Abstract CT187: Comparative analysis of randomized glioblastoma Phase III trials since 2005

Abstract

Objective: We aimed to identify and compare glioblastoma (GBM) Phase III trials of the years 2005 to 2018. Methods:A systematic literature search using PubMed and ClinicalTrials.gov was conducted to provide an overview of clinically relevant GBM Phase III trials (years 2005-2018) that also included younger adult patients. A comparative analysis of positive and negative trails as well as a detailed overview of the main findings of the trials with demonstrated significantly improved survival will be shown. Results: Searching PubMed.gov for “glioblastoma OR gbm” and filtering for Phase III clinical trials identified 61 publications. A query on ClinicalTrials.gov for “glioblastoma” filtering for “completed, terminated, interventional, adult, older adult, Phase III” found 29 entries. Among these trials a total of three GBM Phase III trials reporting OS benefit, including the EORTC/NCIC study (PMID: 15758009), EF-14 (NCT00916409) and CeTeG (NCT01149109). A broad overview of the studies identified and a comparison between negative and positive trials will be provided. The latest two identified trials (EF-14 and CeTeG) will be described in more detail. The EF-14 trial randomized 695 patients with newly diagnosed GBM, irrespective of MGMT promoter methylation status, to treatment with temozolomide (TMZ) or tumor treating fields (TTFields) plus TMZ (TTFields/TMZ). ITT analysis showed significantly improved OS (p Conclusion: This analysis on GBM Phase III trials conducted since 2005 showed that majority of trials did not show a significant improvement in overall survival. CeTeG and EF-14 are, besides trials on elderly patients only, two recent studies with positive survival outcome. Citation Format: Lazaros Lazaridis, Ann-Kathrin Stoppek, Teresa Schmidt, Martin Glas, Sied Kebir. Comparative analysis of randomized glioblastoma Phase III trials since 2005 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT187.