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Efficacy of a Novel Intratumoral Radio Immunotherapeutic Agent Cotara Delivered via Convection-Enhanced Delivery in Recurrent Glioblastoma Multiforme: An Initial Single Institutional Experience with 8 Cases: 980
Gupta, Deepak Kumar M.D.
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INTRODUCTION
Intratumoral therapeutic agents delivered by convection-enhanced delivery (CED) in recurrent glioblastoma multiforme (GBM) appear promising. We report on the safety, feasibility, and efficacy of using CED to administer radioimmunotherapeutic agent to treat patients with recurrent GBM.
METHODS
Eight patients with recurrent GBM received I131chimeric TNT-1/B monoclonal antibody specific for universal intracellular antigen (2.5 mCi/mL baseline clinical target volume [CTV]) using CED pump through 2 stereotactically implanted intratumoral catheters over 25 hours. CTV was noted (baseline) and 8 weekly neurological, magnetic resonance imaging, and laboratory examinations were performed to assess tumor response and progression. Spatial drug distribution was noted using positron-emission tomography and gamma camera 1 week postoperatively. Safety was evaluated on the basis of incidence of procedure related, neurological, and systemic adverse events.
RESULTS
The mean age group (50.1 ± 14.4 years) and median Karnofsky Performance Score was 90. The average baseline CTV was 25.0 ± 13.0 cm3, 42-128 mCi received by tumor tissue (60 ± 31.2) (range, 25.2-120.6 milliCuries) (62-87% of administered radioactivity, mean 78%). The average body radiation exposure at 1 meter from the patient's cranium immediately, 24 hours, 48 hours, 96 hours, and 144 hours after infusion was 151.42, 85.00, 42.57, 27.80, and 18.50 μSieverts/hour. Three patients died of tumor progression. The mean progression-free survival (PFS) and mean overall survival (mOS) after receiving cotara therapy were 22 and 27 weeks, respectively. Among the 5 survivors (follow-up duration, 12-80 weeks), the mean PFS was 42 weeks. Before the last follow-up evaluation, the median overall survival after treatment of first recurrence with cotara therapy was 43 ± 22.2 wks (range, 16-78 weeks). The adverse events (treatment/drug related) noted in 3 patients included brain edema (14.28%) and headache (28.57%).
CONCLUSION
Intratumoral radio immunotherapy using cotara compound is safe, feasible, and efficacious in prolonging survival in recurrent GBM cases. Data from larger cohorts is needed to substantiate the observations of the present therapeutic agent in these cases.
Copyright © by the Congress of Neurological Surgeons
Article OutlineINTRODUCTIONMETHODSRESULTSCONCLUSION
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