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Real-world systemic sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Korea

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Background/Aims Regorafenib has been approved as a second-line systemic therapy for hepatocellular carcinoma (HCC) patients after the phase III RESORCE trial. This study analyzed real-world data to assess the clinical effectiveness and safety of regorafenib compared to the RESORCE trial. Methods This multicenter cohort study included HCC patients treated with regorafenib after sorafenib (n = 133). We evaluated the time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety in patients receiving regorafenib along with the predictors of prognosis. Results The median age was 60 years and 81.2% patients were men. Hepatitis B virus infection (68.4%) was the commonest etiology. Most patients were classified as Child-Pugh A (98.5%) and had extrahepatic metastasis (84%) and vascular invasion (45.1%). This study demonstrated similar characteristics apart from more frequent hepatitis B etiology and more vascular or extrahepatic involvement compared with the RESORCE trial. An objective response rate of 12.5% was obtained for response assessment (n = 112); the disease control rate was 34.8%. Thirty-eight patients died during follow-up. With regorafenib, the median OS, PFS, and TTP were 10.0, 2.7, and 2.6 months, respectively. In the exploratory analysis after sorafenib administration, the median OS was 25.8 months. The rate of response and survival were comparable to those in the RESORCE trial. Child-Pugh score > 5, alpha-fetoprotein > 400 ng/ml, and TTP for sorafenib ≥ median were independently associated with OS. Conclusions This real-word regorafenib study showed comparable effectiveness and safety to the RESORCE trial. Regorafenib improves the prognosis of patients with prolonged TTP during previous sorafenib therapy.

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Acknowledgements

This work was supported by The GlaxoSmithKline Research Fund of the Korean Association for the study of the Liver. We would like to thank Editage (www.editage.co.kr) for English language editing.

Funding

This work was supported by The GlaxoSmithKline Research Fund of the Korean Association for the study of the Liver.

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Author notes

  1. Min Jin Lee and Sung Won Chang contributed equally to this work.

Authors and Affiliations

  1. Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea

    Min Jin Lee, Sung Won Chang, Ji Hoon Kim, Young-Sun Lee, Yeon Seok Seo & Hyung Joon Yim

  2. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Guro Hospital, Korea University College of Medicine, 97, Guro-Dong Gil, Guro-Dong, Guro-Ku, Seoul, 08308, Korea

    Ji Hoon Kim

  3. Department of Gastroenterology and Hepatology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, 264 Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Hwasun, 58128, Republic of Korea

    Sung Bum Cho

  4. Department of Internal Medicine and Gastrointestinal Cancer Center, Dongnam Institute of Radiological and Medical Sciences, Busan, Korea

    Sang Youn Hwang

  5. Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

    Hyun Woong Lee

  6. Department of Internal Medicine, Soonchunhyang University College of Medicine Seoul Hospital, Seoul, Korea

    Young Chang & Jae Young Jang

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  1. Min Jin Lee
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Corresponding authors

Correspondence to Ji Hoon Kim or Sung Bum Cho.

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All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Lee, M.J., Chang, S.W., Kim, J.H. et al. Real-world systemic sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Korea. Invest New Drugs 39, 260–268 (2021). https://doi.org/10.1007/s10637-020-00977-4

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  • DOI: https://doi.org/10.1007/s10637-020-00977-4

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