首页|伊立替康联合卡培他滨和贝伐珠单抗治疗结直肠癌伴肝转移患者的临床研究

伊立替康联合卡培他滨和贝伐珠单抗治疗结直肠癌伴肝转移患者的临床研究

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目的 探讨奥沙利铂与伊立替康分别与卡培他滨+贝伐珠单抗联用对结直肠癌(CRC)伴肝转移患者的治疗作用及对血清血管内皮生长因子(VEGF)、糖类抗原199(CA199)的影响.方法 将CRC伴肝转移且CA199升高的患者分为对照组和试验组.对照组给予盐酸伊立替康注射液(150 mg·m-2,静脉滴注,D 1)联合卡培他滨片(1 000 mg·m-2,口服,bid,D 1~D 14)和贝伐珠单抗注射液(7.5 mg·m-2,静脉滴注,D 1);试验组给予奥沙利铂注射液(130 mg·m-2,静脉滴注,D 1)联合卡培他滨片(1 000 mg·m-2,口服,bid,D 1~D 14)和贝伐珠单抗注射液(7.5 mg·m-2,静脉滴注,D 1).21 d为1个治疗周期,2组均持续治疗4个周期.比较2组患者总有效率、疾病控制率、无进展生存期(PFS)、治疗后1年总生存率、血清VEGF和CA199水平,并进行安全性评价.结果 试验组和对照组分别纳入46和52例.治疗后试验组和对照组的总有效率分别为17.31%(9例/52例)和13.04%(6例/46例),疾病控制率分别为59.62%(31例/52例)和50.00%(23例/46例),在统计学上差异均无统计学意义(均P>0.05);试验组和对照组治疗后1年的中位PFS分别为8.50和10.50个月,1年无进展生存率为42.31%(22例/52例)和30.43%(14例/46例),总生存率分别为73.08%(38例/52例)和67.39%(31例/46例),在统计学上差异均无统计学意义(均P>0.05).治疗后,试验组和对照组血清VEGF分别为(442.59±67.90)和(518.56±82.08)pg·mL-1,CA199分别为(73.85±13.66)和(92.28±16.17)U·mL-1,在统计学上差异有统计学意义(均P<0.05).治疗期间,试验组和对照组Ⅲ~Ⅳ级腹泻发生率分别为1.92%(1例/52例)和17.39%(8例/46例),中性粒细胞减少症发生率分别为15.38%(8例/52例)和36.96%(17例/46例),在统计学上差异均有统计学意义(均P<0.05).2组患者恶心呕吐、血小板减少症、贫血、周围神经病变、手足综合征、脱发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 奥沙利铂与伊立替康分别与卡培他滨和贝伐珠单抗联用治疗CRC伴肝转移患者的临床疗效、1年后生存情况效果相当,但奥沙利铂与卡培他滨和贝伐珠单抗联用可显著降低血清VEGF、CA199水平,且安全性更高.
Clinical trial of irinotecan combined with capecitabine and bevacizumab in the treatment of colorectal cancer patients with liver metastases
Objective To explore the efficacy of oxaliplatin and irinotecan combined with capecitabine and bevacizumab on disease control rate,serum vascular endothelial growth factor(VEGF)and carbohydrate antigen 199(CA199)in colorectal cancer(CRC)combined with liver metastases.Methods CRC patients with liver metastases and elevated CA199 were divided into control group and treatment group.The control group was given irinotecan hydrochloride injection(150 mg·m-2,iv infusion,D1)combined with capecitabine tablets(1 000 mg·m-2,oral,bid,D 1-D 14)and bevacizumab injection(7.5 mg·m-2,iv infusion,D1).The treatment group was given oxaliplatin injection(130 mg·m-2,iv infusion,D 1)combined with capecitabine tablets(1 000 mg·m-2,oral,bid,D 1-D 14)and bevacizumab injection(7.5 mg·m-2,iv infusion,D 1).All were treated for 4 cycles(21 d/cycle).The total response rate,disease control rate,progression-free survival(PFS),survival rate at 1 year after treatment,serum VEGF,CA199,and the occurrence of toxic and the safety were evaluated.Results The treatment group and the control group were included in 46 and 52 cases,respectively.Total response rates in treatment group and control group were 17.31%(9 cases/52 cases)13.04%(6 cases/46 cases),disease control rates were 59.62%(31 cases/52 cases)and 50.00%(23 cases/46 cases),the difference was not statistically significant(all P>0.05).The median PFS in treatment group and control group at 1 year after treatment were 8.50 and 10.50 months;progression-free survival rate were 42.31%(22 cases/52 cases)and 30.43%(14 cases/46 cases);overall survival rates were 73.08%(38 cases/52 cases)and 67.39%(31 cases/46 cases),the difference was not statistically significant(all P>0.05).After treatment,levels of serum VEGF in treatment group and control group were(442.59±67.90)and(518.56±82.08)pg·mL-1,CA199 levels were(73.85±13.66)and(92.28±16.17)U·mL-1,the difference were statistically significant(all P<0.05).During treatment,the incidence of grade Ⅲ~Ⅳ diarrhea in oxaliplatin group and irinotecan group were 1.92%(1 case/52 cases)and 17.39%(8 cases/46 cases),respectively,the incidence of neutropenia were 15.38%(8 cases/52 cases)and 36.96%(17 cases/46 cases),respectively,the differences were statistically significant(all P<0.05).There were no significant differences in nausea,vomiting,thrombocytopenia,anemia,peripheral neuropathy,hand-foot syndrome and alopecia between 2 groups(all P>0.05).Conclusion Oxaliplatin and irinotecan respectively combined with capecitabine and bevacizumab have similar clinical curative effect and survival at 1 year after treatment in patients with CRC and liver metastasis.However,oxaliplatin and capecitabine combined with bevacizumab can significantly reduce serum VEGF,CA199 levels with higher safety.

oxaliplatin injectionirinotecan hydrochloride injectioncapecitabine tabletcolorectal cancerliver metastasisdisease control ratevascular endothelial growth factorcarbohydrate antigen 199

王韡、程晋坤、杨政道

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宁波市医疗中心李惠利医院肛肠外科,浙江宁波 315040

奥沙利铂注射液 盐酸伊立替康注射液 卡培他滨片 晚期结直肠癌伴肝转移 疾病控制率 血管内皮生长因子 糖类抗原199

2024

中国临床药理学杂志
中国药学会

中国临床药理学杂志

CSTPCD北大核心
影响因子:1.91
ISSN:1001-6821
年,卷(期):2024.40(18)
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