To identify risk factors for the development of tumor-related epilepsy (TRE) and investigate its natural history in adults with new diffuse gliomas (DG).
Sunday, April 26April 14, 2020Free AccessScores and Performance of Patient Reported Outcome Measures in Patients with High Grade Glioma at Diagnosis (5378)Samantha Myers, Peggy Auinger, Gretchen Birbeck, Joy Burke, Chinazom Ibegbu, Nimish Mohile, Andrea Wasilewski, Jennifer Serventi, and Thomas WychowskiAuthors Info & AffiliationsApril 14, 2020 issue94 (15_supplement)https://doi.org/10.1212/WNL.94.15_supplement.5378 Letters to the Editor
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 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.
To describe predictors of adverse outcomes in older patients with glioblastoma (GBM).
Background:
Older adults with GBM have poor survival and are vulnerable to treatment toxicities. Optimal therapy is not defined and decision making depends on identifying risk factors associated with poor outcomes.
Design/Methods:
We prospectively enrolled patients over age 65 with newly-diagnosed GBM to undergo a comprehensive geriatric assessment (CGA) and geriatric-8 (G8) prior to disease-directed therapy. The G8 is a brief, valid and feasible tool that consists of eight items assessing age, food intake, weight loss, mobility, neuropsychology, body mass index, prescription drug, and self-perception of health. CGA consisted of several tests including Short Physical Performance Battery (SPPB), Geriatric depression scale (GDS-15), and Montreal Cognitive Assessment (MoCA). Patients were followed for adverse events, hospitalizations, and survival. Logistic regression modeled contributions of MGMT methylation status, extent of resection (EOR), G8 score and elements of CGA. Cox regression was also used to model impact of these factors on survival time.
Results:
27 patients were enrolled with median age of 73.5. 20 patients were male and 11 were methylated. 21 patients are deceased (median survival=11.6 months). 44% of patients (n=12) had unplanned hospitalizations. Most common causes were for seizures (n=3), focal weakness (n=5), and cognitive decline (n=3). Poor G8 score (low) predicted unplanned hospitalizations (OR=3.38, p=0.0386). Age, EOR, MGMT methylation, GDS-15, and CGA elements were not significantly associated with hospitalization. Only MoCA score was significantly associated with improved survival (HR=0.7, p=0.02).
Conclusions:
Nearly half of older patients with GBM had unplanned hospitalizations. Poor G8 score predicted hospitalizations, suggesting that G8 may reveal underlying vulnerability to treatment toxicity and should be studied prospectively to validate these findings. Future studies should evaluate if treatment decisions based on G8 can reduce hospitalizations, improve patient quality of life, and decrease healthcare cost. Disclosure: Mr. Whitt has nothing to disclose. Dr. Hemminger has nothing to disclose. Miss Cawley has nothing to disclose. Dr. Mohile has nothing to disclose. Dr. Wasilewski has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novocure. Dr. Hardy has received research support from Del Monte Institute for Neuroscience.
Objective: To describe causes, frequency and outcomes of acute care visits (ACV) in GBM. Background: Utilization of inpatient medical services in GBM is not well studied. Methods: IRB approved retrospective study of 158 GBM patients at the University of Rochester over 5 years. Documents in the EMR were reviewed to identify all local and outside ACV. Results: 71[percnt] (112/158) of GBM patients had 235 ACV corresponding to 163 hospitalizations (69[percnt]) and 72 ED visits (31[percnt]). 63[percnt] of patients had multiple visits. 80[percnt] (130/163) of visits were to a medical floor and 20[percnt] to an ICU. Admission diagnoses were seizure (31[percnt]), neurosurgical procedure (10[percnt]), infection (8.5[percnt]), focal neurologic symptoms (8[percnt]) and VTE (7.7[percnt]). 49 patients had 1 or more visits for seizures. GBM progression was documented in 38[percnt] of visits. Median time to first ACV was 65.6 days (Range: 1-972 days) and 22[percnt] of patients had an ACV within 30 days of diagnosis. Median length of stay was 5 days (range 1 to 59) per visit and 10 days over a lifetime. 50[percnt] of patients were discharged home; 47[percnt] required a higher level of care (19[percnt] home with services, 13[percnt] to a SNF, 11[percnt] to hospice, 4[percnt] to acute rehab) and 3[percnt] died. 38[percnt] of patients had ACV encounters within 30 days of death. Median survival for patients with ACV was 337 vs. 364 days for patients without ACV. Hospitalized patients spent a median of 3.3[percnt] of their survival time in the hospital (range: 0.07-57.14[percnt]). Conclusion: Acute care is utilized by the majority of GBM patients, most commonly for seizures. The high number of ED visits, short length of stay and high number of patients being discharged to home suggest that some ACVs are avoidable. Future studies should focus on interventions and improved seizure control to reduce the frequency of ACV. Disclosure: Dr. Wasilewski has nothing to disclose. Dr. Serventi has nothing to disclose. Dr. Kamalyan has nothing to disclose. Dr. Wychowski has nothing to disclose. Dr. Mohile has nothing to disclose.
