Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Department of Interventional Oncology, People's Hospital of Ma'anshan, Ma'anshan, China.
Cancer Med. 2020 Jul;9(14):5008-5014. doi: 10.1002/cam4.3105. Epub 2020 May 22.
Apatinib has been demonstrated to be effective and safe among patients with gastric cancer failing after at least two lines chemotherapy. This study aimed to evaluate its effectiveness and safety of low-dose apatinib for the treatment of gastric cancer in real-world practice. We performed a prospective, multicenter observation study in a real-world setting. Patients with advanced gastric cancer more than 18 years old were eligible and received low-dose apatinib (500 mg or 250mg per day) therapy. The median progression-free survival (PFS), median overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety were assessed. Between September 2017 and April 2019, a total of 747 patients were enrolled. The mPFS was 5.56 months (95% CI 4.47-6.28), and mOS was 7.5 months (95% CI 6.74-8.88). Four patients achieved complete response, 47 achieved partial response, and 374 patients achieved stable disease. The ORR was 6.83% and DCR was 56.89%. In addition, multivariate Cox regression analysis indicated that hand-foot syndrome was one independent predictor for PFS and OS. The most common adverse events (AEs) at any grade were hypertension (36.55%), proteinuria (10.26%), hand-foot syndrome (33.53%), fatigue (24.9%), anemia (57.35%), leukopenia (44.49%), thrombocytopenia (34.21%), and neutropenia (53.33%). Grade 3-4 AEs with incidences of 5% or greater were anemia (13.97%), thrombocytopenia (7.14%), and neutropenia (6.67%). No treatment-related death was observed during the treatment of apatinib. The prospective study suggested that low-dose apatinib was an effective regimen for the treatment of advanced gastric cancer with tolerable or controlled toxicity in real world. Trial registration: NCT03333967.
阿帕替尼在至少接受二线化疗后失败的胃癌患者中显示出有效性和安全性。本研究旨在评估低剂量阿帕替尼治疗真实世界中晚期胃癌的疗效和安全性。我们在真实环境中进行了一项前瞻性、多中心观察性研究。符合条件的患者为年龄大于 18 岁的晚期胃癌患者，并接受低剂量阿帕替尼（500mg 或 250mg/天）治疗。评估中位无进展生存期（PFS）、中位总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性。2017 年 9 月至 2019 年 4 月，共纳入 747 例患者。mPFS 为 5.56 个月（95%CI 4.47-6.28），mOS 为 7.5 个月（95%CI 6.74-8.88）。4 例患者达到完全缓解，47 例患者达到部分缓解，374 例患者达到疾病稳定。ORR 为 6.83%，DCR 为 56.89%。此外，多变量 Cox 回归分析表明，手足综合征是 PFS 和 OS 的独立预测因素。任何级别的最常见不良事件（AE）为高血压（36.55%）、蛋白尿（10.26%）、手足综合征（33.53%）、乏力（24.9%）、贫血（57.35%）、白细胞减少（44.49%）、血小板减少（34.21%）和中性粒细胞减少（53.33%）。发生率为 5%或以上的 3-4 级 AE 为贫血（13.97%）、血小板减少（7.14%）和中性粒细胞减少（6.67%）。在阿帕替尼治疗期间未观察到与治疗相关的死亡。该前瞻性研究表明，低剂量阿帕替尼是一种有效的治疗方案，可用于治疗真实世界中晚期胃癌，具有可耐受或可控制的毒性。试验注册：NCT03333967。
