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

  • Shuntaro ObiEmail author
  • Takahisa Sato
  • Shinpei Sato
  • Miho Kanda
  • Yuta Tokudome
  • Yuichiro Kojima
  • Yoji Suzuki
  • Kenji Hosoda
  • Toshihiro Kawai
  • Yuji Kondo
  • Yoshihiro Isomura
  • Hiroshi Ohyama
  • Keiko Nakagomi
  • Hiroshi Ashizawa
  • Yuko Miura
  • Hiroyuki Amano
  • Hitoshi Mochizuki
  • Masao Omata
Original Article
  • 154 Downloads

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.

Keywords

Lenvatinib Hepatocellular carcinoma Clinical practice Efficacy 

Notes

Compliance with ethical standards

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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Copyright information

© Asian Pacific Association for the Study of the Liver 2019

Authors and Affiliations

  • Shuntaro Obi
    • 1
    • 2
    • 3
    Email author
  • Takahisa Sato
    • 1
  • Shinpei Sato
    • 1
    • 3
  • Miho Kanda
    • 2
    • 3
  • Yuta Tokudome
    • 4
  • Yuichiro Kojima
    • 2
  • Yoji Suzuki
    • 2
  • Kenji Hosoda
    • 2
  • Toshihiro Kawai
    • 1
    • 3
  • Yuji Kondo
    • 3
  • Yoshihiro Isomura
    • 3
  • Hiroshi Ohyama
    • 2
  • Keiko Nakagomi
    • 2
  • Hiroshi Ashizawa
    • 2
  • Yuko Miura
    • 2
  • Hiroyuki Amano
    • 2
  • Hitoshi Mochizuki
    • 2
  • Masao Omata
    • 2
    • 5
  1. 1.Internal Medicine, Chiba General Medical CenterTeikyo UniversityIchiharaJapan
  2. 2.Department of GastroenterologyYamanashi Prefectural Central HospitalKofuJapan
  3. 3.Department of Gastroenterology and HepatologyKyoundo Hospital of Sasaki InstituteTokyoJapan
  4. 4.Department of PharmacyKyoundo Hospital of Sasaki InstituteTokyoJapan
  5. 5.Department of GastroenterologyTokyo UniversityTokyoJapan

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