An ambispective, observational real-world study of tumor-treating fields for treatment of Chinese patients with newly diagnosed or recurrent/progressive glioblastoma

Background: Glioblastoma is the most common and aggressive central nervous system malignancy with poor prognosis. Tumor-treating fields (TTFields), approved in China in May 2020, represents a significant advancement in GBM treatment. Leveraging the extensive real-world data accumulated in the Chinese Medical Information and Big Data Association (CHMIA) database, this study aims to assess clinical outcomes of Chinese patients with glioblastoma on TTFields therapy. Methods: This ambispective, observational study assessed post-marketing safety (data cut-off: November 15, 2021) and effectiveness (data cut-off: May 18, 2024) of TTFields in Chinese patients with newly diagnosed glioblastoma (ndGBM) and recurrent glioblastoma (rGBM). Safety outcomes included incidence and severity of skin adverse events (AEs); effectiveness was measured by overall survival (OS) and landmark OS rates. Results: = 105). In the ndGBM cohort, the median OS was 19.9 months (95% CI: 13.4-24.8), with a 12-month OS rate of 63.5% (95% CI: 54.8-71.0). In the rGBM cohort, the median OS was 8.1 months (95% CI: 5.3-9.8), and 3-month and 6-month OS rates were 80.2% (95% CI: 70.4-87.1) and 58.7% (95% CI: 47.0-68.7), respectively. Most treatment-emergent AEs (TEAEs), including skin TEAEs, were mild to moderate (Grade 1-2). Conclusions: This study provided the largest real-world dataset to-date on TTFields in Chinese patients with glioblastoma. These patients showed survival outcomes similar to those in prior pivotal studies, without new safety concerns identified, supporting its use in Chinese glioblastoma population.