中国临床药理学杂志2025，Vol.41Issue(23)：3321-3327,7.DOI:10.13699/j.cnki.1001-6821.2025.23.004
安罗替尼联合标准化疗方案治疗复发转移性宫颈癌患者的临床研究
Clinical trial of anlotinib combined with standard chemotherapy regimen in the treatment of patients with recurrent and metastatic cervical cancer
摘要
Abstract
Objective To observe the clinical efficacy and safety of anlotinib hydrochloride capsules combined with standard chemotherapy(cisplatin for injection+paclitaxel injection)in the treatment of patients with recurrent and metastatic cervical cancer.Methods The patients with recurrent and metastatic cervical cancer were divided into treatment group and control group according to the treatment methods.In control group,paclitaxel injection(175 mg·m-2,infused within 3 hours)and cisplatin for injection(infusion time ≥1 h)were intravenously infused.In treatment group,based on the treatment in control group,anlotinib hydrochloride capsules(12 mg qd)were orally administered.Both groups were continuously treated for 4 courses.The clinical efficacy,tumor marker levels,tumor angiogenesis-related indicators,quality of life,short-term prognosis of the two groups were compared,and the safety was evaluated.Results The patients(n=125)were divided into control group(n=64)and treatment group(n=61).After treatment,the disease control rate(DCR)was 67.19％(43 cases/64 cases)in control group and 83.61％(51 cases/61 cases)in treatment group;the objective response rate(ORR)were 23.44％(15 cases/64 cases)and 40.98％(25 cases/61 cases),respectively;the median progression-free survival(PFS)were 6.40 and 11.31 months,respectively;and the median overall survival(OS)were 10.22 and 16.13 months,respectively.All the aforementioned indicators in treatment group were statistically significantly different from those in control group(all P＜0.05).After treatment,the squamous cell carcinoma antigen levels in control group and treatment group were(2.80±0.53)and(2.56±0.47)ng·mL-1,respectively;the carcinoembryonic antigen levels were(3.09±0.62)and(2.85±0.45)μg·L-1,respectively;the carbohydrate antigen 19-9 levels were(21.08±3.04)and(19.59±2.72)U·mL-1,respectively;the cytokeratin 19 fragment antigen 21-1 levels were(26.09±3.44)and(24.63±3.01)μg·L-1,respectively;the vascular endothelial growth factor receptor levels were(461.93±97.86)and(415.74±101.87)pg·mL-1,respectively;the platelet-derived growth factor receptor levels were(69.68±12.15)and(64.87±11.39)pg·mL-1,respectively;the physiological condition scores were(18.66±4.04)and(21.49±4.15)points,respectively;the social/family situation scores were(17.16±4.03)and(19.57±4.15)points,respectively;the functional status scores were(14.64±2.99)and(16.36±3.81)points,respectively;and the emotional state scores were(16.89±3.32)and(18.46±5.19)points,respectively.All the above-mentioned indicators in treatment group had statistically significant differences from those in control group(all P＜0.05).No statistical significant difference in adverse drug reactions was observed between the two groups(P＞0.05).Conclusion Anlotinib combined with the standard chemotherapy regimen has a remarkable efficacy in treating patients with recurrent and metastatic cervical cancer.It can reduce the levels of tumor markers in patients,inhibit tumor angiogenesis,improve their quality of life and short-term prognosis,and is highly safe.关键词
安罗替尼胶囊/顺铂冻干粉针剂/紫杉醇注射液/复发转移性宫颈癌/疗效Key words
anlotinib hydrochloride capsule/cisplatin for injection/paclitaxel injection/recurrent and metastatic cervical cancer/efficacy分类
医药卫生引用本文复制引用
孔守芳,蔡怡园,徐向前,袁汇..安罗替尼联合标准化疗方案治疗复发转移性宫颈癌患者的临床研究[J].中国临床药理学杂志,2025,41(23):3321-3327,7.基金项目
山东省医药卫生科技发展计划基金资助项目(2016WS0303) （2016WS0303）
青岛市医药科研指导计划基金资助项目(2018-WJZD041) （2018-WJZD041）
