304P A phase II study of anlotinib in the treatment of recurrent high-grade glioma: Updated results

Abstract

Recurrent high-grade glioma is associated with limited survival and there is no standard treatment option currently. Anlotinib had demonstrated moderate efficacy and favorable tolerance in the treatment of these patients, aspreviously report (2021 ESMO). We updated the latest efficacy and safety data. This is an open-label, single-arm, single-center, phase II clinical trial (NCT04822805). Eligible patients were aged more than 18 years old, histologically confirmed high-grade glioma with progression after surgery followed by radiotherapy and temozolomide chemotherapy. Additional inclusion criteria included KPS≥60, disease progression on MRI as defined by Response Assessment in Neuro-Oncology (RANO) criteria, and at least 12 weeks after completion of postoperative adjuvant radiotherapy. Patients received 12mg anlotinib once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Safety assessment was done in patients who received at least one dose of anlotinib. From April 2020 to April 2022, 26 of 27 patients (19 males and 7 females) were enrolled, and the median age was 54 (range 35-78). Pathological types (defined by 2016 WHO Classification of Tumors of the Central Nervous System) included glioblastoma (n=23), anaplastic astrocytoma (n=3). At the cutoff date on April 15, 2022, 24 patients were eligible for the evaluation of tumor response. 4 achieved complete response (CR), 7 achieved partial response (PR) and the objective response rate (ORR) was 42.3% (11/26). 12 had stable disease (SD) and the disease control rate (DCR) was 88.5% (23/26). The median PFS was 8.3 months [95% CI 3.5-13.1]. Anlotinib-related adverse events were mainly grade 1 or 2, and grade 3 adverse events occurred in 6 (23.1%) of 26 patients, including neutrophil count decrease (7.7%), white blood cell decrease (7.7%), white blood cell increase (3.8%), and hypertension (3.8%). There were no grade 4 or 5 adverse events related to anlotinib through the follow-up. Anlotinib has shown encouraging anti-tumor activity and is tolerated well in treatment of recurrent high-grade glioma.