ArticleTranslational cancer research2026
A real-world feasibility and safety study of anlotinib monotherapy in heavily pretreated or temozolomide-ineligible recurrent malignant glioma.
Article in Translational cancer research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Anlotinib, a multi-target angiogenesis inhibitor, has shown antitumor activity in various solid tumors. However, its role as monotherapy in recurrent malignant glioma remains unclear. This study aimed to evaluate the safety, tolerability, and preliminary efficacy of anlotinib monotherapy in patients with recurrent malignant glioma who had limited treatment options after failure of standard therapies or were unable to tolerate further chemotherapy or re-irradiation. Methods: Patients who had failed prior therapy, were not able to tolerate current therapy, or who did not qualify for additional temozolomide or radiotherapy received anlotinib monotherapy. All patients received oral anlotinib at an initial dose of 12 mg once daily on days 1-14 of each 21-day cycle until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or death. Follow-up duration was estimated using the reverse Kaplan-Meier method. The primary endpoint was the 6-month progression-free survival (PFS) rate. Secondary endpoints included the objective response rate (ORR), disease control rate (DCR), treatment exposure, dose modifications, and treatment-emergent adverse events (TEAEs). Results: In this small cohort of 18 patients, the median follow-up duration was 9.2 months (range, 3.1-18.4 months). The estimated 6-month PFS rate was 66.7% [95% confidence interval (CI): 42.0-91.4%], and median PFS was not reached at the data cutoff. The ORR was 38.9% (7/18; 95% CI: 17.3-64.3%), and the DCR was 88.9% (16/18; 95% CI: 65.3-98.6%). The median treatment duration was 6.3 months (range, 1.4-16.8 months), corresponding to a median of 9 treatment cycles (range, 2-24 cycles). Six patients (33.3%) required temporary treatment interruption, and 3 patients (16.7%) required dose reduction from 12 to 10 mg daily. Most TEAEs were grade 1-2. One patient (5.6%) experienced grade 3 thrombocytopenia, and no treatment-related deaths occurred. Overall survival (OS) data were immature because of the short follow-up duration. Conclusions: In this small retrospective cohort, anlotinib monotherapy showed preliminary short-term disease control with manageable toxicity. Given the 9.2-month median follow-up and immature OS data, these exploratory findings require prospective validation.
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