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QOLP-24. PATIENTS’/PARENTS’ EXPERIENCES OF RECEIVING OPTUNE DELIVERED TUMOR TREATMENT FIELDS: A PEDIATRIC BRAIN TUMOR CONSORTIUM STUDY: PBTC-048

ABSTRACT: Abstract BACKGROUND Optune-delivered TTFields is a promising anti-mitotic FDA-approved cancer therapy in adult patients with high-grade gliomas (HGG), although effectiveness is not yet proven in pediatric patients. A multicenter trial [NCT03033992] evaluating the feasibility and device-related toxicity for children with recurrent or progressive supratentorial high-grade glioma (HGG) and ependymoma is being conducted. This presentation reports the interim health-related quality of life (HRQOL) and device-use experiences reported by patients and parents. METHODS Participating patients (aged 5–21 years) and one of their parents completed the following measures at baseline and prior to each intervention cycle: PROMIS Fatigue, Anger, Anxiety, Depressive Symptoms, Mobility, Upper Extremity Function, and Peer Relationships and Neuro-QOL Stigma. Participants completed an exit survey when they were off the study regarding their experiences wearing the device. RESULTS This planned interim analysis included 11 patients (7 males/4 females) with supratentorial tumors: ten HGG and one ependymoma. Median age was 14.2 (6.4–21.3) years. Patients reported worse HRQOL than the norms on all domains. Of these 11 patients, 6 completed the exit survey. No significant changes (p< 0.05) between the baseline and the final assessment were found except for Stigma. Patients perceived less stigma at baseline than at the final assessment (t=2.82, p=0.0370). Of these 6 parents who completed the Exit Survey: most considered wearing the device to be easy (n=5).Patient reminders were unnecessary (n=5), patients rarely/didn’t complain (n=4) or refuse (n=5) to wear the device, there was rare/no (n=4) difficulty with daily activities because of the device, and patients were not (n=4) or sometimes (n=2) embarrassed to wear the device. CONCLUSION Preliminary results indicate Optune-delivered TTFields therapy is feasible and accepted by children and parent with no evidence of negatively impacting patients’ QOL. Accrual has been expanded beyond the interim analysis.

SUBMITTER: Lai J

PROVIDER: S-EPMC6847231 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Project description:Abstract BACKGROUND Children with recurrent or progressive pediatric CNS tumors have poor prognoses. Optune delivers TTFields, an anti-mitotic FDA-approved cancer therapy, for adult patients with newly diagnosed and recurrent supratentorial GBM. Methods This multicenter trial [NCT03033992] examines the feasibility and device-related toxicity of TTFields in 20 children aged 5–21 years with recurrent supratentorial HGG and ependymoma. Secondary objectives include: response rate, event-free survival, compliance and QoL. Feasibility in this trial is defined as the ability of pediatric subjects to wear Optune ≥18 hours/day for at least 23/28 days of cycle one following a 7-day learning period. Treatment may continue up to 26 cycles based on observed benefit and safety. QOL instruments include PROMIS and Neuro-QOL. Following enrollment of the 11th evaluable subject, the study will be temporarily suspended to share interim feasibility and safety data with the FDA. RESULTS This planned interim analysis included 11 patients (7 males/4 females) with supratentorial tumors: ten HGG and one ependymoma. Median age was 14.2 (6.4–21.3) years. Ten patients were evaluable (1 Progressive Disease) during the feasibility period) and 4 remained on study through 4 cycles and one patient is currently on Cycle 14. One grade 5 intracranial hemorrhage not associated with the device and no grade IV toxicities occurred, 3 patients had seizures (grade 1–3), fatigue, scalp pain, localized rash, and headache (none greater than grade 3). Of the 10 evaluable patients, 7 satisfied the feasibility criteria for the Optune therapy, which is above the prespecified threshold of at least 6/11. CONCLUSION This is the first prospective safety and feasibility trial for Optune in children with recurrent supratentorial HGG and ependymoma. Preliminary results indicate feasibility with minimal toxicity. Accrual to the study is ongoing. An amendment is in progress adding a stratum for newly diagnosed diffuse intrinsic pontine glioma (DIPG) patients.

Project description:BackgroundTo date, there has been no large-scale, real-world study of the health-related quality of life outcomes for patients using tumor treating fields (TTFields) therapy for glioblastoma (GBM) treatment.MethodsA survey was mailed to 2,815 patients actively using TTFields for treatment of GBM in the USA (n = 2,182) and Europe (n = 633). The survey included patient-reported demographic and clinical information, as well as EuroQol's EQ-5D-5L and visual analogue scale (EQ-VAS) overall health score.ResultsA total of 1,106 applicable patients responded to the survey (USA = 782 and Europe = 324), with a mean age of 58.6 years (SD = 12.3). The average time since diagnosis and time using TTFields were 21.5 months (SD = 25.1) and 13.5 months (SD = 13.2), respectively. Over 61% of patients had been diagnosed at least 1 year prior and 28.4% at least 2 years prior; 45 patients (4.2%) had been diagnosed at least 5 years prior. Progressed disease was reported in 307 patients, while 690 reported non-progressed disease. Regression analyses showed that GBM disease progression and older age had predictable negative associations (p < 0.001) with most EQ-5D-5L dimensions and the EQ-VAS. However, longer time since diagnosis was associated with improved self-care (p < 0.05), usual activities (p < 0.01), and EQ-VAS (p < 0.05) overall and in patients with progressed disease (p < 0.01, p < 0.05, and p < 0.01, respectively). Additionally, longer time using TTFields was associated with improved mobility (p < 0.05), self-care (p < 0.001), usual activities (p < 0.01), and EQ-VAS (p < 0.01) overall; with improved EQ-VAS in progression-free patients (p < 0.05); and with improved mobility (p < 0.05), self-care (p < 0.01), usual activities (p < 0.05), and EQ-VAS (p < 0.05) in patients with progressed disease.ConclusionThis is the largest real-world study of patient-reported quality of life in GBM and TTFields treatment to date. It shows unsurprising negative associations between quality of life and disease progression and older age, as well as more novel, positive associations between quality of life and longer time since diagnosis and time using TTFields therapy.

Dataset Information

QOLP-24. PATIENTS’/PARENTS’ EXPERIENCES OF RECEIVING OPTUNE DELIVERED TUMOR TREATMENT FIELDS: A PEDIATRIC BRAIN TUMOR CONSORTIUM STUDY: PBTC-048

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