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The efficacy and safety of lenvatinib for advanced hepatocellular carcinoma in a real-world setting

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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.

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Authors and Affiliations

  1. Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 Anesaki, Ichihara, 299-0111, Chiba, Japan

    Shuntaro Obi, Takahisa Sato, Shinpei Sato & Toshihiro Kawai

  2. Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 Fujimi, Kofu, 400-8506, Yamanashi, Japan

    Shuntaro Obi, Miho Kanda, Yuichiro Kojima, Yoji Suzuki, Kenji Hosoda, Hiroshi Ohyama, Keiko Nakagomi, Hiroshi Ashizawa, Yuko Miura, Hiroyuki Amano, Hitoshi Mochizuki & Masao Omata

  3. Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan

    Shuntaro Obi, Shinpei Sato, Miho Kanda, Toshihiro Kawai, Yuji Kondo & Yoshihiro Isomura

  4. Department of Pharmacy, Kyoundo Hospital of Sasaki Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan

    Yuta Tokudome

  5. Department of Gastroenterology, Tokyo University, 7-3-1 Hongo, Bunkyo, Tokyo, 113-8655, Japan

    Masao Omata

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  1. Shuntaro Obi
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  2. Takahisa Sato
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  18. Masao Omata
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Corresponding author

Correspondence to Shuntaro Obi.

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Ethical approval

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008.

Informed consent

Informed consent was obtained from all patients for being included in the study. All relevant institutional review boards approved the study.

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Obi, S., Sato, T., Sato, S. et al. The efficacy and safety of lenvatinib for advanced hepatocellular carcinoma in a real-world setting. Hepatol Int 13, 199–204 (2019). https://doi.org/10.1007/s12072-019-09929-4

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  • DOI: https://doi.org/10.1007/s12072-019-09929-4

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