Department of Internal Medicine, Division of Gastroenterology and Hepatology, Korea University College of Medicine, Seoul, Korea.
J Clin Gastroenterol. 2014 Mar;48(3):e22-9. doi: 10.1097/MCG.0b013e3182a54ec8.
The goal of the study was to compare the efficacy and safety of sorafenib with those of systemic cytotoxic chemotherapy.
Sorafenib treatment has shown to improve the survival in patients with advanced hepatocellular carcinoma (HCC) when compared with placebo. However, whether sorafenib controls advanced-stage HCC better than systemic cytotoxic chemotherapy has not been elucidated.
We retrospectively reviewed the medical records of 220 patients with measurable advanced HCC who had not received systemic treatment previously between January 2007 and April 2012. Among these patients, 78 had been treated with sorafenib. Another 14 patients who were treated with a 4-weekly regimen of adriamycin, cisplatin, and capecitabine were included as the historical control group for comparison. The median overall survival, the progression-free survival, response rates, and safety profiles were evaluated.
Baseline characteristics were similar between the treatment groups. The median overall survival was 7.2 months [95% confidence interval (CI), 5.6-8.8] in the sorafenib group and 11.2 months (95% CI, 8.1-14.2) in the cytotoxic chemotherapy group (P=0.10). The median progression-free survival was 3.2 months (95% CI, 2.2-4.3) in the sorafenib group and 5.9 months (95% CI, 3.6-8.2) in the cytotoxic chemotherapy group (P=0.07). The deterioration of liver function and neutropenia were the most frequent serious adverse events in the sorafenib and the systemic chemotherapy group.
Although a direct head-to-head comparison could not be done, there were some patients who showed a good response to systemic cytotoxic chemotherapy. Further assessment is necessary to study the role of chemotherapy in patients who are intolerant or intractable to sorafenib.
本研究旨在比较索拉非尼与全身细胞毒性化疗的疗效和安全性。
与安慰剂相比,索拉非尼治疗可改善晚期肝细胞癌(HCC)患者的生存。然而,尚不清楚索拉非尼是否比全身细胞毒性化疗更能控制晚期 HCC。
我们回顾性分析了 2007 年 1 月至 2012 年 4 月期间未接受过全身治疗的 220 例可测量的晚期 HCC 患者的病历。这些患者中,78 例接受了索拉非尼治疗。另 14 例接受阿霉素、顺铂和卡培他滨每周方案治疗的患者被纳入历史对照组进行比较。评估了中位总生存期、无进展生存期、缓解率和安全性。
治疗组的基线特征相似。索拉非尼组的中位总生存期为 7.2 个月(95%CI,5.6-8.8),细胞毒性化疗组为 11.2 个月(95%CI,8.1-14.2)(P=0.10)。索拉非尼组的中位无进展生存期为 3.2 个月(95%CI,2.2-4.3),细胞毒性化疗组为 5.9 个月(95%CI,3.6-8.2)(P=0.07)。肝功能恶化和中性粒细胞减少是索拉非尼和全身化疗组最常见的严重不良事件。
尽管不能直接进行头对头比较,但有些患者对全身细胞毒性化疗反应良好。需要进一步评估来研究化疗在不耐受或难治性索拉非尼患者中的作用。