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Investigational New Drugs

, Volume 36, Issue 2, pp 307–314 | Cite as

The outcome of sorafenib monotherapy on hepatocellular carcinoma with portal vein tumor thrombosis

  • Yuan-Hung Kuo
  • I-Pei Wu
  • Jing-Houng Wang
  • Chao-Hung Hung
  • Kun-Ming Rau
  • Chien-Hung Chen
  • Kwong-Ming Kee
  • Tsung-Hui Hu
  • Sheng-Nan Lu
PHASE III STUDIES

Summary

Sorafenib is not recommended for advanced hepatocellular carcinoma (HCC) patients with Vp4 (portal invasion at the main trunk) by the Japan Society of Hepatology (JSH) due to a risk of hepatic failure. This study aimed to elucidate the safety and efficacy of sorafenib monotherapy on HCC with macro-vascular invasion (MVI). A total of 415 consecutive advanced HCC patients received sorafenib in our hospital. Patients with only MVI and sorafenib monotherapy were retrospectively enrolled. We enrolled 113 (27.2%) patients, including 56 (49.5%) Vp3 (portal invasion at the first branch) and 57 (50.5%) Vp4. Their median intervals of follow-up and sorafenib-use were 7.8 months and 2.7 months respectively. Using sorafenib, more Vp4 had hepatic decompensation (HD) (37% VS 18.2%, p = 0.028) than Vp3 patients. The multivariate analysis showed Vp4 (Odds ratio: 2.91; 95% CI: 1.02–8.3, p = 0.041) and baseline alpha-fetoprotein (AFP) ≥ 200 ng/ml were associated with HD. Dividing our patients into four subgroups as Vp3 + AFP < 200 ng/ml, Vp3 + AFP ≥ 200 ng/ml, Vp4 + AFP < 200 ng/ml and Vp4 + AFP ≥ 200 ng/ml, the proportions of HD were 16.7%, 19.4%, 16.7% and 55.2% respectively (p = 0.002). The overall survival rates were distributed with a significant decreasing trend as 10.2 ± 4.4 months, 6.5 ± 1.0 months, 6.0 ± 1.3 months and 2.5 ± 0.5 months (p = 0.001). We found only Vp4 plus AFP ≥ 200 ng/ml could induce more HD and a poorer prognosis than Vp3 patients. Hence, in Vp4 patients with higher AFP, sorafenib should not be the first-line treatment due to its limited survival benefit.

Keywords

Alpha-fetoprotein Hepatic decompensation JSH guideline Sorafenib Vp4 

Notes

Acknowledgements

We appreciated Miss Chih-Yun Lin and the Biostatistics Center, Kaohsiung Chang Gung Memorial Hospital for the excellent statistical analysis.

Compliance with ethical standards

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional Review Board of Kaohsiung Chang Gung Memorial Hospital and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all individual participants included in the present study.

Conflict of interest

Prof. Sheng-Nan Lu received a grant from Chang Gung Memorial Hospital (CMRPG:8B1413). The remaining authors have no conflict of interest.

Funding

This study was supported by a grant from Chang Gung Memorial Hospital (CMRPG:8B1413) to Prof. Sheng-Nan Lu.

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Copyright information

© Springer Science+Business Media New York 2017

Authors and Affiliations

  • Yuan-Hung Kuo
    • 1
  • I-Pei Wu
    • 1
    • 2
  • Jing-Houng Wang
    • 1
  • Chao-Hung Hung
    • 1
  • Kun-Ming Rau
    • 3
  • Chien-Hung Chen
    • 1
  • Kwong-Ming Kee
    • 1
  • Tsung-Hui Hu
    • 1
  • Sheng-Nan Lu
    • 1
  1. 1.Division of Hepatogastroenterology, Department of Internal MedicineKaohsiung Chang Gung Memorial Hospital and Chang Gung University College of MedicineKaohsiung CityTaiwan
  2. 2.Master of Nursing Health CareMeiho UniversityPingtungTaiwan
  3. 3.Division of Hematology-Oncology, Department of Internal MedicineKaohsiung Chang Gung Memorial Hospital and Chang Gung University College of MedicineKaohsiungTaiwan

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