bluuebunny/crossref_metadata_2025_split huggingface dataset:
QOLP-04. PILOT STUDY OF A VIDEOCONFERENCE-BASED PSYCHOLOGICAL INTERVENTION FOR FAMILY CAREGIVERS OF PATIENTS WITH MALIGNANT GLIOMAS
Authors: Forst Deborah , Mesa Michelle , Kaslow-Zieve Emilia , El-Jawahri Areej , Greer Joseph , Sereno Isabella , Corveleyn Amy , Anand Maya , Landay Sophia , Horenstein Arielle , Temel Jennifer , Jacobs Jamie 
Published: December 2020

Abstract

BACKGROUND
Caregivers of patients with malignant gliomas experience substantial anxiety symptoms while caring for someone with progressive neurological decline. Yet, interventions to reduce psychological distress and improve quality of life (QoL) in this caregiver population are lacking.

METHODS
We conducted an open pilot study evaluating feasibility and acceptability of a cognitive behavioral therapy-based intervention for caregivers of patients with malignant gliomas with clinically significant anxiety (Generalized Anxiety Disorder [GAD-7] score ≥ 5). Caregivers participated in six videoconference sessions with a mental health provider. We defined the intervention as feasible if ≥ 70% of eligible caregivers enrolled and ≥ 70% of those enrolled completed ≥ 50% of sessions. We evaluated intervention acceptability in semi-structured interviews. Caregivers completed baseline and post-intervention surveys assessing anxiety and depression symptoms (Hospital Anxiety and Depression Scale), QoL (Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), self-efficacy (Lewis Cancer Self-Efficacy Scale), and perceived coping skills (Measure of Current Status-Part A). We explored post-intervention changes using paired t-tests.

RESULTS
We obtained consent from 70.0% (21/30) of caregivers approached, of which 66.7% (14/21) had clinically significant anxiety and thus were eligible to participate (mean age=55.7 years, 64.3% female). Among enrolled caregivers, 71.4% (10/14) completed ≥ 50% of sessions. In semi-structured interviews, all participants found the intervention helpful and valued the ability to participate remotely via videoconference. Among caregivers who completed at least one session, 80.0% (8/10) completed all assessments and were included in analyses. Post-intervention, caregivers reported reduced anxiety symptoms (P=.02) and improved QoL (P=.03) and coping skills (P=.001). We found no significant change in depression, caregiving burden, or self-efficacy.

CONCLUSION
Our videoconference-based intervention is feasible and acceptable to caregivers. Participants reported significant improvements in anxiety symptoms, quality of life, and coping skills post-intervention, supporting further investigation of the intervention in a randomized controlled trial.
QOLP-24. ENGAGING PATIENTS AND CAREGIVERS TO IMPROVE THE IMPORTANCE AND QUALITY OF SUPPORTIVE CARE RESEARCH IN NEURO-ONCOLOGY
Authors: Peters Katherine , Randazzo Dina , Johnson Margaret , Kim Jung-Young , Patel Mallika , Affronti Mary 
Published: December 2020

Abstract

BACKGROUND
From the time of diagnosis to end of life, patients with primary brain tumors experience challenges to maintain quality of life. While traditional research focuses on clinical trials that involve directly treating cancer, we have designed a specific research committee at our institution that promotes supportive care research to improve patients’ and caregivers’ quality of life. Past research has shown that issues key to patients and caregivers often differ from what researchers and providers might appreciate as important. Incorporating input from brain tumor patients and caregivers is vital to direct the most relevant and necessary supportive care research.

METHODS
As part of an IRB-approved quality improvement project, we sought the opinions of our supportive care research committee about what are the essential quality of life issues for brain tumor patients and caregivers. We polled our committee before and after a session with patients and caregivers discussing factors relevant to their quality of life. After this patient/caregiver intervention, we used a group discussion and note comparison technique to distill down key elements to advance supportive care research for this population.

RESULTS
Engagement of the committee included members that were neuro-oncology providers, biostatisticians, and data/regulatory/clinical trial staff. Before the intervention, common themes about key issues for patients and caregivers were comfort, pain management, counteracting side effects, cognitive issues, and financial toxicity. While similar themes emerged after the patient/caregiver intervention, the committee gleaned that aspects of communicating outcomes and support of caregivers were consistently mentioned from the discussion session with patients and caregivers.

CONCLUSIONS
Opinions of brain tumor patients and caregivers are crucial in driving future direction and relevance of supportive care research in neuro-oncology. Our supportive care research committee will continue to engage patients and caregivers and are planning interventions to improve communication and support for caregivers.
QOLP-30. FEAR OF CANCER RECURRENCE IN PRIMARY BRAIN TUMOR PATIENTS: DO DISEASE-RELATED CHARACTERISTICS MATTER?
Authors: Braun Sarah , Aslanzadeh Farah , Thacker Leroy , Loughan Ashlee 
Published: December 2020

Abstract

BACKGROUND/PURPOSE
Fear of cancer recurrence (FCR) is associated with disease-related variables including cancer stage and time since diagnosis in non-CNS cancer patients. However, no studies have investigated these relationships in primary brain tumor patients (PBT), with most research on FCR excluding this population purposefully. Given that a diagnosis of PBT is diverse in terms of prognosis, treatment, and disease trajectory, FCR in neuro-oncology may be different from other cancer populations and warrants investigation.

METHODS
PBT patients receiving care at an NCI-designated cancer center completed the FCR-7, a validated questionnaire assessing FCR. Disease-related variables, including tumor grade, tumor hemisphere, and time since diagnosis were obtained via medical records and investigated as correlates of FCR using t-test, non-parametric Kruskal-Wallis test, and Pearson correlation, respectively.

RESULTS
Eighty PBT patients (58% female; M age=50.83, range=20-86) agreed to participate. Average patient FCR7 was 17.15 (SD=8.93). The 60th percentile of patient FCR7 was 17.00 and the 90th percentile was 31.90. There was no difference in FCR between low and high tumor grades (p = 0.50). There was no difference in FCR between left, right, and bilateral tumor hemispheres (p = 0.67). Similarly, time since diagnosis was unrelated to FCR (p = 0.54).

CONCLUSION
Inconsistent with findings in non-CNS cancer, FCR was not related to disease-related variables in PBT patients. Given the certainty of tumor recurrence in this population, FCR may be a more robust experience in PBT patients, such that disease characteristics do not buffer this cancer-specific distress. These results emphasize the need for inclusion of PBT in psycho-oncology research, particularly investigations of psychotherapy targeting FCR across disease-related variables such as tumor grade, tumor hemisphere, and time since diagnosis. The lack of generalizability of non-CNS cancer findings and the further exclusion of this population will prevent efforts to provide patient-centered end-of-life care within neuro-oncology.
RADT-02. CLINICAL OUTCOMES OF BREAST BRAIN METASTASES BY SUBTYPE FOLLOWING LINAC BASED STEREOTACTIC RADIATION
Authors: Thawani Chetna , Mills Matthew , Figura Nicholas , Sarangkasiri Siriporn , Washington Iman , Robinson Timothy , Diaz Roberto , Etame Arnold , Vogelbaum Michael , Yu Hsiang-Hsuan , Ahmed Kamran 
Published: December 2020

Abstract

BACKGROUND
Management of breast cancer brain metastases has become an increasing concern due to improved systemic control. Failure patterns in the brain may vary by breast cancer subtype.

OBJECTIVE
In this study, we sought to distinguish our institutional clinical outcomes following stereotactic radiation by breast cancer subtype.

METHODS
A total of 180 breast cancer patients treated over 279 stereotactic sessions to 646 brain metastases were identified from our LINAC based stereotactic radiation institutional registry. Patients were treated between August 2004 and May 2019. Outcomes including distant brain metastases control (DC) as well as overall survival (OS) following stereotactic radiation were assessed from review of the clinical chart and radiologic examinations.

RESULTS
The median age of patients was 55 (range: 28-86 years). Subtypes in order of decreasing frequency were hormone receptor (HR)+ (n=64; 36%), HR+/HER2+ (n=47; 26%), triple negative (TN) (n=43; 24%), and HR-/HER2+ (n=26; 14%). TN patients had the shortest interval from systemic metastases to brain metastases diagnosis; HR-/HER2 + 16 months, HR+ 13.3 months, HR+/HER2 + 11 months, and TN 1.4 months (p=0.02). Median follow-up from brain metastases diagnosis was 21.2 months (range: 0.9-135.4 months). Twenty-four month Kaplan-Meier (KM) DC rates varied by subtype and were 49% (HR+/HER2+), 38% (HR+), 33% (HR-/HER2+) and 21% (TN) (p=0.0004), respectively. Similar differences were noted in OS with 24 month KM rates of 58% (HR+/HER2+), 51% (HR-/HER2+), 27% (HR+), and 14% (TN), p&lt; 0.0001. A total of 26 patients (14%) were noted to undergo leptomeningeal disease (LMD) progression. No differences were noted by subtype and LMD progression (p=0.88).

CONCLUSIONS
In our institutional series of breast cancer brain metastases treated with stereotactic radiation, significant differences were noted in clinical outcomes by breast cancer subtype. HR+/HER2+ patients had the best DC and OS rates while outcomes were poorest for TN patients.
RADT-19. EFFECTS OF RADIATION DOSE-RATE AND TUMOR CHARACTERISTICS ON LOCAL CONTROL AND TOXICITY AFTER RADIOSURGERY FOR ACOUSTIC NEUROMAS
Authors: Josef Villafuerte Conrad , Gentili Fred , Shultz David , Berlin Alejandro , Heaton Robert , van Prooijen Monique , Cusimano Michael , Schwartz Michael , Zadeh Gelareh , Payne David , Tsang Derek 
Published: December 2020

Abstract

INTRODUCTION
The effect of stereotactic radiosurgery (SRS) dose-rate on tumor control for acoustic neuroma (AN, or vestibular schwannoma) is unclear.

METHODS
This was a retrospective study of all patients treated for AN with frame-based cobalt-60 SRS at the Toronto Western Hospital between 2005-2019. Dose rates on the day of SRS were calculated from the calibration dose-rate while accounting for the cobalt-60 half-life of 5.2713 years. Local failure was defined as continued tumor growth &gt;36 months post-SRS, tumor resection for LF, or use of any repeat SRS for LF. Cumulative incidence of LF was reported after accounting for competing risks of death, on a per-lesion basis. Comparisons of actuarial LF were made using Gray’s test. Multivariable analysis of LF was performed using a proportional hazards model.

RESULTS
A total of 607 patients were treated for 617 acoustic neuromas. Median follow-up was 5.0 years. 158 tumors (26%) were cystic. 71 tumors (12%) had previous resection. Nine patients received 10-11 Gy due to large tumor size; all remaining patients received 12 Gy to approximately the 50% isodose line. Median dose rate was 2.4 Gy/min (range, 1.3-3.7). There was no association between dose rate and LF (≥ 2.4 Gy/min vs. &lt; 2.4 Gy/min, 6.07% vs. 6.12% at 5-year follow-up, p = 0.75). The adjusted local failure-specific hazard ratio (HR) for dose rate (per Gy/min) was 1.2 (95% CI 0.69-2.1, p = 0.52). Patients with previous surgery had higher LF, with a HR of 3.6 (95% CI 1.7-7.8, p = 0.0012), after adjusting for presence of cysts (HR 0.27, p = 0.034) and maximum tumor diameter (HR 1.055 per cm, p = 0.071).

CONCLUSIONS
In a large cohort of patients with acoustic neuromas, radiosurgery dose-rate was not associated with tumor control. Previous resection was a strong risk factor for local failure after SRS.
RADT-41. ASSESSING THE ROLE OF ADJUVANT RADIATION THERAPY AND RISK FACTORS FOR RECURRENCE FOLLOWING GROSS TOTAL RESECTION OF ATYPICAL MENINGIOMAS
Authors: Harrison Farber S , So Veronica , Mooney Michael , Cole Tyler , Przybylowski Colin , Rogers Leland , Sanai Nader 
Published: December 2020

Abstract
While meningiomas are commonly benign brain tumors, as many as 30% may be classified as atypical, or WHO Grade 2. Patients are at risk of recurrence following resection and often are prescribed adjuvant radiation therapy (RT)-although most data on this treatment is retrospective and has shown mixed RESULTS: In this study we assessed the influence of adjuvant RT following gross total resection (GTR) in patients with newly diagnosed atypical meningiomas at our institution and sought to determine predictors of tumor recurrence. All patients who underwent GTR (Simpson Grade I and II) at their index operation from 1994-2014 were retrospectively reviewed. Patients then either underwent observation or adjuvant RT (Intensity-Modulated Radiation Therapy (IMRT) or stereotactic radiosurgery (SRS)). A total of 145 patients had documented GTR at the time of initial resection, including 88 females (61%) and 57 males (39%), with a mean age of 58 +/- 15.7 years. 118 patients were followed with observation after surgery while 27 (18.6%) patients received adjuvant RT prior to known recurrence (IMRT for 15 patients (55.5%) and SRS in 12 patients (44.4%)). Patients receiving adjuvant RT had significantly larger tumors, as well as a higher incidence of spontaneous necrosis and small cell phenotype on histopathology. Overall 5-year PFS in our cohort was 71.6% (CI 60.6%-84.7%) and was unchanged by adjuvant RT (p = 0.52). 23 patients (15.8%) had a recurrence with a mean follow up of 42.9 months (17.1-53.5 months). Male gender (HR=1.02, p=0.019), tumor size (HR=1.17, p= 0.002) and MIB-1 &gt; 4 (HR=8.50, p=0.04) were associated with increased recurrence risk. There was no association between radiation type (SRS vs. IMRT) and risk of recurrence (p= 0.154). In our patients, adjuvant RT following GTR of atypical meningiomas did not improve PFS. Risk factors for recurrence included male gender, larger tumor size, and MIB-1 &gt; 4.
RADT-46. SYSTEMATIC REVIEW OF RADIOSENSITIZERS FOR MALIGNANT BRAIN TUMORS: POTENTIAL FOR LEARNING FROM PAST FAILURES
Authors: Beg Usman , Snyder Brianna , Madhani Sarosh , Hamidi Nima , Mansouri Alireza 
Published: December 2020

Abstract

INTRODUCTION
Radiation therapy (RT) is the cornerstone of management of malignant CNS tumors but its efficacy is limited in hypoxic tumors. Although numerous radiosensitizer compounds have been developed to enhance the effect of RT, progress has been stagnant. Through this systematic review of the literature on radiosensitizers for malignant CNS tumors, we have sought to provide an overview of radiosensitizers developed to date, summarize their safety and efficacy, and evaluate areas for possible improvement.

METHODS
PUBMED, EMBASE, Cochrane, and Web of Science were searched using terminology pertaining to radiosensitizers for brain tumor RT according to PRISMA guidelines. Publications reporting clinical evidence of non-antineoplastic radiosensitizers with RT for malignant CNS tumors were included. Pre-specified variables were extracted. Outcomes of interest were overall survival, progression-free survival, adverse events, and quality-of-life outcomes.

RESULTS
Forty-eight publications were identified which included 20 unique non-antineoplastic radiosensitizing agents. Only 2/20 agents, fluosol with oxygen, and efaproxiral, showed improvement in outcomes in patients with glioblastoma and brain metastasis, respectively. A larger study was not able to confirm the latter. While molecular similarities between these two agents were not identifiable, the effective mechanism of action allowed them to modulate hypoxia from within blood vessels, without crossing blood-brain barrier. Nine agents required dose modification, change of schedule, or complete discontinuation due to toxicities.

CONCLUSION
Despite decades of research, progress in the field of radiosensitizers for malignant CNS tumors has been limited. Available data demonstrates the lack of progress in identifying effective radiosensitizers for brain tumors. Of the many non-antineoplastic radiosensitizers that have been tested, only two have showed (limited) efficacy by targeting tumor oxygenation. Alternative strategies such as synthetic drug design, based on a mechanism of action that is independent of crossing the blood-brain barrier, may be necessary. Such studies are currently underway.
RTID-01. RADIOSURGERY FOLLOWED BY TUMOR TREATING FIELDS FOR BRAIN METASTASES (1-10) FROM NSCLC IN THE PHASE 3 METIS TRIAL
Authors: Mehta Minesh , Gondi Vinai , Brown Paul , Ahluwalia Manmeet 
Published: December 2020

Abstract

BACKGROUND
Tumor Treating Fields (TTFields) are non-invasive, loco-regional, anti-mitotic treatment modality comprising alternating electric fields. TTFields have demonstrated efficacy in preclinical non-small cell lung cancer (NSCLC) models. TTFields treatment to the brain was safe and extended overall survival in newly-diagnosed glioblastoma. The objective of the METIS study [NCT02831959] is evaluation of the efficacy and safety of TTFields in NSCLC patients with brain metastases.

METHODS
NSCLC patients (N=270) with 1-10 brain metastases were randomized 1:1 to stereotactic radio surgery (SRS) followed by continuous TTFields ((150 kHz, &gt; 18 hours/day) within 7 days of SRS or supportive care. The portable device delivered TTFields to the brain using 4 transducer arrays, while patients received the best standard-of-care for systemic disease. Patients were followed every two months until second intracranial progression. Key inclusion criteria: KPS ≥70, new diagnosis of 1 inoperable or 2–10 supra- and/or infratentorial brain metastases from NSCLC amenable to SRS; and optimal therapy for extracranial disease. Prior WBRT, surgical resection of metastases, or recurrent brain metastases were exclusionary. Primary endpoint was time to 1st intracranial progression. Secondary endpoints included time to neurocognitive failure (HVLT, COWAT and TMT), overall survival, radiological response rate (RANO-BM and RECIST V1.1); quality-of-life; adverse events; time to first/second intracranial progression for patients with 1–4 and 5–10 brain metastases; bi-monthly intracranial progression rate from 2–12 months; and time to second intracranial and distant progression. The sample size (N=270) was calculated using a log-rank test (Lakatos 1988 and 2002) with 80% power at two sided alpha of 0.05 to detect a hazard ratio of 0.57. On September, 2019, an independent Data Monitoring Committee (DMC) reviewed METIS trial data collected to that point. The DMC concluded that no unexpected safety issues had emerged and recommended continuation of the METIS study as planned.
RTID-06. ENHANCING TUMOR TREATING FIELDS THERAPY FOR RECURRENT GLIOBLASTOMA WITH TARGETED AND INDIVIDUALIZED SKULL REMODELING SURGERY. A MULTI-CENTER RANDOMIZED PHASE 2 TRIAL
Authors: Mikic Nikola , Korshøj Anders 
Published: December 2020

Abstract

BACKGROUND
We present an upcoming(Sep. 2020) randomized, comparative, multi-center, investigator-initiated, interventional, phase 2 trial testing the efficacy of a novel therapeutic concept for recurrent glioblastoma(GBM). The intervention combines personalized targeted skull remodeling surgery(SR-surgery) with Tumor Treating Fields(TTFields) and best practice medical oncological therapy. SR-surgery involves strategically placed burr holes to strengthen the electric field in the tumor region. Preclinical studies indicate that SR-surgery provides a marked and focal enhancement(~100%) of TTFields. We recently concluded a phase 1 safety/feasibility study indicating promising clinical efficacy and no clinically significant toxicity related to the intervention. This subsequent randomized, comparative phase 2 trial aims to validate superior efficacy of the treatment.

METHOD
We will utilize a comparative, 1:1 randomized, minimax two-stage phase 2 design with an expected sample size of 70 patients, interim futility analysis at 1-yr follow-up of the first 52 patients and a maximum sample size of 84 patients. Patients will receive either 1)TTFields and best practice medical oncological treatment(control arm) or 2) SR-surgery plus TTFields and best practice medical oncological treatment (interventional arm). Major eligibility criteria include age ≥ 18 years, supratentorial GBM, Karnofsky performance score(KPS) ≥ 70, focal tumor, and lack of uncontrollable epilepsy or significant co-morbidity. The study is designed to detect a 20% increase in the overall survival rate 12 months(OS12) assuming OS12=40% in the control group and OS12= 60% in the intervention group. Secondary endpoints include hazard ratio of overall survival and progression-free survival, objective response rate, QoL, KPS, steroid dose, and toxicity. Patients will be followed for the whole trial period(36 months). The average expected follow-up is 18 months and includes regular assessment of toxicity, response and QoL. Endpoint data will be collected at the end of the trial, occurrence of suspected unexpected serious adverse reactions(SUSARs) or unacceptable serious adverse events(SAEs), withdrawal of consent, or loss-to-follow-up.
RTID-10. SURGEONS TRIAL OF PROPHYLAXIS FOR EPILEPSY IN SEIZURE NAÏVE PATIENTS WITH MENINGIOMA: A RANDOMIZED CONTROLLED TRIAL (STOP ‘EM)
Authors: Jenkinson Michael , Helmy Adel , Huckey Helen , Mills Samantha , Grant Robin , Hughes Dyfrig , Marson Tony , Tangney Rebecca , Bulbeck Helen , Ali Usama , Gamble Carrol 
Published: December 2020

Abstract

BACKGROUND
Meningioma is the commonest primary brain tumour. 70% of patients are seizure-free at presentation, but approximately 12% will have seizures within 12 months of surgery. Seizures impact quality of life. Neurosurgeons administer prophylactic anti-epileptic drugs (AED) to prevent seizures despite a lack of evidence to support this. A meta-analysis of RCTs in brain tumours suggests that older AED may prevent seizures in the first week after surgery but not thereafter. There are no studies assessing newer AEDs in the prophylactic setting.

RESEARCH QUESTION
In patients with meningioma who have never had a seizure and are undergoing surgical resection, does prophylactic levetiracetam reduce the risk of developing seizures?

DESIGN
multi-centre, double-blind RCT in 20 UK centres. 1:1 randomisation of 14 days levetiracetam 500mg bd started one day before surgery compared to placebo.

PRIMARY OBJECTIVE
Determine whether 2 weeks prophylactic levetiracetam reduces the risk of developing seizures within 12 months of surgery compared to placebo.

ECONOMIC OBJECTIVE
Estimate cost-effectiveness of prophylactic levetiracetam.

SECONDARY OBJECTIVES
Determine effect of prophylaxis on time to first seizure and first convulsive seizure, whether prophylaxis affects quality of life and influences return to driving, safety of prophylaxis.

POPULATION
seizure-naïve meningioma undergoing surgery.

SAMPLE SIZE
seizure rate at 12 months is 12.3%. A 50% reduction is clinically beneficial. A two-group chi-squared test with 5% two-sided significance level will have 90% power to detect the difference between a Group 1 proportion of 0.12 and a Group 2 proportion of 0.06 when the sample size in each group is 477. Allowing for 5% dropout, 1004 patients will be recruited.

FUNDING
NIHR (£1.64M) award June 2020. Study opens March 2021.

TRANSLATIONAL RESEARCH
MRI, blood and tissue will be collected to explore risk factors for seizures.

CONCLUSIONS
study will provide class I evidence of the role of prophylactic levetiracetam in meningioma surgery.