首页|期刊导航|疑难病杂志|贝伐珠单抗联合尼拉帕利在复发性卵巢癌维持治疗中的疗效与安全性

贝伐珠单抗联合尼拉帕利在复发性卵巢癌维持治疗中的疗效与安全性OA

Efficacy and safety of bevacizumab combined with niraparib in the maintenance treatment of recurrent ovarian cancer

中文摘要英文摘要

目的 评估贝伐珠单抗联合尼拉帕利在复发性卵巢癌维持治疗中的疗效与安全性.方法 选取2020年1月-2024年8月甘肃省武威肿瘤医院妇瘤科诊治的复发性卵巢癌患者112例,通过随机数字表按1∶1随机分为观察组和对照组.患者基础治疗方案为卡铂+紫杉醇或吉西他滨+多西他赛,化疗结束后,对照组联合应用贝伐珠单抗,观察组在对照组方案基础上联合应用尼拉帕利,维持治疗2年.比较2组患者临床疗效,治疗前后肿瘤标志物水平、生活质量,以及总不良反应发生率.结果 入组的112例患者中110例完成随访并明确治疗终点,随访率为98.2%(110/112),末次随访时间为2025年2月20日;观察组客观缓解率(ORR)、疾病控制率(DCR)高于对照组(x2/P=4.406/0.036、4.251/0.039);观察组中位无进展生存期(PFS)及中位总生存期(OS)均高于对照组(Log-rank x2/P=7.406/0.007、6.576/0.010).治疗3个周期及6个周期后,观察组糖类抗原125(CA125)、人附睾蛋白 4(HE4)水平低于对照组(治疗 3 个周期:t/P=4.328/<0.001、2.068/0.041;治疗 6 个周期:t/P=2.855/0.005、3.535/0.001);观察组躯体功能、角色功能、情绪功能、社会功能、总体生活质量评分均高于对照组(治疗3个周期:t/P=4.564/<0.001、4.420/<0.001、3.169/0.002、3.559/0.001、7.061/<0.001;治疗 6 个周期:t/P=4.153/<0.001、4.696/<0.001、6.367/<0.001、3.412/0.001、8.392/<0.001);2组患者总不良反应发生率比较,差异无统计学意义(x2/P=0.591/0.442).结论 贝伐珠单抗联合尼拉帕利在复发性卵巢癌患者疾病控制方面更具优势,可更显著降低肿瘤标志物水平并提升患者的生活质量,且该联合治疗方案具有可靠的临床安全性.

Objective To evaluate the efficacy and safety of bevacizumab combined with niraparib in maintenance therapy for recurrent ovarian cancer.Methods A total of 112 patients with recurrent ovarian cancer treated at the Department of Gynecologic Oncology,Gansu Wuwei Cancer Hospital,from January 2020 to August 2024 were enrolled.Patients were randomly assigned in a 1∶1 ratio to an observation group or a control group using a computer-generated random number table.The foundation chemotherapy regimens were carboplatin+paclitaxel or gemcitabine+docetaxel.The control group received bevacizumab,while the observation group received niraparib in addition to the regimen of the control group.Clinical efficacy,changes in tumor marker levels,quality of life,and incidence of adverse reactions were compared between the two groups.Re-sults Among the 112 enrolled patients,110 completed follow-up and reached the treatment endpoint,with a follow-up rate of 98.2%(110/112).The last follow-up was on February 20,2025.The objective response rate(ORR)and disease control rate(DCR)in the observation group were 61.8%(34/55)and 90.9%(50/55),respectively,which were significantly higher than those in the control group[41.8%(23/55)and 76.4%(42/55)](x2=4.406,P=0.036;x2=4.251,P=0.039).The median pro-gression-free survival(PFS)in the observation group was 16 months(95%CI:11.95-21.06),and the median overall survival(OS)was 20 months(95%CI:12.97-25.03);in the control group,the median PFS and OS were 12 months(95%CI:9.11-14.89)and 16 months(95%CI:13.11-18.89),respectively(Log-rank x2=7.406,P=0.007;Log-rank x2=6.576,P=0.010).Se-rum levels of carbohydrate antigen 125(CA125)and human epididymis protein 4(HE4)decreased significantly in both groups during treatment,while scores for physical function,role function,emotional function,social function,and overall quality of life increased significantly(all P<0.05).After 3 and 6 cycles of treatment,patients in the observation group had significantly lower serum CA125 and HE4 levels and significantly higher scores for the aforementioned quality-of-life domains compared with the control group(all P<0.05).The overall incidence of adverse reactions in the observation group was 47.3%(26/55),which was not statistically significantly different from that in the control group[40.0%(22/55)](x2=0.591,P=0.442).Con-clusion The combination of bevacizumab and niraparib demonstrates superior disease control in patients with recurrent ovar-ian cancer,more significantly reduces tumor marker levels,and improves patients' quality of life,with a favorable clinical safety profile.

李京;郭玮;袁红燕;骆秀花;安存莲

733000 武威,甘肃省武威肿瘤医院妇瘤科733000 武威,甘肃省武威肿瘤医院妇瘤科733000 武威,甘肃省武威肿瘤医院妇瘤科733000 武威,甘肃省武威肿瘤医院妇瘤科733000 武威,甘肃省武威肿瘤医院妇瘤科

医药卫生

卵巢癌,复发性贝伐珠单抗尼拉帕利临床疗效安全性

Ovarian cancer,recurrentBevacizumabNiraparibClinical efficacySafety

《疑难病杂志》 2026 (6)

658-662,668,6

武威市科技计划项目(2025WW02924) Wuwei Science and Technology Plan Project(2025WW02924)

10.3969/j.issn.1671-6450.2026.06.004

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