Abstract
Background: Anlotinib is a multi-target anti-angiogenic agent. This retrospective study aimed to evaluate the efficacy and safety of anlotinib alone or in combination with temozolomide for the treatment of recurrent high-grade glioma. Materials and Methods: The clinical data of patients with recurrent high-grade glioma treated with anlotinib alone or in combination with temozolomide in our cancer center were collected and analyzed. Treatment response was evaluated according to the response assessment for neuro-oncology criteria. Progression-free survival, progression-free survival at 6 months, overall survival, and overall survival at 12 months were evaluated by Kaplan–Meier method and compared by log-rank test. Results: Between August 2019 and December 2020, 31 patients with recurrent high-grade glioma (21 of grade 4 and 10 of grade 3) were enrolled in this study. Seventeen patients received anlotinib alone and 14 received anlotinib plus temozolomide. All patients were heavily treated, the median lines of previous treatments were 2, and the median Karnofsky score was 60. At the data cutoff date, the median progression-free survival was 4.5 months and the progression-free survival at 6 months was 43.5%. The median overall survival was 7.7 months, and the overall survival at 12 months was 26.7%. The progression-free survival at 6 months and the overall survival at 12 months for 21 patients with grade 4 glioma was 40.2 and 27.9%, respectively. The tumor objective response rate was 41.9% in all patients and 33.3% in patients with grade 4 glioma. No grade 3 or worse treatment-related adverse events were recorded during the treatment. Conclusion: Anlotinib alone or in combination with temozolomide showed encouraging efficacy and favorable tolerability in patients with recurrent high-grade glioma who had been heavily treated.
Highlights
High-grade glioma (HGG) is the most common type of malignant brain tumor in adults, accounting for over 60% of malignant primary brain tumors
Materials and Methods: The clinical data of patients with recurrent high-grade glioma treated with anlotinib alone or in combination with temozolomide in our cancer center were collected and analyzed
The key eligibility criteria included at least one measurable lesion according to the Response Assessment for Neuro-oncology (RANO) criteria, Karnofsky Performance Status score (KPS) ≥40, age ≤75 years, and adequate organ function revealed by normal blood routine, liver and kidney function, coagulation function, and electrocardiogram
Summary
High-grade glioma (HGG) is the most common type of malignant brain tumor in adults, accounting for over 60% of malignant primary brain tumors. The 5-year survival for newly diagnosed GBM is lower than 10% with standard radiotherapy in combination with temozolomide (TMZ) (Stupp et al, 2009). Recurrent HGG is refractory and has limited treatment options. Conventional cytotoxic chemotherapies, such as nitrosourea, irinotecan, cisplatin, carboplatin, etoposide, cyclophosphamide, and ifosfamide, show unsatisfying efficacy and obvious toxicities (Seystahl et al, 2016; Parasramka et al, 2017). This retrospective study aimed to evaluate the efficacy and safety of anlotinib alone or in combination with temozolomide for the treatment of recurrent high-grade glioma
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