Hospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saúde, Rio de Janeiro, RJ, 20221-903, Brazil.
Universidade Federal Fluminense, Niterói, Brazil.
Invest New Drugs. 2018 Oct;36(5):911-918. doi: 10.1007/s10637-018-0621-x. Epub 2018 Jun 13.
Sorafenib has been widely used to treat unresectable hepatocellular carcinoma (HCC) but most studies have been done in Child-Pugh A (CP-A) patients with well-preserved liver function. We evaluated the overall survival (OS) and tolerance to sorafenib in a large cohort of Child-Pugh B (CP-B) HCC patients as compared to CP-A HCC patients. We prospectively studied 130 patients with advanced HCC who started sorafenib between January 2011 and December 2015. Patients were classified as CP-A (n = 65) or CP-B (n = 65). The average OS for all 130 patients was 10 months. CP-A patients had a median survival rate significantly longer than CP-B patients: 12 months vs. 6 months. The OS found in our group of CP-B patients was 6.5 months, which is higher than that found in most studies done so far. When stratified, our CP-B patients had better OS than ever reported. The dose of the drug was interrupted due to adverse events (AEs) in 38 (29%) of the patients, of whom 20 (30%) were CP-A patients and 18 (28%) were CP-B patients. This real-life cohort of CP-B HCC patients treated with sorafenib had a higher survival than that described in the literature, with a satisfactory safety profile. Despite the high prevalence of severe AEs in CP-B patients, there were fewer treatment interruptions in this group, indicating that Child-Pugh B patients can tolerate treatment and may benefit from sorafenib.
索拉非尼已广泛用于治疗不可切除的肝细胞癌（HCC），但大多数研究都是在肝功能良好的 Child-Pugh A（CP-A）患者中进行的。我们评估了大样本 CP-B HCC 患者与 CP-A HCC 患者相比，接受索拉非尼治疗的总生存期（OS）和耐受性。我们前瞻性研究了 130 例 2011 年 1 月至 2015 年 12 月开始接受索拉非尼治疗的晚期 HCC 患者。患者分为 CP-A（n=65）或 CP-B（n=65）。所有 130 例患者的平均 OS 为 10 个月。CP-A 患者的中位生存率明显长于 CP-B 患者：12 个月 vs. 6 个月。我们 CP-B 组患者的 OS 为 6.5 个月，高于迄今为止大多数研究的结果。分层后，我们 CP-B 组患者的 OS 优于以往报道。由于不良事件（AE），38 例（29%）患者中断了药物治疗，其中 CP-A 患者 20 例（30%），CP-B 患者 18 例（28%）。接受索拉非尼治疗的 CP-B HCC 患者的这一真实队列的生存率高于文献报道，安全性良好。尽管 CP-B 患者严重 AE 的发生率较高，但该组中断治疗的患者较少，这表明 CP-B 患者可以耐受治疗并可能从索拉非尼中获益。
