FOLFOX 4方案治疗中晚期原发性肝癌的临床研究

目的 观察评价FOLFOX 4方案系统化疗治疗国人中晚期原发性肝癌（PLC）的疗效和安全性。方法 2004年7月至2012年7月，共77例中晚期PLC患者接受FOLFOX 4方案的系统化疗，具体为：奥沙利铂（OXA） 85mg／m² 静滴，d₁；亚叶酸钙（LV） 200mg／m² 静滴2h，d₁、d₂； 氟尿嘧啶（5-FU） 400mg／m² 静推，继以600mg／m²持续静滴22h，d₁、d₂，每2周为1周期。按照RECIST 1.0 版标准每3个周期评价客观疗效，观察疾病进展时间（TTP） 和总生存期（OS），并动态监测血清甲胎蛋白（AFP）的变化。毒副反应按照NCI-CTC 3.0标准观察和判定；神经系统毒性参照OXA专用神经病变分级标准评判。结果 全组患者中72例可评价疗效，获PR 3例， SD 37例，PD 32例，客观缓解率（RR）为4.2％，疾病控制率（DCR） 为55.6％，中位TTP为2.7个月，中位OS为6.1个月。AFP反应率为11.1％。分层分析显示，曾接受过系统治疗患者的化疗疗效并不劣于初治患者，但是有门脉侵犯或肝外转移患者的疗效和预后更差。常见的毒副反应为白细胞减少和轻度的周围神经毒性。结论 采用奥沙利铂为主的FOLFOX 4方案进行系统化疗，对于国人中晚期PLC患者具有良好的病情控制和生存获益，不良反应较轻，患者易于耐受，值得在临床上广泛应用。

Clinical study on FOLFOX 4 regimen as systemic chemotherapy for advanced primary liver carcinoma

Objective To observe the efficacy and safety of oxaliplatin（OXA） combined with LV/5-FU as FOLFOX 4 regi- men for patients with primary liver carcinoma（PLC）. Methods From July 2004 to July 2012,77 patients were treated with FOLFOX 4 regimen as systemic chemotherapy. FOLFOX4 regimen, namely OXA 85 mg/m2 iv,dI ; LV 200 mg/m2 iv 2h,dI and d2 ; 5-FU 400 mg/m2 ,iv bolus,dI and d2 ; 5-FU 600 mg/m2 , CIV 22 h,d1 and d2, two weeks was a cycle. Tumor evaluation was performed every 3 cycles according to RECIST 1.0 criteria. The time to progression（TTP） and overall survival（OS） were observed. Serum AFP level was also monitored according to the schedule. Toxicities were evaluated according to NCI-CTC 3.0 and OXA special Levi neurotoxieity cri- teria. Results Seventy-seven patients were observed and 72 were evaluatable for efficacy. Three patients obtained partial response （PR） ,37 patients stable disease（SD） and 32 patients disease progression（PD）. The objective response rate（RR） was 4. 2%0 and dis- ease control rate（DCR） was 55. 6%. The median TIP and median OS were 2. 7 months and 6. 1 months, respectively. AFP response rate was 11.1%. The stratified analysis showed the efficacy of patients who received systemic therapy before was not inferior to that of initial treatment patients, but patients who have portal vein invasion or extrahepatic metastasis had worse efficacy and prognosis. The main observed adverse effects were leucopenia and mild periphery neurotoxicity. Conclusion Systemic chemotherapy with OXA-based FOLFOX 4 regimen for advanced PLC shows better disease control and survival benefit with mild adverse effects. Thus, it＇ s worthy of further clinical application widely.