目的 观察贝伐珠单抗联合紫杉醇和卡铂治疗复发/转移性宫颈癌的疗效,并探究其对患者生存预后的影响.方法 将复发/转移性宫颈癌患者按治疗方法不同分为对照组和试验组.对照组给予紫杉醇联合卡铂方案化疗,静脉滴注170 mg·m-2紫杉醇、卡铂(按照AUC=5 mg·mL-1·min计算),3周为1个疗程;试验组在对照组的基础上给予15 mg·kg-1贝伐珠单抗,静脉输注,每3周给药1次.1个治疗周期为3周,2组均治疗3个周期.比较2组患者的临床疗效、血清肿瘤标志物水平、生活质量、生存预后以及治疗过程中的药物相关不良反应发生情况.结果 试验组41例,对照组48例.治疗后,试验组和对照组患者客观缓解率(ORR)分别为31.71％(13例/41例)和14.58％(7例/48例),在统计学上差异无统计学意义(P＞0.05).治疗后,对照组和试验组疾病控制率(DCR)分别为62.50％(30例/48例)和82.93％(34例/41例),鳞状细胞癌抗原(SCCA)分别为(3.58±0.73)和(2.52±0.57)ng·mL-1,糖抗原 19-9(CA19-9)分别为(23.60±4.29)和(19.19±3.72)U·mL-1,糖抗原 15-3(CA15-3)分别为(27.13±5.36)和(22.86±3.94)U·mL-1,糖抗原 125(CA125)分别为(39.24±6.88)和(26.47±5.09)U·mL-1,生存质量总改善率分别为41.67％(20例/48例)和73.17％(30例/41例),无进展生存时间分别为8.67 个月(95％CI:7.82～9.53)和 10.25 个月(95％CI:9.68～10.81),总生存时间分别为 9.96 个月(95％CI:9.13～10.79)和 11.47 个月(95％CI:11.00～11.93),在统计学上差异均有统计学意义(均P＜0.05).2组恶心呕吐、白细胞减少、血小板减少、肝肾功能损害等药物不良反应发生率比较,在统计学上差异均无统计学意义(均P＞0.05).结论 贝伐珠单抗联合化疗治疗复发/转移性宫颈癌疗效显著,可降低血清肿瘤标志物水平,提升生活质量,改善生存预后,安全性良好.
Objective To analyze the efficacy of bevacizumab combined with paclitaxel+carboplatin in the treatment of recurrent/metastatic cervical cancer,and to explore the influence on survival prognosis of patients.Methods Patients with recurrent/metastatic cervical cancer were divided into control group and treatment group according to different treatment methods.The control group received paclitaxel combined with carboplatin chemotherapy regimen(intravenous infusion of 170 mg·m-2 paclitaxel and carboplatin(AUC=5 mg·mL-1·min)for 3 weeks as a course of chemotherapy),and the treatment group was given bevacizumab on the basis of control group,intravenous infusion of 15 mg·kg-1 bevacizumab,once every 3 weeks.Both groups were treated for 3 cycles of treatment by taking 3 weeks as 1 treatment cycle.The clinical efficacy,levels of serum tumor markers,quality of life,survival prognosis and occurrence of drug-related adverse reactions during treatment were compared between the two groups.Results There were 41 cases in treatment group and 48 cases in control group.After treatment,the overall response rate(ORR)of treatment group and control group were 31.71％(13 cases/41 cases)and 14.58％(7 cases/48 cases),with no statistical significance(P＞0.05).After treatment,the disease control rate(DCR)in control group and treatment group were 62.50％(30 cases/48 cases)and 82.93％(34 cases/41 cases);the squamous cell carcinoma antigen(SCCA)levels were(3.58±0.73)and(2.52±0.57)ng·mL-1;carbohydrate antigen 19-9(CA19-9)levels were(23.60±4.29)and(19.19±3.72)U·mL-1;carbohydrate antigen 15-3(CA15-3)levels were(27.13±5.36)and(22.86±3.94)U·mL-1;carbohydrate antigen 125(CA125)levels were(39.24±6.88)and(26.47±5.09)U·mL-1;the overall improvement rates of quality of life were 41.67％(20 cases/48 cases)and 73.17％(30 cases/41 cases),the progression-free survival times were 8.67 months(95％CI:7.82-9.53)and 10.25 months(95％CI:9.68-10.81),the total survival times were 9.96 months(95％CI:9.13-10.79)and 11.47 months(95％CI:11.00-11.93),all with significant difference(all P＜0.05).There were no statistically significant differences in the incidence of nausea and vomiting,leukopenia,thrombocytopenia and liver-kidney function impairment between both groups(all P＞0.05).Conclusion Bevacizumab combined with chemotherapy has significant efficacy in the treatment of recurrent/metastatic cervical cancer,and it can reduce the levels of serum tumor markers,enhance the quality of life,and improve the survival prognosis,and it has good safety.
向阳;曹金龙;聂桂梅;李英;孙艳影;王舒;谢苹荣
酒泉市人民医院妇产科,甘肃酒泉 735000
药学
贝伐珠单抗;紫杉醇;卡铂;复发/转移性宫颈癌;生活质量;生存预后
bevacizumab;paclitaxel;carboplatin;recurrent/metastatic cervical cancer;quality of life;survival prog-nosis
《中国临床药理学杂志》 2024 (008)
1121-1125 / 5
10.13699/j.cnki.1001-6821.2024.08.007
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