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Published on: October 24, 2015
The efficacy and safety of lenvatinib for advanced hepatocellular carcinoma in a real-world setting
Shuntaro Obi1,2,3, Takahisa Sato4, Shinpei Sato4,5
1Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 Anesaki, Ichihara, 299-0111, Chiba, Japan. obis@med.teikyo-u.ac.jp.
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.
Insights
Lenvatinib demonstrated good response and safety in advanced hepatocellular carcinoma patients in a real-world setting. Adverse events were manageable with dose adjustments, showing lenvatinib
Area of Science:
- Hepatocellular Carcinoma Research
- Oncology Drug Efficacy
- Real-World Evidence Studies
Background:
- Lenvatinib, a multi-targeted tyrosine kinase inhibitor, showed non-inferiority to sorafenib in advanced hepatocellular carcinoma (HCC) during the REFLECT trial.
- Real-world data is crucial for understanding treatment outcomes beyond controlled clinical trials.
Purpose of the Study:
- To evaluate the efficacy and safety of lenvatinib in a real-world patient population with advanced HCC.
- To assess treatment response and adverse event profiles in routine clinical practice.
Main Methods:
- A retrospective, multicenter, observational study design.
- Inclusion/exclusion criteria mirrored the REFLECT trial.
- Patients received lenvatinib (8 or 12 mg/day) with observation for at least 12 weeks; response assessed by m-RECIST at week 8.
Main Results:
- The study included 16 patients with prior treatment history, a median of 3.9 years post-initial treatment.
- Most frequent adverse events (AEs) included fatigue, hypertension, and proteinuria, often exceeding Grade 2 but manageable.
- Objective response rate was 40% (6 partial responses, 8 stable disease).
Conclusions:
- Lenvatinib treatment is feasible and effective in a real-world setting for advanced HCC.
- Manageable adverse events and a notable objective response rate support lenvatinib's utility.
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Overview of Advanced Functional Groups
Functional groups are groups of atoms with specific chemical properties that occur within organic molecules and are sometimes denoted as “R”. Functional groups can “functionalize” a compound by enabling it to adopt different physical and chemical properties.
Types of Advanced Functional Groups
The table below summarizes some of the major functional groups in organic chemistry.
Extraction: Advanced Methods

