Department of Internal Medicine, Uijeongbu Eulji Medical Center, Eulji University College of Medicine, Uijeongbu, Korea.
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Gut Liver. 2024 Jan 15;18(1):116-124. doi: 10.5009/gnl220406. Epub 2023 Jun 19.
BACKGROUND/AIMS: Sorafenib is the standard of care in the management of advanced hepatocellular carcinoma (HCC). The purpose of this study was to investigate the characteristics, treatment patterns and outcomes of sorafenib among HCC patients in South Korea.
This population-based retrospective, single-arm, observational study used the Korean National Health Insurance database to identify patients with HCC who received sorafenib between July 1, 2008, and December 31, 2014. A total of 9,923 patients were recruited in this study.
Among 9,923 patients, 6,669 patients (68.2%) received loco-regional therapy prior to sorafenib, and 1,565 patients (15.8%) received combination therapy with concomitant sorafenib; 2,591 patients (26.1%) received rescue therapy after sorafenib, and transarterial chemoembolization was the most common modality applied in 1,498 patients (15.1%). A total of 3,591 patients underwent rescue therapy after sorafenib, and the median overall survival was 14.5 months compared to 4.6 months in 7,332 patients who received supportive care after sorafenib. The mean duration of sorafenib administration in all patients was 105.7 days; 7,023 patients (70.8%) received an initial dose of 600 to 800 mg. The longest survival was shown in patients who received the recommended dose of 800 mg, subsequently reduced to 400 mg (15.0 months). The second longest survival was demonstrated in patients with a starting dose of 800 mg, followed by a dose reduction to 400-600 mg (9.6 months).
Real-life data show that the efficacy of sorafenib seems similar to that observed in clinical trials, suggesting that appropriate subsequent therapy after sorafenib might prolong patient survival.
背景/目的：索拉非尼是治疗晚期肝细胞癌（HCC）的标准治疗方法。本研究的目的是调查韩国 HCC 患者使用索拉非尼的特点、治疗模式和结局。
本项基于人群的回顾性、单臂、观察性研究使用韩国国家健康保险数据库，确定 2008 年 7 月 1 日至 2014 年 12 月 31 日期间接受索拉非尼治疗的 HCC 患者。本研究共纳入 9923 例患者。
在 9923 例患者中，6669 例（68.2%）在接受索拉非尼治疗前接受了局部区域治疗，1565 例（15.8%）接受了索拉非尼联合治疗；2591 例（26.1%）在接受索拉非尼治疗后接受了挽救性治疗，1498 例（15.1%）患者接受了最常见的经动脉化疗栓塞治疗。在接受索拉非尼治疗后进行挽救性治疗的 3591 例患者中，中位总生存期为 14.5 个月，而在接受索拉非尼治疗后接受支持性治疗的 7332 例患者中，中位总生存期为 4.6 个月。所有患者索拉非尼治疗的平均持续时间为 105.7 天；7023 例患者（70.8%）接受 600-800mg 的初始剂量。最长生存时间见于接受推荐剂量 800mg 随后减为 400mg 的患者（15.0 个月）。其次是起始剂量为 800mg 随后剂量减为 400-600mg 的患者（9.6 个月）。
真实世界数据表明，索拉非尼的疗效似乎与临床试验观察到的疗效相似，提示索拉非尼治疗后适当的后续治疗可能延长患者的生存时间。
