Subgroup analysis by prior anti-VEGF or anti-EGFR target therapy in FRESCO, a randomized, double-blind, Phase III trial.
Ruihua XuShukui QinWeijian GuoYuxian BaiYanhong DengLei YangZhendong ChenHaijun ZhongHongming PanYongqian ShuYing YuanJianfeng ZhouNong XuTianshu LiuDong MaChangping WuYing ChengJianming XuDonghui ChenWei LiSanyuan SunZhuang YuPeiguo CaoJian LiHaihui ChenJiejun WangShubin WangHongbing WangNing WangBin ZhangRubing HanWeiguo SuXiaojun GuoJin LiPublished in: Future oncology (London, England) (2020)
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).
Keyphrases
- phase iii
- clinical trial
- end stage renal disease
- double blind
- open label
- ejection fraction
- newly diagnosed
- phase ii
- placebo controlled
- chronic kidney disease
- small cell lung cancer
- free survival
- squamous cell carcinoma
- randomized controlled trial
- patient reported outcomes
- epidermal growth factor receptor
- tyrosine kinase