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      Convection Enhanced Delivery of Topotecan for Gliomas: A Single-Center Experience

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          Abstract

          A key limitation to glioma treatment involves the blood brain barrier (BBB). Convection enhanced delivery (CED) is a technique that uses a catheter placed directly into the brain parenchyma to infuse treatments using a pressure gradient. In this manuscript, we describe the physical principles behind CED along with the common pitfalls and methods for optimizing convection. Finally, we highlight our institutional experience using topotecan CED for the treatment of malignant glioma.

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          Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma

          Roger Stupp, Warren P Mason, Martin J van den Bent … (2005)
          Glioblastoma, the most common primary brain tumor in adults, is usually rapidly fatal. The current standard of care for newly diagnosed glioblastoma is surgical resection to the extent feasible, followed by adjuvant radiotherapy. In this trial we compared radiotherapy alone with radiotherapy plus temozolomide, given concomitantly with and after radiotherapy, in terms of efficacy and safety. Patients with newly diagnosed, histologically confirmed glioblastoma were randomly assigned to receive radiotherapy alone (fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy) or radiotherapy plus continuous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was overall survival. A total of 573 patients from 85 centers underwent randomization. The median age was 56 years, and 84 percent of patients had undergone debulking surgery. At a median follow-up of 28 months, the median survival was 14.6 months with radiotherapy plus temozolomide and 12.1 months with radiotherapy alone. The unadjusted hazard ratio for death in the radiotherapy-plus-temozolomide group was 0.63 (95 percent confidence interval, 0.52 to 0.75; P<0.001 by the log-rank test). The two-year survival rate was 26.5 percent with radiotherapy plus temozolomide and 10.4 percent with radiotherapy alone. Concomitant treatment with radiotherapy plus temozolomide resulted in grade 3 or 4 hematologic toxic effects in 7 percent of patients. The addition of temozolomide to radiotherapy for newly diagnosed glioblastoma resulted in a clinically meaningful and statistically significant survival benefit with minimal additional toxicity. Copyright 2005 Massachusetts Medical Society.
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            Astrocyte-endothelial interactions at the blood-brain barrier.

            N. Abbott, Lars Rönnbäck, Elisabeth Hansson (2006)
            The blood-brain barrier, which is formed by the endothelial cells that line cerebral microvessels, has an important role in maintaining a precisely regulated microenvironment for reliable neuronal signalling. At present, there is great interest in the association of brain microvessels, astrocytes and neurons to form functional 'neurovascular units', and recent studies have highlighted the importance of brain endothelial cells in this modular organization. Here, we explore specific interactions between the brain endothelium, astrocytes and neurons that may regulate blood-brain barrier function. An understanding of how these interactions are disturbed in pathological conditions could lead to the development of new protective and restorative therapies.
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              Recurrent Glioblastoma Treated with Recombinant Poliovirus

              Darell D. Bigner, Dani Bolognesi, Allan Friedman … (2018)
              BACKGROUND The prognosis of patients with recurrent World Health Organization (WHO) grade IV malignant glioma is dismal, and there is currently no effective therapy. We conducted a dose-finding and toxicity study in this population of patients, evaluating convection-enhanced, intratumoral delivery of the recombinant nonpathogenic polio–rhinovirus chimera (PVSRIPO). PVSRIPO recognizes the poliovirus receptor CD155, which is widely expressed in neoplastic cells of solid tumors and in major components of the tumor microenvironment. METHODS We enrolled consecutive adult patients who had recurrent supratentorial WHO grade IV malignant glioma, confirmed on histopathological testing, with measurable disease (contrast-enhancing tumor of ≥1 cm and ≤5.5 cm in the greatest dimension). The study evaluated seven doses, ranging between 10 7 and 10 10 50% tissue-culture infectious doses (TCID 50 ), first in a dose-escalation phase and then in a dose-expansion phase. RESULTS From May 2012 through May 2017, a total of 61 patients were enrolled and received a dose of PVSRIPO. Dose level −1 (5.0×10 7 TCID 50 ) was identified as the phase 2 dose. One dose-limiting toxic effect was observed; a patient in whom dose level 5 (10 10 TCID 50 ) was administered had a grade 4 intracranial hemorrhage immediately after the catheter was removed. To mitigate locoregional inflammation of the infused tumor with prolonged glucocorticoid use, dose level 5 was deescalated to reach the phase 2 dose. In the dose-expansion phase, 19% of the patients had a PVSRIPO-related adverse event of grade 3 or higher. Overall survival among the patients who received PVSRIPO reached a plateau of 21% (95% confidence interval, 11 to 33) at 24 months that was sustained at 36 months. CONCLUSIONS Intratumoral infusion of PVSRIPO in patients with recurrent WHO grade IV malignant glioma confirmed the absence of neurovirulent potential. The survival rate among patients who received PVSRIPO immunotherapy was higher at 24 and 36 months than the rate among historical controls.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Pharmaceutics
                Journal ID (iso-abbrev): Pharmaceutics
                Journal ID (publisher-id): pharmaceutics
                Title: Pharmaceutics
                Publisher: MDPI
                ISSN (Electronic): 1999-4923
                Publication date (Electronic): 30 December 2020
                Publication date Collection: January 2021
                Volume: 13
                Issue: 1
                Electronic Location Identifier: 39
                Affiliations
                [1 ]Department of Neurological Surgery, Columbia University Irving Medical Center, New York, NY 10032, USA; efs2110@ 123456cumc.columbia.edu (E.F.S.); mga2122@ 123456cumc.columbia.edu (M.G.A.); jnb2@ 123456cumc.columbia.edu (J.N.B.)
                [2 ]Department of Cell Biology and Pathology, Columbia University Irving Medical Center, New York, NY 10032, USA; pc561@ 123456cumc.columbia.edu
                Author notes
                Author information
                https://orcid.org/0000-0003-2071-6965
                https://orcid.org/0000-0003-3374-9037
                https://orcid.org/0000-0002-6844-0286
                Article
                Publisher ID: pharmaceutics-13-00039
                DOI: 10.3390/pharmaceutics13010039
                PMC ID: 7823846
                PubMed ID: 33396668
                SO-VID: aa8b3c79-a452-4750-9306-59566867ff03
                Copyright © © 2020 by the authors.
                License:

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 04 December 2020
                Date accepted : 24 December 2020
                Categories
                Subject: Review

                Keywords: convection enhanced delivery,glioma,glioblastoma,topotecan
                Data availability:
                Keywords: convection enhanced delivery, glioma, glioblastoma, topotecan

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