Longo Larisse, de Freitas Laura Bainy Rodrigues, Santos Deivid, Grivicich Ivana, Álvares-da-Silva Mário Reis
Graduate Program in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.
Experimental Laboratory of Hepatology and Gastroenterology, Center for Experimental Research, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.
Dig Dis. 2018;36(5):377-384. doi: 10.1159/000490378. Epub 2018 Jul 13.
Sorafenib (SOR) has proved to be effective in patients with advanced hepatocellular carcinoma (HCC), since overall survival was higher in phase III clinical trials; however, disease progression can occur.
The study aimed to describe real-life experience in advanced HCC treatment with SOR at a university hospital in Brazil and to estimate the number of patients with indication of second-line therapy.
This is a retrospective study that included cases of HCC with prescription of SOR based on real-life practice between 2011 and 2016. Demographic, clinical, and laboratory data were collected.
From 572 patients with HCC, SOR was prescribed in 103 cases. From them, 62.1% were classified as Child-Pugh (CP)-A, 54.4% as Barcelona Clinic Liver Cancer (BCLC)-C, and 74 (71.8%) started treatment. Overall survival was 25.5 (95% CI 17.0-34.1) months and 1-year survival was greater in patients who received SOR than in non-treated (88.7 vs. 44.4%, p < 0.001). There was no difference in survival between BCLC-B and C (p = 0.405), as well as CP-A and B (p = 0.919). In 21.6% of the patients, a second-line therapy with regorafenib was indicated.
In this real-life study, SOR significantly increased the survival rate by 1 year in patients with advanced HCC regardless of BCLC staging and CP score. Second-line therapy would be indicated in 21.6% of cases.
索拉非尼(SOR)已被证明对晚期肝细胞癌(HCC)患者有效,因为在III期临床试验中总生存期更长;然而,疾病仍可能进展。
本研究旨在描述巴西一家大学医院使用SOR治疗晚期HCC的实际经验,并估计二线治疗适应症患者的数量。
这是一项回顾性研究,纳入了2011年至2016年间基于实际临床实践开具SOR处方的HCC病例。收集了人口统计学、临床和实验室数据。
在572例HCC患者中,103例开具了SOR处方。其中,62.1%被归类为Child-Pugh(CP)-A,54.4%为巴塞罗那临床肝癌(BCLC)-C,74例(71.8%)开始治疗。总生存期为25.5(95%CI 17.0-34.1)个月,接受SOR治疗的患者1年生存率高于未治疗患者(88.7%对44.4%,p<0.001)。BCLC-B和C组之间的生存率无差异(p=0.405),CP-A和B组之间也无差异(p=0.919)。21.6%的患者有使用瑞戈非尼进行二线治疗的指征。
在这项实际临床研究中,无论BCLC分期和CP评分如何,SOR均可显著提高晚期HCC患者1年生存率。21.6%的病例有二线治疗指征。