Wang Yi, Xu Jianfen, Dong Mingjun, Liu Kaitai, Lu Yi, Chen Ke, Cao Yuepeng, Shi Hang, Bei Yanping, Li Jianjiong, Zhao Jianpei, Cao Yisheng, Lu Ning, Yang Lu, Liu Haizhong, Cai Ping, Li Kai, Yang Tong, He Ning, Dong Jing, Zhang Chen
Department of Radiotherapy and Chemotherapy, Ningbo No. 2 Hospital, Ningbo, China.
Department of Medical Oncology, Ningbo No. 2 Hospital, Ningbo, China.
J Gastrointest Oncol. 2024 Aug 31;15(4):1519-1533. doi: 10.21037/jgo-24-559. Epub 2024 Aug 28.
Randomized trials have shown a survival benefit for fruquintinib over placebo in patients with metastatic colorectal cancer (mCRC) that progressed after standard therapies, but real-world prognostic analyses have been seldom reported. We evaluated survival, safety outcomes, and predictive and prognostic factors in patients treated with fruquintinib in a real-life setting.
We conducted a multi-center study by collecting relevant data on patients with advanced colorectal cancer (CRC) who received fruquintinib, focusing on progression-free survival (PFS), overall survival (OS), and L3 skeletal muscle index (SMI), including safety follow-up.
From January 2020 to January 2022, a total of 140 patients were selected and included in this study. The cut-off date was 30 July 2022. The median follow-up time was 18.3 months (range, 6-29.3 months) and the median age of included cases was 63 years (range, 32-81 years). The median PFS and OS for the 140 patients was 6.3 and 12.6 months, respectively. The median PFS and OS for the 76 patients who were included in SMI analysis was 6.0 and 12.0 months, respectively. Multivariate analysis suggested brain metastasis {hazard ratio (HR) [95% confidence interval (CI)]: 2.779 (1.162-6.646), P=0.02}, decrease in SMI of >5% [HR (95% CI): 9.732 (2.201-43.028), P=0.003], and baseline carcinoembryonic antigen (CEA) level [HR (95% CI): 4.061 (1.391-11.858), P=0.01] as independent predictors of OS. The most common treatment-related adverse events (TRAEs) were hypertension (24, 17.1%), fatigue (21, 15%), and hand-foot syndrome (20, 14.3%); 9 (13.6%) and 15 (10.7%) patients had dose reduction and treatment discontinuation due to TRAEs respectively.
The real-world efficacy and safety of fruquintinib in advanced CRC patients are numerically superior to that in the previous phase III studies. SMI, brain metastasis and CEA could serve as potential markers for patient selection.
随机试验表明，对于在标准治疗后病情进展的转移性结直肠癌（mCRC）患者，呋喹替尼相比安慰剂具有生存获益，但很少有关于真实世界的预后分析报道。我们评估了在现实环境中接受呋喹替尼治疗的患者的生存情况、安全性结局以及预测和预后因素。
我们通过收集接受呋喹替尼治疗的晚期结直肠癌（CRC）患者的相关数据进行了一项多中心研究，重点关注无进展生存期（PFS）、总生存期（OS）和L3骨骼肌指数（SMI），包括安全性随访。
从2020年1月至2022年1月，共筛选出140例患者纳入本研究。截止日期为2022年7月30日。中位随访时间为18.3个月（范围6 - 29.3个月），纳入病例的中位年龄为63岁（范围32 - 81岁）。140例患者的中位PFS和OS分别为6.3个月和12.6个月。纳入SMI分析的76例患者的中位PFS和OS分别为6.0个月和12.0个月。多因素分析表明，脑转移{风险比（HR）[95%置信区间（CI）]：2.779（1.162 - 6.646），P = 0.02}、SMI下降>5%[HR（95%CI）：9.．732（2.201 - 43.028），P = 0.003]以及基线癌胚抗原（CEA）水平[HR（95%CI）：4.061（1.391 - 11.858），P = 0.01]是OS的独立预测因素。最常见的治疗相关不良事件（TRAEs）为高血压（24例，17.1%）、疲劳（21例，15%）和手足综合征（20例，14.3%）；分别有9例（13.6%）和15例（10.7%）患者因TRAEs进行了剂量减少和治疗中断。
呋喹替尼在晚期CRC患者中的真实世界疗效和安全性在数值上优于先前的III期研究。SMI、脑转移和CEA可作为患者选择的潜在标志物。
