Objective: To retrospectively analyze the clinical efficacy, safety and the main factors affecting the prognosis of anlotinib hydrochloride in the treatment of advanced primary liver cancer. Methods: Fifty-five cases with advanced primary liver cancer who received anlotinib hydrochloride were enrolled. The baseline data of the patients, such as prothrombin time, total bilirubin, albumin, Child-Pugh score, procalcitonin, alpha fetoprotein, extrahepatic metastasis, cirrhosis, portal hypertension, whether or not combined surgery, pathological staging, etc before treatment were recorded. Hematological and imaging results of the patients were reviewed. Adverse events that appeared in patients at any time until the end of follow-up or loss- to- follow-up or death were recorded. The survival curve was plotted by Kaplan-Meier method, and the difference of survival time between groups was examined by log-rank test. Cox regression model of single and multiple factor were used to analyze the factors affecting the prognosis. Results: As of the last follow-up, 2 patients were lost-to-follow-up, 30 died, and 23 survived. The median survival time was 6.5 months (196 days). Grade 3 or higher adverse events included hypertension (12.73%), leukopenia (3.64%), absolute neutropenia (1.82%), thrombocytopenia (9.09%), fatigue (3.64%), anemia (1.82%), and diarrhea (1.82%). Adverse events were effectively controlled. One case had fatal ruptured esophageal varices, which were not medically related. Multivariate Cox regression analysis showed that total bilirubin (HR = 0.247, P = 0.003), albumin (HR = 0.279, P = 0.003) and procalcitonin (HR = 0.105, P = 0.012) were independent factors affecting the prognosis of advanced HCC. Conclusion: Anlotinib hydrochloride therapy is safe, effective and well tolerated in patients with advanced liver cancer, and total bilirubin, albumin, and procalcitonin are independent factors that affect the prognosis of patients with advanced liver cancer.
目的： 回顾性分析盐酸安罗替尼治疗晚期原发性肝癌的临床疗效、安全性，探索影响预后的主要因素。 方法： 纳入55例接受盐酸安罗替尼治疗的晚期原发性肝癌患者。记录患者治疗前的基线资料，如凝血酶原时间、总胆红素、白蛋白、Child-Pugh评分、降钙素原、甲胎蛋白、肝外转移、肝硬化、门静脉高压、是否联合手术、病理类型等，记录患者的血液学及影像学复查结果，随时记录患者出现的不良反应，直至患者随访截止或失访或死亡。采用Kaplan-Meier法绘制生存曲线，并使用Log-rank检验比较组间生存期差异；采用Cox单因素及多因素回归模型分析预后影响因素。 结果： 截至末次随访，2例患者失访、30例死亡、23例生存，中位生存时间6.5个月（196 d）；3级以上不良事件有高血压(12.73%)、白细胞计数降低(3.64%)、中性粒细胞绝对值降低(1.82%）、血小板计数降低（9.09%）、乏力（3.64%）、血红蛋白降低（1.82%）、腹泻（1.82%）等；不良反应都能得到有效控制；1例患者出现致死性食管静脉曲张破裂出血，为非药物相关性。多因素Cox回归分析证明总胆红素（HR = 0.247、P = 0.003）、白蛋白（HR = 0.279、P = 0.003）、降钙素原（HR = 0.105、P = 0.012）是影响晚期肝癌预后的独立因素。 结论： 盐酸安罗替尼治疗晚期肝癌患者安全有效，耐受性良好；总胆红素、白蛋白、降钙素原是影响晚期肝癌患者预后的独立因素。.
Keywords: Anlotinib hydrochloride; Primary hepatic carcinoma; Prognostic factors.