140987406","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}
N. Agrawal, Jack M. Shireman, K. Shiue, A. Kamer, La Keisha Boyd, Y. Zang, Neel Mukherjee, James C. Miller, C. Kulwin, Aaron A. Cohen-Gadol, Troy Payner, Chih-Ta Lin, Jesse J. Savage, Brandon Lane, Bradley Bohnstedt, T. Lautenschlaeger, Naoyuki Saito, Mitesh Shah, G. Watson, Mahua Dey
Stereotactic radiosurgery (SRS) following surgical resection is the standard of care for patients with symptomatic oligo brain metastasis (BM), however, it is associated with 10-15% local failure. Targeting a resection cavity is imprecise, thus pre-operative radiosurgery where the target is well defined may be superior, however, the efficacy of pre-operative SRS has not yet been tested in a clinical trial. We conducted a phase II, single-arm trial of pre-operative SRS followed by surgical resection in patients with 1-4 symptomatic oligo BMs (NCT03398694) with the primary objective of measuring 6-month local control (LC). SRS was delivered to all patients utilizing gamma knife or linear accelerator as per RTOG-9005 dosing criteria24 based on tumor diameter with the exception that the largest lesion diameter treated was 5 cm with 15 Gy with all SRS treatment given in single fraction dosing. The trial screened 50 patients, 48 patients were treated under the protocol and 32 patients completed the entire follow-up period. Of all the patients who completed the follow-up period, primary endpoint of 6-month LC was 100% (95% CI: 0.891-1.000; p=0.005). Secondary endpoints, presented as medians, were overall-survival (17.6 months), progression-free survival (5.3 months), distant in-brain failure (40.8% at 1 year), leptomeningeal failure (4.8% at 1 year), and radiation necrosis (7.7% at 1 year). Our data confirms superior local control in patients who received pre-operative SRS when compared to historical controls. Further study with a larger randomized cohort of patients is warranted to fully understand the benefits of pre-operative SRS.
{"title":"Pre-operative Stereotactic Radiosurgery for Patients with One to Four Brain Metastases: A Single-Arm Phase 2 Trial Outcome Analysis (NCT03398694)","authors":"N. Agrawal, Jack M. Shireman, K. Shiue, A. Kamer, La Keisha Boyd, Y. Zang, Neel Mukherjee, James C. Miller, C. Kulwin, Aaron A. Cohen-Gadol, Troy Payner, Chih-Ta Lin, Jesse J. Savage, Brandon Lane, Bradley Bohnstedt, T. Lautenschlaeger, Naoyuki Saito, Mitesh Shah, G. Watson, Mahua Dey","doi":"10.1093/nop/npae043","DOIUrl":"https://doi.org/10.1093/nop/npae043","url":null,"abstract":"\u0000 \u0000 \u0000 Stereotactic radiosurgery (SRS) following surgical resection is the standard of care for patients with symptomatic oligo brain metastasis (BM), however, it is associated with 10-15% local failure. Targeting a resection cavity is imprecise, thus pre-operative radiosurgery where the target is well defined may be superior, however, the efficacy of pre-operative SRS has not yet been tested in a clinical trial.\u0000 \u0000 \u0000 \u0000 We conducted a phase II, single-arm trial of pre-operative SRS followed by surgical resection in patients with 1-4 symptomatic oligo BMs (NCT03398694) with the primary objective of measuring 6-month local control (LC). SRS was delivered to all patients utilizing gamma knife or linear accelerator as per RTOG-9005 dosing criteria24 based on tumor diameter with the exception that the largest lesion diameter treated was 5 cm with 15 Gy with all SRS treatment given in single fraction dosing.\u0000 \u0000 \u0000 \u0000 The trial screened 50 patients, 48 patients were treated under the protocol and 32 patients completed the entire follow-up period. Of all the patients who completed the follow-up period, primary endpoint of 6-month LC was 100% (95% CI: 0.891-1.000; p=0.005). Secondary endpoints, presented as medians, were overall-survival (17.6 months), progression-free survival (5.3 months), distant in-brain failure (40.8% at 1 year), leptomeningeal failure (4.8% at 1 year), and radiation necrosis (7.7% at 1 year).\u0000 \u0000 \u0000 \u0000 Our data confirms superior local control in patients who received pre-operative SRS when compared to historical controls. Further study with a larger randomized cohort of patients is warranted to fully understand the benefits of pre-operative SRS.\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140999693","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}
Martin Hong, Lucy Leigh, Connor Ballinger, Penny Reeves, Alisha Gooley, Sandy Nixon, Chris Paul, J. Lynam
Cancer care coordinators (CCCs) are recognised as having an important role in patients’ and carers’ cancer journey. However, there are no studies investigating the impact of CCCs on quantitative outcomes. We performed a retrospective cohort study investigating the impact of Brain Cancer Care Coordinators (BCCCs) on health service resource use and survival in patients with glioblastoma. All patients diagnosed with glioblastoma between 2012 and 2019 in Hunter New England Local Health District, Australia (HNELHD) were included and the patients were divided into two cohorts: before and after introduction of the BCCC. Any patient diagnosed in 2016, during the introduction of the BCCC, were excluded. Main outcomes assessed were overall survival, health service resource use, odds of being admitted to hospital after emergency presentation, and cost-offset analysis to examine the economic implications of BCCCs. A total of 187 patients were included. There were no significant differences in overall survival between the two groups (mOS 12.0 vs 11.16 months, HR 0.95). However, there was a reduction in the number of ED presentations and admissions. This was associated with a 24% reduction in aggregate length of stay with the BCCC. There was no statistically significant difference in mean patient costs, however our hospital may have saved over AUD$500,000 with BCCCs. The introduction of BCCC did not improve survival but appeared to be associated with reduced health resource utilisation. This study provides economic justification, in addition to established quality of life improvements, to support the presence of BCCCs.
{"title":"The Impact of Brain Cancer Care Coordinators on Healthcare Utilisation and Outcomes in Patients with Glioblastoma","authors":"Martin Hong, Lucy Leigh, Connor Ballinger, Penny Reeves, Alisha Gooley, Sandy Nixon, Chris Paul, J. Lynam","doi":"10.1093/nop/npae030","DOIUrl":"https://doi.org/10.1093/nop/npae030","url":null,"abstract":"\u0000 \u0000 \u0000 Cancer care coordinators (CCCs) are recognised as having an important role in patients’ and carers’ cancer journey. However, there are no studies investigating the impact of CCCs on quantitative outcomes. We performed a retrospective cohort study investigating the impact of Brain Cancer Care Coordinators (BCCCs) on health service resource use and survival in patients with glioblastoma.\u0000 \u0000 \u0000 \u0000 All patients diagnosed with glioblastoma between 2012 and 2019 in Hunter New England Local Health District, Australia (HNELHD) were included and the patients were divided into two cohorts: before and after introduction of the BCCC. Any patient diagnosed in 2016, during the introduction of the BCCC, were excluded. Main outcomes assessed were overall survival, health service resource use, odds of being admitted to hospital after emergency presentation, and cost-offset analysis to examine the economic implications of BCCCs.\u0000 \u0000 \u0000 \u0000 A total of 187 patients were included. There were no significant differences in overall survival between the two groups (mOS 12.0 vs 11.16 months, HR 0.95). However, there was a reduction in the number of ED presentations and admissions. This was associated with a 24% reduction in aggregate length of stay with the BCCC. There was no statistically significant difference in mean patient costs, however our hospital may have saved over AUD$500,000 with BCCCs.\u0000 \u0000 \u0000 \u0000 The introduction of BCCC did not improve survival but appeared to be associated with reduced health resource utilisation. This study provides economic justification, in addition to established quality of life improvements, to support the presence of BCCCs.\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141014389","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}
Susan Zelt, Tabitha Cooney, Sandie Yu, Shailaja Daral, Blake Krebs, Riddhi Markan, Peter Manley, Mark Kieran, Sandya Govinda Raju
Despite high long-term survival rates, pediatric low-grade gliomas (pLGGs) are linked with significant tumor- and treatment-associated morbidities that may persist throughout life. The aims of this descriptive cross-sectional pilot study were to characterize health conditions among a cohort of patients with pLGG and explore the feasibility of quantifying disease burden and healthcare resource utilization (HRU). Optum® Market Clarity Data were used to identify patients aged ≤18 years with an ICD-10 code for brain neoplasm, ≥1 physician notes, and with evidence of pLGG recorded between January 1, 2017 – June 30, 2018. Outcomes including health characteristics, HRU, medications, and procedures were assessed at six-month intervals over 36 months. 154 patients were identified with pLGG and over half experienced headache/migraine, respiratory infection, pain, or behavioral issues during the 36-month study period. The most common comorbidities were ocular/visual (including blindness), mental health disorders, seizure, and behavioral/cognition disorders. Most symptoms and comorbidities persisted or increased during the study period, indicating long-term health deficits. HRU, including specialty care visits, filled prescriptions, and administered medications, was common; 74% of patients had prescriptions for anti-infectives, 56% antiemetics, and 52% requiring pain or fever relief. Sixty-five percent of patients underwent treatment to control their pLGG, the most common being brain surgery. Little decline was observed in medication use during the study period. Patients with pLGG have complex healthcare needs requiring high HRU, often over a long time. Patients need to be optimally managed to minimize disease- and treatment-related burden and HRU.
{"title":"Disease burden and healthcare utilization in pediatric low-grade glioma: a United States retrospective study of linked claims and electronic health records","authors":"Susan Zelt, Tabitha Cooney, Sandie Yu, Shailaja Daral, Blake Krebs, Riddhi Markan, Peter Manley, Mark Kieran, Sandya Govinda Raju","doi":"10.1093/nop/npae037","DOIUrl":"https://doi.org/10.1093/nop/npae037","url":null,"abstract":"\u0000 \u0000 \u0000 Despite high long-term survival rates, pediatric low-grade gliomas (pLGGs) are linked with significant tumor- and treatment-associated morbidities that may persist throughout life. The aims of this descriptive cross-sectional pilot study were to characterize health conditions among a cohort of patients with pLGG and explore the feasibility of quantifying disease burden and healthcare resource utilization (HRU).\u0000 \u0000 \u0000 \u0000 Optum® Market Clarity Data were used to identify patients aged ≤18 years with an ICD-10 code for brain neoplasm, ≥1 physician notes, and with evidence of pLGG recorded between January 1, 2017 – June 30, 2018. Outcomes including health characteristics, HRU, medications, and procedures were assessed at six-month intervals over 36 months.\u0000 \u0000 \u0000 \u0000 154 patients were identified with pLGG and over half experienced headache/migraine, respiratory infection, pain, or behavioral issues during the 36-month study period. The most common comorbidities were ocular/visual (including blindness), mental health disorders, seizure, and behavioral/cognition disorders. Most symptoms and comorbidities persisted or increased during the study period, indicating long-term health deficits. HRU, including specialty care visits, filled prescriptions, and administered medications, was common; 74% of patients had prescriptions for anti-infectives, 56% antiemetics, and 52% requiring pain or fever relief. Sixty-five percent of patients underwent treatment to control their pLGG, the most common being brain surgery. Little decline was observed in medication use during the study period.\u0000 \u0000 \u0000 \u0000 Patients with pLGG have complex healthcare needs requiring high HRU, often over a long time. Patients need to be optimally managed to minimize disease- and treatment-related burden and HRU.\u0000","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140652048","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}
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