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Effectiveness and Safety of Apatinib in Patients with Advanced or Metastatic Adenocarcinoma of Stomach or Gastroesophageal Junction: A Prospective Observation Study.
阿帕替尼治疗晚期或转移性胃或胃食管结合部腺癌患者的有效性和安全性: 一项前瞻性观察研究。
- 影响因子：2.97
- DOI：10.2147/OTT.S232287
- 作者列表："Shen B","Jiang H","Wang L","Qian J","Shu Y","Chen P","Mao G","Liu B","Zhang X","Liu C","Wu J","Li X","Cai W","Shen W","Wang Q","He J","Hua D","Zhang Z","Zhang Y","Feng J
- 发表时间：2020-05-20
Abstract
Background:Apatinib showed promising efficacy in the treatment of advanced or metastatic gastric cancer (mGC) in previous clinical studies. However, the real-world data are limited, and this study aimed to assess the effectiveness and safety of apatinib for the treatment of advanced or mGC in this setting. Methods:In this prospective observational study, progression-free survival (PFS), overall survival (OS), overall response rate (ORR), disease control rate (DCR) and treatment-related adverse events (AEs) were recorded and evaluated. Univariate and multivariate analyses were conducted to explore potential biomarkers which might be related to the effectiveness. Results:A total of 321 mGC patients from 47 centers in China were enrolled between July 1, 2015, and March 1, 2018. Thirty-two patients achieved partial response, 155 patients achieved stable disease, and 115 patients had progressive disease, and no CR was achieved, illustrating an ORR of 10.60% and a DCR of 61.92%. The median PFS and OS were 4.0 and 8.2 months, respectively. Multivariate Cox analysis showed that the potential biomarkers associated with longer PFS were combination regimens plus taxel/docetaxel, and apatinib initial dosage ≥500mg, occurrence of AEs of leukopenia, and hand-foot syndrome. Main AEs were proteinuria (17.1%), hypertension (15.9%), and handfoot syndrome (8.7%). Conclusion:The present prospective observational study showed favorable effectiveness and safety of apatinib in real-world patients with advanced or metastatic GC in China. (A prospective, multi-center, non-intervention study of apatinib in the treatment of advanced gastric cancer-Trial Registry Number: ChiCTR-OPN-15006601).
摘要
背景: 在以往的临床研究中，阿帕替尼在治疗晚期或转移性胃癌 (mGC) 方面显示出有希望的疗效。然而，真实世界的数据有限，本研究旨在评估阿帕替尼治疗晚期或 mGC 的有效性和安全性。 方法: 在这项前瞻性观察性研究中，无进展生存期 (PFS) 、总生存期 (OS) 、总反应率 (ORR) 、疾病控制率 (DCR) 记录并评价治疗相关不良事件 (AEs)。进行单变量和多变量分析，探索可能与有效性相关的潜在生物标志物。 结果: 2015 年 7 月 1 日至 20 18 年 3 月 1 日期间，共有来自中国 47 个中心的 321 例 mGC 患者入组。32 例患者获得部分缓解，155 例患者获得稳定，115 例患者疾病进展，未获得 CR，ORR 为 10.60%，DCR 为 61.92%。中位 PFS 和 OS 分别为 4.0 和 8.2 个月。多因素 cox 分析显示，与较长 PFS 相关的潜在生物标志物是联合方案加紫杉醇/多西他赛，阿帕替尼初始剂量 ≥ 500mg，出现白细胞减少的 ae 和手足综合征。主要不良反应为蛋白尿 (17.1%) 、高血压 (15.9%) 和手足综合征 (8.7%)。 结论: 本前瞻性观察性研究显示阿帕替尼治疗中国真实世界晚期或转移性胃癌患者的有效性和安全性。(阿帕替尼治疗晚期胃癌的前瞻性、多中心、非干预性研究-试验注册号: ChiCTR-OPN-15006601)。
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