■Lenvatinib适用于晚期肝细胞癌(aHCC)的前沿治疗,但其使用可能受到食管胃静脉曲张(EGV)出血风险的限制.这项研究评估了患病率,预测因子,来伐替尼治疗的aHCC患者的EGV并发症。
■在这项多中心国际回顾性研究中,使用lenvatinib治疗aHCC的肝硬化患者,如果在治疗前6个月内可进行上消化道内镜检查,则纳入研究。主要终点是乐伐替尼治疗期间EGV出血的发生率;次要终点是EGV出血的预测因子,患病率,以及基线时存在EGV和高风险EGV的危险因素,以及EGV出血对患者生存的影响。
■535名患者被纳入研究(中位年龄:72岁,78%男性,63%的病毒病因,89%Child-PughA,16%肿瘤门静脉血栓形成[nPVT],56%巴塞罗那诊所肝癌-C):234人患有EGV(44%),70(30%)处于高风险,59处于初级预防。在lenvatinib治疗期间,17例EGV出血患者(3级5),12个月累积发病率为3%.EGV出血的唯一基线独立预测因素是存在基线高风险EGV(风险比:6.94,95%置信区间[CI]:2.23-21.57,p=0.001)。在这些患者中,12个月的风险为17%。高风险静脉曲张与Child-PughB评分独立相关(比值比[OR]:2.12;95%CI:1.08-4.17,p=0.03),nPVT(OR:2.54;95%CI:1.40-4.61,p=0.002),血小板<150,000/μL(OR:2.47;95%CI:1.35-4.50,p=0.003)。
■在接受lenvatinib治疗的肝细胞癌患者中,EGV出血风险大多较低,但仅在基线时存在高危EGV的患者中显著.
UNASSIGNED: Lenvatinib is indicated for the forefront treatment of advanced hepatocellular carcinoma (aHCC), but its use may be limited by the risk of esophagogastric
varices (EGV) bleeding. This study assessed the prevalence, predictors, and complications of EGV in aHCC patients treated with lenvatinib.
UNASSIGNED: In this multicenter international retrospective study, cirrhotic patients treated with lenvatinib for aHCC, were enrolled if upper-gastrointestinal endoscopy was available within 6 months before treatment. Primary endpoint was the incidence of EGV bleeding during lenvatinib therapy; secondary endpoints were predictors for EGV bleeding, prevalence, and risk factors for the presence of EGV and high-risk EGV at baseline, as well as impact of EGV bleeding on patients\' survival.
UNASSIGNED: 535 patients were enrolled in the study (median age: 72 years, 78% male, 63% viral etiology, 89% Child-Pugh A, 16% neoplastic portal vein thrombosis [nPVT], 56% Barcelona Clinic Liver Cancer-C): 234 had EGV (44%), 70 (30%) were at high risk and 59 were on primary prophylaxis. During lenvatinib treatment, 17 patients bled from EGV (3 grade 5), the 12-month cumulative incidence being 3%. The only baseline independent predictor of EGV bleeding was the presence of baseline high-risk EGV (hazard ratio: 6.94, 95% confidence interval [CI]: 2.23-21.57, p = 0.001). In these patients the 12-month risk was 17%. High-risk
varices were independently associated with Child-Pugh B score (odds ratio [OR]: 2.12; 95% CI: 1.08-4.17, p = 0.03), nPVT (OR: 2.54; 95% CI: 1.40-4.61, p = 0.002), and platelets <150,000/μL (OR: 2.47; 95% CI: 1.35-4.50, p = 0.003).
UNASSIGNED: In hepatocellular carcinoma patients treated with lenvatinib, the risk of EGV bleeding was mostly low but significant only in patients with high-risk EGV at baseline.