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Retrospective evaluation of the effect of Ninjin’yoeito in hepatocellular carcinoma patients treated with lenvatinib

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Abstract

Purposes

Lenvatinib (LEN) is a molecular-target drug, used for unresectable hepatocellular carcinoma (HCC). It is associated with adverse events (AEs), including hypertension, proteinuria, fatigue, and anorexia, which may force dose reduction or discontinuation. Ninjin’yoeito (NYT) is a Chinese–Japanese herbal compound that can effectively treat fatigue and anorexia, and which has been used for chronic liver diseases. NYT reduces AEs and improves the liver function in patients treated with sorafenib but its effect on LEN is unclear.

Methods

The present study included 46 patients (male, n = 32; female, n = 14) who received LEN for HCC at our hospital. Their median age was 70 years (range 36–88 years), and their median body weight was 61.5 kg (range 38.4–97.0 kg). Patients were divided into two groups, depending on whether they received NYT medication. Their AEs and liver function were examined one month after starting LEN.

Results

The NYT group suffered less fatigue (63.6% vs. 11.4%, P = 0.0014) and showed elevated aspartate aminotransferase levels (45.5% vs. 14.3%, P = 0.0433) in comparison to the non-NYT group. The non-NYT group also showed a significantly exacerbated albumin-bilirubin (ALBI) grade (P = 0.0342) and ALBI score (average change: + 0.232, P = 0.0001) at 1 month in comparison to baseline.

Conclusion

NYT apparently suppressed LEN-induced fatigue and helped maintain liver function in patients with HCC.

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Abbreviations

AEs:

Adverse events

ALBI:

Albumin–bilirubin

BW:

Body weight

HCC:

Hepatocellular carcinoma

LEN:

Lenvatinib

NYT:

Ninjin’yoeito

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Acknowledgements

We thank Marla Brunker, from Edanz Group (https://en-author-services.edanz.com/ac) for editing a draft of this manuscript.

Funding

This study was supported by the following grant: JSPS KAKENHI, a Grant-in-Aid from the Ministry of Health, Labour and Welfare, Japan (Numbers JP-19K09198). The funding source had no role in the collection, analysis, or interpretation of the data or in the decision to submit the article for publication.

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Authors and Affiliations

  1. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan

    Katsuya Toshida, Shinji Itoh, Tomoharu Yoshizumi, Tomonari Shimagaki, Huanlin Wang, Takeshi Kurihara, Takeo Toshima, Yoshihiro Nagao, Noboru Harada & Masaki Mori

  2. Department of Pharmacy, Kyushu University Hospital, 3-1-1 Maidashi, Higashiku, Fukuoka, 812-8582, Japan

    Kojiro Hata, Yoko Makihara & Hiroyuki Watanabe

Authors
  1. Katsuya Toshida
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  2. Shinji Itoh
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  3. Tomoharu Yoshizumi
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Contributions

KT participated in study conception and design, analysis, and drafting of the article. SI participated in study conception and design, and critical revision of the manuscript. TY participated in critical revision of the manuscript. TS, HW, TK, TT, YN and NH participated in acquisition of data, analysis, and interpretation of data. KH, YM and HW participated in evaluating AEs of patients. MM participated in critical revision of the manuscript.

Corresponding author

Correspondence to Shinji Itoh.

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Conflict of interest

K.T. and other co-authors have no conflict of interest.

Ethics approval and informed consent

This retrospective study was approved by the Ethics Committee of Kyushu University (approval codes: 2020-671).

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Toshida, K., Itoh, S., Yoshizumi, T. et al. Retrospective evaluation of the effect of Ninjin’yoeito in hepatocellular carcinoma patients treated with lenvatinib. Surg Today 52, 441–448 (2022). https://doi.org/10.1007/s00595-021-02358-7

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  • DOI: https://doi.org/10.1007/s00595-021-02358-7

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