首页|贝伐珠单抗注射液联合顺铂注射液和伊立替康注射剂治疗晚期乳腺癌的临床研究

贝伐珠单抗注射液联合顺铂注射液和伊立替康注射剂治疗晚期乳腺癌的临床研究

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目的 探讨贝伐珠单抗联合顺铂注射液和伊立替康在晚期乳腺癌患者二线治疗中的疗效及安全性.方法 60例一线氟尿嘧啶联合奥沙利铂治疗方案失败的晚期乳腺癌患者按随机对照的方法分为实验组与对照组,每组均为30例.对照组第二天静脉滴注顺铂注射液30 mg/m2,滴注15 min;并同一天静脉滴注伊立替康300 mg/m2,滴注120 min.实验组在对照组的基础上,给予第一天静脉滴注贝伐珠单抗7.5 mg/kg加生理盐水100 mL,滴注90 min.2组患者均21 d为1个周期,均治疗2个周期.比较实验组与对照组治疗晚期乳腺癌患者的临床疗效、无进展生存期(PFS)与总生存期(OS)及药物的不良反应.结果 实验组的疾病进展(PD)为30.00%,对照组的PD为56.67%,差异有统计学意义(P<0.05);实验组的客观缓解率(ORR)为40.00%,对照组的ORR为16.67%,差异有统计学意义(P<0.05);实验组的疾病控制率(DCR)为70.00%,对照组的DCR为43.33%,差异有统计学意义(P<0.05);实验组的中位OS为14个月(95%CI:8.7~17.9),对照组的中位OS为11个月(95%CI:5.1~13.9),差异有统计学意义(P<0.05);实验组的中位PFS为8个月(95%CI:6.5~8.2),对照组的中位PFS为5个月(95%CI:4.3~7.2),差异有统计学意义(P<0.05),2组均以骨髓抑制、恶心呕吐、疲乏及转氨酶异常较为明显,以Ⅰ~Ⅱ级不良反应为主,其中实验组的中粒细胞减少Ⅰ~Ⅱ级不良反应的发生率高于对照组,差异有统计学意义(46.67%vs.20.00%,P=0.028);实验组的恶心呕吐Ⅰ~Ⅱ级不良反应的发生率高于对照组,差异有统计学意义(43.33%vs.16.67%,P=0.024).结论 贝伐珠单抗联合顺铂注射液与伊立替康方案在晚期乳腺癌患者二线治疗中可以提高患者ORR及DCR,延长PFS及OS,虽然产生一定的药物不良反应但是可以接受的.
Clinical study of Cisplatin Injection and Bevacizumab Injection joint irinotecan injection in the treatment of advanced stage of advanced breast cancer
Objective To investigate the efficacy and safety of bevacizumab in combination with Cisplatin Injection and irinotecan in patients with advanced second-line treatment of advanced breast cancer. Methods 60 cases of advanced a cancer patients who failed the treatment of first-line fluorouracil combined with oxaliplatin were divided into the experimental group and the control group by random control method, each group was 30 cases. The control group was given intravenous infusion of Cisplatin Injection 30 mg/m2 at second days, 15 min infusion, and intravenous infusion of irinotecan 300 mg/m2 on the same day, and instillation of 120 min. The experimental group in the first day on the basis of the control group, given intravenous infusion of bevacizumab 7.5 mg/kg plus saline 100 mL, intravenous infusion 90 min. Two groups of patients were 21d for a cycle, two cycles were treated. The clinical efficacy, progression free survival (PFS), overall survival (OS) and toxicity of the drug were compared between the experimental group and the control group in the treatment of advanced advanced breast cancer. Results The experimental groups of disease progression (PD) was 30.00%, the control group PD was 56.67%, the difference was statistically significant (P<0.05); objective remission rate of the experimental group (ORR) was 40.00%, the control group ORR was 16.67%, the difference was statistically significant (P<0.05); experimental group, the disease control rate (DCR 70%), the control group DCR was 43.33%, the difference was statistically significant (P<0.05); OS in the experimental group was 14 months (95% CI:8.7-17.9 ), OS in control group was 11 months (95% CI:5.1-13.9), the difference was statistically significant (P<0.05);in PFS of the experimental group was 8 months (95% CI:6.5-8.2), PFS in control group was 5 months (95% CI:4.3-7.2), the difference was statistically significant (P<0.05); the experimental group and the control group were myelosuppression, nausea and vomiting, and fatigue were abnormal obviously, to I - II The main level of toxicity, including granulocyte in experimental group decreased I-II adverse reaction rate was higher than the control group, the difference was statistically significant (46.67% vs. 20%, P=0.028); the incidence of postoperative nausea and vomiting in the experimental group I-II adverse reaction rate was higher than the control group, the difference was statistically significant (43.33% vs. 16.67%, P=0.024). Conclusion Bevacizumab and irinotecan combined with Cisplatin Injection can improve ORR and DCR in patients with irinotecan in patients with advanced scheme for second-line treatment of advanced breast cancer, prolonged PFS and OS, although have certain adverse drug reactions but acceptable.

bevacizumabCisplatin Injectionirinotecanadvanced breast cancer

应佳可、叶宇、方迪龙

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杭州市红十字会医院 普外科,浙江 杭州 310003

贝伐珠单抗 顺铂注射液 伊立替康 晚期乳腺癌

2017

中国生化药物杂志
南京生物化学制药研究所,全国生化制药情报中心站,中国生化制药工业协会,中国药品生物制品检定所

中国生化药物杂志

ISSN:1005-1678
年,卷(期):2017.37(11)
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