Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan.
Hepatol Res. 2011 Apr;41(4):296-302. doi: 10.1111/j.1872-034X.2011.00778.x. Epub 2011 Feb 23.
Sorafenib is approved for the treatment of advanced hepatocellular carcinoma (HCC) in Japan; however, its tolerability and efficacy in elderly patients with HCC have not been clarified. We aimed to evaluate the tolerability and efficacy of sorafenib with increasing age.
As part of a retrospective, multicenter cohort study conducted between May 2009 and February 2010, patients with advanced HCC received 400 mg sorafenib twice daily (standard dosage) or once daily (half-dosage) until disease progression or treatment intolerance.
The mean age of the enrolled patients (n = 76) was 70.3 years, and 24 of them were ≥75 years old. The prognostic factors for survival were age < 75 years, performance status score zero, α-fetoprotein level < 1000 ng/mL, des-gamma-carboxy prothrombin level < 1000 ng/mL, and treatment duration ≥ 1 month. The median treatment duration and overall incidence of adverse drug reactions (ADRs) were not statistically different with increasing age. However, subgroup analysis revealed that treatment discontinuation because of ADRs was more frequent among the ≥75-year-old patients (41.7%) than among the <75-year-old ones (15.0%) with the standard dosage (P = 0.047); this trend was not observed among those who received the half-dose regimen.
Sorafenib has modest efficacy and acceptable toxicity in younger (<75 years) patients with HCC; however, elderly patients experience some side effects when it is administered at the standard dosage.
索拉非尼在日本被批准用于治疗晚期肝细胞癌（HCC）；然而，其在老年 HCC 患者中的耐受性和疗效尚未明确。我们旨在评估索拉非尼随年龄增长的耐受性和疗效。
作为 2009 年 5 月至 2010 年 2 月进行的一项回顾性、多中心队列研究的一部分，晚期 HCC 患者接受 400mg 索拉非尼每日两次（标准剂量）或每日一次（半剂量）治疗，直至疾病进展或不耐受治疗。
入组患者（n=76）的平均年龄为 70.3 岁，其中 24 例患者年龄≥75 岁。生存的预测因素为年龄<75 岁、体能状态评分 0 分、甲胎蛋白水平<1000ng/mL、脱γ-羧基凝血酶原水平<1000ng/mL 以及治疗持续时间≥1 个月。随着年龄的增长，中位治疗持续时间和总体不良反应（ADR）发生率没有统计学差异。然而，亚组分析显示，由于 ADR 而停止治疗的患者在≥75 岁组（41.7%）比<75 岁组（15.0%）更常见（标准剂量，P=0.047）；在接受半剂量方案的患者中未观察到这种趋势。
索拉非尼在年龄较小（<75 岁）的 HCC 患者中具有适度的疗效和可接受的毒性；然而，老年患者在标准剂量下使用时会出现一些副作用。
