Bluefish Pharma, Limited Liability Company, Warsaw, Poland.
Department of Education and Research of Health Sciences, Medical University of Warsaw, Warsaw, Poland.
Med Sci Monit. 2021 Aug 31;27:e931856. doi: 10.12659/MSM.931856.
BACKGROUND The mortality caused by hepatocellular carcinoma is expected to rise in the upcoming decade. Sorafenib has become the preferred systemic treatment option in patients with unresectable HCC. This study aimed to present the median overall survival (OS) in a group of patients with advanced HCC, treated with sorafenib in Poland between 2011 and 2019. MATERIAL AND METHODS The analyzed group of patients was qualified for treatment with sorafenib, financed by the National Health Fund, based on the guidelines of the Polish Drug Program. Kaplan-Meier method was used to plot the OS curves, and the log-rank test was used for testing. Multivariate assessment of factors (sex and age) related to the time to death of the patient was done using Cox regression. RESULTS Of the 2072 treated patients, 75% were men (1556) and 25% were women (516). The minimum age of patients in the trial group was 18 years and the maximum age was 90 years. Among the 1556 analyzed cases in males, 27.44% (427) did not end with death (by the date of completing the analysis). The percentage of one-year survival for this population was 58.16%, and the 2-, 3-, and 5-year survival rates were 34.45%, 21.81%, and 9.72%, respectively. The percentage of censored cases in the 516 females was 25.78% (133). The 1-2-, 3-, and 5-year survival for this population was 59.30%, 36.27%, 22.47%, and 11.34%, respectively. Statistical tests did not reveal a significant difference in the curve profiles by sex. There were no associations between OS and age. CONCLUSIONS Systemic treatment with sorafenib in accordance with the presented criteria allows for very good results, comparable to the results of selected groups of patients presented by other authors.
预计在未来十年,肝细胞癌导致的死亡率将会上升。索拉非尼已成为不可切除肝细胞癌患者的首选系统治疗方案。本研究旨在报告 2011 年至 2019 年期间在波兰接受索拉非尼治疗的晚期 HCC 患者的中位总生存期(OS)。
根据波兰药品计划的指南,符合国家健康基金资助索拉非尼治疗条件的患者被纳入分析。使用 Kaplan-Meier 法绘制 OS 曲线,并使用对数秩检验进行检验。使用 Cox 回归对与患者死亡时间相关的因素(性别和年龄)进行多变量评估。
在 2072 名接受治疗的患者中,75%为男性(1556 名),25%为女性(516 名)。试验组患者的最小年龄为 18 岁,最大年龄为 90 岁。在男性分析的 1556 例中,27.44%(427 例)未死亡(在完成分析的日期)。该人群的一年生存率为 58.16%,两年、三年和五年生存率分别为 34.45%、21.81%和 9.72%。女性 516 例中,截尾病例的百分比为 25.78%(133 例)。该人群的 1-2 年、3 年和 5 年生存率分别为 59.30%、36.27%、22.47%和 11.34%。统计学检验未显示性别曲线形态存在显著差异。OS 与年龄之间没有关联。
根据所提出的标准进行索拉非尼系统治疗可获得非常好的结果,与其他作者报告的选定患者组的结果相当。