Yin Jun, Yin Wenya, Zheng Linlin, Li Yimin, Luo Cheng, Zhang Shuo, Duan Lei, Zhou Hang, Cheng Kai, Lang Jinyi, Xu Ke
Department of Radiation Oncology, Radiation Oncology Key Laboratory Of Sichuan Province, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, China.
Clinical Medical College, Chengdu Medical College, Chengdu, China.
Clin Med Insights Oncol. 2023 Jul 6;17:11795549231175714. doi: 10.1177/11795549231175714. eCollection 2023.
Anlotinib is a multi-target anti-angiogenic agent. The retrospective study was conducted to evaluate the safety and effectiveness of anlotinib as monotherapy or combination therapy for the treatment of recurrent high-grade gliomas.
In this retrospective study, patients with recurrent high-grade glioma (according to the 2021 World Health Organization classification as levels III-IV) at Sichuan Cancer Hospital from June 2019 to June 2022 were included. The patients were divided into an anlotinib-monotherapy group and an anlotinib-combination group, and received oral anlotinib 8 to 12 mg once a day, with 2 weeks on/1 week off. The primary endpoint was progression-free survival (PFS). The Secondary endpoints included overall survival (OS), 6-month PFS rate, objective response rate (ORR), and disease control rate (DCR). Also, adverse events were evaluated using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE version 5.0).
A total of 29 patients (including 20 glioblastomas, 1 diffuse midline glioma, 5 anaplastic astrocytoma, and 3 anaplastic oligodendroglioma) were included in this study. Of these, 34.48% of the patients were treated with anlotinib alone and 65.52% with anlotinib combination therapy. The median follow-up time was 11.6 months (95% confidence interval [CI]: 9.4-15.7). The median PFS was 9.4 months (95% CI: 6.5-12.3), and the 6-month PFS rate was 62.1%. The median OS was 12.7 months (95% CI: 9.7-15.7), and the 12-month OS rate was 48.3%. Evaluation of treatment response was performed according to RANO (response assessment in neuro-oncology, RANO) criteria, including 21 partial response, 6 stable disease, and 2 PFS events. The ORR and DCR were 72.4%, and 93.1%, respectively. Grade III AEs occurred in 2 patients, and the others were less than grade III. The most common AE was thrombocytopenia, with an incidence rate of 31.0%. All AEs were alleviated and controlled by symptomatic treatment. No treatment-related deaths occurred.
Anlotinib had a low incidence of AEs and good safety in the treatment of recurrent high-grade glioma. Moreover, it showed good short-term effectiveness and significantly prolonged the PFS of patients, which may become a promising therapeutic option for recurrent high-grade glioma and lay a foundation for further clinical studies.
安罗替尼是一种多靶点抗血管生成药物。本回顾性研究旨在评估安罗替尼单药治疗或联合治疗复发性高级别胶质瘤的安全性和有效性。
在这项回顾性研究中，纳入了2019年6月至2022年6月在四川省肿瘤医院就诊的复发性高级别胶质瘤患者（根据2021年世界卫生组织分类为III-IV级）。患者分为安罗替尼单药治疗组和安罗替尼联合治疗组，口服安罗替尼8至12毫克，每日一次，服药2周，停药1周。主要终点是无进展生存期（PFS）。次要终点包括总生存期（OS）、6个月PFS率、客观缓解率（ORR）和疾病控制率（DCR）。此外，使用美国国立癌症研究所的不良事件通用术语标准（CTCAE第5.0版）评估不良事件。
本研究共纳入29例患者（包括20例胶质母细胞瘤、1例弥漫性中线胶质瘤、5例间变性星形细胞瘤和3例间变性少突胶质细胞瘤）。其中，34.48%的患者接受了安罗替尼单药治疗，65.52%的患者接受了安罗替尼联合治疗。中位随访时间为11.6个月（95%置信区间[CI]：9.4-15.7）。中位PFS为9.4个月（95%CI：6.5-12.3），6个月PFS率为62.1%。中位OS为12.7个月（95%CI：9.7-15.7），12个月OS率为48.3%。根据神经肿瘤学反应评估（RANO）标准进行治疗反应评估，包括21例部分缓解、6例病情稳定和2例PFS事件。ORR和DCR分别为72.4%和93.1%。2例患者发生III级不良事件，其他患者不良事件级别低于III级。最常见的不良事件是血小板减少症，发生率为31.0%。所有不良事件均通过对症治疗得到缓解和控制。未发生与治疗相关的死亡。
安罗替尼治疗复发性高级别胶质瘤的不良事件发生率低，安全性良好。此外，它显示出良好的短期疗效，显著延长了患者的PFS，这可能成为复发性高级别胶质瘤的一种有前景的治疗选择，并为进一步的临床研究奠定基础。
