【摘要】 目的:比较多西他赛联合塞替派方案和多西他赛联合卡培他滨方案治疗转移性乳腺癌的临床疗效及其安全性。方法:选择北京大学临床肿瘤学院乳腺肿瘤内科2006年8月至2008年9月收治的女性乳腺癌患者共46例,采用多西他赛联合塞替派(A组)或卡培他滨(B组)方案进行随机、对照临床治疗试验,A组第1、8天多西他赛35 mg/m2静脉滴注,第1天塞替派60~65 mg/m2静脉滴注,B组第1、8天多西他赛35 mg/m2静脉滴注,第1~14天卡培他滨1 000 mg/m2,口服,每日2次。21 d为1个周期,至少应用2个周期。结果:多西他赛联合塞替派组22例,多西他赛联合卡培他滨组24例,两组患者基线情况一致。可评价疗效多西他赛联合塞替派组21例,多西他赛联合卡培他滨组22例。两组疗效分别为部分缓解9.52%vs.27.27%(2/21例,6/22例),稳定52.38%vs.31.82%(11/21例,7/22例),进展38.10%vs.40.91%(8/21例,9/22例),疾病控制率分别为61.90%vs.59.09%(13/21例,13/22例),中位无进展生存期分别为7.9个月(95%CI0.77~15.03)vs.8.3个月(95%CI4.01~12.59),1年生存率分别为88.2%vs.81%,P值均>0.05,每两组间差异无统计学意义。无化疗相关死亡病例。多西他赛联合塞替派组和多西他赛联合卡培他滨组最常见的不良反应为骨髓抑制,主要不良反应Ⅲ~Ⅳ度发生率分别为白细胞减少45.45%vs.26.09%,中性粒细胞减少45.45%vs.21.74%,血小板减少9.09%vs.0%,手足综合征0%vs.13.04%,P值均>0.05,每两组间差异无统计学意义。结论:多西他赛联合塞替派方案治疗转移性乳腺癌有一定近期疗效,不良反应可耐受,可以作为经济、有效的解救方案。更多还原

【Abstract】 Objective: To evaluate the efficacy and safety of docetaxel plus thiotepa(TXT/TSPA) and docetaxel plus capecitabine(TXT/CAPE) in patients with metastatic breast cancer.Methods: The patients were randomized to give intravenous TXT 35 mg/m2 on days 1 and 8 plus intravenous TSPA 60-65 mg/m2 on day 1 every 3 weeks,or intravenous TXT 35 mg/m2 on days 1 and 8 plus oral CAPE 1 000 mg/m2 twice daily on days 1 to 14 every 3 weeks,at least 2 cycles applied.Results: TXT/TSPA group(22 patients) and TXT/CAPE group(24 patients) had consistent baseline.Docetaxel thiotepa group(21 cases) and docetaxel combined with capecitabine group(22 cases) were evaluated for their clinical responses,which showed that 2 of the 21(9.52%) from TXT/TSPA group and 6 of the 22(27.27%) from TXT/CAPE group had achieved partial remission;11 of the 21(52.38%) from TXT/TSPA group versus 7 of the 22(31.82%) from TXT/CAPE group for stable diseases;8 of the 21(38.10%) from TXT/TSPA group versus and 9 of the 22(40.91%) from TXT/CAPE group for progressive diseases,respectively.The disease control rate was 61.90%(13/21) and 59.09%(13/22) for TXT/TSPA and TXT/CAPE groups,the median progression-free survival(PFS) was 7.9 months [95% confidence interval(CI) 0.77 to 15.03] from TXT/TSPA group versus 8.3 months(95% CI 4.01 to 11.79) from TXT/CAPE group.One year survival rate was 88.20% for TXT/TSPA versus 81.00% for TXT/CAPE group,respectively.P values all exceeded 0.05,and the two groups showed no difference.No chemotherapy-related deaths occurred.Myelosuppression was the major side effect.The adverse events of grades 3 to 4 respectively occurred in TXT/TSPA and TXT/CAPE groups:leucocytopenia was 45.45% vs.26.09%;neutropenia 45.45% vs.21.74%;thrombocytopenia 9.09% vs.0%;hand-foot syndrome 0% vs.13.04%.P values all exceeded 0.05,and the two groups showed no difference.Conclusion: Combination of docetaxel and thiotepa in the treatment of metastatic breast cancer has some curative effect and adverse reactions can be tolerated.It can be used as an economical and effective rescue plan.更多还原