P14.62 Safety and adverse event profile post-market surveillance analysis of Tumor Treating Fields (TTFields) in EMEA

Abstract

Abstract BACKGROUND Tumor Treating Fields (TTFields) are established as modality in glioblastoma (GBM) therapy. GBM is the most aggressive brain tumor in adults, constituting approximately 15 % of all primary brain tumors. At diagnosis, a considerable subgroup of GBM patients is ≥65 years of age. The phase 3 EF-14 trial demonstrated a significant improvement of progression free, overall and longterm survival in newly diagnosed GBM (ndGBM) patients by the addition of TTFields compared temozolomide therapy. No treatment limiting systemic adverse events in the EF-14 trial for ndGBM or in the EF-11 trial for recurrent GBM (rGBM) were observable. Here, we present post-market surveillance data from patients in the EMEA region including elderly patients (≥ 65 years) treated with TTFields. METHODS Based on the MedDRA body system (system organ class) and preferred terms surveillance data of patients in the EMEA region were assessed. Additionally, surveillance data of patients < 65 as well as ≥ 65 years of age in this region were separately analyzed. RESULTS A total of 11,048 patients were treated with TTFields (ndGBM 53.3 %, rGBM 39.5 %, other diagnoses 7.2 %) of whom 2,252 (20.4 %) patients were treated in the EMEA region. 19.6 % of patients treated in this region were ≥65 years of age at the time of TTFields therapy initiation. One or more adverse events were reported by 64 % of EMEA patients < 65 and in 67 % of elderly EMEA patients. The most prevalent adverse event in both age groups was skin reactions, occurring in 30 % of patients < 65 years of age and 33 % elderly patients. Likewise, further adverse events in elderly patients in the EMEA region were comparable to patients younger than 65 years of age, e.g. heat sensation (< 65; ≥ 65: 4 %; 4 %) and general physical health deterioration (14 %; 18 %). CONCLUSION These real-life data demonstrate a good safety profile of TTFields in elderly patients as well as in patients < 65. The most frequent registered adverse event was skin reaction, which is in line with the results of the phase 3 EF-11 trial for rGBM and the EF-14 trial for ndGBM patients. In summary, these results from post-marketing surveillance emphasize the safety of TTFields in GBM treatment, particularly in the elderly population.