Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study

Thoracic Cancer

Qiming Wang¹  Xiaoling Li²  Jianhua Shi³  Haifeng Qin⁴  Kai Li⁵  Gongyan Chen⁶  Baohui Han⁷  Jie Wang⁸  Ying Liu⁹  Ying Cheng⁹  Lin Wu^1,10  Jianxing He^1,11 

[1] Department of Internal Medicine Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital Zhengzhou China;Department of Medical Oncology Liaoning Cancer Hospital Shenyang China;Department of Medical Oncology Shandong Linyi Tumor Hospital Linyi China;Department of Pulmonary Oncology The Fifth Medical Centre of Chinese PLA General Hospital Beijing China;Department of Pulmonary Oncology Tianjin Medical University Cancer Institute and Hospital Tianjin China;Department of Respiratory Medicine Harbin Medical University Cancer Hospital Harbin China;Department of Respiratory Medicine Shanghai Chest Hospital, Shanghai Jiaotong University Shanghai China;Department of Thoracic Medical Oncology Cancer Hospital Chinese Academy of Medical Sciences Beijing China;Department of Thoracic Medical Oncology Jilin Cancer Hospital Changchun China;Department of Thoracic Medical Oncology The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University (Hunan Cancer Hospital) Changsha China;Department of Thoracic Surgery The First Affiliated Hospital of Guangzhou Medical University Guangzhou China;

关键词: anlotinib;    objective response;    pleural effusion;    small‐cell lung cancer;    survival;   

DOI  :  10.1111/1759-7714.14176

来源: DOAJ

【 摘 要 】

Abstract Background The presence of pleural effusion is an independent predictor for poor survival in patients with small‐cell lung cancer (SCLC). The aim of this study was to assess the efficacy and safety of anlotinib in patients with SCLC and pleural effusion. Methods This was a randomized, double‐blind, multicenter, phase II trial. Patients histologically diagnosed with SCLC and pleural effusion and had received at least two lines of chemotherapy were enrolled into the study. The patients received anlotinib 12 mg/day or a placebo. Results The overall response rate (ORR) was 3.7% for anlotinib (n = 27) and 0% in the placebo group (n = 15) (p = 1.000). The disease control rate (DCR) of the anlotinib group (63.0%) was higher than that of the placebo group (0%, p < 0.0001). The median progression‐free survival (PFS) increased in the anlotinib group (2.8 months) compared to the placebo group (0.7 months, HR = 0.10, 95% CI: 0.03–0.28, p < 0.001). The median overall survival of the anlotinib group (6.5 months) was higher than that of the placebo group (2.8 months, HR = 0.52, 95% CI: 0.22–1.23, p = 0.1285). The incidence of any grade adverse events was 100% in both groups. The percentage of grade 3–4 adverse events in the anlotinib group was 44.4% (12/27) compared to 40.0% (6/15) in the placebo group. Hypertension (37.0%), fatigue (29.6%), and loss of appetite (29.6%) typically appeared in the anlotinib group. Conclusions In this post hoc analysis, anlotinib was associated with improved PFS in patients with SCLC and baseline pleural effusion. However, additional studies with a large sample size are necessary to substantiate the current findings.

【 授权许可】

Unknown