KEY TAKEAWAYS
- The study aimed to present an updated global post-marketing surveillance safety analysis of patients with CNS malignancies treated with TTFields therapy.
- The study concluded that TTFields showed good tolerability and a consistent safety profile across CNS malignancy patients.
Tumor Treating Fields (TTFields) are alternating electric fields that disrupt cancer cell processes. TTFields therapy is approved for treating brain cancer, including recurrent glioblastoma (rGBM) and newly diagnosed glioblastoma (ndGBM) with concomitant temozolomide in the US, and for grade IV glioma in the EU.
Maciej M. Mrugala and the team aimed to provide an updated global post-marketing surveillance safety analysis of patients with CNS malignancies treated with TTFields therapy.
Safety data were collected from routine post-marketing activities for patients in North America, Europe, Israel, and Japan from October 2011 to October 2022. Adverse events (AEs) were stratified by age, sex, and diagnosis.
The results revealed that 25,898 patients were included (diagnoses: ndGBM [68%], rGBM [26%], anaplastic astrocytoma/oligodendroglioma [4%], other CNS malignancies [2%]). The median age was 59 (range: 3–103) years, and 66% of patients were male. Most patients (69%) were aged 18–65 years; 0.4% were < 18 years; and 30% were > 65 years. All-cause and TTFields-related AEs occurred in 18,798 (73%) and 14,599 (56%) patients, respectively.
The most common treatment-related AEs were beneath-array skin reactions (43%), electric sensation (tingling; 14%), and heat sensation (warmth; 12%). Treatment-related skin reactions were comparable across pediatric (39%), adult (42%), and elderly (45%) groups, and between males (41%) and females (46%); and similar across diagnostic subgroups (ndGBM, 46%; rGBM, 34%; anaplastic astrocytoma/oligodendroglioma, 42%; other, 40%). No TTFields-related systemic AEs were reported.
The study concluded that TTFields demonstrated good tolerability in over 25,000 patients with CNS malignancies. Most therapy-related adverse events were manageable, localized, non-serious skin reactions. The safety profile of TTFields remained consistent across various subgroups, including age, sex, and diagnosis, indicating its broad applicability.
Funding was provided by the Novocure Inc.
Source: https://link.springer.com/article/10.1007/s11060-024-04682-7
Mrugala, M.M., Shi, W., Iwomoto, F. et al. (2024). “Global post‑marketing safety surveillance of Tumor Treating Fields (TTFields) therapy in over 25,000 patients with CNS malignancies treated between 2011–2022.” J Neurooncol (2024). https://doi.org/10.1007/s11060-024-04682-7
