Open AccessSubgroup analysis by prior anti-VEGFor anti-EGFR target therapy in FRESCO,a randomized, double-blind, Phase III trial
Author(s) -
RuiHua Xu,
Shukui Qin,
Weijian Guo,
Yuxian Bai,
Yanhong Deng,
Lei Yang,
Zhendong Chen,
Zhong Huang,
Hongming Pan,
Yongqian Shu,
Ying Yuan,
Jianfeng Zhou,
g Xu,
Tianshu Liu,
Ding Ma,
Changping Wu,
Ying Cheng,
Jianming Xu,
Donghui Chen,
Wei Li,
Shuai Sun,
Yu Zhang,
Peiguo Cao,
Jian Li,
Haihui Chen,
Jiejun Wang,
Shubin Wang,
Hongbing Wang,
Ning Wang,
Bin Zhang,
Rong Han,
Weiguo Su,
Xiaojun Guo,
Jin Li
Publication year - 2021
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2020-0875
Subject(s) - medicine , subgroup analysis , placebo , adverse effect , colorectal cancer , randomized controlled trial , clinical trial , oncology , surgery , cancer , meta analysis , pathology , alternative medicine
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 )