Objective To evaluate the therapeutic efficacy and safety of TACE combined with hepatic arterial infusion chemotherapy (HAIC) using oxaliplatin (OXA), 5-fluorouracil (5Fu) and folinic acid (FA) for patients with intermediate and advanced hepatocellular carcinoma (HCC). Methods A total of 50 patients of pathologically or clinically proved inoperable HCC with no distant metastases, encountered during the period from July 2008 to December 2010 in authors' hospital, were enrolled in this study. All patients underwent TACE combined with HAIC by using OXA/5-Fu/CF. After TACE , HAIC with OXA (60 - 75mg/m2 in 0 - 4 hours), CF (200 mg /m2 in 4 - 6 hours) and 5-Fu (1000 - 1500 mg/m2 in 6-24 hours) via the indwelling catheter was carried out, and the therapeutic course was repeated every 4 - 6 weeks, until complete response (mRECIST version 1.1) was obtained, or liver function turned to Child-Pugh C,or distant metastases developed , or the adverse effects became intolerable to the patient. After the treatment, the patients were kept under close observation for untoward reactions. The laboratory examinations,enhanced CT or MRI were periodically performed to evaluate the therapeutic results. All the patients were followed up regularly. Results A total of 232 therapeutic courses of TACE combined with HAIC using OXA/5-Fu/CF were completed in 50 patients. Complete response, partial response, stable disease and progressive disease were obtained in 10, 21, 6 and 13 patients, respectively. Objective response rate was 74%, and disease control rate was 62%. The median follow-up time was 17.1 months (ranged 2.6 - 37.1 months), while the median PFS and median OS for all the patients were 9.3 and 21.4 months , respectively. The 1-year and the 2 year survival rates were 76% and 44%, respectively. The patients who had a liver function of Child-Pugh A (P = 0.006) and a total bilirubin < 34.2 umol/L (P = 0.023) and with no tumor vessel invasion (P = 0.003) carried a better prognosis than the patients of control group (Kaplan-Meier method, Logrank test, P < 0.05). Multivariate analysis revealed that the presence of tumor vessel invasion (P = 0.045) was a harmful independent prognostic factor. Adverse reactions (Ⅲ - Ⅳ grade) were less common, and neurotoxicity (Ⅲ grade) was observed in only 2 patients. No indwelling catheter-related complications occurred. Conclusion For inoperable intermediate and advanced HCC with no distant metastases , TACE combined with HAIC using 0XA/5Fu/FA is a safe treatment with reliable effectiveness. (J Intervent Radiol, 2012, 21: 377-383)%目的 评价肝动脉化疗栓塞术(TACE)联合奥沙利铂(OXA)/氟尿嘧啶(5-Fu)/亚叶酸钙(CF)方案肝动脉化疗治疗中晚期原发性肝癌(HCC)的可行性、疗效和安全性.方法 2008 年7 月至2010 年12 月,经组织病理活检诊断或临床诊断为不可切除且无远处转移的HCC 50 例患者入组,TACE术后经留置导管实施肝动脉灌注化疗(HAIC),方案:OXA 60 ～ 75 mg/m2,第0 ～ 4小时泵入;CF 200 mg/m2,第4 ～ 6小时泵入;5-Fu 1 ～ 1.5 g/m2,第6 ～ 24小时泵入.每4 ～ 6周一疗程,直至疗效评价CR(mRECIST 1.1标准)或出现肝功能Child-Pugh C级、远处转移及不可耐受的不良反应.术后观察患者不良反应,定期复查实验室指标及增强CT或MRI评估疗效,定期随访.结果 全部50 例患者共进行232次TACE联合OXA、5-Fu、CF方案HAIC治疗.疗效评价:CR10例;PR 21例;SD 6例;PD 13例;客观有效率(ORR )为74%;疾病控制率(DCR)为62%.患者中位随访时间为17.1个月(2.6 ～ 37.1个月),中位疾病无进展生存(PFS)为9.3个月,中位总生存时间(OS)为21.4个月,累计1年、2年生存率为76%、44%.用Log-rank检验行单因素分析:肝功能Child-Pugh A 级(P ＝ 0.006)、无肿瘤血管侵犯(P ＝ 0.003)、总胆红素值＜ 34.2 μmol/L(P ＝ 0.023)的患者预后好于对照组.Cox模型多因素分析:肿瘤血管侵犯(P ＝ 0.045)是患者独立预后不良因素.患者Ⅲ～Ⅳ度不良反应少见,仅有2例发生Ⅲ度神经毒性,无留置导管相关并发症.结论 TACE联合OXA/5-Fu/CF方案HAIC治疗无远处转移且不可切除的HCC,疗效肯定,安全性好.
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