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- Title
Anlotinib Monotherapy for Refractory Metastatic Colorectal Cancer: A Double‐Blinded, Placebo‐Controlled, Randomized Phase III Trial (ALTER0703).
- Authors
Chi, Yihebali; Shu, Yongqian; Ba, Yi; Bai, Yuxian; Qin, Baoli; Wang, Xiuwen; Xiong, Jianping; Xu, Nong; Zhang, Helong; Zhou, Jianfeng; Xu, Jianming; Cheng, Ying; Feng, Jifeng; Hu, Chunhong; Chen, Yigui; Chen, Zhendong; Wang, Jufeng; Dang, Chengxue; Wang, Jianhong; Wan, Yiye
- Abstract
Background: Treatment options for refractory metastatic colorectal cancer (mCRC) were limited. Anlotinib is a novel multitarget tyrosine kinase inhibitor. ALTER0703 study was conducted to assess efficacy and safety of anlotinib for patients with refractory mCRC. Materials and Methods: This was a multicenter, double‐blinded, placebo‐controlled, randomized phase III trial involving 33 hospitals in China. Patients had taken at least two lines of therapies were 2:1 randomized to receive oral anlotinib (12 mg/day; days 1–14; 21 days per cycle) or placebo, plus best supportive care. Randomization was stratified by previous VEGF‐targeting treatments and time from diagnosis to metastases. The primary endpoint was overall survival (OS). The secondary endpoints were progression‐free survival (PFS), objective response rate (ORR), disease control rate (DCR), quality of life (QoL), and safety. Results: A total of 419 patients (anlotinib: 282; placebo: 137) were treated from December 2014 to August 2016. The median PFS was improved in anlotinib group (4.1 months; 95% confidence interval [CI], 3.4–4.5) over placebo group (1.5 months; 95% CI, 1.4–1.5), with a hazard ratio (HR) of 0.34 (95% CI, 0.27–0.43; p <.0001). However, median OS was similar between two groups (8.6 months; 95% CI, 7.8–9.7 vs. 7.2 months; 95% CI, 6.2–8.8; HR, 1.02; p =.870). Improvements of ORR and DCR were observed in anlotinib over placebo. The most common grade ≥ 3 anlotinib related adverse events were hypertension (20.92%), increased γ‐GT (7.09%), and hand‐foot skin reaction (6.38%). Conclusion: Anlotinib was tolerated in Chinese patients with refractory mCRC. Although OS did not reach significant difference, anlotinib still provided clinical benefits by substantially prolonged PFS in these patients. Implications for Practice: In this randomized clinical trial that included 419 patients with refractory metastatic colorectal cancer, substantial prolonged in progression‐free survival was noted in patients who received anlotinib compared with those given placebo. Improvements on objective response rate and disease control rate was also observed in anlotinib group. However, overall survival was similar between the two groups. In a word, in third‐line or above treatment of Chinese patients with refractory metastatic colorectal cancer, anlotinib provided clinical benefit by significantly prolonged progression‐free survival. The ALTER0703 study was conducted to assess the efficacy and safety of anlotinib for patients with refractory metastatic colorectal cancer. Results are reported here.
- Subjects
CHINA; THERAPEUTIC use of antineoplastic agents; DRUG efficacy; RESEARCH; DISEASE progression; HYPERTENSION; HAND-foot syndrome; GAMMA-glutamyltransferase; CONFIDENCE intervals; METASTASIS; ANTINEOPLASTIC agents; MEDICAL cooperation; PROTEIN-tyrosine kinase inhibitors; COLORECTAL cancer; RANDOMIZED controlled trials; PLACEBOS; CANCER patients; COMPARATIVE studies; BLIND experiment; DESCRIPTIVE statistics; SURVIVAL analysis (Biometry); QUALITY of life; STATISTICAL sampling; EVALUATION
- Publication
Oncologist, 2021, Vol 26, Issue 10, pe1693
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1002/onco.13857