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Abstract：
BACKGROUND: 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 to excessive toxicities.
CONCLUSIONS: The safety profile of fruquintinib in the real world was generally consistent with that in clinical studies, and the incidence of TEAEs was numerically lower than known VEGF/VEGFR inhibitor-related AEs. Fruquintinib exhibited manageable safety and tolerability in Chinese patients in the real-world setting.
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 to excessive toxicities.
CONCLUSIONS: The safety profile of fruquintinib in the real world was generally consistent with that in clinical studies, and the incidence of TEAEs was numerically lower than known VEGF/VEGFR inhibitor-related AEs. Fruquintinib exhibited manageable safety and tolerability in Chinese patients in the real-world setting.
摘要：
背景：Fruquintinib在中国被批准用于转移性结直肠癌（CRC）患者，这些患者在2行化疗后进展。进行这项上市后研究是为了评估佛喹替尼在中国人群中的安全性，包括以前治疗过的晚期CRC和其他实体瘤患者。
方法：纳入第一周期的患者或预期在一周内开始的患者。Fruquintinib根据标签或每个医师的判断给予。在基线时收集患者特征和安全性信息，1个月,同意后6个月（或最后一次剂量后30天）。
结果：总体而言，在2019年4月24日至2022年9月27日之间招募了3005名患者。所有登记的患者接受至少一个剂量的氟喹替尼。大多数患者在基线时有转移。中位年龄为60岁。超过一半（64.0％）的患者开始服用5mg的氟喹替尼，中位治疗暴露时间为2.7个月.近三分之一（32.5%）的CRC患者接受了氟喹替尼与抗肿瘤药物的联合治疗。在626例（20.8%）患者中报告了导致剂量调整的治疗紧急不良事件（TEAE），469例（15.6%）患者出现TEAE导致治疗中断。最常见的≥3级TEAE是高血压（6.6%），掌-足底红质感觉综合征（2.2％），血小板计数下降（1.0%）。联合治疗不会导致过度的毒性。
结论：氟喹替尼在现实世界中的安全性与临床研究基本一致，TEAE的发生率在数值上低于已知的VEGF/VEGFR抑制剂相关的AE。在现实世界中，Fruquintinib在中国患者中表现出可控的安全性和耐受性。
方法：纳入第一周期的患者或预期在一周内开始的患者。Fruquintinib根据标签或每个医师的判断给予。在基线时收集患者特征和安全性信息，1个月,同意后6个月（或最后一次剂量后30天）。
结果：总体而言，在2019年4月24日至2022年9月27日之间招募了3005名患者。所有登记的患者接受至少一个剂量的氟喹替尼。大多数患者在基线时有转移。中位年龄为60岁。超过一半（64.0％）的患者开始服用5mg的氟喹替尼，中位治疗暴露时间为2.7个月.近三分之一（32.5%）的CRC患者接受了氟喹替尼与抗肿瘤药物的联合治疗。在626例（20.8%）患者中报告了导致剂量调整的治疗紧急不良事件（TEAE），469例（15.6%）患者出现TEAE导致治疗中断。最常见的≥3级TEAE是高血压（6.6%），掌-足底红质感觉综合征（2.2％），血小板计数下降（1.0%）。联合治疗不会导致过度的毒性。
结论：氟喹替尼在现实世界中的安全性与临床研究基本一致，TEAE的发生率在数值上低于已知的VEGF/VEGFR抑制剂相关的AE。在现实世界中，Fruquintinib在中国患者中表现出可控的安全性和耐受性。
