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Characteristics of patients with sorafenib-treated advanced hepatocellular carcinoma eligible for second-line treatment

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Summary

Background Regorafenib has been investigated for its efficacy and safety as a second-line treatment in patients with advanced hepatocellular carcinoma (HCC). We assessed the characteristics of patients with HCC treated with sorafenib who might be eligible for second-line treatment in general and regorafenib in particular. Methods Patients with HCC treated with sorafenib were retrospectively analyzed. We defined second-line candidate patients as maintaining Child–Pugh A and ECOG-PS ≤1 at the time of sorafenib failure. We also defined regorafenib candidate patients as follows: 1) continuing sorafenib at the time of radiological progression, 2) maintaining Child–Pugh A and ECOG-PS ≤ 1 at the time of sorafenib failure, and 3) continuing sorafenib 400 mg or more without intolerable adverse events at least 20 days of the last 28 days of treatment. Results Of 185 patients, 130 (70%) and 69 (37%) were candidates for second-line treatment and regorafenib. Child-Pugh score 6 and ECOG-PS 1 at the time of starting sorafenib were significantly lower in both second-line treatment and regorafenib candidate patients. Moreover, hand–foot skin reaction and liver failure during sorafenib treatment were associated with significantly low and high probabilities, respectively, of both Child–Pugh score > 6 and ECOG-PS > 1 at the time of sorafenib failure. Conclusion Regorafenib candidate patients after sorafenib failure are limited, and generally fewer than those who are candidates for second-line treatment. A lower Child–Pugh score and a better ECOG-PS were predictors of eligibility for second-line therapy and regorafenib treatment in sorafenib-treated patients with advanced HCC patients.

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Funding

This research was partially supported by grants from the Japan Society for the Promotion of Science (JSPS) and the Research Program on Hepatitis from Japan Agency for Medical Research and Development (AMED).

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Authors and Affiliations

  1. Department of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan

    Sadahisa Ogasawara, Tetsuhiro Chiba, Yoshihiko Ooka, Eiichiro Suzuki, Takahiro Maeda, Masayuki Yokoyama, Toru Wakamatsu, Masanori Inoue, Tomoko Saito, Kazufumi Kobayashi, Soichiro Kiyono, Masato Nakamura, Shingo Nakamoto, Shin Yasui, Akinobu Tawada, Makoto Arai, Tatsuo Kanda, Hitoshi Maruyama, Osamu Yokosuka & Naoya Kato

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  1. Sadahisa Ogasawara
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  2. Tetsuhiro Chiba
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  3. Yoshihiko Ooka
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  4. Eiichiro Suzuki
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  17. Tatsuo Kanda
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  20. Naoya Kato
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Corresponding author

Correspondence to Tetsuhiro Chiba.

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Conflicts of interest disclosure

Osamu Yokosuka received grant support and honoraria from Bayer. Sadahisa Ogasawara received advisory fee and honoraria from Bayer. The other authors who took part in this study indicated that they did not have anything to declare regarding funding or conflict of interest with respect to this study.

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All procedures performed in studies 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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Ogasawara, S., Chiba, T., Ooka, Y. et al. Characteristics of patients with sorafenib-treated advanced hepatocellular carcinoma eligible for second-line treatment. Invest New Drugs 36, 332–339 (2018). https://doi.org/10.1007/s10637-017-0507-3

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  • DOI: https://doi.org/10.1007/s10637-017-0507-3

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