Subgroup analysis by prior anti-VEGF or anti-EGFR target therapy in FRESCO, a randomized, double-blind, Phase III trial
Ruihua Xu, Shukui Qin, Weijian Guo, Yuxian Bai, Yanhong Deng, Lei Yang, Zhendong Chen, Haijun Zhong, Hongming Pan, Yongqian Shu, Ying Yuan, Jianfeng Zhou, Nong Xu, Tianshu Liu, Dong Ma, Changping Wu, Ying Cheng, Jianming Xu, Donghui Chen, Wei Li, Sanyuan Sun, Zhuang Yu, Peiguo Cao, Jian Li, Haihui Chen, Jiejun Wang, Shubin Wang, Hongbing Wang, Ning Wang, Bin Zhang, Rubing Han, Weiguo Su, Xiaojun Guo, Jin Li, Ruihua Xu, Shukui Qin, Weijian Guo, Yuxian Bai, Yanhong Deng, Lei Yang, Zhendong Chen, Haijun Zhong, Hongming Pan, Yongqian Shu, Ying Yuan, Jianfeng Zhou, Nong Xu, Tianshu Liu, Dong Ma, Changping Wu, Ying Cheng, Jianming Xu, Donghui Chen, Wei Li, Sanyuan Sun, Zhuang Yu, Peiguo Cao, Jian Li, Haihui Chen, Jiejun Wang, Shubin Wang, Hongbing Wang, Ning Wang, Bin Zhang, Rubing Han, Weiguo Su, Xiaojun Guo, Jin Li
Abstract
Background: FRESCO study demonstrated efficacy and safety of fruquintinib in metastatic colorectal cancer patients. Impact of prior targeted therapy (PTT) on efficacy and safety of fruquintinib was evaluated. Materials & methods: In this subgroup analysis of FRESCO trial, patients were divided into PTT and non-PTT subgroups, and efficacy and safety of fruquintinib were assessed, respectively. Results: In non-PTT subgroup, fruquintinib significantly prolonged overall survival (OS) and progression-free survival (PFS) of patients compared with placebo. In PTT subgroup, the median OS and PFS of patients in fruquintinib arm was significantly higher than those in placebo. Treatment-emergent adverse events (TEAEs) rates were similar in both subgroups. Conclusion: Fruquintinib demonstrated clinically meaningful improvement in OS, PFS, objective response rate, and disease control rate with manageable TEAEs in both subgroups. Clinical trial registration: NCT02314819 (ClinicalTrials.gov).
Keywords: VEGF receptor inhibitors; anti-epidermal growth factor receptor; anti-vascular endothelial growth factor; fruquintinib; metastatic colorectal cancer; targeted therapy.
Source: PubMed