Department of Thoracic Oncology II, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China.
Int J Cancer. 2020 Dec 15;147(12):3453-3460. doi: 10.1002/ijc.33161. Epub 2020 Jun 26.
The purpose of this prospective phase II clinical trial was to investigate the efficacy and safety of anlotinib in patients with relapsed small cell lung cancer (SCLC). Forty-five patients with relapsed SCLC were enrolled and treated with anlotinib (one cycle of 12 mg daily for 14 days, discontinued for 7 days, and repeated every 21 days) until disease progression or intolerance of treatment. The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), disease control rate (DCR), objective control rate (ORR) and toxicity. The median PFS was 4.1 months (95% confidence interval [CI] 2.4-5.8) and the median OS was 6.1 months (95% CI 2.2-10.0). The OS for the limited-stage subgroup was significantly longer than that of the extensive-stage subgroup (P = .02). The DCR was 67%, and the ORR was 11%. The most common adverse event was hypertension (13%), which was controlled well with antihypertensive drugs. In conclusion, anlotinib has likely efficacy in patients with relapsed SCLC, and the side effects can be well tolerated. A longer OS was observed in limited-stage SCLC patients treated with anlotinib.
本前瞻性 II 期临床试验的目的是研究安罗替尼在复发性小细胞肺癌（SCLC）患者中的疗效和安全性。共纳入 45 例复发性 SCLC 患者，接受安罗替尼治疗（12mg/d，14d/周期，停药 7d，每 21d 重复），直至疾病进展或不能耐受治疗。主要终点为无进展生存期（PFS）。次要终点为总生存期（OS）、疾病控制率（DCR）、客观缓解率（ORR）和毒性。中位 PFS 为 4.1 个月（95%CI 2.4-5.8），中位 OS 为 6.1 个月（95%CI 2.2-10.0）。局限期亚组的 OS 明显长于广泛期亚组（P =.02）。DCR 为 67%，ORR 为 11%。最常见的不良反应是高血压（13%），经降压药物治疗后可得到良好控制。结论：安罗替尼治疗复发性 SCLC 可能有效，且副作用可耐受。安罗替尼治疗局限期 SCLC 患者的 OS 更长。
