进展期肝癌肝移植术后采用FOLFOX7方案辅助化疗的疗效观察  

Preliminary experience of adjuvant chemotherapy with FOLFOX7 after liver transplantation for advanced hepatocellular carcinoma

作　　者：张庆[1] 陈虹[1] 田彦[1] 沈中阳[1,2] 

机构地区：[1]武警总医院肝脏移植研究所,北京100039 [2]天津市第一中心医院器官移植中心,天津300192

出　　处：《实用器官移植电子杂志》2013年第2期75-81,共7页Practical Journal of Organ Transplantation(Electronic Version)

基　　金：国家高技术研究发展计划(863)项目(2012AA021001)

摘　　要：目的探讨肝移植术后采用FOLFOX7方案辅助化疗对不符合米兰标准肝癌患者的预后影响。方法对武警总医院施行原位肝移植手术的95例肝癌伴肝硬化患者进行观察，将其中58例不符合米兰标准肝癌患者随机分为两组，对照组（单纯肝移植术组）29例，观察组（肝移植术+术后辅助化疗组）29例。观察组采用FOLFOX7化疗方案：奥沙利铂（Oxaliplatin，OXA/L-OHP）100 mg/m2，静脉滴注（静滴），d1；甲酰四氢叶酸钙（CF）200 mg/m2，静滴，d1～3；5-氟尿嘧啶（5-Fu）2000 mg/m2，静脉持续泵入48小时。每次化疗间隔21天，共6个周期。37例符合米兰标准接受单纯肝移植术的肝癌患者作为疗效参照标准组（标准组）。比较两组患者化疗药物的毒副反应、生存与复发情况，分析肿瘤复发的危险因素。结果观察组患者术后1年、3年的生存率分别为89.7%和79.3%，而对照组患者术后1年、3年的生存率分别为69.0%和62.1%，两组术后1年总生存率差异有统计学意义（P＝0.043）；观察组化疗患者的中位生存期较对照组未化疗患者延长了4.57个月；观察组患者术后6个月的无瘤生存率较对照组提高24.1%。Cox多因素回归分析显示，辅助化疗是有统计学意义的独立预测术后生存指标（P＝0.033）。观察组患者对化疗耐受性较好，无一例患者因化疗毒副反应中断化疗。结论肝癌肝移植术后采用FOLFOX7辅助化疗虽然不能阻止肿瘤复发，但有助于改善不符合米兰标准肝癌肝移植受者的预后。本研究结果还需扩大样本量及长期随访进一步明确。Objective To evaluate the efficacy of postoperative adjuvant chemotherapy with FOLFOX7 regimen on the outcome after liver transplant(LT)for hepatocellular carcinoma(HCC)patients who do not meet the Milan criteria. Methods 95 consecutive HCC patients with liver cirrhosis undergoing LT were enrolled. 58 who did not meet the Milan criteria were randomized to open-label treatment with or without adjuvant chemotherapy after LT(29 cases in each group). The FOLFOX7 chemotherapy protocol comprised 3-week cycles of oxaliplatin 100 mg/m2 on day 1,leucovorin(calcium folinate,CF)200 mg/m2 on day 1 followed by 3-day,and 5-fluorouracil (5-FU)2000 mg/m2 as a 48 hours continuous infusion,for up to six courses in the 1st year after transplantation. The remaining 37 patients who satisfied the Milan criteria were untreated with adjuvant chemotherapy or other anti-tumor therapy after LT and served as the reference group. Results The 1- and 3-year survival rates were 89.7%and 79.3%with chemotherapy versus 69.0%and 62.1%without chemotherapy. The cumulative 1-year survival was significantly increased by chemotherapy(log-rank test,P=0.043). Median survival was increased 4.57 months with combination chemotherapy. The 6-month tumor-free survival rate was 24.1% higher with chemotherapy than those without. Cox multivariate analysis showed a significant association between survival and adjuvant chemotherapy (P=0.033). The chemotherapy regimen was generally well tolerated. Conclusions Post-LT adjuvant chemotherapy with oxaliplatin/5-FU/CF could not prevent tumor recurrence post-LT but may contribute to the survival improvement of HCC patients who do not meet the Milan criteria. These results should be verified in a larger sample with a longer follow-up period.

关 键 词：原发性肝癌 肝移植 奥沙利铂 5-氟尿嘧啶 生存 

分 类 号：R735.7[医药卫生—肿瘤]