呋喹替尼治疗晚期恶性肿瘤的临床疗效与安全性真实世界研究  

Efficacy and safety of fruquintinib in treatment of advanced malignant tumors based on real-world

作　　者：瞿俊晨[1] 卢吟秋 殷秋忆 唐剑 顾玉兰[3] 周晨霞[2] Qu Jun-chen;Lu Yin-qiu;Yin Qiu-yi;Tang Jian;Gu Yu-lan;Zhou Chen-xia(Department of Medical Imaging,Changshu Second People’s Hospital,Changshu 215500,China;Department of Pharmacy,Changshu Second People’s Hospital,Changshu 215500,China;Department of Oncology,Changshu Second People’s Hospital,Changshu 215500,China)

机构地区：[1]常熟市第二人民医院影像科,常熟215500 [2]常熟市第二人民医院药学部,常熟215500 [3]常熟市第二人民医院肿瘤科,常熟215500

出　　处：《中国药物应用与监测》2025年第2期333-337,共5页Chinese Journal of Drug Application and Monitoring

基　　金：2020年常熟市卫生健康委员会科技计划项目(csws202008)。

摘　　要：目的通过真实世界观察呋喹替尼二三线治疗晚期肺癌和结直肠癌的疗效及安全性,并分析其不良反应发生的风险因素。方法选择2021年1月至2023年6月在常熟市第二人民医院首次接受呋喹替尼治疗的结直肠癌和肺癌患者作为研究对象,采用横断面方法开展观察研究,具体内容包括:采集病例资料、评价临床疗效、记录不良反应及随访疾病转归情况;统计分析呋喹替尼治疗的有效率、疾病缓解时间及不良反应发生率;采用二元Logistics回归分析不良反应发生的临床风险因素。结果43例患者被纳入研究,其中结直肠癌26例,肺癌17例,分别使用呋喹替尼单药治疗、联合化疗、靶向或免疫治疗。第8周疗效评价客观缓解率(ORR)和疾病控制率(DCR):结直肠癌为23.1%和69.2%,肺癌为5.9%和64.7%;无疾病进展生存期(PFS)中位值:结直肠癌为4.6个月(最长为15.4个月),肺癌为5.1个月(最长为7.3个月);3、6、9及12个月生存率:肠癌为96%、85%、69%及42%(最长随访时间为36.6个月,仍存活),肺癌为100%、88%、53%及18%(最长随访时间为14.1个月,仍存活)。ADR发生率为90.7%,3级及以上ADR发生率为32.6%;主要ADR包括手足皮肤反应(53.5%)、腹胀腹痛/腹部不适(39.5%)、高血压(37.2%)、、乏力(34.9%)、蛋白尿(30.2%)、肝功能异常(23.3%)等;不良反应风险因素分析:乏力与高龄(≥65岁)、女性等因素相关(P<0.05),蛋白尿与超重相关(P<0.05),结直肠癌患者发生蛋白尿的风险高于肺癌患者(P<0.05)。结论呋喹替尼二三线治疗晚期结直肠癌和肺癌的疗效明确,高龄和超重是需重点关注的不良反应高发人群。Objective To observe the efficacy and safety of fruquintinib in the second-and third-line treatment of advanced lung cancer and colorectal cancer in the real world and analyze the risk factors for adverse reaction(ADR)for clinical monitoring and prevention.Methods Patients with colorectal cancer and lung cancer who received treatment with fruquintinib for the first time in Changshu Second People’s Hospital from January 2021 to June 2023 were selected as the study subjects.The observational study was conducted using a cross-sectional approach,with specific components including collection of case data,evaluation of clinical efficacy,documentation of adverse reactions,and follow-up on disease outcomes.The response rate,time to remission and incidence of adverse reactions of fruquintinib were statistically analyzed.Binary logistic regression was used to analyze the clinical risk factors for the occurrence of adverse reactions.Results Forty-three patients,including 26 patients with colorectal cancer and 17 patients with lung cancer,were treated with fruquintinib monotherapy or in combination with chemotherapy,targeted therapy,or immunotherapy,respectively.Objective response rate(ORR)and disease control rate(DCR)were 23.1%and 69.2%for colorectal cancer and 5.9%and 64.7%for lung cancer at the eighth week.Median progression-free survival(PFS)was 4.6 months(maximum PFS 15.4 months)for colorectal cancer and 5.1 months(maximum PFS 7.3 months)for lung cancer,96%,85%,69%and 42%for colorectal cancer(36.6 months follow-up and still alive)and 100%,88%,53%and 18%for lung cancer(14.1 months for maximum follow-up and still alive).The incidence of adverse reactions was 90.7%,and 32.6%for grade 3 and above.The main ADRs included hand and foot skin reactions(53.5%),abdominal distension,abdominal pain/abdominal discomfort(39.5%),hypertension(37.2%),fatigue(34.9%),proteinuria(30.2%),and abnormal liver function(23.3%).Analysis of risk factors for adverse reactions indicated that fatigue was significantly associated with advanced age(�

关 键 词：呋喹替尼 结直肠癌 肺癌 真实世界研究 药品不良反应 

分 类 号：R73[医药卫生—肿瘤]