239 - Newly Adult Malignant Brainstem Glioma Treated with Anlotinib Plus Radiotherapy: A Multicenter, Phase II Study
Presenter(s)
Y. Chen1, L. Guo2, and B. Chen3; 1State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P. R. China., Guangzhou, Guanzhou, China, 2Sun Yat-sen University Cancer Center, Guangzhou, Guangzhou/Guangdong, China, 3Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Purpose/Objective(s):
Due to the challenging location, adult malignant brainstem glioma patients could not undergo aggressive surgery, thus 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.
Materials/Methods:
The phase II, multicenter, single-arm trial investigated the safety, tolerability, and activity of anlotinib combined with radiotherapy in malignant brainstem glioma. Eligible participants included adults (18-70 years old) with newly diagnosed malignant (WHO ? - ?) brainstem glioma based on histology or radiology who didn’t receive radiotherapy (RT), chemotherapy, immunotherapy, or biotherapy. Patients with Karnofsky score < 40 and a life expectancy < 3 months were 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) was concurrently administered with radiotherapy, then consolidatedly used until disease progression or occurrence of intolerable adverse events. The primary outcome included disease control rate (DCR) and 6-month progression-free survival rate (6m-PFS). The secondary outcome included overall survival (OS), and toxicity profile (NCT04668508).
Results:
A total of 25 participants were enrolled. 21 patients have finished radiotherapy. Sixteen patients with a follow-up of 3 months or longer were included in the analysis for the study. The median age was 36 (range 18-68) years old. The median follow-up was 16.5 (range 7.5-39.3) months. Nine patients were pathologically or radiologically diagnosed with high-grade glioma, respectively. The DCR was both 100% (Stable disease, SD: 21/21) at the end of radiotherapy and 100% at 3 months after radiotherapy (Partial response, PR: 4/21; SD: 17/21). The median PFS was 10.5 months (95%CI, 5.4-39.3). The 6m-, 1 year- and 2 year-PFS rates were 90.9%, 50.4% and 14.9%. The median OS was 19.9 months (95%CI, 13.6-26.2). The median OS was 16.5 months (95%CI, 7.5-39.3). The 6m-, 1 year- and 2-year OS rates were 100%, 70.4% and 31.6%. No death occurred during the treatment. No = grade 3 adverse events were observed.
Conclusion: