Introduction 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. Methods 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. Results 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). Conclusion 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.

中文翻译：

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乐伐替尼肝细胞癌患者食管胃静脉曲张出血的发生率和预测因素。


简介 乐伐替尼适用于晚期肝细胞癌 (aHCC) 的前沿治疗，但其使用可能因食管胃静脉曲张 (EGV) 出血的风险而受到限制。本研究评估了接受仑伐替尼治疗的 aHCC 患者中 EGV 的患病率、预测因素和并发症。方法 在这项多中心国际回顾性研究中，如果治疗前 6 个月内可以进行上消化道内镜检查，则纳入接受乐伐替尼治疗 aHCC 的肝硬化患者。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、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。结果 535 名患者参与了该研究（中位年龄：72 岁，78% 为男性，63% 为病毒病因，89% 为 Child-Pugh A，16% 为肿瘤性门静脉血栓 [nPVT]，56% 为巴塞罗那诊所肝癌-C） ：234 人患有 EGV (44%)，70 人 (30%) 处于高风险，59 人正在接受一级预防。仑伐替尼治疗期间，17例患者因EGV出血（3例5级），12个月累积发生率为3%。 EGV 出血的唯一基线独立预测因子是基线高风险 EGV 的存在（风险比：6.94，95% 置信区间 [CI]：2.23-21.57，p = 0.001）。这些患者的 12 个月风险为 17%。高风险静脉曲张与 Child-Pugh B 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）。 结论 在接受乐伐替尼治疗的肝细胞癌患者中，EGV 出血风险大多较低，但仅在基线时具有高风险 EGV 的患者中显着。