Goh Myung Ji, Oh Joo Hyun, Park Yewan, Kim Jihye, Kang Wonseok, Sinn Dong Hyun, Gwak Geum-Youn, Paik Yong-Han, Choi Moon Seok, Lee Joon Hyeok, Koh Kwang Cheol, Paik Seung Woon
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Liver Cancer. 2021 Feb;10(1):52-62. doi: 10.1159/000512239. Epub 2021 Jan 8.
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.
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.
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.
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.
仑伐替尼最近在韩国被批准作为不可切除肝细胞癌（HCC）患者的一线治疗选择。我们旨在研究仑伐替尼治疗在实际临床中的疗效和安全性，并寻找与生存及疾病进展相关的预后因素。
对2018年10月至2020年3月在三星医疗中心接受仑伐替尼治疗的111例连续不可切除HCC患者进行了一项基于医院的回顾性研究。在111例完成首次肿瘤评估的患者中，使用改良实体瘤疗效评价标准（mRECIST）来确定疗效。在116例HCC患者中评估安全性，其中包括5例在首次肿瘤评估前因不良事件（AE）而停用仑伐替尼的患者，使用不良事件通用术语标准5.0版进行评估。
共分析了111例患者，中位年龄59岁，中位随访时间为6.2（4.4 - 9.0）个月。总体生存的Kaplan-Meier估计值为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%）例患者出现AE，16/116（13.8%）例患者出现≥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发生率最高的AE。REFLECT入选标准，包括肿瘤范围≥50%肝占位或骨髓功能不全以及厌食的发生是生存的预后因素，而腹泻的发生是疾病进展的有利因素。
仑伐替尼治疗在实际临床中显示出良好的疗效和安全性。REFLECT入选标准和特定AE可能是预后标志物之一。
