大剂量与小剂量肝动脉灌注化疗治疗难治性晚期肝细胞癌的随机对照研究。

A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma.

机构信息

Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.

出版信息

Cancer Chemother Pharmacol. 2010 Jan;65(2):373-82. doi: 10.1007/s00280-009-1126-2. Epub 2009 Sep 18.

DOI:10.1007/s00280-009-1126-2

PMID:19763572

Abstract

PURPOSE

Hepatic arterial infusion chemotherapy (HAIC) has been reported to be effective in patients with advanced hepatocellular carcinoma (HCC).

METHODS

In this multicenter, prospective, open-labeled, clinical trial, we randomly assigned 68 patients with advanced HCC to receive either low-dose [n = 32, 5-fluorouracil (FU), 170 mg/m(2) and cisplatin, 7 mg/m(2) on days 1-5] or high-dose HAIC (n = 36, 5-FU, 500 mg/m(2) on days 1-3 and cisplatin, 60 mg/m(2) on day 2) every 4 weeks via an implantable port system.

RESULTS

A total of 207 cycles of HAIC was given to the 68 patients. Overall, 6 patients (8.8%) achieved a partial response and 21 patients (30.9%) had stable disease. The objective response rate (CR + PR) was significantly improved in the high-dose group compared to the low-dose group (16.7% vs. 0%, P = 0.024). The median time to disease progression and overall survival were slightly prolonged in the high-dose group compared to the low-dose group (median survival, 193 vs. 153 days; P = 0.108; median time to disease progression, 145 vs. 90 days; P = 0.095). Multivariate analysis showed that tumor response to treatment [P = 0.007, RR 2.27 (95% CI, 1.248-4.132)] was the only factor associated with overall survival. All adverse events were tolerable and successfully managed in both treatment groups.

CONCLUSIONS

Both HAIC regimens are safe and effective in patients with advanced HCC. High-dose HAIC achieves a better tumor response compared to low-dose HAIC.

摘要

目的

已有报道称肝动脉灌注化疗（HAIC）对晚期肝细胞癌（HCC）患者有效。

方法

在这项多中心、前瞻性、开放标签、临床试验中，我们将 68 例晚期 HCC 患者随机分为低剂量组（n = 32，5-氟尿嘧啶 [FU]，170 mg/m2 和顺铂，7 mg/m2，第 1-5 天）或高剂量 HAIC 组（n = 36，5-FU，500 mg/m2，第 1-3 天，顺铂 60 mg/m2，第 2 天），每 4 周通过植入式端口系统给药。

结果

68 例患者共接受 207 个周期的 HAIC。总的来说，6 例（8.8%）患者达到部分缓解，21 例（30.9%）患者疾病稳定。高剂量组客观缓解率（CR + PR）明显高于低剂量组（16.7%对 0%，P = 0.024）。与低剂量组相比，高剂量组疾病进展时间和总生存期略有延长（中位生存时间，193 对 153 天；P = 0.108；疾病进展时间，145 对 90 天；P = 0.095）。多变量分析显示，肿瘤对治疗的反应（P = 0.007，RR 2.27（95%CI，1.248-4.132））是与总生存相关的唯一因素。两组患者的所有不良反应均耐受且得到有效处理。