Jiang Fenge, Li Junxia, Kong Xiangshuo, Sun Ping, Qu Huajun
Department of Oncology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.
Department of Radiation Oncology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.
Front Pharmacol. 2022 Sep 27;13:973448. doi: 10.3389/fphar.2022.973448. eCollection 2022.
The purpose of this study is to evaluate the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer (NSCLC) who had previously received bevacizumab. The participants were histopathologically or cytologically diagnosed advanced NSCLC patients whose disease progressed after at least one type of systemic therapy and who had previously received bevacizumab treatment. The patients were on 3-week administration cycles, including 2 weeks on-treatment (12 mg anlotinib oral route, once a day) and 1 week off-treatment. The primary end point of the trial was overall survival (OS). The secondary end points were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) and safety. As of the data collection deadline (31 March 2021), 30 patients were enrolled in the study and received anlotinib treatment. All patients were included in the data set except one, who withdrew their consent after the start of treatment. The median follow-up period was 12.1 months (range, 3.6-25.0 months), and 29 patients were included in the evaluation of the treatment. Of the 29 patients, no CR cases occurred. In total, three patients (10.2%) showed a PR, 21 (72.4%) had SD, and five patients (17.2%) had PD. The objective response rate (ORR) was 10.2% (3 of 29 patients), and the disease control rate (DCR) was 82.7% (24 of 29 patients). The median progression-free survival (PFS) was 5.6 months (95% CI, 5.0-6.1 months; Figure 2). The median overall survival (OS) was 10.6 months (95% CI, 9.4-11.8 months; Figure 3). The overall tolerance of the anlotinib treatment was high among the enrolled patients. No treatment-related grade four or five toxicities were observed. Of the 29 patients, one patient's anlotinib administration was reduced to 8 mg/day due to hypertension and headache. Most adverse events (AEs) were grade one or two; the most common AEs were fatigue (51.7%), hypertension (41.3%), hand-foot syndrome (41.4%), anorexia (34.5%) and hypertriglyceridemia (34.5%). Anlotinib demonstrated favourable activity and manageable toxicity in NSCLC patients who were treated with bevacizumab previously.
本研究的目的是评估安罗替尼在既往接受过贝伐单抗治疗的晚期非小细胞肺癌（NSCLC）患者中的疗效和安全性。参与者为经组织病理学或细胞学诊断的晚期NSCLC患者，其疾病在至少一种全身治疗后进展，且既往接受过贝伐单抗治疗。患者接受为期3周的给药周期，包括2周治疗期（口服安罗替尼12mg，每日一次）和1周停药期。试验的主要终点是总生存期（OS）。次要终点为无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性。截至数据收集截止日期（2021年3月31日），30例患者入组本研究并接受了安罗替尼治疗。除1例患者在治疗开始后撤回同意书外，所有患者均纳入数据集。中位随访期为12.1个月（范围3.6 - 25.0个月），29例患者纳入治疗评估。29例患者中，无完全缓解（CR）病例。共有3例患者（10.2%）出现部分缓解（PR），21例（72.4%）疾病稳定（SD），5例患者（17.2%）疾病进展（PD）。客观缓解率（ORR）为10.2%（29例患者中的3例）；疾病控制率（DCR）为82.7%（29例患者中的24例）。中位无进展生存期（PFS）为5.6个月（95%置信区间，5.0 - 6.1个月；图2）。中位总生存期（OS）为10.6个月（95%置信区间，9.4 - 11.8个月；图3）。在入组患者中，安罗替尼治疗的总体耐受性良好。未观察到与治疗相关的四级或五级毒性反应。29例患者中，1例患者因高血压和头痛将安罗替尼剂量减至8mg/天。大多数不良事件（AE）为一级或二级；最常见的不良事件为疲劳（51.7%）、高血压（41.3%）、手足综合征（41.4%）、厌食（34.5%）和高甘油三酯血症（34.5%）。安罗替尼在既往接受贝伐单抗治疗的NSCLC患者中显示出良好的活性和可管理的毒性。
