Anlotinib is a tyrosine kinase inhibitor inhibiting angiogenesis. This multicenter, randomized phase II trial aimed to investigate the efficacy and safety of anlotinib in comparison with sunitinib as first-line treatment for patients with metastatic renal cell carcinoma (mRCC).
Patients with mRCC from 13 clinical centers were randomly assigned in a 2:1 ratio to receive anlotinib (n = 90) or sunitinib (n = 43). Anlotinib was given orally at a dose of 12 mg once daily (2 weeks on/1 week off), and sunitinib was given orally at 50 mg once daily (4 weeks on/2 weeks off). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.
The median PFS was similar with anlotinib and sunitinib (17.5 vs. 16.6 months, p > .05). The median OS (30.9 vs. 30.5 months, p > .05), ORR (30.3% vs. 27.9%), and 6-week DCR (97.8% vs. 93.0%) were similar in the two groups. Adverse events (AEs) of grade 3 or 4 were significantly less frequent with anlotinib than with sunitinib (28.9% vs. 55.8%, p < .01), especially in terms of thrombocytopenia and neutropenia. AEs occurring at a lower frequency with anlotinib were hand-foot syndrome, eyelid edema, hair depigmentation, skin yellowing, neutropenia, thrombocytopenia, and anemia. The incidence of serious AEs was lower with anlotinib than with sunitinib.
The clinical efficacy of anlotinib was similar to that of sunitinib as the first-line treatment for mRCC, but with a more favorable safety profile.
This study evaluated the efficacy and safety of anlotinib for the first-line treatment of metastatic renal cell carcinoma. Anlotinib, which was developed independently in China, is a new tyrosine kinase inhibitor inhibiting multiple kinases involved in angiogenesis and tumor proliferation. Results indicated that the efficacy of anlotinib is comparable to and the safety is better than that of sunitinib.
The oncologist. 2019 Mar 22 [Epub ahead of print]
Ai-Ping Zhou, Yuxian Bai, Yan Song, Hong Luo, Xiu-Bao Ren, Xiuwen Wang, Benkang Shi, Cheng Fu, Ying Cheng, Jiyan Liu, Shukui Qin, Jun Li, Hanzhong Li, Xianzhong Bai, Dingwei Ye, Jinwan Wang, Jianhui Ma
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China., Harbin Medical University Affiliated Tumor Hospital, Harbin, Heilongjiang, People's Republic of China., Chongqing Cancer Hospital, Chongqing, Chongqing, People's Republic of China., Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China., Qilu Hospital of Shandong University, Jinan, People's Republic of China., Liaoning Province Tumor Hospital, Shenyang, Liaoning, People's Republic of China., Jilin Cancer Hospital, Changchun, People's Republic of China., West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China., The 81st Hospital of Chinese PLA, Nanjing, Jiangsu, People's Republic of China., Gansu Province Cancer Hospital, Lanzhou, People's Republic of China., Peking Union Medical College Hospital, Beijing, People's Republic of China., Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, People's Republic of China., Cancer Hospital of Fudan University, Shanghai Shanghai, People's Republic of China., National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China .