P09.10.a Adult Newly Malignant Brainstem Glioma Treated With Anlotinib Plus Radiotherapy: a Multicenter, Phase Ii Study
Year: 2025
Type: conference-abstract
Abstract: BACKGROUND Due to the challenging location, adult malignant brainstem glioma can not undergo aggressive surgery and is associated with a quite poor prognosis. Effective therapy regimens for this disease have not been developed. This study assessed the efficacy and safety of anlotinib, a multitarget tyrosine kinase inhibitor, combined with radiotherapy in treating this group of patients. METHOD This is an ongoing phase II, multicenter, single-arm trial investigating the safety, tolerability, and activity of anlotinib combined with radiotherapy in malignant brainstem glioma. Eligible participants include adults (18-70 years old) with newly diagnosed malignant (WHO III - IV) brainstem glioma based on histology or radiology who are radiotherapy (RT), chemotherapy, immunotherapy, or biotherapy naïve. Patients with Karnofsky score < 40 and a life expectancy < 3 months are excluded. All participants received 54-60 Gy radiotherapy (RT,1.8-2.0 Gy per fraction, five days per week). Anlotinib (10mg, orally, daily, d1-14/3 weeks) concurrently administered with radiotherapy, then consolidatedly used until disease progression or occurrence of intolerable adverse events. The primary objective includes disease control rate (DCR) and 6-month progression-free survival rate (6m-PFS). The secondary objective includes overall survival (OS), and toxicity profile (NCT04668508). RESULTS As of November 18, 2024, 22 participants have enrolled, 21 patients have completed radiotherapy. Sixteen patients who with a follow-up of 3 months or longer were included in the analysis for this report. The median age is 38 (range 18-68) years old. The median follow-up is 24.6 (range 3.1-39.3) months. Nine patients were pathologically diagnosed and nine patients were radiologically diagnosed with high-grade glioma. The DCR is 100% (Stable disease, SD: 21/21) at the end of radiotherapy and is 100% three months after radiotherapy (Partial response, PR: 4/21; SD: 17/21). The median PFS is 10.7 months, 95%CI 5.9-15.5, and the 6m-PFS and 1 year-PFS rates are 90.0% and 42.0%. The median OS is 19.9 months, 95%CI 13.6-26.2, the 6m-OS and 1 year-OS rates are 100%and 67.4%. No death occurred during the treatment. No ≥ grade 3 adverse events were observed up to the last follow-up (November 18, 2024) of this study. CONCLUSION Anlotinib combined with radiotherapy is efficacious and well-tolerated and might be a treatment option for newly diagnosed malignant brain stem glioma in adults.
Source: Neuro-Oncology
Authors: Y Chen, P Li
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4414792256
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