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Safety and tolerance of sorafenib in Japanese patients with advanced hepatocellular carcinoma

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Abstract

Purpose

Sorafenib provides a survival benefit for patients with advanced hepatocellular carcinoma (HCC). However, there has been little experience with it in Japan. This study evaluated the safety and tolerance of sorafenib in Japanese patients with HCC.

Methods

Clinical data for patients given sorafenib for advanced HCC were captured from eight institutions. All patients were classified as Child-Pugh A and the treatment was started at 400 mg twice daily. We recorded adverse events, treatment duration, and survival retrospectively. Adverse events were graded using Common Terminology Criteria, version 3.0; tumor response was assessed according to Response Evaluation Criteria in Solid Tumor, version 1.1.

Results

Of the 54 patients treated, their median age was 69 years (range 48–82), 91% were males, 52% had HCV infection, and 22% had HBV infection. The most common drug-related adverse events were hand–foot skin reactions (HFSR) (72%), aspartate transaminase elevation (55%), alanine aminotransferase elevation (52%), rash (50%), fatigue (41%), and diarrhea (32%). Liver failure occurred in 19%. The median time to treatment failure was 2 months. Dose reduction was required in 83% of the patients, and this occurred within 2 weeks in 44%. The median overall survival was 6.9 months.

Conclusions

These data suggest that sorafenib is generally tolerated in Japanese patients with HCC. Nevertheless, the majority needed a dose reduction. Adverse events including HFSR, rash, and liver failure occurred more frequently in our patients than those reported elsewhere. Careful attention must be paid to these adverse events during sorafenib administration.

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Acknowledgements

We want to thank Yu Yoshida, Kazuyoshi Nakamura, and Takao Nishikawa for their contributions.

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Authors and Affiliations

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

    Sadahisa Ogasawara, Fumihiko Kanai, Takeshi Toriyabe, Yusuke Shinozaki, Yoshihiko Ooka, Rintaro Mikata, Tetsuhiro Chiba, Shinichiro Okabe, Fumio Imazeki, Masaharu Yoshikawa & Osamu Yokosuka

  2. Department of Gastroenterology and Hepatology, Kyoundo Hospital, 1-8 Kandasurugadai, Chiyoda-ku, 101-0062, Tokyo, Japan

    Shuntaro Obi & Shinpei Sato

  3. Department of Gastroenterology, Chiba Cancer Centre, 666-2 Nitonacho, Chuo-ku, 260-8717, Chiba, Japan

    Taketo Yamaguchi

  4. Department of Gastroenterology, Kimitsu-Chuo Hospital, 1010 Sakurai, 292-8535, Kisarazu, Japan

    Ryosaku Azemoto

  5. Department of Gastroenterology, Funabashi Municipal Medical Centre, 1-21-1 Kanasugi, 273-8588, Funabashi, Japan

    Hideaki Mizumoto

  6. Department of Gastroenterology, Saitama Red Cross Hospital, 8-3-33 Kamiochiai, Chuo-Ku, 333-8533, Saitama, Japan

    Youhei Koushima

  7. Department of Gastroenterology, Shimotsuga-Sogo Hospital, 5-32 Fujimi, 328-8505, Tochigi, Japan

    Naoki Morimoto

  8. Department of Gastroenterology, Kameda Medical Centre, 929 Higashicho, 296-0042, Kamogawa, Japan

    Nobuto Hirata

Authors
  1. Sadahisa Ogasawara
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  2. Fumihiko Kanai
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  3. Shuntaro Obi
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  4. Shinpei Sato
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  6. Ryosaku Azemoto
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  7. Hideaki Mizumoto
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  8. Youhei Koushima
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  9. Naoki Morimoto
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  11. Takeshi Toriyabe
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  12. Yusuke Shinozaki
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  13. Yoshihiko Ooka
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  14. Rintaro Mikata
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  15. Tetsuhiro Chiba
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  16. Shinichiro Okabe
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  17. Fumio Imazeki
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  18. Masaharu Yoshikawa
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  19. Osamu Yokosuka
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Corresponding author

Correspondence to Fumihiko Kanai.

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Ogasawara, S., Kanai, F., Obi, S. et al. Safety and tolerance of sorafenib in Japanese patients with advanced hepatocellular carcinoma. Hepatol Int 5, 850–856 (2011). https://doi.org/10.1007/s12072-010-9249-4

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  • DOI: https://doi.org/10.1007/s12072-010-9249-4

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