Article
The use of TTFields for newly diagnosed GBM patients in Germany in routine clinical care (TIGER – TTFields in Germany in routine clinical care)
Studie zur Anwendung von TTFields in der klinischen Routine, bei Patientinnen und Patienten mit einem neudiagnostizierten Glioblastom in Deutschland (TIGER Studie)
Search Medline for
Authors
-
Oliver Bähr
- Universitätsklinikum Frankfurt, Dr. Senckenbergisches Institut für Neuroonkologie, Frankfurt, Deutschland
-
Ghazaleh Tabatabai
- Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Tübingen, Deutschland
-
Rainer Fietkau
- Universitätsklinikum Erlangen, Radioonkologie, Erlangen, Deutschland
-
Roland Goldbrunner
- Uniklinik Köln, Zentrum für Neurochirurgie, Köln, Deutschland
-
Martin Glas
- Universitätsklinikum Essen, Abteilung Klinische Neuroonkologie, Essen, Deutschland; University Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland
| Published: | May 8, 2019 |
|---|
Outline
Text
Objective: Survival in Glioblastoma (GBM), which is the most common brain tumor, has remained essentially unchanged since 2005 despite various clinical Phase 3 trials conducted. Tumor treating fields (TTFields) are alternating electric fields with low-intensity and intermediate frequency that inhibit division of cancer cells. In a phase 3 trial (EF-14), adding TTFields to adjuvant temozolomide (TMZ) demonstrated significant extension of median overall, progression-free and long-term survival in patients with newly diagnosed GBM (ndGBM). As there is tremendous interest among prescribing physicians in Germany to further assess these results in routine clinical care, the goal of this study is to evaluate safety and efficacy of TTFields in routine clinical care as well as reasons for patients refusing TTFields treatment, changes in quality of life within 4 months after start of therapy, treatment duration and compliance.
Methods: The TIGER study is a multi-centre, prospective, non-interventional study in Germany (NCT03258021). Patients with ndGBM 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 in the scope of clinical care routine, demographic data as well as the QoL and reasons for therapy decision are evaluated applying the EORTC-QLQ-C30/BN-20 and TTFields questionnaire, respectively. Planned number of patients is about 1000 (500 in each arm with positive and negative treatment decision, respectively) with a follow-up period of 18 months.
Results: At the time point of the last data cut-off (September 2018), more than 240 patients in the trial have made a decision for or against treatment with TTFields. At this point, more than 75% of patients agreed to undergo TTFields therapy, within this population. As expected, the most common adverse event was skin reaction with an incidence of 20.6%, which was already reported in the EF-14 phase 3 trial.
Conclusion: The TIGER trial enables systematic and prospective data analysis for the use of TTFields in routine clinical care including patients’ therapy decision. Moreover, the study supports the assessment of treatment duration and compliance, which could drive future analysis of TTFields treatment duration. Most recent data will be presented at the annual meeting of the German Society of Neurosurgery.
