Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China.
Department of Oncology, Dongtai People's Hospital, Dongtai, 224200, China.
Invest New Drugs. 2023 Dec;41(6):825-833. doi: 10.1007/s10637-023-01398-9. Epub 2023 Oct 14.
Anlotinib plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) achieves good efficacy, but there is still room for improvement. This clinical study examined the effectiveness of anlotinib plus etoposide for maintenance therapy in ES-SCLC.
The current single-arm, prospective phase II study was performed at Jiangsu Cancer Hospital (March 2019 to March 2022). After successful primary etoposide-based therapy, anlotinib was administered at 12 mg/day on days 1 to 14 of 21-day cycles until disease progression or consent withdrawal. All patients also received etoposide at 50 mg/day on days 1 to 14 of 21-day cycles for a maximum of six cycles. Progression-free survival (PFS) constituted the primary study endpoint. Secondary endpoints were overall survival (OS), objective remission rate (ORR), disease control rate (DCR), and safety. In addition, adverse events (AEs) were assessed.
Twenty-eight patients were treated. Median PFS and OS were 8.02 (95%CI 5.36-10.67) and 11.04 (95%CI 10.37-11.68) months, respectively. Totally 9 and 18 participants showed a partial response and stable disease, respectively; ORR and DCR were 32.14% and 96.43%, respectively. The commonest all-grade AEs were fatigue (n = 11, 39.28%), hypertension (n = 11, 39.28%), loss of appetite (n = 9, 32.14%), oral mucositis (n = 7, 25.00%) and proteinuria (n = 6, 21.40%). Grade 3-4 AEs included fatigue (n = 4, 14.28%), hypertension (n = 2, 7.14%), hand and foot syndrome (n = 2, 7.14%), oral mucositis (n = 1, 3.57%), hemoptysis (n = 1, 3.57%), proteinuria (n = 1, 3.57%), gingival bleeding (n = 1, 3.57%), and serum creatinine elevation (n = 1, 3.57%).
Maintenance anlotinib plus etoposide achieves promising PFS and OS in clinical ES-SCLC.
ChiCTR1800019421.
安罗替尼联合化疗作为广泛期小细胞肺癌（ES-SCLC）的一线治疗方案疗效显著，但仍有进一步提高的空间。本临床研究旨在评估安罗替尼联合依托泊苷用于 ES-SCLC 维持治疗的疗效。
这是一项在江苏省肿瘤医院进行的单臂、前瞻性的 II 期临床试验，于 2019 年 3 月至 2022 年 3 月期间入组患者。在成功完成依托泊苷为基础的一线治疗后，患者接受安罗替尼治疗，剂量为 12mg/天，第 1 天至第 14 天，每 21 天为一个周期，直至疾病进展或患者撤回同意。所有患者还接受依托泊苷治疗，剂量为 50mg/天，第 1 天至第 14 天，每 21 天为一个周期，最多 6 个周期。无进展生存期（PFS）为主要研究终点。次要终点包括总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性。此外，还评估了不良事件（AEs）。
共 28 例患者接受了治疗。中位 PFS 和 OS 分别为 8.02 个月（95%CI 5.36-10.67）和 11.04 个月（95%CI 10.37-11.68）。共有 9 例和 18 例患者分别表现为部分缓解和疾病稳定；ORR 和 DCR 分别为 32.14%和 96.43%。最常见的所有级别 AEs 为乏力（n=11，39.28%）、高血压（n=11，39.28%）、食欲减退（n=9，32.14%）、口腔黏膜炎（n=7，25.00%）和蛋白尿（n=6，21.40%）。3-4 级 AEs 包括乏力（n=4，14.28%）、高血压（n=2，7.14%）、手足综合征（n=2，7.14%）、口腔黏膜炎（n=1，3.57%）、咯血（n=1，3.57%）、蛋白尿（n=1，3.57%）、牙龈出血（n=1，3.57%）和血肌酐升高（n=1，3.57%）。
安罗替尼联合依托泊苷维持治疗在广泛期小细胞肺癌患者中显示出良好的 PFS 和 OS。
ChiCTR1800019421。
