The management of recurrent meningioma is challenging. Multimodality treatments, including combining resection with implantable collagen-tile cesium-131 brachytherapy (STaRT) (GammaTile®, GT Medical Technologies, Tempe, AZ, USA), may be a good therapeutic option. To assess the efficacy of resection and STaRT for management of aggressive recurrent meningioma on a prospective, multi-center observational study. The first 44 consecutive patients with recurrent meningioma enrolled on the observational registry (NCT04427384) were assessed at 21 centers for patient demographics, tumor characteristics, local control (LC), and adverse events (AEs). These data were collected from 1/28/2021-5/16/2025. Patients with recurrent meningioma (six World Health Organization Grade 1, twenty-one Grade 2, and seventeen Grade 3) underwent resection and STaRT. Expressed a medians, age was 61 years (24-83), follow-up was 11.2 months (0.2-36.1), and maximum preoperative tumor diameter was 4.3 cm (1.2-9.8), 90.5% had prior radiation, with a median interval of 38.4 months (3.4-126.3). By Grade, LC at 6, 12, and 15 months were 83.3%, 83.3%, and 66.7% for Grade 1; 100.0%, 68.6%, and 68.6% for Grade 2; and 92.9%, 76.0%, and 63.3% for Grade 3. For all Grades combined, LC at 6, 12, and 15 months were 94.4%, 78.3%, and 67.0%. Progression-free survival (PFS) by grade at 6, 12, and 15 months were 83.3%, 83.3%, 66.7% for Grade 1; 84.6%, 52.7%, and 52.7% for Grade 2; and 60.0%, 20.0%, and 13.3% for Grade 3. For all Grades combined, PFS at 6, 12, and 15 months were 74.6%, 45.5%, and 37.1%. Median overall survival has not been reached. Seven patients (15.9%) had eight Grade ≥3 AEs (3 infection/dehiscence, 2 each hematoma and edema/necrosis [1 radiation-related], and 1 seizure). This report from 21 centers demonstrates that resection plus STaRT for aggressive, recurrent meningiomas resulted in encouraging LC and low AE rate.
Determining true recurrence versus necrosis alone after previous radiotherapy (RT) for brain metastasis based on imaging alone is challenging. Accurate diagnosis is critical to patient management, as further RT is contraindicated in the setting of radiation necrosis without tumor (TUM-). Rates of intraoperative frozen section pathology reporting tumor +/- necrosis (TUM+) or necrosis without tumor (TUM-) were examined in patients undergoing resection for presumed RBM after prior same-site RT. All cases were prospectively enrolled on a multi-institutional registry for patients undergoing resection and intraoperative cesium-131 collagen tile brachytherapy (NCT04427384)(GammaTile, GT Medical Technologies, Tempe AZ, USA). Preoperative evaluation varied by center, and patient demographics, primary site, lesion size, and prior therapies were also examined. From 10/2020 to 2/2024, 60 patients (64 lesions) underwent resection and intraoperative frozen section pathologic evaluation. Per patient, primary sites were 53% lung, 15% melanoma, 13% breast, 7% renal, and 10% other. Median age was 62, median preoperative maximum diameter was 2.9 cm, F:M ratio was 31:29, and median time from prior RT was 15.4 months. Across all histologies, TUM+ was seen in 88% (53/60) and TUM- in 12% (7/60). Rates of TUM- by primary type were highest for lung (16%), breast (13%), and melanoma (11%). The TUM- rate for lung metastasis was 16% vs 7% for non-lung origin. All TUM- patients received RT and prior chemotherapy, immunotherapy, or both. For all previously irradiated metastasis, pathologic evaluation at time of presumed radiographic recurrence demonstrated an actual 12% rate of TUM-. These findings underscore the importance of pathologic tumor confirmation before considering re-RT for presumed radiographic recurrence.
Recurrent Grade IV gliomas are difficult to treat, particularly in patients who have already received definitive radiotherapy. Surgically targeted radiation therapy (STaRT) using Cesium-131 (Cs-131) collagen-tile brain brachytherapy (GammaTile®, GT Medical Technologies, Tempe, Arizona, USA), delivers immediate, localized radiation to the surgical cavity at higher doses than conventional adjuvant therapies, potentially improving clinical outcomes. The prospective observational registry (NCT04427384) is a multicenter study that evaluates clinical outcomes that measures effectiveness and safety of patients receiving brain tumor resection and STaRT. Herein, prospectively collected data from 122 patients with recurrent Grade IV glioma treated at 27 USA institutions were analyzed. Baseline demographic, clinical, and operative data were collected, including isocitrate dehydrogenase (IDH) mutation, O6-methylguanin-DNA methyltransferase (MGMT) promoter methylation status, extent of resection, and treatment-related toxicity. Patients were followed longitudinally to assess survival, recurrence, and toxicity. Kaplan-Meier curves and Cox regression were used for survival analysis. The cohort included 71 males and 51 females (median age 61) and preoperative Karnofsky Performance Scale (KPS) of 80, but recovered by one month. Most patients (91.8%) had prior radiotherapy (median dose 60 Gy). Gross total resection was achieved in 66.7% of cases. A 12.2% toxicity rate occurred within 30 days; one patient experienced Grade 4 toxicity, there were no Grade 5 events. Median follow-up was 7.5 months, with overall median survival from STaRT of 13.6 months. IDH-mutant patients had longer survival than IDH wild-type (18.9 versus 13.1 months; p=0.045). MGMT methylation status was not associated with survival differences. Six- and 12-month progression-free survival rates were 74.6% and 56.6%, with local control (LC) at 91.8% and 87.7%, respectively. STaRT was well-tolerated, demonstrating promising survival and LC outcomes, with median survival from STaRT exceeding published operative series. These results support further investigation of STaRT as part of a multimodal strategy for recurrent glioblastoma.
The optimal management of previously irradiated recurrent brain metastases is a challenging clinical scenario and despite several salvage strategies, to date no prospective, multi-institutional outcomes for surgically targeted radiation therapy (STaRT) have been reported. We sought to assess the efficacy of STaRT for the management of patients with recurrent brain metastases enrolled onto a prospective, multi-institutional study. A prospective, multi-institutional observational registry (NCT04427384) was created to capture clinical outcomes following brain tumor resection and STaRT using collagen-tile Cesium-131 brachytherapy (GammaTile®, GT Medical Technologies, Tempe, Arizona, USA). Herein, the first 50 consecutive patients with recurrent, previously irradiated brain metastases were assessed for patient demographics, tumor characteristics, and cumulative incidence rates of local failure. RESULTS: 50 consecutive patients with 56 recurrent brain metastases underwent resection (94.6% gross total resection) and STaRT at 19 separate centers. The median age was 60 (Range [R]: 28-81) years; the Male:Female ratio was 1:1; and 50%, 14%, 18%, and 18% of patients had tumors of lung, breast, melanoma, or other, respectively. Median follow up was 12.7 months, and median maximum tumor diameter was 3.0 cm (R: 0.4-5.7). The median time to recurrence after prior radiotherapy was 11.0 months (R: 2.5-44.9) (n=26), with the median time from last radiotherapy treatment to STaRT being 14.1 months (R: 3.5-56.3). After STaRT, cumulative incidences of local failure per-patient at 6, 12, and 15 months were 11.7%, 18.4%, and 22.5%, respectively. Survival probabilities at 6, 12, and 15 months were 79.0%, 65.4%, and 62.4%, respectively. Median overall survival was 22.0 months. Symptomatic adverse radiation effects (AREs) occurred in 3 patients (6%). This analysis demonstrates encouraging outcomes with STaRT for salvaging previously irradiated, recurrent brain metastases after prior radiotherapy across 19 different centers with a low cumulative incidence rate of local failure and AREs.
Abstract PURPOSE/OBJECTIVE(S) Determining true recurrence versus necrosis alone after previous radiation therapy (RT) for brain metastasis based on imaging alone is difficult. Proper diagnosis is essential, as further radiation is contraindicated in the setting of radiation necrosis without tumor (TUM-). To better understand the rate of pathologic tumor positivity (TUM+) vs TUM-, we examined frozen section results from a cohort of patients with prior same-site RT undergoing resection of presumed recurrent brain metastasis (RBM). MATERIALS/METHODS Rates of intraoperative frozen section pathology disclosing tumor +/- necrosis (TUM+) or necrosis without tumor (TUM-) were examined in patients undergoing resection for presumed RBM after prior same-site RT. All cases had been prospectively enrolled on a multi-institution registry for patients undergoing resection and intraoperative cesium-131 collagen tile brachytherapy (NCT04427384)(GammaTile, GT Medical Technologies, Tempe AZ, USA). Preoperative evaluation varied by center, and patient demographics, primary site, lesion size, and prior therapies were also examined. RESULTS From 10/2020 to 2/2024 60 patients (64 lesions) underwent resection and intraoperative frozen section pathologic evaluation. Per patient, primary sites were 53% lung, 15% melanoma, 13% breast, 7% renal, and 10% other. F:M ratio was 31:29; median age 62, maximum preoperative diameter 2.9 cm, and median time from prior RT 15.4 months. Across all histologies TUM+ was seen in 88% (53/60) and TUM- in 12% (7/60). Rates of TUM- by primary type were highest for lung (16%), breast (13%), and melanoma (11%). The TUM- rate for lung metastasis was 16% vs 7% for non-lung origin. All TUM- patients received RT and prior chemotherapy, immunotherapy, or both. CONCLUSION For all previously irradiated metastasis, pathology demonstrated a 12% rate of TUM-. As all cases necessitated surgery, the adverse event grading would be ≥ Gr 4. These findings highlight the importance of pathologic confirmation before undertaking re-irradiation for presumed radiographic recurrence.
Abstract BACKGROUND Resection and intraoperative brachytherapy for operable recurrent brain metastasis allows for pathologic confirmation of recurrent disease, mass effect relief, and immediate initiation of radiotherapy (RT). In this analysis, we report patterns-of-use and treatment-related adverse events (AEs) for rBM patients treated with Cs-131 collagen tiles, an FDA-cleared intracranial brachytherapy device. METHODS Patients with rBM who underwent resection and surgically-targeted radiation therapy (GammaTile, GT Medical Technologies Inc., Tempe, AZ USA) on a prospectively enrolling phase 4 registry study (NCT04427384) were analyzed. AEs were graded per CTCAE v5.0. RESULTS Between 11/2020 and 2/2024, 56 rBM in 51 consecutive patients underwent STaRT at 19 centers, with 5 patients having 2 metastases implanted concurrently. 44 patients (86%) had prior same-site RT (median interval 14.5 mo, range 3-56). Primary tumor histologies were lung (27), melanoma (8), breast (7), renal (4), colon (2), and “other” (3). Median pre-operative maximum diameter was 3.0 cm (range 1.4-5.7); age 63 (range 28-81); 53% females; KPS median 90 (range 40-100); and median implantation time 3 minutes. 26 patients were implanted at a 1st, 15 at a 2nd, and 10 at ≥ 3rd same-site recurrence (range 1-9). At a median follow-up of 6.2 months (range <1-35.1), 6/51 patients (11.8%) experienced ≥Gr 3 AEs at a median of 12 (range 1-69) days postoperatively (POD). No radiation necrosis (RN) events were observed, and no AEs occurred in multi-implant cases or where STaRT was the initial form of RT. CONCLUSIONS In this prospective multi-institutional study, STaRT demonstrated an excellent safety profile in a cohort of larger rBM, even in the setting of multi-recurrent disease. Accrual and follow-up are on-going and will provide data on tumor control and long-term RN rates.
Abstract INTRO This is the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers, for patients with intracranial tumors. METHODS Since October 2020, 37 sites to-date have enrolled 359 patients with primary & metastatic intracranial tumors into the R+STaRT registry to assess the safety & efficacy of the addition of Gamma Tile to medically needed resection. Local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE’s are collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULTS Demographics include 359 patients, avg. age 57 y.o.. 162 malignant gliomas, 125 metastatic tumors, 38 meningiomas, and 34 rare other tumors. 197 Males (163 White, 23 Black, 5 Asian, and other races) and 157 Females (White 121, 28 Black, 0 Asian, and 8 other races). No unexpected outcomes reported in the hands of experienced providers have occurred, although close clinical-radiographic follow-up, to ensure early detection of possible treatment-effects, is paramount. Steroid-use, and above endpoints, continue to be collected. CONCLUSIONS In this observational registry of Gamma Tiles (Cs-131 source brachy-therapy) added to medically needed resections for patients with primary and metastatic intracranial tumors continues. Data will be used to benchmark clinical outcomes of R+STaRT therapy and allow for comparisons to existing standard-of-care treatments. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.
Background:GammaTile (GT), a form of brachytherapy utilizing cesium-131 seeds in a bioresorbable collagen tile, has gained popularity for the treatment of recurrent intracranial tumors and more recently for newly diagnosed metastases. This study reports early experience utilizing GT in upfront brain metastases with a focus on clinical applications and perioperative safety. Methods:The STaRT Registry (NCT04427384) was queried for all patients receiving GT for upfront metastases from August 2021 to August 2023. Data regarding patient demographics, procedure details, and adverse events (AEs) were extracted and analyzed. Results:Twenty-eight patients, median age 65 years (range 28-81), with 30 treated metastases were reported from 6 institutions. Patients had 2.8 metastases on average (range 1-15) at the time of surgery; however, most patients had a single metastasis (60.7%). The mean diameter of treated metastases was 3.4 cm (range 1.5-4.7). A median of 4.0 tiles (range 1-10) were used per tumor. The median follow-up was 3.0 months (range 1.0-11.2) with 6 attributed AEs (21.4%), including 1 grade ≥ 3 (infection). In the immediate postoperative period (<14 days), 2 patients reported pain or headache, and 1 reported facial edema. One patient developed seizures on postoperative day 8 requiring medication. At 1-month follow-up, there was 1 superficial wound infection, in a previously colonized patient, requiring surgical intervention without explantation of tiles. At 3-month follow-up, 1 patient reported facial pain not requiring treatment. There were no symptomatic hematomas. Conclusions:GT demonstrates a favorable safety profile in upfront brain metastases with a 3.6% rate of serious AEs (grade ≥ 3) within 90 days of the procedure.
Objective: To evaluate the safety and feasibility of combining resection with immediate initiation of radiation and subsequent Stupp protocol in newly diagnosed GBM. Background: GBM is highly proliferative, with rapid early local progression (REP) after surgical resection, prior to the initiation of concurrent EBRT/TZM documented in 25–50% of patients. This high rate of REP supports initiation of an effective postoperative treatment as early as safely possible. FDA cleared GammaTiles (GT)(GT Medical Technologies, Inc, Tempe, AZ) consist of Cesium-131 radiation sources precisely imbedded in bio-resorbable collagen tiles. Intraoperatively tiles are permanently placed to line the at-risk areas of the resection bed achieving an immediate initiation of surgically targeted radiation therapy (STaRT). Design/Methods: GESTALT is a single arm 61 patient multi-center trial. Adults with suspected or confirmed GBM consented pre-operatively undergo a maximum safe resection and GT placement. Subjects with confirmed molecular GBM (WHO 2021 criteria) start concurrent EBRT/TMZ beginning 25±4 days post-surgery. Subsequent EBRT (20 fractions, 4 weeks) to low and high-risk PTV takes GT dose into account to a combined biologically equivalent dose of 46 and 60 Gy delivered in 2Gy/fraction, respectively. Adjuvant TMZ (6 cycles) begins 28±7 days after EBRT/TMZ; TTF is allowed. IDH-mutated tumors will be followed for safety. Outcomes include feasibility of incorporating GT without delay of Stupp protocol, consent/attrition rates, safety, OS, progression free survival, local control, functional decline (ECOG-PS) and immune competence (absolute lymphocyte counts). Results: The trial opened for enrollment in August of 2022 at 3 sites with 12 additional sites pending (NCT05342883). Clinical results to-date will be presented. Conclusions: This is the first trial in newly diagnosed GBM patients combining resection, GT, and the Stupp protocol, and attempts to reduce REP. The outcomes of this trial, if suggestive, will be used as the basis for a subsequent randomized trial. Disclosure: Dr. Dunbar has nothing to disclose. Dr. McCracken has received personal compensation for serving as an employee of GT Medical. Dr. McCracken has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GT Medical. Dr. McCracken has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for GT Medical. Dr. Nowlan has received personal compensation for serving as an employee of GT Medical. Dr. Nowlan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GT Medical. Kathryn Dusenbery has nothing to disclose. Dr. Ferreira has nothing to disclose. Dr. Lee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GT Medical. Dr. Lee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novocure. Dr. Lee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GT Medical. Dr. Lee has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Huff Powell Bailey Law Firm. An immediate family member of Dr. Lee has stock in Remedy Pharmaceuticals. An immediate family member of Dr. Lee has stock in Martin Pharmaceuticals. An immediate family member of Dr. Lee has stock in Critical Diagnostics. An immediate family member of Dr. Lee has stock in Woolsey Pharmaceuticals. An immediate family member of Dr. Lee has stock in Monogram Orthopaedics. An immediate family member of Dr. Lee has stock in Cytonics. An immediate family member of Dr. Lee has stock in 20-20 Gene Systems. Dr. Peach has nothing to disclose. Dr. Corns has nothing to disclose. Clark Chen has nothing to disclose.
Existing literature suggests that humiliation experiences, coupled with a negative family context, significantly predicts persecutory ideation in non-clinical participants. Whether this may also be linked to attenuated psychotic experiences is unknown. The current study aimed to assess whether familial adversity and humiliation may be related to hallucination-like experiences (HLEs) and other psychotic symptoms, and if state anxiety significantly contributed to these relationships. This cross-sectional study recruited a community sample of 93 adults (38% male; mean age = 27.3 years, standard deviation = 10.8 years), who completed measures of maladaptive familial environments, past and anticipated humiliation experiences, state anxiety and attenuated psychotic symptoms. Correlations and hierarchical regressions tested for direct and indirect relationships amongst study variables. A maladaptive family context, and humiliation (past and anticipated) were positively correlated with HLEs, and facets of attenuated psychotic symptoms. Anxiety uniquely predicted audio-visual and multisensory HLEs. Past humiliation and anxiety jointly predicted cognitive-perceptual disturbance and disorganisation, whereas fear of humiliation and anxiety jointly predicted interpersonal difficulty. Elevated state anxiety, coupled with humiliation, may increase attenuated psychotic symptoms in adulthood. Future research is needed to ascertain if these relationships hold true in clinical cohorts to examine the clinical significance of these data.
Abstract BACKGROUND Recurrent glioblastoma is an aggressive disease with dismal prognosis despite advances in standard therapy, making the maintenance of functional status and quality of life (QOL) in patients an important endpoint during treatment. Here, we report functional status (KPS) and QOL metrics (LASA and FACT-Br) at 6-months post-treatment for recurrent glioblastoma patients treated with maximal safe resection followed by intraoperative placement of collagen tile brachytherapy with Cesium-131 (Surgically Targeted Radiation Therapy or STaRT), a novel brachytherapy carrier. OBJECTIVE To assess the impact of STaRT on KPS and QOL among patients with recurrent glioblastoma (rGBM) at 6-months post-treatment. METHODS Patients were treated between 10/2020 and 05/2023 as part of a multi-institutional registry study (NCT#04427384). KPS was used to measure functional status. Linear Analog Self-Assessment (LASA) and Functional Assessment of Cancer Therapy – Brain (FACT-Br) were used to measure QOL. All assessments were collected at pre-surgery, and 1,3, and 6-months post-treatment. RESULTS 57 rGBM patients were treated on the Registry between 10/2020 and 05/2023. Of the 57 participants, 47 participants remain in the study, with 21 participants reaching the 6-month time point (5 exits, 5 deaths). Median age was 60 years (range 28-81). Methylguanine methyltransferase (MGMT) promoter was methylated in 17.5%, unmethylated in 38.5%, and unknown in 44%. Gross total resection was achieved in 72% of participants. Median KPS was 80% (range 40%-100%) at screening versus 70% (range 40%-90%) at 6 months post-treatment. Median LASA was 37 (range 8-50) at pre-surgery versus 34 (range 5-48) at 6-months post-treatment. Minimally important differences (MID) were noted between pre-surgery (136.9 ± 29.5) and 6-months post-treatment (112.5 ± 35.7) for the FACT-Br Total Score. CONCLUSION This interim data analysis supports further investigation of STaRT as a treatment for recurrent glioblastomas as a means of providing stable functional status and quality of life.
Background: Psychiatric intensive care units (PICUs) house some of the highest acuity patients within the mental health system. Little is known about patient characteristics and adverse events occurring in these settings and this study aimed to examine clinical, demographic and offending characteristics and correlates of problem behaviours for patients admitted to the first forensic PICU in Australia. Aims: To identify common characteristics held by patients admitted to one high secure forensic PICU in Australia. Method: Retrospective file review occurred for patients admitted between March 2019 and May 2020, during which 96 male patients were admitted. Results: Mean (range) age was 37.3 (21–76) years, and when admitted most patients were: single (n = 80; 83.3%), homeless (n = 52; 54.2%), had not completed high-school education (n = 60; 62.5%), had histories of trauma (n = 38; 39.6%) and antisocial behaviour (n = 40; 41.7%) in adolescence and presented with personality disorder (n = 23; 24.0%) and substance abuse (n = 93; 96.9%). Frequent problem behaviours, particularly aggression (n = 65; 67.7%), were encountered and rates of seclusion (n = 62; 64.6%) were high. Segregation in prison prior to admission and co-morbid personality disorder were associated with increased likelihood of aggression or self-harm respectively occurring. Conclusion: With high mental illness acuity and significant behavioural risk complicated by multi-vulnerability, forensic PICUs need specialist environments, models of care and high level relational and de-escalation staff expertise to maintain safety and promote recovery.
Abstract OBJECTIVE To evaluate the safety and feasibility of combining resection with immediate initiation of radiation and subsequent Stupp protocol in newly-diagnosed glioblastoma (GBM). BACKGROUND Rapid early local progression (REP) after resection, prior to the initiation of EBRT+/-chemotherapy, occurs in 25-50%. This high-rate of REP supports initiation of an effective postoperative treatment as early as safely possible. Bio-resorbable collagen tiles with imbedded cesium-131 radiation sources (Gammatiles™) are FDA cleared for this use. Intraoperatively, tiles are placed within the resection bed, thus achieving an immediate initiation of surgically targeted radiation therapy (STaRT). DESIGN/ METHODS GESTALT is a single-arm 61 patient multi-center trial. Consented adults with suspected or confirmed GBM undergo a maximum safe resection with Gammatile™ (STaRT). Patients with molecular GBM (WHO 2021 criteria) start concurrent EBRT/Temozolomide beginning 25±4 days post-surgery. Subsequent EBRT (20 fractions, 4 weeks) to low and high-risk PTV takes Gammatile™ dose into account to a combined biologically equivalent dose of 46 and 60 Gy delivered in 2Gy/fraction, respectively. Adjuvant TMZ (6 cycles) begins 28±7 days after EBRT/Temozolomide. TTF is allowed. IDH-mutated gliomas are followed for safety. Outcomes include feasibility of incorporating Gammatile™ without delay of Stupp protocol, consent/attrition rates, safety, performance status trajectory (ECOG, KPS), immune competence (absolute lymphocyte counts), local control, PFS, and OS. RESULTS The trial opened in Fall 2022 at 4 sites. 12 additional sites are onboarding (NCT05342883). 16 patients are on trial as of abstract submission. Currently, this trial appears feasible and without any unexpected intolerances/toxicities. CONCLUSIONS This is the first trial in newly diagnosed GBM patients to combine resection, Gammatile™, and the Stupp protocol, in an attempt to reduce REP, as well as possibly, improve other outcomes. RESULTS will inform the routine and investigational use of Gammatile™, and if suggestive, will form the basis for a subsequent randomized trial.
Abstract BACKGROUND Recurrent glioblastoma remains a disease without established standard of care. Here, we report the safety profile and survival outcome of recurrent glioblastoma patients treated with maximal safe resection followed by intraoperative placement of GammaTile (GT), a collagen tile-embedded Cs-131 brachytherapy platform. METHODS The study included isocitrate Dehydrogenase (IDH) wild-type glioblastoma patients who suffered tissue confirmed recurrence after concurrent temozolomide-radiation therapy. The series included consecutively patients treated at the University of Minnesota, Barrow Neurological Institute, Vidant Health, and Emory University Hospital. Survival results were stratified by methyl-guanine methyl transferase (MGMT) promoter methylation status RESULTS In total 48 patients were treated between 2019 and 2022 in this multi-institutional experience. The median days of hospitalization following the procedure was two (range: 1-15), with 72.5% of the GT implanted patients discharged home before postoperative day three. In terms of post-operative course, two patients suffered new-onset seizure post-surgery (4.0%). There was one (2%) 30-day mortality from intracranial hemorrhage secondary to heparinization for an ischemic limb. There were 13% readmission within 30 days, including hydrocephalus (n=2), urinary tract infection (n=1), deep venous thrombosis (n=1), failure to thrive (n=1), and infected wound (n=1). Of note, the patient with the infected wound had suffered a previous wound infection prior to the GT implantation and the pathogenic organism for both infections were the same (S. aureus). With a median follow-up of 250 days, twelve-month local control was 82%. Median overall survival (OS) from the time of diagnosis was 19 and 33 months for the MGMT unmethylated and methylated tumors, respectively. Select patients (n = 6) treated with adjuvant ketogenic diet in addition to GT and subsequent chemotherapy exhibited survival beyond expectation (> 14 mo, median survival not reached). CONCLUSION This multi-institutional experience supports further investigation of GT brachytherapy as a treatment for recurrent glioblastomas.
Objective Stepped care as a model of provision of mental health services has been frequently described from clinical or health administration perspectives, but less is known about the consumer perspective of stepped models of care. Method Qualitative interviews were undertaken with 18 consumers across a range of residential mental health services in Melbourne, Australia. Interviews were designed to help understand consumers' needs and experiences in navigating different services to meet their needs at different times in their mental health journey. Results Consumers experience fluctuations in their mental state that are best responded to by having access to a range of services, as well as to services that can respond flexibly to changing needs. Consumers do not necessarily progress through stepped care in a linear or step-up, step-down fashion. Conclusion Stepped care services need to be flexible in accommodating people along a continuum of care and responsive to where the consumer is at on their journey, rather than predetermining the trajectory of care. What is known about the topic? Stepped care has been identified as a critical component of comprehensive mental health care, bridging the gap between primary care and acute mental health services. The components of effective stepped care models have been broadly articulated, but the experience of moving through different components of care in response to changing needs has not previously been well described. What does the paper add? This paper presents consumer perspectives on a model of stepped care that is designed to respond flexibly to the changing needs of consumers, rather than representing a linear model of progress through the system. What are the implications for practitioners? Mental health services are increasingly grappling with provision of care to the 'missing middle': people with chronic mental illness yet not in an acute phase requiring in-patient hospital care. This paper presents a model of stepped care that responds to the fluctuating needs of consumers.