摘要
目的本研究旨在探讨信迪利单抗(Sintilimab)联合调强适形放疗(IMRT)和化疗对晚期宫颈癌(ACC)患者的临床疗效和安全性。方法回顾性收集西安市第九医院妇产科2019年1月至2020年6月诊治的ACC患者临床资料。根据治疗方案,将ACC患者分为Sintilimab组(信迪利单抗+IMRT联合顺铂和紫杉)和对照组(IMRT联合顺铂和紫杉醇)。观察并比较治疗前后ACC患者血清肿瘤标志物[鳞状细胞癌抗原(SCCA)、癌胚抗原(CEA)、糖类抗原724(CA724)和糖类抗原199(CA199)]、免疫功能[CD3+、CD4+和CD8+]和生活质量[生活质量(QOL)量表评估]。比较ACC患者短期疗效[客观缓解率(ORR)和疾病控制率(DCR)]和长期疗效[死亡率、局部复发率、远处转移率和总生存期(OS)]。根据美国肿瘤放射治疗协作组织和不良事件通用术语标准评估药品不良反应发生情况。结果研究共纳入118例ACC患者,Sintilimab组和对照组各59例。治疗前,两组患者血清SCCA、CEA、CA724、CA199表达水平、CD3+、CD4+、CD8+/CD4+和生活质量差异无统计学意义(P>0.05)。治疗后,Sintilimab组血清SCCA、CEA、CA724、CA199表达水平、CD3+、CD4+和CD8+/CD4+水平显著低于对照组(P<0.05),而生活质量显著优于对照组(P<0.05);Sintilimab组ORR高于对照组(P<0.05),而两组患者DCR差异无统计学意义(P>0.05);Sintilimab组ACC患者死亡率、局部复发率和远处转移率明显低于对照组(P<0.05);Kaplan-Meier分析表明,Sintilimab组ACC患者的OS明显高于对照组(P<0.05)。此外,Sintilimab组和对照组药品不良反应差异无统计学意义(P>0.05)。结论信迪利单抗联合IMRT和化疗对ACC患者疗效显著,可降低肿瘤标志物水平,改善生活质量,降低死亡率、局部复发率和远处转移率,提高OS,且安全性高。
Objective To investigate the clinical efficacy and safety of sintilimab in combination with intensity-modulated radiotherapy(IMRT)and chemotherapy in patients with advanced cervical cancer(ACC).Methods The clinical data of ACC patients diagnosed and treated in the Department of Obstetrics and Gynecology of Xi'an Ninth Hospital from January 2019 to June 2020 were retrospectively collected.According to the treatment regimen,ACC patients were divided into Sintilimab group(sintilimab+IMRT combined with cisplatin and taxane)and control group(IMRT combined with cisplatin and paclitaxel).Serum tumor markers[squamous cell carcinoma antigen(SCCA),carcinoembryonic antigen(CEA),carbohydrate antigen 724(CA724)and carbohydrate antigen 199(CA199)],immune function[CD3+,CD4+and CD8+]and quality of life[quality of life(QOL)scale assessment]were observed and compared before and after treatment.The short-term efficacy[objective response rate(ORR)and disease control rate(DCR)]and long-term efficacy[mortality,local recurrence rate,distant metastasis rate,and overall survival(OS)]in patients with ACC were compared.The occurrence of adverse drug reactions were assessed according to the American Radiation Oncology Collaboration(RTOG)and Common Terminology Criteria for Adverse Events.Results A total of 118 ACC patients were included in the study,including 59 patients in the sintilimab group and 59 in the control group.Before treatment,there were no significant differences in serum SCCA expression level,serum CEA expression level,serum CA724 expression level,serum CA199 expression level,CD3+,CD4+,CD8+/CD4+and quality of life between the two groups(P>0.05).After treatment,the serum SCCA level,CEA expression level,CA724 expression level,serum CA199 expression level,CD3+,CD4+and CD8+/CD4+levels in the Sintilimab group were significantly lower than those in the control group(P<0.05),the quality of life and the ORR were significantly higher than that in the control group(P<0.05),while there was no significant difference in DCR between the two
作者
唐江月
王琳
张婧
任蓉
陈玲
Jiang-Yue TANG;Lin WANG;Jing ZHANG;Rong REN;Ling CHEN(Department of Gynecology and Obstetrics,Xi'an Ninth Hospital,Xi'an 710054,China;Department of Pharmacy,Shaanxi Cancer Hospital,Xi'an 710068,China)
出处
《中国药师》
CAS
2023年第12期456-464,共9页
China Pharmacist
关键词
晚期宫颈癌
信迪利单抗
调强适形放疗和化疗
临床疗效
安全性
Advanced cervical cancer
Sindilimab
Intensity modulated radiotherapy and chemotherapy
Clinical efficacy
Security
