Abstract 357P
Background
Recurrent high-grade glioma is associated with limited survival and there is no standard treatment option currently. We assessed if anlotinib, a multitarget tyrosine kinase inhibitor, is safe and effective for the treatment of these patients.
Methods
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 at least 12 weeks after completion of postoperative adjuvant radiotherapy. Patients were 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. Here we report the results of a planned interim analysis.
Results
From April 2020 to February 2021, 12 of 27 patients (9 males and 3 females) were enrolled, and the median age is 57 (range 23-69). Pathological types included glioblastoma (n=9), anaplastic astrocytoma (n=2), anaplastic oligodendroglioma (n=1). At the data cutoff date on April 22, 2021, the median duration of treatment was 8.1 months, and the median PFS was not reached. 11 patients were eligible for the evaluation of tumor response. 2 achieved complete response (CR), 3 achieved partial response (PR) and the objective response rate (ORR) was 45.4% (5/11). 6 had stale disease (SD) and the disease control rate (DCR) was 100% (11/11). The clinical benefit rate (CBR), defined as the proportion of patients who achieved durable disease control (CR/PR/SD) more than 6 months, was 72.7% (8/11). Most adverse events were grade 1 or 2. Grade 3 adverse events occurred in 3 (25%) of 12 patients, included seizures, neutropenia, leukopenia, respectively. And there was a death due to intracranial hemorrhage during the treatment.
Conclusions
This interim analysis showed anlotinib is effective and well toleranced for recurrent high-grade glioma patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.