多西紫杉醇联合方案经动脉介入治疗结直肠癌肝转移的临床研究

Clinical research of Docetaxel combination regimen by artery interventional treatment for liver metastasis from colorectal cancer

摘要:

目的 探讨多西紫杉醇联合方案经动脉介入治疗结直肠癌肝转移的临床疗效及安全性。方法 选取2009年1月-2011年12月期间该院收治的60例无法进行手术切除的结直肠癌肝转移患者作为研究对象，随机分为实验组和对照组，两组各30例。实验组患者经腹腔动脉缓慢灌注5-FU 750 mg/m2、亚叶酸钙200 mg/m2、奥沙利铂120 mg/m2，然后将超液化碘油+50 mg表柔吡星缓慢注入肿瘤的靶血管，第2天从股动脉穿刺管缓慢泵入多西紫杉醇75 mg/m2，4周为1个疗程，对照组采用同一个化疗方案进行全身静脉化疗。全部患者均进行随访，截止至2014年9月。比较两组的近期疗效、生存状况及不良反应。结果 57例（实验组29例+对照组28例）患者至少完成2个疗程，其中实验组的整体疗效显著优于对照组（P <0.05）。实验组的临床受益率（CBR）为79.3%，显著优于对照组的50.0%（P <0.05）；全部患者的中位生存时间是19.2个月，实验组第1、2及3年的总生存率为79.3%、51.7%和37.9%，其中3年生存率显著高于对照组的14.3%（P <0.05）。全部患者最常见的不良反应是白细胞减少，未出现严重的心、肝、肾等脏器损害及超敏反应。实验组的白细胞减少的发生率显著低于对照组（P <0.05），其余不良反应比较差异无统计学意义（P >0.05）。结论 与全身静脉化疗相比，采用多西紫杉醇联合方案进行经动脉介入治疗可显著提高化疗药物在肿瘤组织中的有效浓度，肿瘤的近期控制效果及远期生存状况更令人满意，更加安全可靠，值得临床推广应用。

Abstract:

【Objective】 To investigate the clinical effect and safety of Docetaxel combination regimen by artery interventional treatment for patients with liver metastasis from colorectal cancer. 【Methods】 A total of 60 patients with unresectable liver metastasis from colorectal cancer from Jan. 2009 to Dec. 2011 were enrolled for the study and randomly divided into experimental group and control group with 30 cases in each group. The patients in the experimental group were given 5-FU 750 mg/m2, calcium folinate 200 mg/m2 and Oxaliplatin 120 mg/m2 by perfusion of celiac artery, then lipiodol emulsion and Epirubicin 50 mg were slowly injected into the target vessels of the tumor. On the second day, Docetaxel 75 mg/m2 was slowly pumped into femoral artery puncture tube, and the treatment course was 4 weeks. The cases in the control group were given the same regimen by systemic vein chemotherapy. All the cases were followed up till Sep. 2014. The recent curative effect, survival condition and adverse reactions were compared between both groups. 【Results】Among the 60 patients, 57 cases (29 cases in the experimental group and 28 cases in the control group) received at least two courses of complete treatment. In them, the overall curative effect of the experimental group was superior to that of the control group (P < 0.05). The clinical benefit rate (CBR) in the experimental group was 79.3%, which was significantly higher than 50.0% in the controls (P < 0.05). The median survival time of all the cases was 19.2 months; and one-year, two-year and three-year survival rates in the experimental group were 79.3%, 51.7% and 37.9% respectively. The three-year survival rate in the experimental group was significantly higher than that in the control group (14.3%, P < 0.05). Leukopenia was the most common adverse reaction. There was no serious heart, liver, kidney or other viscera damage or allergic reaction. The incidence of leukopenia in the experimental group was significantly lower than that in the control group (P < 0.05), and there were no significant differences in incidences of other adverse reactions between both groups (P > 0.05). 【Conclusions】 Compared with systemic vein chemotherapy, Docetaxel combination regimen via artery interventional treatment could significantly raise the effective concentration of chemotherapeutic drugs in tumor tissue, have more satisfied short-term tumor control effect and long-term survival condition, which is safer, more reliable and worthy of clinical promotion and application.