447MO - A clinical study of the safety and efficacy of anlotinib hydrochloride combined with temozolomide dose density scheme for the treatment of recurrent high grade glioma

Background

There is no optimal standard treatment for recurrent high grade glioma. However, even with aggressive treatment, the prognosis of recurrent high grade glioma is still poor. Anlotinib Hydrochloride is a novel small molecule multi-targeted tyrosine kinase receptor inhibitor (VEGFR1, VEGFR2, VEGFR3, c-Kit, PDGFRβ), which can effectively penetrate the blood-brain barrier. Currently, inhibition of tumour growth has been observed in a variety of tumours with significant efficacy with Anlotinib Hydrochloride. Previous literature indicated that targeting angiogenesis prolonged PFS, but was not effective in OS. This research project innovatively proposes Anlotinib Hydrochloride combined with temozolomide for the treatment of recurrent high grade glioma.

Methods

This trial is a prospective, open, single arm, phase II clinical study evaluating the safety and efficacy of the Anlotinib Hydrochloride combined with temozolomide in the treatment of recurrent high grade glioma. The primary objective is to evaluate the overall survival (OS) of patients. The secondary objectives are to evaluate the progression-free survival (PFS), objective remission rate (ORR), and safety of this regimen in patients with recurrent high grade glioma.

Results

A total of 94 patients were enrolled from 2020.4 to 2024.4, including 57 males and 37 females, with a mean age of 46 years. At the time of enrollment, the mean KPS of all patients was 72. The median OS was 8.97 months, PFS was 6.13 months, and ORR was 32.9%. A total of 40 cases of treatment-related AE occurred, including 10 cases of grade 3 or higher, no terminal AE occurred.

Conclusions

Anlotinib Hydrochloride combined with temozolomide was effective in prolonging recurrent high grade glioma patient survival, while treatment-related toxicity was acceptable.

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.