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Open Access 01-07-2020 | Glioblastoma | Clinical Study

Global post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice

Authors: Wenyin Shi, Deborah T. Blumenthal, Nancy Ann Oberheim Bush, Sied Kebir, Rimas V. Lukas, Yoshihiro Muragaki, Jay-Jiguang Zhu, Martin Glas

Published in: Journal of Neuro-Oncology | Issue 3/2020

Abstract

Introduction

Tumor Treating Fields (TTFields; antimitotic treatment) delivers low-intensity, intermediate-frequency, alternating electric fields through skin-applied transducer arrays. TTFields (200 kHz) was FDA-approved in glioblastoma (GBM), based on the phase 3 EF-11 (recurrent GBM, rGBM) and EF-14 (newly diagnosed GBM, ndGBM) trials. The most common TTFields-related adverse event (AE) in both trials was array-associated skin irritation. We now report on TTFields-related AEs in the real-world, clinical practice setting.

Methods

Unsolicited, post-marketing surveillance data from TTFields-treated patients (October 2011–February 2019) were retrospectively analyzed using MedDRA v21.1 preferred terms, stratified by region (US, EMEA [Europe, Middle East, Africa], Japan), diagnosis (ndGBM, rGBM, anaplastic astrocytoma/oligodendroglioma, other brain tumors), and age (< 18 [pediatric], 18–64 [adults], ≥ 65 [elderly]; years of age).

Results

Of 11,029 patients, 53% were diagnosed with ndGBM and 39% were diagnosed with rGBM at any line of disease recurrence. Most were adults (73%), 26% were elderly, and the male-to-female ratio was ~ 2:1 (close to published ratios of typical GBM populations). The most commonly reported TTFields-related AE was array-associated skin reaction, occurring in patients with ndGBM (38%), rGBM (29%), anaplastic astrocytoma/oligodendroglioma (38%), and other brain tumors (31%); as well as 37% of pediatric, 34% of adult, and 36% of elderly patients. Most skin AEs were mild/moderate and manageable. Other TTFields-related AEs in patients with ndGBM/rGBM included under-array heat sensation (warmth; 11%, 10%, respectively) and electric sensation (tingling; 11%, 9%, respectively), and headache (7%, 6%, respectively).

Conclusions

This TTFields safety surveillance analysis in > 11,000 patients revealed no new safety concerns, with a favorable safety profile comparable with published TTFields/GBM trials. The safety profile remained consistent among subgroups, suggesting feasibility in multiple populations, including elderly patients.

Graphic abstract

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Title: Global post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice
Authors: Wenyin Shi
Deborah T. Blumenthal
Nancy Ann Oberheim Bush
Sied Kebir
Rimas V. Lukas
Yoshihiro Muragaki
Jay-Jiguang Zhu
Martin Glas
Publication date: 01-07-2020
Publisher: Springer US
Keywords: Glioblastoma
Astrocytoma
Glioma
Glioma
Astrocytoma
Glioblastoma
Brain Tumor
Astrocytoma
Glioblastoma
Oligodendroglioma
Glioma
Published in: Journal of Neuro-Oncology / Issue 3/2020
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI: https://doi.org/10.1007/s11060-020-03540-6

At a glance: The STEP trials

Springer Medicine

Global post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice

Abstract

Introduction

Methods

Results

Conclusions

Graphic abstract

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusions

Graphic abstract

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