TPRG-06 TRIAL IN PROGRESS: BRACER: EFFICACY AND SAFETY OF BEVACIZUMAB WHEN COMBINED WITH OTHER SYSTEMIC AGENTS IN THE TREATMENT OF BRAIN METASTASES RADIATION NECROSIS IN THE MODERN ERA

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Abstract Background Stereotactic radiosurgery (SRS) is standard of care for patients with brain metastases (BrM) arising from solid tumors. While intracranial responses to SRS are >90%, radiation therapy necrosis (RN) is a common sequela following SRS. Interventions to treat RN include steroid therapy, neurosurgical resection, and laser interstitial therapy, as well as bevacizumab (monoclonal antibody targeting vascular endothelial growth factor). While small studies and trials illustrate RN responses with bevacizumab, its optimal dosing, sequencing with local therapies, and safety in combination with modern targeted therapies have yet to be fully explored. Methods BRACER is an international, multi-site, retrospective/prospective study of patients with BrM from solid tumors and a diagnosis of RN. Patients are stratified based on receipt or non-receipt of bevacizumab following RN diagnosis. The co-primary objectives are to: (1) describe treatment-related toxicities and disease-related adverse events following a diagnosis of RN stratified by receipt or non-receipt of bevacizumab and (2) estimate the percentage of patients who received anti-cancer therapy after a diagnosis of symptomatic RN stratified by receipt or non-receipt of bevacizumab. Secondary objectives include assessments of intracranial and extracranial progression, steroid use, change in neurologic function, etc. Duke University (lead) plus 15 sites across 4 countries (USA, Mexico, Greece, Italy) are contributing data. Results On 3/24/2026, data for 381 patients (n = 116 bevacizumab cohort [29% breast, 39% lung, 14% melanoma, 18% unknown/other] and n = 265 non-bevacizumab cohort [43% breast, 26% lung, 15% melanoma, 17% unknown/other]) had been collected. Data collection is ongoing. Conclusion BRACER will provide foundational, retrospective data around the efficacy and safety of bevacizumab combined with targeted therapies in patients with BrM and RN based on modern practice patterns. Optimal dosing of bevacizumab and sequencing of novel, local therapy approaches will also be examined to inform how to most effectively treat patients with RN clinically.

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