Ma Jia, Pi Guoliang, Bi Jianping, Li Ying, He Hanping, Li Yanping, Hu Desheng, Verma Vivek, Han Guang
Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Clin Lung Cancer. 2021 Mar;22(2):e211-e214. doi: 10.1016/j.cllc.2020.10.007. Epub 2020 Oct 21.
Brain radiotherapy (BR) is a well-recognized approach for multiple brain metastases (BMs) from non-small-cell lung cancer (NSCLC). However, the prognosis for these patients remains poor. Apatinib, an antiangiogenic agent targeting vascular endothelial growth factor receptor-2, has shown excellent efficacy in multiple solid tumors. This phase II (WWW. ClinicalTrials.gov Identifier: VEGFR-2 NCT03801200) randomized trial aims to evaluate the efficacy and safety of this combined modality paradigm in patients with BMs from driver mutation-negative NSCLC. This is a multicenter, open-label, randomized controlled clinical trial. A total of 90 eligible patients will be allocated in a 1:1 ratio, to either the experimental group (concurrent apatinib and BR) or the control group (BR alone). The primary endpoint is intracranial progression-free survival. The secondary endpoints include intracranial objective response rate, intracranial disease control rate, intracranial time to progression, overall survival, and occurrence of peritumoral brain edema using standardized measurement. Quality of life and adverse events will also be evaluated. Assessments will be carried out before enrollment (baseline) along with 4 and 12 weeks after radiotherapy, followed by every 12 weeks thereafter and up to 24 months. In summary, the aim of this trial is to demonstrate the clinical efficacy and safety of concurrent BR and apatinib in patients with driver mutation-negative NSCLC with multiple BMs, in efforts to expand management options for this population with poor prognosis.
脑放射治疗（BR）是一种公认的用于治疗非小细胞肺癌（NSCLC）所致多发性脑转移（BMs）的方法。然而，这些患者的预后仍然很差。阿帕替尼是一种靶向血管内皮生长因子受体-2的抗血管生成药物，已在多种实体瘤中显示出优异的疗效。这项II期（临床试验注册号：NCT03801200）随机试验旨在评估这种联合治疗模式对驱动基因突变阴性的NSCLC所致BMs患者的疗效和安全性。这是一项多中心、开放标签、随机对照临床试验。总共90名符合条件的患者将按1:1的比例分配到实验组（阿帕替尼与BR联合治疗）或对照组（单纯BR治疗）。主要终点是颅内无进展生存期。次要终点包括颅内客观缓解率、颅内疾病控制率、颅内进展时间、总生存期以及使用标准化测量方法评估的瘤周脑水肿的发生率。还将评估生活质量和不良事件。在入组前（基线）以及放疗后4周和12周进行评估，此后每12周评估一次，直至24个月。总之，本试验的目的是证明BR与阿帕替尼联合治疗对驱动基因突变阴性的NSCLC伴多发性BMs患者的临床疗效和安全性，努力为这一预后不良人群拓展治疗选择。
