Use of bevacizumab to treat glioblastoma in France: Regional practices in PACA and Corsica show a real therapeutic need.

Glioblastomas, the most common and aggressive brain tumors in adults, present a significant therapeutic challenge. Despite the limited treatment options outlined by current guidelines, bevacizumab has emerged as a critical, yet controversial option. This study investigates the off-label use of bevacizumab in France, highlighting its therapeutic demand despite the absence of marketing authorization. Since the European Medicines Agency (EMA) rejected its application for glioblastoma treatment in 2009, it has not been re-evaluated at the European level. This research primarily aims to explore clinical practices surrounding bevacizumab's use and assess its relevance and potential benefits for patients with glioblastoma in real-world settings. A cross-sectional, observational epidemiological survey was conducted using data from ScanSanté® and feedback from hospitals in the Provence-Alpes-Côte d'Azur (PACA) and Corsica regions. These findings were then compared to literature data. In 2023, bevacizumab was used in 97.3% of hospital days related to malignant brain tumors treated off-label in France. Among off-label prescriptions for glioblastomas, 82.0% were for recurrent glioblastomas, 13.1% for newly diagnosed glioblastomas, and 4.9% had no precise diagnosis. Literature reviews indicate a favorable benefit-risk balance for certain patient profiles, particularly showing improved progression-free survival and quality of life when bevacizumab is employed. The significant off-label use of bevacizumab in glioblastoma treatment underscores an urgent therapeutic need in France. These findings were submitted to the French National Agency for the Safety of Medicines and Health Products (ANSM) to advocate for its regulated use in clinical practice.