HCC Surveillance: Tests, Intervals, and Uptake

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1 HCC : Tests, Intervals, and Uptake Hepatocellular carcinoma is a global problem Amit Singal MD MS Assistant Professor of Medicine Medical Director of Liver Tumor Program UT Southwestern Medical Center Age-adjusted incidence rates per 100,000 person-years HCC surveillance is recommended is efficacious for HCC detection Addition of AFP improved sensitivity to 69% but not statistically significant Singal et al. Aliment Pharm Ther 2009 Best Case of Efficacious may not equate to effective Prospective study of 164 patients with 200 HCC, referred for RFA 86% cirrhosis, majority Child A Median tumor size 2.1 cm (0.8-5 cm) Independently assessed by 3 operators One senior faculty with > 1000 case experience Tumor could not be visualized in pre-rfa ultrasound in 17% of patients Median tumor size 1.9 cm ( cm) Efficacy Access Recommendation Adherence Effectiveness Therapy A 50% 90% 90% 90% 37% Therapy B 90% 80% 60% 50% 22% Kim MJ, et al. Korean J Radiol 2008 El Serag et al. Hepatology

2 is not as effective in clinical practice There is a large gap between the efficacy and effectiveness of ultrasound Test AFP alone alone 27/41 (65.9%) 18/41* (43.9%) 19/41 (46.3%) 13/41 (31.7%) Specificity 363/401 (90.5%) 367/401 (91.5%) Test AFP alone alone 35/51 (69%) 43/51 (84%) Efficacy 25/51 (49%) 32/51 (63%) Effectiveness 27/41 (65.9%) 18/41* (43.9%) 19/41 (46.3%) 13/41 (31.7%) Singal et al. Cancer Epi Biomarkers Prev 2012 Singal et al. Cancer Epi Biomarkers Prev 2012 Limitations of Using AFP improves sensitivity for early tumor detection in clinical practice Operator characteristics Variable experience and training of ultrasound technicians Test Efficacy Effectiveness Patient characteristics Obesity Liver nodularity Presence of acsites AFP alone alone and AFP 35/51 (69%) 43/51 (84%) 47/51 (92%) 25/51 (49%) 32/51 (63%) 35/51 (69%) 27/41 (65.9%) 18/41* (43.9%) 37/41 (90.2%) 19/41 (46.3%) 13/41 (31.7%) 26/41 (63.4%) Finberg et al. J Med 2004 Singal et al. Cancer Epi Biomarkers Prev 2012 Cost Effectiveness of AFP performance varies by cirrhosis etiology Study Saab 2003 Lin 2004 Cohort Cirrhosis Awaiting liver transplant Child A cirrhosis Cost-effective Strategy US q6 months US annually AFP q6 months Thompson 2007 Child A cirrhosis AFP triage q6 months HCV Positive HCV Negative 70.4% 69.6% Specificity 82.6% 98.0% Andersson 2008 Child A cirrhosis US q6 months Saab et al, Liver Transplant 2003 Lin et al. Aliment Pharm Ther 2004 Andersson et al. Clin Gastro Hep 2008 Thompson et al. Health Technol Assess 2007 Percent Correctly Classified 76.9% 89.4% Gopal et al Clin Gastro Hep (in press) 2

3 Longitudinal measurements can further improve utility of AFP Better biomarkers are still needed Lee et al Clin Gastro Hep 2013 Marrero et al Gastroenterology 2009 Semiannual better than annual surveillance Semiannual better than annual surveillance N=510 Singal et al. Aliment Pharm Ther 2009 Santi et al J Hepatology month better than annual surveillance 3-month is not better 6-month surveillance Variable 4-month (n=387) 24 HCC 12-month (n=357) 15 HCC Variable 3-month (n=640) 6-month (n=638) Tumor size < 2 cm 17 (71%) 3 (20%) BCLC stage Very Early Early Beyond Early 9 (38%) 13 (54%) 2 (8%) 1 (7%) 10 (67%) 4 (27%) Curative therapy 13 (54%) 3 (20%) 1-year Survival of HCC patients 96% 80% Focal lesion < 1 cm 73 (41%) 43 (28%) Focal lesion 1-2 cm 71 (40%) 78 (50%) HCC development Less than 2 cm Within Milan 53 (28%) 20 (38%) 42 (79%) 70 (42%) 29 (41%) 50 (71%) 5-year survival 85% 86% Wang et al Am J Gastro 2013 Trinchet et al Hepatology

4 Summary: tests and interval is efficacious for early HCC detection Gap between efficacy and effectiveness of ultrasound should be performed every 6 months (Level 1B). AFP can be combined with ultrasound to maximize early tumor detection but may be associated with higher false positives and costs (Level 2A-B) Benefit of AFP is dependent on ultrasound operator expertise Better biomarkers are needed but further studies are needed prior to routine use (Level 3B) Providers report performing HCC surveillance in patients with cirrhosis Survey among AASLD members found high selfreported rates of HCC surveillance 84% of providers reported performing HCC surveillance among patients with cirrhosis Inherent limitations of survey studies Respondent bias Recall bias Chalassani et al Am J Gastroenterol 1999 is being underutilized is being underutilized Among 1873 patients with HCC, only 17% had received prior regular surveillance In subset of 541 patients with known cirrhosis, only 29% had prior regular surveillance Among 1873 patients with HCC, only 17% had received prior regular surveillance In subset of 541 patients with known cirrhosis, only 29% had prior regular surveillance Regular surveillance included: 52% ultrasound and AFP 46% AFP alone 2% ultrasound alone Davila et al Hepatology 2010 Davila et al Hepatology 2010 is being underutilized Less than 2% of patients undergo consistent biannual HCC surveillance rates assessed in ~900 patients with cirrhosis Inconsistent surveillance rate: 66.7% Consistent annual surveillance rate: 13.4% Consistent biannual surveillance rate: 1.7% Singal et al, J Gen Intern Med 2012 Singal et al (submitted) 4

5 Many at-risk patients are not identified prior to HCC presentation Many at-risk patients are not identified prior to HCC presentation Patients with NASH are significantly less likely to have recognized liver disease Why is surveillance not being utilized? Variable Adjusted Odds Ratio Viral etiology 3.60 ( ) NAFLD etiology 0.12 ( ) Hepatic decompensation 2.23 ( ) Bilirubin level 1.05 ( ) Platelet count 1.00 ( ) 18% of patients with NASH had recognized liver disease 87% of patients with viral liver disease had recognized liver disease 65% of remaining patients had recognized liver disease Primary care providers report multiple barriers to HCC surveillance Summary: Failure to screen Provider-reported barriers Percent Less than 20% of patients undergo HCC surveillance (Level 2A) Lack of knowledge about guidelines 68.2% Competing interests in clinic 51.6% Lack of time in clinic 40.5% Difficulty recognizing at-risk patients 35.4% capacity 23.0% Doubt patients will complete 9.3% Underutilization of surveillance is largely related to providers not ordering HCC tests (Level 2B) Patient adherence does not appear to be major issue Unclear what intervention strategies are optimal Provider education Electronic reminders/prompts Outreach directly to patients Dalton-Fitzgerald et al (submitted AASLD) 5

6 Summary Failure of detection is most common reason for advanced HCC in academic centers Singal et al Am J Gastro 2013 underuse is most common reason for advanced HCC in many centers So many issues, which should we tackle first? Singal et al Am J Nat Comp Cancer Network (in press) Mourad et al. Hepatology (in press) Hope of a brighter future for HCC surveillance Early Detection Research Network Evaluating performance of AFP, AFP-L3, and DCP in detecting HCC Enrolling 1000 patients with cirrhosis though 7 sites in the United States Prospectively followed for 4 years, anticipating ~ 100 patients will develop HCC Collecting serum and plasma every 6 months Building biorepository of longitudinal specimens to test novel biomarkers in future 6

7 Utilization Intervention Conclusions RCT comparing clinical effectiveness of intervention strategies to increase HCC screening completion Group 1: Visit based screening Group 2: Visit based screening + mailed outreach invitations to patients Group 3: Visit based screening + mailed outreach invitations + nurse navigation for test completion HCC is an important issue with a rapidly rising incidence and mortality HCC surveillance is associated with early tumor detection and improved survival in cirrhosis Multiple process failures must be addressed to optimize the effectiveness of surveillance in reducing mortality Lack of recognition of liver disease and cirrhosis Underuse of HCC surveillance in those with known cirrhosis Suboptimal effectiveness of current surveillance tools Efforts are ongoing to address several of these barriers 7

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