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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

4801 - A diagnostic model for hepatitis B virus-related hepatocellular carcinoma in China: a large-scale, multi-center study

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Tian Yang

Citation

Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269

Authors

T. Yang1, H. Xing1, G. Wang2, S. Cai3, F. Shen4

Author affiliations

  • 1 Department Of Hepatobiliary Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, 200438 - Shanghai/CN
  • 2 Department Of Public Health, Peking University Health Science Center, Beijing/CN
  • 3 Department Of Public Health, The Second Xiangya Hospital of Central South University, Hunan/CN
  • 4 Department Of Hepatobiliary Surgery Iv, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, 200438 - Shanghai/CN
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Resources

Abstract 4801

Background

Almost one third of carriers of hepatitis B virus (HBV) world-wide are in China and more than 80% hepatocellular carcinoma (HCC) in China are associated with HBV infection. So early detection of HCC in HBV-infected patients is necessary. In the present study, we aimed to develop a diagnostic model by combining protein induced by Vitamin K absence or antagonist-II (PIVKA-II) and α-fetoprotein (AFP) for HBV-related HCC.

Methods

We recruited consecutive patients with HBV-related HCC, chronic hepatitis B, HBV-related cirrhosis and healthy controls at 11 hospitals in China from June 2016 to May 2017 for a training cohort. A validation cohort was enrolled at the same sites from FebruaryJune 2017 to September 2017. HCC was defined on the basis of ultrasound, CT, or MRI characteristics and confirmed by histopathology. Serum PIVKA-II level was measured by ARCHITECT immunoassay and AFP was measured with commercially available ELISA. Receiver operating characteristics (ROC) were used to calculate diagnostic accuracy.

Results

The training cohort consisted of 2019 participants, 908 with HBV-related HCC, 289 with chronic hepatitis B, 314 with HBV-related cirrhosis, and 508 healthy controls. The validation cohort comprised 655 participants, 289 with HBV-related HCC, 113 with chronic hepatitis B, 98 with HBV-related cirrhosis, and 155 healthy controls. Levels of PIVKA-II in serum were significantly higher in HBV-related HCC than all controls. ROC curves showed the optimum diagnostic cutoff for PIVKA-II was 44.18 mAU/mL (area under curve [AUC], 0.907 [95% CI 0.892-0.922], sensitivity 81.13%, and specificity 94.97% in the training cohort; 0.909 [0.883-0.934], 79.02%, and 95.46% in the validation cohort). PIVKA-II maintained diagnostic accuracy for patients with HBV-related HCC who were AFP negative. A model combined PIVKA-II, AFP, age, gender and liver cirrhosis improved diagnostic accuracy for HBV-related HCC versus all controls compared with either test alone (0.951 [0.929-0.973] in the training cohort; 0.954 [0.945-0.962] in the validation cohort).

Conclusions

PIVKA-II could complement measurement of AFP in the diagnostic of HBV-related HCC and distinguish HCC from non-malignant chronic liver disease.

Clinical trial identification

NCT03047603.

Legal entity responsible for the study

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University.

Funding

The National Natural Science Foundation of China.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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