Safety of fruquintinib in Chinese patients with colorectal cancer: an age subgroup analysis from a phase IV real-world clinical practice study

作者：Yi Wang, Yifu He, Zhi‐Qiang Wang, Haijun Zhong, Zuoxing Niu, Shujun Yang, Tao Zhang, Liangjun Zhu, Yongqian Shu, Jianjun Peng, Yan Song, Jian Li, Ying Yuan, Haibo Zhang, Gengsheng Yu, Yunqi Hua, Jianjun Xiao, Jianfei Fu, Yulong Zheng, Jingyu Zhu, Xue Hua, Xian Luo, Michael Shi, Weiguo Su, Jin Li, Shukui Qin · 发表于：Therapeutic Advances in Medical Oncology · 年份：2025 · DOI：10.1177/17588359251363537 · 被引用次数：2 · 研究领域：Colorectal Cancer Treatments and Studies、Lung Cancer Treatments and Mutations、Advanced Breast Cancer Therapies

Background: Colorectal cancer (CRC) is increasingly prevalent among young adults (<50 years) in China, a demographic that has been historically underrepresented in clinical studies. While most patients with CRC are aged ⩾65 years, this age group is also underrepresented in trials, highlighting the need for a better understanding of treatment outcomes in both younger and older populations. A recent phase IV trial evaluating the safety of fruquintinib in Chinese patients with metastatic CRC (mCRC) showed a manageable profile. Objectives: This subgroup analysis of the phase IV study primarily aims to evaluate the safety of fruquintinib in different age groups. Design: Prospective real-world study. Methods: The data of patients with CRC from the phase IV fruquintinib trial (NCT04005066) were collected for the young (<50 years) and the late elderly (⩾75 years) patients with CRC who were enrolled between April 24, 2019, and September 27, 2022. The safety outcomes, including treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs), were recorded. Results: A total of 2798 patients with CRC enrolled in the phase IV study were categorized into two subgroups: 512 were young (age <50), and 239 were late elderly (age ⩾75). The young CRC subgroup received more intense treatment with a median treatment duration of 2.75 months, and the late elderly received a median treatment duration of 2.40 months. Combination therapy duration was longer than that of monothera...