Department of Respiratory Medicine, National Key Clinical Specialty, Branch of National Clinical Research Center for Respiratory Disease, Xiangya Hospital, Central South University, Changsha, China.
Xiangya Lung Cancer Center, Xiangya Hospital, Central South University, Changsha, China.
Cancer Med. 2022 Oct;11(19):3563-3571. doi: 10.1002/cam4.4736. Epub 2022 May 8.
Anlotinib as a third-line or beyond therapy for extensive-stage small-cell lung cancer (ES-SCLC) was studied. This single-arm phase II trial was to investigate the value of anlotinib plus platinum-etoposide as first-line treatment in ES SCLC.
The primary endpoint was progression-free survival (PFS) and objective response rate (ORR). The secondary endpoints included overall survival (OS), disease control rate (DCR), time to progression (TTP), duration of remission (DoR), and safety. The subgroups of preset liver metastasis and brain metastasis were analyzed.
In 35 ES-SCLC patients, the median PFS, ORR, DCR, and OS were 8.02 months [95% confidence interval (CI): 6.90-9.66], 85.71% (95% CI: 69.74-95.19), 94.29% (95% CI: 80.84-99.30), and 15.87 months (95% CI: 10.38-18.89), respectively. The median PFS in the liver metastasis and brain metastasis subgroups was 7.33 months (95% CI: 4.76-9.69) and 7.34 months (95% CI: 5.68-9.20), respectively. The most common AEs with grade 3-4 were hand-foot syndrome (17%), granulocytosis (17%), stomatitis (14%), hypertriglyceridemia (11%), hypercholesterolemia (11%), as well as nausea and vomiting (11%), and no grade 5 AEs were recorded.
Anlotinib combined with platinum-etoposide provided an effective and safe therapy for patients with ES-SCLC.
安罗替尼作为广泛期小细胞肺癌（ES-SCLC）三线或后线治疗药物进行了研究。这项单臂 II 期临床试验旨在研究安罗替尼联合铂类依托泊苷作为 ES-SCLC 一线治疗的价值。
主要终点是无进展生存期（PFS）和客观缓解率（ORR）。次要终点包括总生存期（OS）、疾病控制率（DCR）、进展时间（TTP）、缓解持续时间（DoR）和安全性。预设了肝转移和脑转移亚组进行分析。
在 35 例 ES-SCLC 患者中，中位 PFS、ORR、DCR 和 OS 分别为 8.02 个月[95%置信区间（CI）：6.90-9.66]、85.71%（95%CI：69.74-95.19）、94.29%（95%CI：80.84-99.30）和 15.87 个月（95%CI：10.38-18.89）。肝转移和脑转移亚组的中位 PFS 分别为 7.33 个月（95%CI：4.76-9.69）和 7.34 个月（95%CI：5.68-9.20）。最常见的 3-4 级不良反应是手足综合征（17%）、粒细胞增多症（17%）、口腔炎（14%）、高甘油三酯血症（11%）、高胆固醇血症（11%）、恶心和呕吐（11%），无 5 级不良反应发生。
安罗替尼联合铂类依托泊苷为 ES-SCLC 患者提供了一种有效且安全的治疗选择。
