A phase IV study to evaluate the safety of fruquintinib in Chinese patients in real-world clinical practice

作者：Jin Li, Zhi‐Qiang Wang, Haijun Zhong, Yifu He, Chen Zhang, Zuoxing Niu, Shujun Yang, Tao� Zhang, Liangjun Zhu, Yongqian Shu, Yong Gao, Jianjun Peng, Yan Song, Li J, Ying Yuan, Haibo Zhang, Gengsheng Yu, Yunqi Hua, Jianjun Xiao, Jianfei Fu, Yulong Zheng, Xue Hua, Xian Wu Luo, Ming Shi, Weiguo Su, Shukui Qin · 发表于：The Oncologist · 年份：2024 · DOI：10.1093/oncolo/oyae073 · 被引用次数：11 · 研究领域：Colorectal Cancer Treatments and Studies、Advanced Breast Cancer Therapies、Lung Cancer Treatments and Mutations

INTRODUCTION: Fruquintinib is approved in China for patients with metastatic colorectal cancer (CRC) who progressed after 2 lines of chemotherapy. This postmarketing study was conducted to evaluate the safety of fruquintinib in the Chinese population, including previously treated patients with advanced CRC and other solid tumors. METHODS: Patients in the first cycle of fruquintinib or expected to start fruquintinib within a week were enrolled. Fruquintinib was administrated according to the label or per physicians' discretion. Patient characteristics and safety information were collected at baseline, 1 month, and 6 months after consent (or 30 days after the last dose). RESULTS: Overall, 3005 patients enrolled between April 24, 2019 and September 27, 2022. All enrolled patients received at least one dose of fruquintinib. Most patients had metastases at baseline. The median age was 60 years. More than half (64.0%) of the patients started fruquintinib at 5 mg, and the median treatment exposure was 2.7 months. Nearly one-third (32.5%) of patients with CRC received fruquintinib with concomitant antineoplastic agents. Treatment-emergent adverse events (TEAEs) leading to dose modification were reported in 626 (20.8%) patients, and 469 (15.6%) patients experienced TEAEs leading to treatment discontinuation. The most common grade ≥ 3 TEAEs were hypertension (6.6%), palmar-plantar erythrodysesthesia syndrome (2.2%), and platelet count decreased (1.0%). Combination therapy did not lead ...