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1134A AASLD ABSTRACTS HEPATOLOGY, October, 2015 1897 Diagnostic Performance of Contrast-enhanced Imaging Techniques for Small Hepatocellular Carcinoma Measuring less than 2 cm Seong Hee Kang 1 , Jong Eun Yeon 1 , Young-Sun Lee 1 , Tae Suk Kim 1 , Yang Jae Yoo 1 , Sang Jun Suh 1 , Young Kul Jung 1 , Ji Hoon Kim 1 , Hyung Joon Yim 1 , Chang Hee Lee 2 , Kwan Soo Byun 1 ; 1 Gastroenterology & Hepatology, Korea University Medical Center, Seoul, Korea (the Republic of); 2 Radiology, Korea University Medical Center, Seoul, Korea (the Republic of) BACKGROUND: Recent guidelines recommend ultrasound follow-up for nodules (< 1 cm) discovered via ultrasonography surveillance (US) in liver cirrhosis patients. Nodules larger than 1cm should be followed the recall policy with either dynamic contrast 4-phase CT scan or dynamic enhanced contrast MRI. There is no specified recall policy of nodule less than 1 cm found on US. We evaluated CT and MRI efficacy in hepatocellular carcinoma (HCC) diagnosis in nodules lesser than 1cm and 1~2 cm. METHODS: We retrospectively analyzed 130 ultrasonography-detected liver nodules
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 1135A 1899 Efficacy of Delta-AFP in Predicting the Development of Hepatocellular Carcinoma in Cirrhotic Patients Ross Mund 1 , Yanhong Deng 2 , Maria Ciarleglio 2 , Tamar H. Taddei 1,3 ; 1 Yale University School Of Medicine, New Haven, CT; 2 Yale Center for Analytical Sciences, New Haven, CT; 3 VA Connecticut Healthcare System, West Haven, CT Background: Current AASLD practice guidelines recommend abdominal ultrasound every six months for hepatocellular carcinoma (HCC) screening in at risk individuals. Serum AFP was removed from guidelines in 2011 due to poor sensitivity. This study evaluated the change in AFP over time (delta AFP) as a predictor of HCC development in cirrhotic patients. Methodology: This retrospective cohort study included all cirrhotic patients without HCC from the VA Connecticut Healthcare System who had a baseline AFP and two subsequent AFP measurements during 2006-2011. AFP was measured at baseline, first serial AFP at an average of 320.88 days (std dev 103.13), and last serial AFP at an average of 605.75 days (std dev 122.21) from the baseline. The absence of HCC was defined by absence of a focal hepatic mass consistent with HCC on dynamic imaging from the time of baseline AFP to the last measurement. Subjects were classified according to whether they had hepatitis C (HCV) cirrhosis or not. Longitudinal analysis with patient level random effects were used to model change in AFP between those who developed and did not develop HCC. Logistic regression analysis was used to examine the link between delta AFP and HCC. Results: 169 subjects met criteria for the study. N=91 for HCV cirrhosis (53.85%). 17 subjects developed HCC (10.06%). Delta AFP was assessed between the two groups. There was significant difference in delta AFP from baseline to the first serial measurement between HCC-N and HCC-Y groups (+0.2 and +8.75, respectively, p=0.0362, 95% CI: 0.56-16.55), and from the baseline to the last AFP measurement (+1.72 and +85.73, respectively, p +20 were 5.342 times more likely to develop HCC as compared to those with delta AFP < +20 (p= 0.0067; 95% CI: 1.593-17.919). HCV as a moderator could not be assessed due to limited sample size. Conclusion: This study revealed statistically significant differences in delta AFP in cirrhotic subjects who developed HCC versus those who did not develop HCC. Importantly, this difference in delta AFP was seen at the first serial AFP value, an average of 284.87 days prior to the development of HCC. Additionally, the risk of developing HCC for subjects with a delta AFP > +20 over a 2 year span was significantly increased. Due to small sample size and wide confidence intervals, this study should be validated in a larger, prospective cohort. This study supports the hypothesis that AFP may be a cost effective, readily available and early biomarker for the diagnosis of HCC, once we better understand thresholds and changes that may increase its sensitivity. Disclosures: Tamar H. Taddei - Consulting: Onyx Pharmaceuticals; Grant/Research Support: Bayer HealthCare The following authors have nothing to disclose: Ross Mund, Yanhong Deng, Maria Ciarleglio 1900 A mass spectrometry based serum test for the detection of hepatocellular carcinoma (HCC) in high risk patients Devalingam Mahalingam 1 , Julio A. Gutierrez 1 , W. Kenneth Washburn 1 , Glenn A. Halff 1 , Leonidas Chelis 2 , Stylianos Kakolyris 2 , Stylianos Vradelis 3 , Julia Grigorieva 4 , Carlos Oliveira 4 , Heinrich Roder 4 , Joanna Roder 4 ; 1 Cancer Therapy and Research Center, University of Texas Health Sciences Center San Antonio, San Antonio, TX; 2 Department of Medical Oncology, Democritus University of Thrace, Alexandroupolis, Greece; 3 2nd Department of Internal Medicine, Democritus University of Thrace, Alexandroupolis, Greece; 4 Biodesix, Boulder, CO Improved screening protocols (SP) for patients at high risk of developing HCC could lead to improved patient outcome and possibly cure if detected early. The current SPs, ultrasound with the possible addition of alpha-fetoprotein (AFP) measurement, suffer from insufficient sensitivity and specificity, and less than 30% of patients are diagnosed early enough to be suitable candidates for resection or transplantation. A better biomarker for the early detection of HCC is clearly needed. We used mass spectrometry analysis of serum samples combined with specialized deep learning techniques to train and validate such a test. Samples were available from two patient cohorts. The first was of patients undergoing transplant or resection for HCC (N=48; median MELD = 14), and patients with advanced cirrhosis undergoing liver transplant (N =52; median MELD = 25); underlying cause of liver disease was 49% hepatitis C infection (HCV). The second cohort consisted of patients with advanced HCC (N= 110; 72/27/11 Child-Pugh A/B/C) and liver disease but no HCC (N= 83; 74/7/2 Child-Pugh A/B/C), with 68% of patients having hepatitis B infection (HBV). The two cohorts were combined to create a more representative set of patients with and at risk of HCC, which was split into development and validation sets, stratified by cause and severity of liver disease and stage of HCC. The classifier was trained especially to avoid confounding by liver function. The resulting test showed a sensitivity/specificity of 83%/84% in cross validation in the development set, with 73% of patients with HCC who could be treated by resection or transplant (BCLC A) correctly identified. Performance was good across all represented causes of liver disease. Validation set performance was similar with sensitivity/specificity of 81%/79%, an accuracy of 64% for patients with BCLC A HCC, and little dependence on cause of liver disease (overall accuracy: 91% HBV, 79% HCV). Within the validation set, when compared with AFP alone, the test had 22% greater specificity at fixed sensitivity and 12% greater sensitivity at fixed specificity. Results from further ongoing validation of the test on independent patient cohorts will also be presented. The developed test shows promise in the early detection of HCC as a screening tool in high risk patients independent of the cause of underlying liver disease. While further validation will be necessary to conclusively prove its clinical validity, we believe such a test could substantially improve early detection of HCC. Disclosures: Glenn A. Halff - Board Membership: texas organ sharing alliance, texas organ sharing alliance, texas organ sharing alliance, texas organ sharing alliance; Stock Shareholder: xenex, xenex, xenex, xenex Julia Grigorieva - Stock Shareholder: Biodesix Carlos Oliveira - Employment: Biodesix; Patent Held/Filed: Biodesix Heinrich Roder - Employment: Biodesix Joanna Roder - Employment: Biodesix; Patent Held/Filed: Biodesix; Stock Shareholder: Biodesix The following authors have nothing to disclose: Devalingam Mahalingam, Julio A. Gutierrez, W. Kenneth Washburn, Leonidas Chelis, Stylianos Kakolyris, Stylianos Vradelis
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1000A AASLD ABSTRACTS HEPATOLOGY, O
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1312A AUTHOR INDEX HEPATOLOGY, Octo
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1366A CATEGORY INDEX HEPATOLOGY, Oc
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