Background: Lenvatinib has been recently approved as a first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC) in Korea. We aimed to study the efficacy and safety of lenvatinib therapy in a real-world practice and to find prognostic factors related to survival and disease progression. Methods: A hospital-based retrospective study was conducted on 111 consecutive patients who had unresectable HCC and were treated with lenvatinib at Samsung Medical Center from October 2018 to March 2020. Efficacy was determined using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria in 111 patients who completed 1st tumor assessment. Safety was evaluated in 116 HCC patients including 5 patients who discontinued lenvatinib due to adverse events (AEs) before 1st tumor assessment using Common Terminology Criteria for AEs version 5.0. Results: A total of 111 patients with a median age of 59 years were analyzed during a median follow-up duration of 6.2 (4.4–9.0) months. The Kaplan-Meier estimate of overall survival was 10.5 months, and the median progression-free survival was 6.2 months. Based on mRECIST criteria, the objective response rate was 18.9% and disease control rate was 75.7%. AEs developed in 86/116 (74.1%) patients, and grade ≥3 AEs developed in 16/116 (13.8%) patients. Diarrhea, hand-foot skin rash, abdominal pain, hypertension, and anorexia were identified as the AEs with the highest frequencies of any grade. REFLECT eligibility criteria including tumor extent ≥50% liver occupation or inadequate bone marrow function and occurrence of anorexia were prognostic factors for survival, and occurrence of diarrhea was a favorable factor for disease progression. Conclusion: Lenvatinib therapy showed a favorable efficacy and safety in a real-world practice. The REFLECT eligibility criteria and specific AEs could be one of the prognostic markers.
Liver Cancer

中文翻译：

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Lenvatinib 治疗不可切除肝细胞癌的疗效和安全性在韩国的真实世界实践中

背景： Lenvatinib 最近在韩国被批准为不可切除肝细胞癌 (HCC) 患者的一线治疗选择。我们旨在研究乐伐替尼治疗在现实世界中的疗效和安全性，并寻找与生存和疾病进展相关的预后因素。方法：对 2018 年 10 月至 2020 年 3 月在三星医疗中心接受乐伐替尼治疗的 111 名连续无法切除的 HCC 患者进行了一项基于医院的回顾性研究。使用修改后的实体瘤反应评估标准 (mRECIST) 标准在 111完成第一次肿瘤评估的患者。对 116 名 HCC 患者的安全性进行了评估，其中 5 名患者在使用 AE 通用术语标准 5.0 版进行第一次肿瘤评估前因不良事件 (AE) 而停用乐伐替尼。结果：在 6.2 (4.4-9.0) 个月的中位随访期间，共分析了 111 名中位年龄为 59 岁的患者。Kaplan-Meier 估计的总生存期为 10.5 个月，中位无进展生存期为 6.2 个月。根据mRECIST标准，客观缓解率为18.9%，疾病控制率为75.7%。86/116 (74.1%) 名患者出现 AE，16/116 (13.8%) 名患者出现≥3 级 AE。腹泻、手足皮疹、腹痛、高血压和厌食被确定为任何级别中频率最高的 AE。REFLECT 纳入标准包括肿瘤范围≥50% 肝脏占位或骨髓功能不足以及发生厌食是生存的预后因素，而腹泻的发生是疾病进展的有利因素。结论： Lenvatinib 治疗在实际实践中显示出良好的疗效和安全性。REFLECT 资格标准和特定 AE 可能是预后标志物之一。
肝癌