Department of Medical Oncology, Tongji University East Hospital, Shanghai, China.
Department of Medical Oncology, Shanghai Medical College, Fudan University Shanghai Cancer Center, Shanghai, China.
Adv Ther. 2020 Nov;37(11):4585-4598. doi: 10.1007/s12325-020-01477-w. Epub 2020 Sep 8.
In FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI), is not well known. The present analysis evaluated the safety profile and AESIs for fruquintinib in the FRESCO trial.
In FRESCO, eligible Chinese patients were randomized (2:1) to receive fruquintinib (5 mg once daily for 3 weeks, followed by 1 week off in 28-day cycles) or placebo plus best supportive care. Treatment-related AESIs and time to first occurrence of AESIs were summarized. Treatment-related TEAEs by age, sex, and BMI were also summarized.
A total of 266 patients (95.7%) in the fruquintinib group and 97 (70.8%) in the placebo group had at least one treatment-related TEAE; the mean relative dose intensity was 92% and 98%, respectively. In the fruquintinib group, the most common (in > 40% of patients) treatment-related AESIs were hypertension (55.4%), palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR)] (49.3%), and proteinuria (42.1%). The most common treatment-related grade ≥ 3 AESIs (≥ 3% of patients) were hypertension (21.2%), HFSR (10.8%), and proteinuria (3.2%); the median time to onset of these events was 10, 21, and 20 days, respectively. Subgroup analysis by age, sex, and BMI revealed that the frequencies of treatment-related TEAEs were similar across all subgroups, and were consistent with the overall safety profile of fruquintinib.
The most common treatment-related grade ≥ 3 AEs were hypertension, HFSR, and proteinuria. The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
Clinical Trials identifier NCT02314819.
在 FRESCO（三线以上转移性结直肠癌患者中呋喹替尼的疗效和安全性）试验中，呋喹替尼在转移性结直肠癌（mCRC）中国患者中显示出具有统计学意义和临床意义的总生存获益。然而，其安全性概况，包括特殊关注的不良事件（AESI）和治疗后出现的不良事件（TEAE），按年龄、性别和体重指数（BMI）分组，目前尚不清楚。本分析评估了 FRESCO 试验中呋喹替尼的安全性概况和 AESI。
在 FRESCO 中，合格的中国患者被随机（2:1）接受呋喹替尼（5mg 每日一次，连续 3 周，然后在 28 天周期中休息 1 周）或安慰剂加最佳支持治疗。总结了治疗相关 AESI 和首次发生 AESI 的时间。还总结了按年龄、性别和 BMI 分组的治疗相关 TEAEs。
在呋喹替尼组中，266 例患者（95.7%）和安慰剂组中 97 例患者（70.8%）至少有一次治疗相关 TEAEs；平均相对剂量强度分别为 92%和 98%。在呋喹替尼组中，最常见（>40%的患者）的治疗相关 AESI 是高血压（55.4%）、掌跖红细胞感觉不良综合征（俗称手足皮肤反应（HFSR））（49.3%）和蛋白尿（42.1%）。最常见的治疗相关≥3 级 AESI（≥3%的患者）是高血压（21.2%）、HFSR（10.8%）和蛋白尿（3.2%）；这些事件的中位发生时间分别为 10、21 和 20 天。按年龄、性别和 BMI 进行的亚组分析表明，各亚组之间治疗相关 TEAEs 的频率相似，与呋喹替尼的总体安全性一致。
最常见的治疗相关≥3 级不良事件是高血压、HFSR 和蛋白尿。在中国 mCRC 患者中，呋喹替尼的治疗相关 TEAEs 与总体人群中的报告相似，在不同亚组中也相似。
临床试验标识符 NCT02314819。
