gms | German Medical Science

73. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC)
Joint Meeting mit der Griechischen Gesellschaft für Neurochirurgie

Deutsche Gesellschaft für Neurochirurgie (DGNC) e. V.

29.05. - 01.06.2022, Köln

First results of the TIGER study – treatment decision and quality of life of glioblastoma patients during TTFields therapy in routine clinical care

Erste Ergebnisse der TIGER-Studie: Behandlungsentscheidung und Lebensqualität von Glioblastom-Patientinnen und -Patienten während der TTFields-Therapie in der klinischen Routineversorgung

Meeting Abstract

  • Oliver Bähr - Hospital Aschaffenburg-Alzenau, Clinic of Neurology, Aschaffenburg, Deutschland
  • Ghazaleh Tabatabai - Universitätsklinikum Tübingen, Department of Neurology and Interdisciplinary Neurooncology, Tübingen, Deutschland
  • Rainer Fietkau - Universitätsklinikum Erlangen, Department of Radiation Oncology, Erlangen, Deutschland
  • Roland Goldbrunner - Universitätsklinikum Köln, Zentrum für Neurochirurgie, Köln, Deutschland
  • presenting/speaker Martin Glas - Universitätsklinikum Essen, Klinik für Neurologie, Abteilung für Klinische Neuroonkologie, Essen, Deutschland; Universitätsklinikum Essen, West German Cancer Center (WTZ) and German Cancer Consortium Partner Site, Essen, Deutschland

Deutsche Gesellschaft für Neurochirurgie. 73. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Griechischen Gesellschaft für Neurochirurgie. Köln, 29.05.-01.06.2022. Düsseldorf: German Medical Science GMS Publishing House; 2022. DocV228

doi: 10.3205/22dgnc220, urn:nbn:de:0183-22dgnc2206

Published: May 25, 2022

© 2022 Bähr et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Objective: Current treatment strategies for glioblastoma (GBM) in clinical routine are maximal safe resection, radiotherapy and an alkylating chemotherapy. Based on the positive survival results of the EF-14 phase III trial, adding Tumor Treating Fields (TTFields) to maintenance temozolomide (TMZ) constitutes an additional routine treatment method. The TIGER study (TTFields In GErmany in Routine Clinical Care) investigates GBM patients applying TTFields therapy with a focus on patients' treatment decision, health-related quality of life (HRQoL) within 4 months after starting therapy, treatment compliance and duration.

Methods: This multi-center prospective non-interventional study (NCT03258021) included newly diagnosed GBM patients eligible for TTFields therapy. Provided they agreed to study participation, patients received an introduction to the therapy and baseline demographic data were collected. Reasons for decision for or against TTFields therapy were evaluated with a questionnaire (scale 1 (not at all)–5 (strongly)) at baseline in both arms, follow-up information on how patients cope with the therapy was collected 2 months after TTFields treatment start, if applicable. HRQoL was assessed in patients deciding for TTFields therapy at baseline, at 2 months and 4 months thereafter by EORTC-QLQ-C30/BN-20 questionnaires.

Results: 710 eligible patients (259 female/451 male) were enrolled at 81 participating centers between Aug 2017 and Nov 2019. Their mean age was 59 years (range: 19-85). 582 (82%) decided to start TTFields and 128 (18%) refused TTFields treatment. The proportion of female patients was similar in both groups (36% vs 38%). The prospect of treatment success (mean 4.5) and doing something against their disease (4.2) were the main reasons for deciding to start TTFields therapy, whereas patients deciding not to apply TTFields were influenced the most by carrying a device (4.4). HRQoL did not decline during 4 months of TTFields therapy except for itchy skin, comparable to the results of the EF-14 phase 3 trial. This included global health status, social functioning, insomnia, headaches, and fatigue.

Conclusion: The TIGER study is the largest non-interventional trial on the use of TTFields in routine clinical care to date. Most patients were willing to undergo the therapy, with hope for efficacy and being active against their disease themselves as major motivators. HRQoL was not impaired during the follow-up period, except for more itchy skin.