Actr-31. the use of ttfields for newly diagnosed gbm patients in germany in routine clinical care (tiger: ttfields in germany in routine clinical care)

Abstract OBJECTIVE Survival for the most common brain tumor, glioblastoma (GBM), has not improved since 2005, despite numerous phase 3 trials. The phase 3 EF-14 trial demonstrated significantly improved overall, progression-free and long-term survival in newly diagnosed GBM (ndGBM) patients by addition of TTFields to adjuvant temozolomide chemotherapy. As there is very high interest among prescribing physicians from all disciplines to further evaluate these effects in routine clinical care, the aim of the TIGER study is to assess safety and efficacy of TTFields in routine care and reasons for patients refusing TTFields treatment, quality of life, treatment duration and compliance. METHODS The TIGER study is a multi-centre, prospective, non-interventional study in Germany (NCT03258021). All ndGBM patients who are eligible for TTFields therapy are asked for consent for study-participation and comprehensively introduced to the therapy to allow them to make a conscious positive or negative therapy decision. At baseline and 2–4 months after treatment start, demographic data, the QoL and reasons for therapy decision are evaluated utilizing the EORTC-QLQ-C30/BN-20 and TTFields questionnaire. Inclusion of 1000 patients is planned (500 with positive/negative treatment decision, respectively) with a follow-up period of 18 months. RESULTS At the last data cut-off (May 2019), 497 patients have made a decision regarding treatment with TTFields. Within this population, 84% of patients decided to undergo TTFields therapy. The median age of patients included in the trial is currently 58.3 years (19–85). 91% of patients report that the prospect of treatment success considerably or strongly affects treatment decision. Most recent data will be presented at the meeting. CONCLUSION Systematic and prospective data assessment for using TTFields in routine clinical care including patient’s therapy decision can be evaluated in TIGER. Additionally, the study supports the analysis of treatment duration and usage rate, which could drive future assessment of TTFields treatment duration.