Abstract

Abstract BACKGROUND TTFields therapy, concurrent with temozolomide, is approved for treatment of newly diagnosed glioblastoma (ndGBM), following results from the pivotal EF-14 study. The multicenter, prospective TIGER study (NCT03258021) investigated real-world use of TTFields therapy in patients with ndGBM during routine clinical care in Germany. Data on patient treatment decisions and health-related quality of life (HRQoL) are reported. METHODS Reasons for patient decision to receive TTFields therapy were evaluated via questionnaire (scoring scale: 1 [not at all] to 5 [strongly]) at baseline. In patients who decided to receive TTFields therapy, HRQoL was assessed via the EORTCQLQC30/BN20 questionnaire at baseline, and 2 and 4 months after initiating therapy. HRQoL parameters included: global health status and functioning, insomnia, headaches, fatigue, nausea/vomiting, pain, itchy skin, hair loss, seizures, dyspnea, appetite loss, constipation, diarrhea, visual disorder, leg weakness, drowsiness, bladder control, motor dysfunction, communication deficit, future uncertainty, and financial difficulties. RESULTS Overall, 710 patients (259 female; 451 male) were enrolled (Aug 2017–Nov 2019). Mean age was 59 years (range: 19–85). In total, 582 (82%) patients decided to start TTFields therapy, while 128 (18%) declined; the proportion of women was similar in each group (36% and 38%, respectively). Predominant reasons for deciding to start TTFields therapy were the prospect of treatment success (mean score: 4.5) and doing something to fight their disease (4.2). Predominant reason for deciding against TTFields therapy was carrying the device (4.4). During 4-month study follow-up, there was no decline or improvement in any HRQoL parameter, except for more itchy skin, consistent with EF-14 data. CONCLUSION TIGER is the largest non-interventional study to date on TTFields therapy use in routine clinical care. Most patients opted to receive TTFields therapy, with fighting their disease and hope for treatment success as major motivators. HRQoL was not impaired during follow-up, except for skin itchiness.

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