bluuebunny/crossref_metadata_2025_split huggingface dataset:
P06.20.B LONG-TERM CLINICAL RESULTS OF 493 CASES OF NEWLY DIAGNOSED GLIOBLASTOMA AND SURVIVAL BENEFIT BY COMBINATION WITH PDT AND AFTV, AIMING TO ESTABLISH NEW STANDARD TREATMENT
Authors: Nitta M , Muragaki Y , Saito T , Tsuzuki S , Koriyama S , Kuwano A , Kawamata T 
Published: September 2023

Abstract

BACKGROUND
Glioblastoma has the worst prognosis of brain tumors. Evidence for improving prognosis by maximal tumor removal is being established, and in recent years, new treatments such as photodynamic therapy (PDT, 2014 in Japan), and TTF therapy (2018) have been approved, the treatment results are improving. In principle, our facility performs maximum tumor removal using intraoperative MRI (iMRI) follow by the standard chemoradiation. Intraoperative PDT and autologous tumor vaccine (AFTV) will be given to desired patients. We retrospectively analyzed the long-term clinical results of the patients with newly diagnosed glioblastoma who underwent surgical treatment at our facility, and the treatment results by era and treatment method.

MATERIAL AND METHODS
The clinical features, extent of removal (EOR), OS and PFS of the adult patients with newly diagnosed glioblastoma treated from 2001 to 2021 were analyzed retrospectively. Clinical results of those patients who received PDT and AFTV treatment was also investigated.

RESULTS
The number of cases was 493, median age 58 years (18-85 years), 293 males, 200 females. The median and average EOR of contrast-enhanced lesions were 98% and 96.6%, respectively. The median PFS and OS of all cases (including biopsy) were 9.4 months and 22.7 months, respectively. When the cases were analyzed separately for 2001-2006 (before TMZ), 2007-2010, 2011-2015, and 2016-2021, the median OS for each age group was 12.9 months, 22.9 months, 23 months, and 31.1 months. The treatment results improved with age (p &lt;0.0001). In particular, the median OS of 23 cases treated with PDT and AFTV was 63.1 months. The efficacy of AFTV for newly diagnosed glioblastoma is currently being verified in a multicenter Physician-led clinical trial.

CONCLUSION
The treatment results for glioblastoma have improved over the years. The combination of maximal tumor removal using iMRI, PDT and AFTV may aim for a 5-year survival rate of 50%.
P07.01.A MR-GUIDED LITT THERAPY IN PATIENTS WITH PRIMARY IRRESECTABLE GLIOBLASTOMA: A CONTROLLED, PROSPECTIVE PILOT STUDY (EMITT PILOT-STUDY)
Authors: Viozzi I , Neutel C , Overduin C G , Rijpma A , Rovers M M , ter Laan M 
Published: September 2023

Abstract

BACKGROUND
Laser interstitial thermal therapy (LITT) is growing as a minimally invasive procedure in the treatment of brain tumours, even if high-quality evidence is lacking. We aimed to assess practical feasibility of a randomized controlled trial (RCT) in patients with primary irresectable glioblastoma (nGBM) and to collect pilot data on technical feasibility and safety of LITT.

METHODS
Adult patients with radiologically suspected glioblastoma where the multidisciplinary tumour board advised biopsy-only with KPS ≥70 and feasible trajectories to reach ≥70% ablation were prospectively included. Patients were randomized to receive either biopsy combined with LITT or biopsy alone, followed by chemoradiation (CRT). Main endpoints were practical feasibility of RCT (inclusion rate, willingness to be randomized and ability to complete the follow-up procedures), technical feasibility (time from indication to procedure, time from procedure to CRT, duration of procedure) and safety (complications reported following the Clavien Dindo classification (CD).

RESULTS
A total of 15 patients with an irresectable nGBM were included in the study (5 in the control and 10 in the LITT arm). Patients were highly motivated to participate to the study and all patients completed the follow-up procedure. After including 9 patients randomization was stopped. All patients were planned within 2 weeks after indication and no delay was observed in referring patients for adjuvant CRT. One, two or three laser probes were used to reach ≥70% expected ablation. Total procedure time varied between 200-540 minutes. Two CD≥3 complications occurred in the LITT arm.

CONCLUSION
Our pilot data suggest an RCT investigating LITT in patients with an irresectable nGBM is feasible, with initial safety data appearing in line with that of tumour resection. As a next step, we have designed a national multicenter RCT in order to evaluate survival benefit, quality of life and cost-effectiveness of LITT in this population.
P07.09.B A RANDOMIZED PHASE 2B STUDY OF SURVIVIN VACCINE SURVAXM PLUS ADJUVANT TEMOZOLOMIDE FOR NEWLY-DIAGNOSED GLIOBLASTOMA (SURVIVE)
Authors: Ahluwalia M S , Ciesielski M , Abad A , Reardon D , Aiken R , Barbaro M , Sinicrope K , Peereboom D M , Odia Y , Brenner A , Venur V , Butowski N , Belal A , Qiu J , Ozair A , Khosla A A , Schilero C , Figel S , Casucci D , Mechtler L , Fenstermaker R 
Published: September 2023

Abstract

BACKGROUND
Newly-diagnosed glioblastoma (nGBM) has a dismal prognosis with a median overall survival (OS) of nearly 16 months. nGBM cells have high expression of tumor-associated survivin protein. Survivin, localized to the cell surface through presentation by MHC class I molecules, is recognized by antibodies and cytotoxic T-lymphocytes (CTLs). A Phase 2a trial (NCT02455557) showed that a 15-amino acid-peptide-conjugate vaccine (SurVaxM) stimulates the production of survivin-directed antibodies and anti-tumor CTL in nGBM patients, resulting in a median OS of 25.9 months. This Phase 2b randomized controlled trial (RCT) aims to further investigate the efficacy of SurVaxM and adjuvant temozolomide for nGBM.

METHODS
This multicenter, placebo-controlled, investigator- and patient-blinded, in-progress RCT randomizes nGBM patients receiving standard of care to either SurVaxM (arm A) or saline placebo (arm B) in a 3:2 ratio at 15 sites. Included patients have age ≥18 years, normal organ function, Karnofsky Performance Status (KPS) ≥70, surgical resection, residual MRI contrast enhancement of ≤1 cm3 within 72 hours of resection, and adjuvant temozolomide (TMZ) therapy. Patients with recurrent, multicentric, brainstem- or cerebellar-origin GBM are excluded, as well as patients on tumor-treating fields or other immunotherapies. All patients undergo 3 phases: (1) vaccine priming (VP) phase, starting within 4 weeks after completion of chemoradiation, where 4 doses of SurVaxM or Placebo are administered every 2 weeks; (2) adjuvant TMZ phase, started after ≥1 VP dose; and (3) vaccine maintenance phase, started 8 weeks after VP, with SurVaxM or placebo given every 8 weeks. TMZ phase overlaps with VP and VM phases. The primary endpoint is median OS. Assuming a 1-year survival rate of 75% in the SurVaxM arm, comparable to the median OS in early phase trials, and 60% in the control arm, the study will enroll 265 patients, 159 in arm A and 106 in arm B. A log-rank test stratified by KPS (70-80 and 90-100), MGMT status (methylated and unmethylated), and IDH status (mutant and wild-type) will be used for analysis. Secondary endpoints per study arm are survival at 15, 18, and 24 months, median progression-free survival, toxicity, and progression-free survival at 3, 6, and 12 months. A single sequential OS-driven interim analysis is planned when 50% of OS events (deaths) occur. The study is expected to take 35 months, with ongoing accrual.

RESULTS
69 patients have been enrolled as of April 11, 2023.

CONCLUSION
Findings from this trial will demonstrate the safety and efficacy of survivin vaccine in GBM (Clinical trial information: NCT05163080).
P07.13.B A RANDOMIZED STUDY OF LOW-INTENSITY FOCUSED ULTRASOUND FOR BLOOD-BRAIN BARRIER DISRUPTION FOR BRAIN METASTASIS FROM NON-SMALL CELL LUNG CANCER (LIMITLESS)
Authors: Ahluwalia M S , McDermott M , Ozair A , Khosla A A , Sahgal A , Mishra M , Achrol A , Woodworth G , Lipsman N 
Published: September 2023

Abstract

BACKGROUND
The blood-brain barrier (BBB) limits the efficacy of systemic therapies for brain metastases (BM), for which non-small cell lung cancer (NSCLC) is the most common etiology. BBB disruption (BBBD) has been demonstrated, in preclinical models, to improve systemic drug delivery for BM. Low-intensity focused ultrasound (LIFU) results in non-invasive BBBD synergistically with intravenously (IV) administered microbubble oscillators. This randomized controlled trial (RCT) aims to determine the safety and efficacy of LIFU-mediated BBBD for NSCLC BM with immunotherapy.

METHODS
LIMITLESS is an ongoing prospective, multicenter, parallel-arm, open-label RCT that randomizes patients with NSCLC BM on pembrolizumab monotherapy prescribed as per standard-of-care to LIFU plus pembrolizumab (arm 1) or pembrolizumab alone (arm 2) in 2:1 ratio. Included patients have age ≥18 years, normal organ function, Karnofsky Performance Status ≥70, EGFR- and ALK-negative primary tumor, and ≤3 BM with ≥1 BM meeting measurable disease criteria as per response assessment in neuro-oncology for BM (RANO-BM). Patients on both arms receive standard-of-care therapy, while those on arm 1 also undergo LIFU before each dose of pembrolizumab (200 mg IV every 3 weeks). These patients undergo pre-treatment MRI brain, followed by IV administration of oscillating microbubbles for enhanced sonication. MR-guided BBBD is then performed using a 220 kHz LIFU device with real-time acoustic feedback for maintaining effective cavitation. Pembrolizumab is infused immediately thereafter, and a repeat MRI is done 24-48 hours later to confirm the closure of BBB each cycle. The primary study endpoint is the overall objective response rate (ORR) at 6 months, as assessed using RANO-BM criteria. Using a Bayesian design for power analysis, a superior ORR of 60% is assumed for the LIFU arm versus 30% in the control arm for a total sample size of N=96, 64 subjects in LIFU and 32 in the control arm, for 80% power using a two-sided chi-square test with an alpha of 0.05. For the upper-bound estimate ORR of 45% in the LIFU arm and 30% in the control arm, the study needs N=369 subjects; 246 in the LIFU arm and 123 in the control arm. The secondary outcomes are the best objective response rate and median time-to-response per treatment arm. The exploratory outcomes are median progression-free survival (PFS), overall survival (OS), median intracranial PFS, median extracranial PFS, and quality of life.

RESULTS
Patient enrollment commenced in 2022.

CONCLUSION
Findings from this trial will be critical to liquid biopsy in brain metastases (Clinical trial information: NCT05317858).
P08.05.A A LONGITUDINAL CASE STUDY OF PATIENTS' EXPERIENCES IN THE INITIAL PHASE OF A BRAIN CANCER PATHWAY - AIMING TO IMPROVE PATIENT CARE
Authors: Vedelø T , Sørensen J , Hall E , Delmar C 
Published: September 2023

Abstract

BACKGROUND
A brain cancer diagnosis is life-transforming and involves accelerated diagnostics and treatment and care involving multiple settings and healthcare professionals. Patients are confronted with an uncurable cancer disease but also face progressive neurological and cognitive deficits over time, adding to the uncertain and stressful situation. Knowledge of patients' experiences during their hospital stay in the initial diagnostic phase is sparse. This study aimed to explore patients' experiences at the hospital during the diagnostic workup, the brain surgery, and the post-operative period until discharge and to describe what matters to patients when diagnosed with a malignant brain tumour.

MATERIAL AND METHODS
We used a descriptive longitudinal single-case study design to produce in-depth, context-dependent knowledge and capture real-life situations in patients' day-to-day care experiences from admission to discharge across three different departments throughout the initial diagnostic phase. To explore patients' views directly in the actual situations unfolding in practice, we followed one patient at a time and did 180 hours of field observation and 16 semi-structured interviews. We analyzed field notes and interviews by applying systematic text condensation.

RESULTS
An overarching theme, "A fast transition", was identified, describing the patients' experiences in the two central themes; "From feeling fine to an unknown journey" and "Patient involvement determined by system factors". Within the two themes, six subthemes emerged from the data: Overwhelming uncertainty and fear, Putting life on hold, An unfamiliar dependency and Being unprepared and side-lined, The significance of close relatives, and Managing care needs and demands.

CONCLUSION
The results add to understanding patients' experiences during the initial diagnostic phase. While part of the findings are a fact of life for patients diagnosed with a brain tumour, others point to specific areas for improvement. Small changes in care delivery can enhance patient involvement by proactively informing patients about their care plan, ensuring the presence of relatives during information giving and identifying patients' care needs and preferences. Establishing a patient and public involvement group in 2023 will provide more knowledge gaps for future research.
P08.08.A EXPLORATION OF SURVIVORSHIP ISSUES AND QUALITY OF LIFE IN A COHORT OF IDH MUTATED HIGH GRADE GLIOMA 5 YEARS FOLLOWING DEFINITIVE TREATMENT
Authors: Engel S J , Yim J , Kastelan M , Wheeler H , Back M 
Published: September 2023

Abstract

BACKGROUND
Approximately 2000 people are diagnosed with brain cancer in Australia each year. Compared to glioblastoma patients, the IDH-mutated high-grade glioma (IDHmHGG) is a more favourable diagnosis; better prognosis and survival outcomes. Coupled with improved treatments, the IDHmHGG cohort is living longer which means treatment side effects (eg. fatigue, cognitive deficits, physical limitations etc.) can significantly impact their quality of life in the survivorship years. Hence there is a need to identify and determine the survivorship issues most pertinent for the IDHmHGG cohort.

MATERIAL AND METHODS
A mixed-

METHODS
cross-sectional study was conducted to investigate the relationship between socio-demographic, clinical factors and quality of life in the IDHmHGG cohort. Qualitative data collection consisted of a neuro-oncology clinician focus group (n=11) regarding survivorship issues and was contrasted with semi-structured patient interviews (n=27). Quantitative data collection (n=41) involved socio-demographic questions, the Functional Assessment of Cancer Therapy - Brain (FACT-Br) tool and The Hospital Anxiety and Depression Scale (HADS).

RESULTS
The results indicate that marital status, employment status, and treatment complications are strongly associated with quality of life in IDHmHGG patients. Being single and unemployed is associated with lower quality of life (p&lt;0.05). Similarly, our findings show that psychological distress, specifically the presence of anxiety and depressive symptoms, is a major factor that can negatively impact the QoL in an IDHmHGG cohort. The order of ranking between clinician and patient identified issues only matched for physical limitations (ranked 3rd). Although not matched in ranking, both groups identified cognitive function, employment, social function, isolation and mental health as commonly experienced in the survivorship years.

CONCLUSION
This study highlights the importance of considering socio-demographic and clinical factors in the care and support of brain cancer patients. The most important finding of this study was that being single and unemployed negatively predicted QoL. Additionally, it is notable that our results show a discrepancy between clinician identified issues and patient identified issues. This finding suggests that in order to deliver patient-centred and meaningful care, there is a need to incorporate a more patient focused perspective. Future survivorship models of care for the IDHmHGG cohort should be co-designed with patients.
P08.09.B EFFECTS OF A ONE-WEEK SKIING INTERVENTION ON LOWER LIMB MUSCLE STRENGTH IN BRAIN TUMOR PATIENTS AND THEIR CAREGIVERS
Authors: Jost J , Hansel N , Brandt R , Lemcke L , Stummer W , Wiewrodt R G , Wiewrodt D 
Published: September 2023

Abstract

BACKGROUND
Due to fatigue or feelings of insecurity, many brain tumor patients are not sufficiently active. Among other things, this puts patients at higher risk for sarcopenia predicting overall survival. Exercise interventions of various kinds could effectively counteract this problem. Here, we aim to present the impact of a one-week skiing intervention on leg muscle strength in brain tumor patients and their caregivers as well as feasibility and safety of the intervention.

MATERIAL AND METHODS
Ten brain tumor patients and their families participated in this one-week skiing intervention in a self-catering lodge at 1400m altitude. Daily 4-hour ski sessions (including approx. 1 hour rest) with professional ski instructors were performed in small groups (≤5 participants) divided by proficiency level. Participants could choose between downhill and cross-country skiing. Adverse events were noted daily. Muscle strength was determined 3-10 days pre- and postintervention on 5 different gym machines (knee extension, knee flexion, adductors, abductors, leg press) using Brzycki's equation.

RESULTS
20 adults (10 patients, 10 caregivers) and 7 children participated in the ski-based intervention. All patients were surgically treated at least once and received chemo- and/or radiotherapy (ongoing chemotherapy in 6 patients). No severe adverse events were recorded throughout the week. 15 adults (9 patients, 56% female; 6 caregivers, 67% female) aged 21-69 years (mean 50 years) completed the muscle strength tests. Of those, most patients suffered from grade 4 brain tumors (67%), followed by grade 2 (22%) and grade 1 (11 %) tumors. Mean muscle strength increased in all muscle groups tested (knee extension +13.5%, p=.024, CI 95%: -0.5 - 29.1; knee flexion +7.1%, p=.048 CI 95%: -1.0 - 14.0; adductors +6.6%, p=.039, CI 95%: 1.3 - 13.4; abductors 20.0%, p=.004, CI 95%: 6.9 - 35.7; leg press +19.5%, p=.050, CI 95%: -5.6 - 44.6). Tumor grade, gender, type of ski intervention, and age did not affect the

RESULTS
.

CONCLUSION
During one week of intensive ski training, positive effects on leg muscle strength could be shown in both brain tumor patients and their families regardless of age, gender, downhill/cross-country ski, or WHO grading. Furthermore, this study demonstrates feasibility and safety of ski-based exercises in this patient population. Interventions such as these could help patients overcome (gait) insecurities and motivate them to become more physically active in their daily lives. In the longer term, this may lead to better management of everyday life and improved quality of life.
P08.11.A PREDICTIVE SOCIAL FACTORS ASSOCIATED TO PLACE OF DEATH IN MALIGNANT GLIOMAS
Authors: Benincasa D , Villani V , Focarelli S , Tanzilli A , Cardone F , Biscu A , Alò D , Di Felice S , Pace A 
Published: September 2023

Abstract

BACKGROUND
Malignant gliomas (MG) are tumors affecting central nervous system (CNS) with a poor prognosis. Fast neurological decline (motor, cognitive and behavioural) causes high burden for patients and caregivers and requires specific setting of care (especially palliative care) helping patients to preserve their autonomy and assuring, in the end of life phase, the best care represented by dying at home with dignity that is considered in the literature an indicator of good quality of care in cancer patients.

MATERIAL AND METHODS
The home care program for MG utilized in our Institution is aimed to offer palliative and supportive care during all the trajectory of disease and to facilitate death at home. To identify possible factors related with place of death, we’ve retrospectively investigated social and health data to discover possible factors associated with dying at home in MG patients. Every patient and caregiver/family were analyzed for many factors including sex, work, family relation, presence or absence of caregiver/family, presence of children.

RESULTS
From January 2016 to December 2020, we’ve assisted at home 263 MG patients and collected complete data in 257 patients (6 patients was lost in follow-up). 174 (68%) of them were affected by Glioblastoma Multiforme (GBM) and 83 (32%) were affected by grade 3 anaplastic gliomas; 155 patients (61%) were male and 102 (39%) female. 137 patients (54%) died at home, 88 patients (34%) died in hospice and 32 patients (12%) died in hospital. Male caregivers assisted 178 MG patients of which 141 was male patients (79%); female caregivers assisted 79 MG patients of which 65 was female patients (82%) (p&lt;0.001); presence of social network (family or other type) influenced positively place of death: MG patients who has social network died frequently at home respect on MG patients who didn’t have social network that died frequently in hospital or hospice (p&lt;0.001). No differences were found between age, sex (patient and caregiver), presence of minor children, education level, work, marital status and place of death.

CONCLUSION
In this cohort of MG patients followed with a palliative home care service, place of death and dying with dignity is influenced by presence of social network and reliable caregiver. The evaluation social data in addition to clinical data is an important factor in order to plan timely the end of life phase and the decisions about possible place of death.
P09.06.B GAIT CHARACTERISTICS OF PROGRESSIVE DISEASE IN HIGH GRADE GLIOMA: THE BRAINWEAR STUDY
Authors: Dadhania S , Williams M 
Published: September 2023

Abstract

BACKGROUND
Walking is a useful measure of overall health and walking speed has well-documented predictive value for health-related outcomes such as mortality, quality of life, physical and cognitive functional decline in older people. Wearable technology-based gait analysis is emerging as a powerful tool to detect early disease and monitor progression in areas such as Parkinson’s disease. We present an exploratory analysis of gait characteristics at the time of progressive disease from patients with high grade glioma (HGG) participating in the BrainWear Study which evaluates the use of free-living accelerometers in patients with brain tumours.

MATERIAL AND METHODS
All agreed to wear a wrist-worn Axivity AX3 triaxial accelerometer changed at 14-day intervals. Raw accelerometer data was processed using the UKBiobank OxWearables stepcount model v2.1.2 for Python and inclusion of high-quality wear time selected as ≥72 hours of data in a 7-day data collection and data in each 1-hour period of a 24-hour cycle over multiple days. 12 gait measures were characterised including total daily steps, cadence, cadence peak and minutes walking per day. We analysed variation in gait measures by patient demographics and MRI result. Wilcoxin-signed rank test was used to compare participant gait measures at timepoints of stable disease (SD) or progressive disease (PD). Mixed-effects models were used to evaluate longitudinal changes in gait measures.

RESULTS
17 HGG patients (6 female; 11 male) provided 4654 days of accelerometer data across 49 MRI Head scan

RESULTS
, 32 labelled as PD and 17 as SD. Median age was 62 years (32-79) and mean study participation 273 days (41-550). 8 patients provided accelerometer data at timepoints of both PD and SD allowing for paired analysis. There were no differences in 12 gait measures between age (&lt;60 and &gt;60 years) and gender. In the 6 weeks surrounding an MRI scan, patients with PD walked on average 1856 steps less per day than those with SD, and spent 22 minutes less walking (p=0.0403). Peak 1-minute cadence was 77 steps/min in patients with SD versus 67 steps/min with PD.

CONCLUSION
The complexity of HGG treatment, recovery and survivorship creates a need for novel monitoring approaches. Wearable accelerometry is feasible and acceptable and evaluating gait measures captures objective evidence of significant differences in patients with PD versus SD. Physical activity measures can guide clinicians in optimising quality of life and may act as an alert system prior to events such as disease progression.