Subgroup Analysis by Liver Metastasis in the FRESCO Trial Comparing Fruquintinib versus Placebo Plus Best Supportive Care in Chinese Patients with Metastatic Colorectal Cancer
Year: 2021
Type: article
Abstract: 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. CLINICALTRIALSGOV IDENTIFIER: NCT02314819.
Source: OncoTargets and Therapy
DOI: 10.2147/ott.s307273
Authors: Shukui Qin, Rui-Hua Xu, Lin Shen, Jianming Xu, Yuxian Bai, Lei Yang, Yanhong Deng, Zhen-Dong Chen, Haijun Zhong, Hongming Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianfeng Zhou, Nong Xu, Tianshu Liu, Dong Ma, Changping Wu, Ying Cheng, Donghui Chen, Wei Li, Sanyuan Sun, Zhuang Yu, Peiguo Cao, Haihui Chen, Jiejun Wang, Shubin Wang, Hongbing Wang, Ning Wang, Bin Zhang, Qiang Zhang, Weiguo Su, Xiaojun Guo, Jin Li
Institutions: Nanjing General Hospital of Nanjing Military Command, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Peking University Cancer Hospital, Chinese PLA General Hospital, Harbin Medical University, Third Affiliated Hospital of Harbin Medical University, Nantong Tumor Hospital, Sixth Affiliated Hospital of Sun Yat-sen University, Second Affiliated Hospital of Anhui Medical University, Zhejiang Cancer Hospital, Sir Run Run Shaw Hospital, Zhejiang University, Shanghai Medical College of Fudan University, Fudan University Shanghai Cancer Center, Jiangsu Province Hospital, Second Affiliated Hospital of Zhejiang University, Peking Union Medical College Hospital, First Affiliated Hospital Zhejiang University, Fudan University, Zhongshan Hospital, Guangdong Provincial People's Hospital, The First People's Hospital of Changzhou, Jilin Province Tumor Hospital, Shanghai Jiao Tong University, Shanghai First People's Hospital, First Hospital of Jilin University, Xuzhou Central Hospital, Qingdao University, Affiliated Hospital of Qingdao University, Third Xiangya Hospital, Fourth Affiliated Hospital of Guangxi Medical University, Second Military Medical University, Shanghai Changzheng Hospital, Peking University Shenzhen Hospital, Xuzhou Medical College, Affiliated Hospital of Xuzhou Medical College, Lilly (China), Tongji University, Shanghai East Hospital
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,836
Funder: Eli Lilly and Company
OpenAlex ID: W3193283989