Tumor Treating Fields (TTFields) therapy vs physicians' choice standard-of-care treatment in patients with recurrent glioblastoma: a post-approval registry study (EF-19).

ABSTRACT:

Purpose

Tumor Treating Fields (TTFields) therapy, a noninvasive, anti-mitotic treatment modality, is approved for recurrent glioblastoma (rGBM) and newly diagnosed GBM based on phase III, EF-11 (NCT00379470) and EF-14 (NCT00916409) studies, respectively. The EF-19 study aimed to evaluate efficacy and safety of TTFields monotherapy (200 kHz) vs physicians' choice standard of care (PC-SOC; EF-11 historical control group) in rGBM.

Methods

A prospective, post-marketing registry study of adults with supratentorial rGBM treated with TTFields therapy was conducted. Primary endpoint was overall survival (OS; intent-to-treat [ITT] population) and secondary endpoint was OS per-protocol (PP). Subgroup and toxicity analyses were conducted.

Results

Median OS (ITT population) was c

SUBMITTER: Zhu JJ 

PROVIDER: S-EPMC9568629 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature