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Subgroup Analysis by Liver Metastasis in the FRESCO Trial Comparing Fruquintinib versus Placebo Plus Best Supportive Care in Chinese Patients with Metastatic Colorectal Cancer
OncoTargets and Therapy ( IF 4 ) Pub Date : 2021-08-11 , DOI: 10.2147/ott.s307273
Shukui Qin 1 , Rui-Hua Xu 2 , Lin Shen 3 , Jianming Xu 4 , Yuxian Bai 5 , Lei Yang 6 , Yanhong Deng 7 , Zhen-Dong Chen 8 , Haijun Zhong 9 , Hongming Pan 10 , Weijian Guo 11 , Yongqian Shu 12 , Ying Yuan 13 , Jianfeng Zhou 14 , Nong Xu 15 , Tianshu Liu 16 , Dong Ma 17 , Changping Wu 18 , Ying Cheng 19 , Donghui Chen 20 , Wei Li 21 , Sanyuan Sun 22 , Zhuang Yu 23 , Peiguo Cao 24 , Haihui Chen 25 , Jiejun Wang 26 , Shubin Wang 27 , Hongbing Wang 28 , Ning Wang 29 , Bin Zhang 29 , Qiang Zhang 29 , Weiguo Su 30 , Xiaojun Guo 30 , Jin Li 31
Affiliation  

Objective: The aim of the present subgroup analysis of the FRESCO trial is to determine the efficacy and hepatotoxicity of fruquintinib in Chinese patients with metastatic CRC with liver metastasis (CRLM) who were receiving third-line or posterior-line therapy.
Methods: Overall survival (OS) and progression-free survival (PFS) were evaluated by Kaplan–Meier method. Hazard ratio (HR) was estimated through Cox proportional hazards model. Hepatotoxicity was coded using the standardized MedDRA queries of hepatic failure, fibrosis, cirrhosis, and other liver injury-related conditions and graded using the Common Terminology Criteria Adverse Events grades. The efficacy of fruquintinib in patients with CRLM was evaluated in various subgroups.
Results: A total of 287 (69.0%) patients with metastatic CRC had liver metastasis (LM, fruquintinib: 185 and placebo: 102). Median OS in patients with CRLM was significantly prolonged with fruquintinib compared with placebo (8.61 months vs 5.98 months; HR=0.59, 95% CI, 0.45– 0.77, P< 0.001). In patients with CRLM, the incremental median PFS for patients in the fruquintinib-treated group was significantly higher than in the placebo group (median PFS: 3.71 vs.1.84 months; HR=0.22, 95% CI: 0.17– 0.30; P< 0.001). Compared with placebo, significant improvements in OS were observed with fruquintinib in LM patients regardless of lung metastasis, prior target therapy, and K-RAS status. In patients with CRLM, treatment-emergent hepatotoxicities of any grade occurred in 7 (3.8%) patients in the fruquintinib group vs 2 (2.0%) in the placebo group.
Conclusion: Fruquintinib demonstrated a statistically significant increase in OS and PFS as compared with placebo in Chinese patients with CRLM. The hepatotoxicity of fruquintinib was less reported, and comparable with placebo in patients with CRLM.
ClinicalTrials.gov Identifier: NCT02314819.

Keywords: colorectal cancer, FRESCO trial, fruquintinib, liver metastasis
更新日期:2021-08-11
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