Shuntaro Obi1,2,3, Takahisa Sato4, Shinpei Sato4,5, Miho Kanda6,5, Yuta Tokudome7, Yuichiro Kojima6, Yoji Suzuki6, Kenji Hosoda6, Toshihiro Kawai4,5, Yuji Kondo5, Yoshihiro Isomura5, Hiroshi Ohyama6, Keiko Nakagomi6, Hiroshi Ashizawa6, Yuko Miura6, Hiroyuki Amano6, Hitoshi Mochizuki6, Masao Omata6,8. 1. Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 Anesaki, Ichihara, 299-0111, Chiba, Japan. obis@med.teikyo-u.ac.jp. 2. Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 Fujimi, Kofu, 400-8506, Yamanashi, Japan. obis@med.teikyo-u.ac.jp. 3. Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan. obis@med.teikyo-u.ac.jp. 4. Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 Anesaki, Ichihara, 299-0111, Chiba, Japan. 5. Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan. 6. Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 Fujimi, Kofu, 400-8506, Yamanashi, Japan. 7. Department of Pharmacy, Kyoundo Hospital of Sasaki Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan. 8. Department of Gastroenterology, Tokyo University, 7-3-1 Hongo, Bunkyo, Tokyo, 113-8655, Japan.
Abstract
BACKGROUND/ PURPOSE: Lenvatinib (an inhibitor of vascular endothelial growth factor (GF) receptors 1-3, fibroblast GF receptors 1-4, platelet-derived GF receptor α, rearranged during transfection, and stem cell factor receptor) was non-inferior to sorafenib in a phase 3 (REFLECT) trial of advanced hepatocellular carcinoma. This study examined the efficacy and safety of lenvatinib in a real-world setting. METHODS: This was a retrospective, multicenter, observational study. Inclusion and exclusion criteria were based on the phase 3 trial, and participants were observed for at least 12 weeks. Therapeutic effect was determined using the modified Response Evaluation Criteria In Solid Tumors (m-RECIST) at the 8th week. Patients received oral lenvatinib 12 mg/day (body weight > 60 kg) or 8 mg/day (body weight < 60 kg). Dose interruptions followed by reductions for lenvatinib-related toxicities were permitted. Grades of adverse events (AEs) complied with the Common Terminology Criteria for Adverse Events version 4.0. RESULTS: All 16 patients included in this study had prior treatment history, and a median 3.9 years had passed since the first treatment. Fatigue, hypertension, and proteinuria were the most frequent AEs, and were higher than Grade 2. AEs could be controlled by appropriate dose reduction, interruption, and symptomatic treatment according to the protocol. In the m-RECIST evaluation at the 8th week, 0, 6, 8, and 1 patients had achieved complete response, partial response, stable disease, and progressive disease, respectively. The objective response rate was 40%. CONCLUSION: Lenvatinib treatment could be accomplished with safety and good response in a real-world setting.
BACKGROUND/ PURPOSE:Lenvatinib (an inhibitor of vascular endothelial growth factor (GF) receptors 1-3, fibroblast GF receptors 1-4, platelet-derived GF receptor α, rearranged during transfection, and stem cell factor receptor) was non-inferior to sorafenib in a phase 3 (REFLECT) trial of advanced hepatocellular carcinoma. This study examined the efficacy and safety of lenvatinib in a real-world setting. METHODS: This was a retrospective, multicenter, observational study. Inclusion and exclusion criteria were based on the phase 3 trial, and participants were observed for at least 12 weeks. Therapeutic effect was determined using the modified Response Evaluation Criteria In Solid Tumors (m-RECIST) at the 8th week. Patients received oral lenvatinib 12 mg/day (body weight > 60 kg) or 8 mg/day (body weight < 60 kg). Dose interruptions followed by reductions for lenvatinib-related toxicities were permitted. Grades of adverse events (AEs) complied with the Common Terminology Criteria for Adverse Events version 4.0. RESULTS: All 16 patients included in this study had prior treatment history, and a median 3.9 years had passed since the first treatment. Fatigue, hypertension, and proteinuria were the most frequent AEs, and were higher than Grade 2. AEs could be controlled by appropriate dose reduction, interruption, and symptomatic treatment according to the protocol. In the m-RECIST evaluation at the 8th week, 0, 6, 8, and 1 patients had achieved complete response, partial response, stable disease, and progressive disease, respectively. The objective response rate was 40%. CONCLUSION:Lenvatinib treatment could be accomplished with safety and good response in a real-world setting.