Sho Takuya, Suda Goki, Ogawa Koji, Kimura Megumi, Shimazaki Tomoe, Maehara Osamu, Shigesawa Taku, Suzuki Kazuharu, Nakamura Akihisa, Ohara Masatsugu, Umemura Machiko, Kawagishi Naoki, Natsuizaka Mitsuteru, Nakai Masato, Morikawa Kenichi, Furuya Ken, Baba Masaru, Yamamoto Yoshiya, Kobayashi Tomoe, Meguro Takashi, Saga Akiyoshi, Miyagishima Takuto, Yokoo Hideki, Kamiyama Toshiya, Taketomi Akinobu, Sakamoto Naoya
Department of Gastroenterology and Hepatology, Graduate School of Medicine Hokkaido University Sapporo Japan.
Department of Gastroenterology and Hepatology Japan Community Health Care Organization, Hokkaido Hospital Sapporo Japan.
JGH Open. 2019 Jun 10;4(1):54-60. doi: 10.1002/jgh3.12209. eCollection 2020 Feb.
Lenvatinib has been recently approved as a first-line systematic therapy for patients with advanced hepatocellular carcinoma (HCC) based on the results of the phase 3 clinical trial REFLECT. This trial excluded patients with a history of systemic chemotherapy, bile duct invasion, and Child-Pugh grade B. We aimed to investigate the efficacy and safety of lenvatinib for these patients and in the real-world setting.
Among patients who were administered lenvatinib for advanced HCC between April and October 2018 in Hokkaido University Hospital and related hospitals, we evaluated those who were followed for more than 2 months and whose treatment response was evaluated via dynamic computed tomography at baseline and 2 months after treatment initiation. Meanwhile, patients were excluded if they had decompensated liver cirrhosis, were followed up less than 2 months, or were not evaluated at 2 months. Patients were also stratified according to compliance with the REFLECT inclusion criteria for further analysis.
A total of 41 patients were included; more than 50% did not meet the REFLECT inclusion criteria. In total, 5 (12.2%), 20 (48.8%), 12 (29.3%), and 4 (9.3%) showed complete response, partial response, stable disease, and progressive disease, respectively. The objective response rate was 61.2%. The objective response rate and disease control rate were similar between patients who did and did not meet the REFLECT inclusion criteria. Moreover, the safety profile was also similar between the two patient groups.
Lenvatinib showed high early response rate and tolerability in patients with advanced HCC. Favorable outcomes were similarly observed in patients who did not meet the REFLECT inclusion criteria.
基于3期临床试验REFLECT的结果，乐伐替尼最近被批准作为晚期肝细胞癌（HCC）患者的一线系统治疗药物。该试验排除了有全身化疗史、胆管侵犯和Child-Pugh B级的患者。我们旨在研究乐伐替尼对这些患者以及在真实世界环境中的疗效和安全性。
在2018年4月至10月间于北海道大学医院及相关医院接受乐伐替尼治疗晚期HCC的患者中，我们评估了那些随访超过2个月且在基线和治疗开始后2个月通过动态计算机断层扫描评估治疗反应的患者。同时，如果患者有失代偿期肝硬化、随访时间少于2个月或在2个月时未进行评估，则将其排除。患者还根据是否符合REFLECT纳入标准进行分层以进行进一步分析。
共纳入41例患者；超过50%的患者不符合REFLECT纳入标准。总体而言，分别有5例（12.2%）、20例（48.8%）、12例（29.3%）和4例（9.3%）显示完全缓解、部分缓解、病情稳定和病情进展。客观缓解率为61.2%。符合和不符合REFLECT纳入标准的患者之间的客观缓解率和疾病控制率相似。此外，两组患者的安全性也相似。
乐伐替尼在晚期HCC患者中显示出较高的早期缓解率和耐受性。在不符合REFLECT纳入标准的患者中也观察到了相似的良好结果。
