A retrospective study of 30 cases evaluating the efficacy and safety of anlotinib plus Temozolomide for recurrent/residual glioma from a single center

To evaluate the efficacy and safety of anlotinib plus temozolomide (TMZ) as a first-line treatment for recurrent/Residual glioma. Thirty eligible patients who either relapsed after the standard chemoradiotherapy regimen (TMZ plus radiotherapy) or had macroscopic residual tumors due to involvement of eloquent brain areas were enrolled between March 2018 and January 2021. Patients received anlotinib (12 mg once daily, 14 days on/7 days off) in combination with TMZ (200 mg/m², 5 days on/23 days off) until disease progression or unacceptable toxicity. The efficacy was evaluated using the Response Assessment in Neuro-Oncology(RANO) criteria for high-grade gliomas. Safety was assessed using the NCI-CTCAE 4.0. Survival outcomes were estimated with the Kaplan-Meier method and compared using the log-rank test. By April 2023, the median follow-up time was 28.1 ± 5.07 months(95% CI:18.20-38.06). The median overall survival (OS, measured from recurrence to death or last follow-up) was 17.87 ± 4.29 months (95% CI: 9.46–26.28). 1-year, 1.5 year, 2-year OS rates were 60.0%, 46.7%, and 36.7%, respectively. The median progression-free survival (PFS, measured from initiation of Anlotinib plus TMZ) was 7.83 ± 0.82 months(95% CI, 6.22–9.44). The 6-month, 1-year PFS rates were 63.3% and 36.7%, respectively. Univariate analysis showed that patients with WHO grade 2 gliomas had significantly longer median OS and PFS compared with those with grade 3 or 4 gliomas (grade 2: 30.45 ± 4.32, grade 3: 15.07 ± 5.72, grade 4: 9.21 ± 1.90, P = 0.035). Patients aged ≤ 55 years had significantly longer median PFS than those > 55 years (12.97 ± 1.71 vs. 7.33 ± 1.95. p = 0.010), although the difference in OS did not reach statistical difference (19.90 ± 6.29 m vs. 10.53 ± 1.68 m, p = 0.106). Additionally, sex, 1p/19q and IDH mutations were not significant negative predictors of OS or PFS. Multivariate analysis further indicated that age, pathological grade, and IDH mutation were not independent predictors of PFS or OS in recurrent glioma. Anlotinib combined with TMZ demonstrated potential efficacy for recurrent glioma, as reflected in observed OS and PFS outcomes, and demonstrated an acceptable tolerability profile in this patient cohort. Larger randomized controlled trials are warranted to confirm these findings and further define the role of anlotinib plus TMZ for the management of recurrent glioma.