Ying Cheng1, Qiming Wang2,3, Kai Li4, Jianhua Shi5, Ying Liu6, Lin Wu7, Baohui Han8, Gongyan Chen9, Jianxing He10, Jie Wang11, Donghua Lou12, Hao Yu12, Shanchun Wang13, Haifeng Qin14, Xiaoling Li15. 1. Department of Thoracic Medical Oncology, Jilin Cancer Hospital, Changchun, China. jl.cheng@163.com. 2. Department of Respiratory Medicine, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. 3. Department of Respiratory Medicine, Henan Cancer Hospital, Zhengzhou, China. 4. Department of Pulmonary Oncology, Tianjin Medical University Cancer Hospital, Tianjin, China. 5. Department of Medical Oncology, Linyi Cancer Hospital, Linyi, China. 6. Department of Thoracic Medical Oncology, Jilin Cancer Hospital, Changchun, China. 7. Department of Thoracic Medical Oncology, Hunan Cancer Hospital, Changsha, China. 8. Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China. 9. Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, China. 10. Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. 11. Department of Thoracic Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China. 12. Department of Biostatistics, School of Public Health Nanjing Medical University, Nanjing, China. 13. Chia-tai Tianqing Pharmaceutical Group Co., Ltd, Nanjing, China. 14. Department of Pulmonary Oncology, The Fifth Medical Centre of Chinese PLA General hospital, Beijing, China. 15. Department of Medical Oncology, Liaoning Cancer Hospital and Institute, Shenyang, China.
Abstract
BACKGROUND: This study aimed to evaluate the efficacy and safety of anlotinib as a third-line and subsequent treatment for patients with small cell lung cancer (SCLC). METHODS: We conducted this Phase 2 trial at 11 institutions in China. Patients with pathologically confirmed SCLC who failed at least two lines of chemotherapy were enrolled. Subjects were randomly assigned in a 2:1 ratio to receive either anlotinib 12 mg orally once daily for 14 days every 3 weeks or placebo. The primary endpoint was progression-free survival (PFS). RESULTS: Between March 30, 2017 and June 8, 2018, a total of 82 and 38 patients were randomly assigned to receive anlotinib and placebo. The median PFS was significantly longer in the anlotinib group compared with the placebo group (4.1 months [95% confidence interval (CI), 2.8-4.2] vs 0.7 months [95% CI, 0.7-0.8]; hazard ratio (HR) 0.19 [95% CI, 0.12-0.32], p < 0.0001). Overall survival (OS) was significantly longer with anlotinib than placebo (7.3 months [95% CI, 6.1-10.3] vs 4.9 months [95% CI, 2.7-6.0]; HR 0.53 [95% CI, 0.34-0.81], p = 0.0029). CONCLUSIONS: Anlotinib as a third-line or subsequent treatment for Chinese patients with SCLC showed improved PFS and OS than placebo with favourable safety profile. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT03059797.
BACKGROUND: This study aimed to evaluate the efficacy and safety of anlotinib as a third-line and subsequent treatment for patients with small cell lung cancer (SCLC). METHODS: We conducted this Phase 2 trial at 11 institutions in China. Patients with pathologically confirmed SCLC who failed at least two lines of chemotherapy were enrolled. Subjects were randomly assigned in a 2:1 ratio to receive either anlotinib 12 mg orally once daily for 14 days every 3 weeks or placebo. The primary endpoint was progression-free survival (PFS). RESULTS: Between March 30, 2017 and June 8, 2018, a total of 82 and 38 patients were randomly assigned to receive anlotinib and placebo. The median PFS was significantly longer in the anlotinib group compared with the placebo group (4.1 months [95% confidence interval (CI), 2.8-4.2] vs 0.7 months [95% CI, 0.7-0.8]; hazard ratio (HR) 0.19 [95% CI, 0.12-0.32], p < 0.0001). Overall survival (OS) was significantly longer with anlotinib than placebo (7.3 months [95% CI, 6.1-10.3] vs 4.9 months [95% CI, 2.7-6.0]; HR 0.53 [95% CI, 0.34-0.81], p = 0.0029). CONCLUSIONS: Anlotinib as a third-line or subsequent treatment for Chinese patients with SCLC showed improved PFS and OS than placebo with favourable safety profile. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT03059797.
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