口服与注射长春瑞滨联合卡培他滨治疗蒽环类、紫杉类耐药性晚期乳腺癌的比较研究

Clinical Study on Oral Vinorelbine Plus Capecitabine for Patients with Metastatic Breast Cancer Resistant to Anthracyclines and Taxanes

目的探讨口服长春瑞滨联合卡培他滨治疗蒽环类、紫杉类耐药的转移性乳腺癌的疗效及不良反应。方法80例确诊蒽环类、紫杉类耐药的转移性乳腺癌患者随机分为两组。口服长春瑞滨联合希罗达组(试验组):40例患者口服江苏豪森酒石酸长春瑞滨软胶囊45～50mg/(m2·d),第1、8、15天服用,口服卡培他滨1650mg/(m2·d),连服1～14d,每3周为1个周期,连用4个周期。注射长春瑞滨联合希罗达组(对照组):40例患者,长春瑞滨(江苏豪森)25mg/(m2·d)第1、8天静脉滴注,口服卡培他滨1650mg/(m2·d),连服1～14d,每3周为1个周期,连用4个周期。治疗结束2周后评价疗效。结果入组患者80例均可评价疗效,试验组有效率为42.5%,1年生存率为45.0%,中位进展时间4.7月,中位生存时间11.0月;对照组有效率为37.5%,1年生存率为42.5%,中位进展时间4.6月,中位生存时间10.6月;两组比较差异无统计学意义(P>0.05)。在毒副反应方面,Ⅲ/Ⅳ便秘、局部静脉炎、HB下降、WBC下降、ANC下降、总Ⅲ/Ⅳ反应率两组比较,差异均有统计学意义(P<0.05)。结论口服长春瑞滨联合卡培他滨治疗蒽环类、紫杉类耐药的转移性乳腺癌与静脉剂型疗效一致,并且在毒副反应上,口服长春瑞滨明显较静脉剂型轻,并且应用方便。

Objective To study the efficacy and adverse effect of oral vinorelbine（NVB） plus capecitabine for patients with metastatic breast cancer resistant to anthracyclines and taxanes. Methods 80 patients with metastatic breast cancer resistant to anthracyclines and taxanes were randomly divided into two groups. The test group： 40 patients were given oral NVB capsules 45-50 mg/（m^2·d） dl, 8 and 15, capecitabine 1 650 mg/（m^2·d）, dl-dl4. The two regimens were repeated every three weeks and totally for four cycles. The control groups： 40 patients were given NVB 25 mg/（m^2·d）, intravenous infusion, dl and 8, capecitabine, 1 650 mg/（m^2·d）, dl-dl4. The two regimens were repeated every three weeks and totally for four cycles. The evaluation is performed two weeks after the completion of chemotherapy. Results The curative rates of the test group and the control group were 42.5%（17/40） and 37.5% （15/40）, respectively, P〉0.05; the TTP were 4.7 month and 4.6 months, respectively, P〉0.05; the MST were 11.0 months and 10.6 months, respectively; one-year survival rates were 45.0%（18/40） and 42.5%（17/40）, respectively, P〉 0.05. There were no significant differences between the two groups. For the toxic effect, the rates of grade Ⅲ/Ⅳ constipation of the test group and the control group were 0/40（0%） and 10/40（25.0%）, respectively, P=0.001 ; local venous toxicity were 0/40（0%） and 28/40（70.0%）, P=0.O001; HB decrease were 11/40（27.5%） and 20/40（50.0%）, respectively, P=0.039; WBC decrease were 14/40（35.0%） and 28/40（70.0%）, respectively, P =0.002; ANC decrease were 3/40（7.5%）and 15/40（37.5%）, respectively, P= 0.001; and grade Ⅲ/Ⅳ total side effect were 10/40 （ 25.0% ） and 39/40 （97.5 % ）, respectively, P = 0.0001. There were significant differences between the two groups. Conclusion For the patients with metastatic breast cancer resistant to anthracyclines and taxanes, the efficacy in the oral vinorelbine group is the same as that in the intravenous infusion group. There was less toxic effect in the test groud than that of the intravenous infusion one.