Anlotinib as third- or further-line therapy for short-term relapsed small-cell lung cancer: subgroup analysis of a randomized phase 2 study (ALTER1202)
Jianhua Shi1, Ying Cheng2(), Qiming Wang3, Kai Li4, Lin Wu5, Baohui Han6, Gongyan Chen7, Jianxing He8, Jie Wang9, Haifeng Qin10, Xiaoling Li11
1. Department of Medical Oncology, Linyi Cancer Hospital, Linyi 276002, China 2. Department of Thoracic Medical Oncology, Jilin Cancer Hospital, Changchun 130012, China 3. Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450003, China 4. Department of Pulmonary Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China 5. Department of Thoracic Medical Oncology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University (Hunan Cancer Hospital), Changsha 410031, China 6. Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China 7. Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin 150081, China 8. Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China 9. National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China 10. Department of Pulmonary Oncology, The Fifth Medical Centre of Chinese PLA General Hospital, Beijing 100039, China 11. Department of Medical Oncology, Liaoning Cancer Hospital, Shenyang 110042, China
Patients with small-cell lung cancer (SCLC) relapse within months after completing previous therapies. This study aimed to investigate the efficacy and safety of anlotinib as third- or further-line therapy in patients with short-term relapsed SCLC from ALTER1202. Patients with short-term relapsed SCLC (disease progression within 3 months after completing ≥ two lines of chemotherapy) in the anlotinib (n = 67) and placebo (n = 34) groups were analyzed. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival, objective response rate (ORR), disease control rate, and safety. Anlotinib significantly improved median PFS/OS (4.0 vs. 0.7 months, P < 0.0001)/(7.3 vs. 4.4 months, P = 0.006) compared with placebo. The ORR was 4.5%/2.9% in the anlotinib/placebo group (P = 1.000). The DCR in the anlotinib group was higher than that in the placebo group (73.1% vs. 11.8%, P < 0.001). The most common adverse events (AEs) were hypertension (38.8%), loss of appetite (28.4%), and fatigue (22.4%) in the anlotinib group and gamma-glutamyl transpeptidase elevation (20.6%) in the placebo group. No grade 5 AEs occurred. For patients with short-term relapsed SCLC, third- or further-line anlotinib treatment was associated with improved survival benefit. Further studies are warranted in this regard.
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