Abstract

Abstract OBJECTIVE Current interdisciplinary treatment strategies for glioblastoma (GBM) outside clinical trials include maximally safe resection, followed by radiation and chemotherapy. The results of the positive phase III trial EF-14, adding Tumor Treating Fields (TTFields) to temozolomide (TMZ) maintenance therapy, brought an additional treatment method to clinical routine. The TIGER (TTFields In GErmany in Routine Clinical Care) study documents the use of TTFields in routine clinical care with a focus on health-related quality of life (HRQoL) within 4 months after starting therapy, treatment compliance and duration. METHODS This multi-center, prospective, non-interventional study in Germany (NCT03258021) included ndGBM patients eligible for TTFields therapy. Following their consent, patients received a comprehensive introduction to the therapy and baseline demographic data were collected. Information on TTFields therapy decision was evaluated based on a dedicated TTFields questionnaire at baseline in both arms; follow-up information on how patients handle the therapy was collected two months after TTFields treatment start. HRQoL was assessed in patients deciding for TTFields therapy at baseline and at 2 and 4 months using the EORTC-QLQ-C30/BN-20 questionnaires. RESULTS Between August 2017 and November 2019, 710 patients (259 female/451 male) were enrolled at 81 participating centers. The mean age was 58.5 years (range: 19.0-85.0; Cut-off: August 31, 2020). The overall baseline characteristics of the study group reflects a typical GBM population. Of these, 582 (82%) decided to start TTFields; 128 (18%) refused TTFields treatment. HRQoL did not decline during TTFields therapy except for itchy skin, comparable to the EF-14 trial. A detailed analysis of the cohort as well as their reported QoL will be presented. CONCLUSION The TIGER study is the largest non-interventional trial on the use of TTFields in routine clinical care. The use of TTFields in patients with ndGBM did not impair HRQoL during the follow-up period, except for more itchy skin.

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