Iulia Karlsson
Swedish pharmaceutical company
Title: Temodex – a novel effective local intraoperative chemotherapy treatment for patients with neuroepithelial brain tumors
Biography
Biography: Iulia Karlsson
Abstract
INTRODUCTION: The efficacy of the local chemotherapeutical drug Temodex, constituted of temozolomide as active pharmaceutical ingredient and dextran phosphate as carrier, was studied in a phase II clinical trial.
AIM: To assess whether Temodex improves the standard of care treatment (Stupp) for patients with operable neuroepithelial brain tumors when administered into the cavity formed after tumor resection.
METHODS: An open, controlled, comparative, retro-prospective study with overall survival (OS) as primary endpoint. Totally 95 patients with Grade II-IV glioma were included in the control group and 41 in the Temodex group.
RESULTS: Median OS of patients with highly malignant, Grade III-IV, tumors was significantly improved in the Temodex group compared to control group (14.4 vs 9.1 months, respectively, p=0.0001). Median OS for all patients (Grade II-IV) in the Temodex group was 8.5 months longer compared to control (p=0.0001). Median PFS of patients with Grade III-IV tumors was 13.6 months in the Temodex group compared to 7.8 months in control (p=0.0001). Median PFS in patients with Grade IV tumors in the Temodex group was 12.9 months compared to 7.2 months in control (p=0,0001). One-year cumulative survival ratio of patients with Grade III-IV tumors was 51.9% higher in Temodex group compared to control (p=0.0001). At the time of the latest analysis, 74.4% patients in Temodex and 94.4% patients in the control groups had died.
CONCLUSION: The current study of Temodex efficacy in combination with adjuvant chemo-radiotherapy against Grade II-IV tumors demonstrates an increase in both median OS as well as in median PFS.