Surveillance for HCC. Ultrasound at 6 month interval:does one size fits all?

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1 Surveillance for HCC. Ultrasound at 6 month interval:does one size fits all? Maurizio Pompili MD Department of Internal Medicine and Gastroenterology Università Cattolica del Sacro Cuore Roma maurizio.pompili@unicatt.it

2 Screening in medicine: strategy used to identify the possible presence of a disease in individuals without signs or symptoms. May be mass (whole population) or selective (risk population) Surveillance: the repeated application of the screening test HCC surveillance theoretically fulfills all criteria established by the World Health Organisation The disease burden of HCC is an important health problem There is an identifiable target population (HCC arises in cirrhosis in up to 90% of cases in Western world) Surveillance is accepted by patients and providers Surveillance achieves an acceptable level of accuracy There are effective recall procedures There is an advantage of treating early HCC AASLD CPG Management of HCC: un update Hepatology 2010 EASL EORTC CPG Management of HCC J Hepatol 2012

3 Cost-effectiveness studies indicate that an incidence of 1.5%/year or greater would warrant surveillance of HCC in compensated cirrhotic patients (CTP A-B) irrespective of its etiology Patients with HBV infection are at risk of HCC development even without cirrhosis and surveillance is warranted as HCC incidence exceeds the threshold value of of 0.2%/year (evidence higher for African/Asian pts compared to Western pts) Limited data suggest that HCC does occur in HCV chronic hepatitis with bridging fibrosis at a yearly incidence of about 0.5%/year AASLD CPG Management of HCC: un update Hepatology 2010 EASL EORTC CPG Management of HCC J Hepatol 2012

4 Currently, several international guidelines advice regular surveillance of patients at increased HCC risk J Hepatol 2012 Digest Liver Dis 2013

5 The objective of HCC surveillance must be: to decrease mortality from the disease to improve survival duration Other surrogate endpoints, such as stage migration (detecting earlier stage disease) and 5-year mortality rates are not appropriate due to lead time bias (apparent improved survival that comes from the diagnosis being made earlier in the course of a disease) length time bias (apparent improvement in survival occurring because surveillance preferentially detects slow growing cancers Only RCTs can eliminate these biases completely by comparing mortality rates from the time of patient enrollment in the study instead of from the time of HCC diagnosis AASLD CPG Management of HCC: un update Hepatology 2010 EASL EORTC CPG Management of HCC J Hepatol 2012,

6 pts of whom HBsAg+, HBsAg + CAH, 1566 CAH screened pts (US + AFP every 6-month) not screened pts HCCs: 86 (asymptomatic 52[61%]) HCCs: 67 (asymptomatic 0) Resection 40 (47%) Resection 5 (7,5%) 5-year survival: 46 % 5-year survival: 0 HCC-related mortality: 83.2/100,000 (screened) vs 131.5/100,000 (not screened); screening reduced HCC-related mortality by 37% Limitations: proportion of cirhotics unknown, LT not included among therapies, compliance suboptimal (58%) Zhang BH, J Cancer Res Oncol 2004

7 However, a lack of of randomized trials data does not necessarily equate to a lack of efficacy Meta-analysis of 47 observational cohort studies Association between HCC surv. and curative treatments Association between HCC surv. and survival

8

9 van Meer S, J Hepatol 2015 Cucchetti A, J Hepatol 2014 Surveillance Surv.* (295 pts) No surv. (779 pts) Semiannual surv. (850 pts) Annual surv. (234 pts) No surv. (296 pts) Cirrhosis (yes/no) BCLC 0 and A Curative treatment 5-yr survival (adjusted for lead time bias) (97%/3%) (60%/40%) 100% 100% 100% 61% 21% 81.1% 69.1% 29.7% 57% 32% 60.1% 58.1% 27.1% 39% 22% 25.6% 23.8% 18.2% * At least 2 screening tests within 3 yrs before HCC diagnosis Survival benefit of surveillance becomes factual after the end of the third year of FU (Cucchetti) Survival benefit of surveilled pts remained if tumor DT was <90 days (van Meer) or <120 days (Cucchetti) A precise estimation of the length time bias is still lacking

10 66% 1,000 North Carolina primary care providers contacted by mail 39% completed the survey 89% saw patients with cirrhosis 45% screened for HCC

11 Santi V for the ITALICA group

12 53,9% 46,1% (September 2008-July 2011)

13 A rapidly growing literature indicates that NAFLD contributes to non cirrhotic HCC Baffy G, J Hepatol patients with HCC and MS as the only risk factor for liver disease Mild or no fibrosis in most cases compared to those harboring HCC associated with CLD (65% vs 26%, p< 0.001) Paradis V, Hepatology patients with histologically proven NASH who developed HCC The degree of liver fibrosis was stage 1-3 in 43 patients (49%) and stage 4 in 44 patients (51%) Yasui K, Clin Gastroenterol Hepatol 2011

14 Risk factors for HCC in NAFLD Obesity Diabetes Iron overload Metabolic syndrome Male sex Older age Alcohol consumption Fibrosis Starley BQ Hepatology 2010, Loria P Hepatol Res 2013, Sorrentino P J Hepatol 2009, Yasui K Clin Gastroenterol Hepatol 2011, Ascha MS Hepatology 2010; Baffy G, J Hepatol 2012

15 The epidemiologic evidence supports an association between NAFLD/NASH and increased HCC risk that seems to be limited to patients with cirrhosis NAFLD/NASH cohorts without cirrhosis: minimal HCC risk with cumulative HCC mortality rates ranging between 0% and 3% NASH cirrhosis: increased HCC risk with cumulative HCC incidence ranging between 2.4% and 12.8% (median follow up period years) The lack of robust data in the non cirrhotic NAFLD patients makes it hard to develop evidence-based, cost effective screening policies There is a need for trials addressing the problem of screening in NAFLD and particularly in non cirrhotic individuals Margini C, Liver Int 2016

16 RECOMMENDATIONS FOR HCC SURVEILLANCE HOW TO DO IT? RECOMMENDED TOOL: Ultrasound SURVEILLANCE INTERVAL: 6 months Biomarkers needed for screening and diagnosis EASL EORTC CPG Management of HCC J Hepatol 2012 AASLD CPG Managemnt of HCC, Hepatology 2011 AISF Position paper HCC Digest Liver Dis 2013

17 HCC: ULTRASOUND DETECTION Size Location Detection US pattern Patient features US equipment Operator s experience

18 Ultrasound detection of early HCC (Milan criteria) Singal A, Alim Pharmacol Ther 2009

19 nodule segment Drawbacks in the US detection of HCC nodule pattern Rapaccini GL, Liver Int 2004 Hypoechoic (76%) Hyperechoic (17%) Isoechoic (3.5% Nod. in nod. (3.5%) infiltrating tumor Del Poggio P, Clin Gastroenterol Hepatol 2014 liver and patient features Coarse pattern Bright liver Obesity Enteric bloating Inadequate apnea

20 The performance of US in early detection of HCC is highly dependent on the expertise of the operator and the quality of the equipment EASL EORTC CPG Management of HCC J Hepatol 2012 Japanese cohort of 1432 patients with chronic hepatitis C US surveillance performed by skilled operators resulted in an average size of detected tumors of 1.6 ± 0.6 cm with less than 2% of the cases > 3 cm Sato T, Hepatol Int 2009

21 HCC: ULTRASOUND DETECTION When technical issues limit US accuracy, this should be highlighted in the report and the possible integration of ultrasonography with a radiological contrast enhanced technique (CT, MRI) should be considered AISF Position paper HCC Digest Liver Dis 2013 There are not data supporting the use of CT or MRI for surveillance and the only available prospective study comparing biannual US and annual CT surveillance found that US detected a similar proportion of early HCC as CT (6.0% vs 6.3%) but at a lower cost per HCC detected (about 17,000 USD vs 57,000 USD) EASL EORTC CPG Management of HCC J Hepatol 2012 Pocha C, Alim Pharmacol Ther 2013

22 RECOMMENDATIONS FOR HCC SURVEILLANCE HOW TO DO IT? RECOMMENDED TOOL: Ultrasound SURVEILLANCE INTERVAL: 6 months Biomarkers needed for screening and diagnosis EASL EORTC CPG Management of HCC J Hepatol 2012 AASLD CPG Managemnt of HCC, Hepatology 2011 AISF Position paper HCC Digest Liver Dis 2013

23 Sheu et al Gastroenterology 1985 Median HCC doubling time 117 days: Sheu JC et al, Gastroenterology days: Barbara L et al, Hepatology 1992

24 Santi V for the ITALICA group median 45 months median 30 months (up to a DT of 177 days)

25 Trichet JC, Hepatology cirrhotic pts randomized at 3- vs 6-month US surveillance Prevalence of HCC < 3 cm incidence in diameter was the main endpoint At least one focal lesion detected in 358 pts (28%) but HCC confirmed only in 123 (9.6%) No significant difference in either HCC incidence and prevalence of HCC < 3 cm Increased US surveillance detects more small focal lesions but does not improve detection of small HCC

26 Theoretically, surveillance programs could be improved by patient stratification by clinical and histological scores, but the cost effectiveness of this policy is unknown Colombo M, Liver Int 2009

27 Significant risk factors for HCC development (417 cirrhotic patients multivariate analysis) Male sex Age > 53 yrs AFP > 20 ng/ml Annual incidence of HCC Three factors: 10,6% Two factors: 4,6 7,5% One factor: 2,0 2,4% No factors: 1,6% Sangiovanni A, Gastroenterology 2004

28 Additional factors associated with an increased risk of HCC in the at risk population Age > yrs Male sex AFP > ng/ml AFP-L3 > 5% Mixed etiology (HIV, HBV, HCV, alcohol,nash) Macroregenerative nodules Large cell dysplasia High proliferating liver cell indexes (PCNA, AgNOR) High liver stiffness (HCV,HBV) Colombo M, NEJM 1991; Oka H, Hepatology 1994; Lee G, Hepatology 1997; Borzio M, Mol Pathol 1998; Donato MF, Hepatology 2001; Sangiovanni A, Gastroenterology 2004; Masuzaki R, Hepatology 2009; Kumada T, J Gastroenterol 2011; Kim Mn, Hepatology 2015;

29 RECOMMENDATIONS FOR HCC SURVEILLANCE HOW TO DO IT? RECOMMENDED TOOL: Ultrasound SURVEILLANCE INTERVAL: 6 months Biomarkers needed for screening and diagnosis EASL EORTC CPG Management of HCC J Hepatol 2012 AASLD CPG Managemnt of HCC, Hepatology 2011 AISF Position paper HCC Digest Liver Dis 2013

30 Daniele B, Gastroenterology 2004 In HCC the increased serum AFP level is related to size and grading of the tumor (higher in large undifferentiated neoplasns) Cut-off 20 ng/ml sensitivity 41%-64%, specificity 80%-94% Cut-off >200 sensitivity 17%-22%, specificity > 95% Early HCC cutoff >20 ng/ml : sensitivity 53%-61% - specificity 81%-90% cutoff>200 ng/ml: sensitivity % - specificity 100% Rapaccini GL 2004, Marrero JA, Gastroenterology 2009, Lok A, Gastroenterology 2010

31 Recent studies show improvement of sensitivity for HCC when combining US and AFP Chang TS, Am J Gastroenterol 2015 However, these data describe the performance of US and AFP for HCC detection at any stage. Only 59% of HCCs were detected at an early stage and it is unclear if the 29 cases detected by AFP alone were early or advanced Mehta A, Singal AG, Am J Gastroenterol 2015

32 BIOMARKER HCC STAGE CUTOFF SENSITIVITY SPECIFICITY AUTHOR Descarboxyprothrombin (DCP) Early (BCLC-A) 150 mau/ml mau/ml 61% 56% 70% 77% Marrero 2009 Any (early HCC 24/39) 150 mau/ml 40 mau/ml 43% 74% 100% 86% Lok 2010 Lectin-bound AFP (AFP-L3) Early (BCLC-A) Any 10% 10% 28% 37% 97% 92% Marrero 2009 Sterling RK 2007 Panel of 7 mirnas Any BCLC 0 BCLC A Plasma microarray positive 81.8% 86.1% % 76.8% 83.5% Zhou J 2011 Glypican 3 (GPC3) Any Detectable in serum 53% 99% Tangkijvanich 2010 Squamous cell carcinoma antigen (SCCA)-IgM Any 89 AU/mL 89% 50% Pozzan 2014

33 EASL recommendations EASL EORTC CPG Management of HCC J Hepatol 2012

34 670 pts with either CLD (339) or HCC (331) recruited into a case-control study Logistic regression analysis to determine independent factors associated with HCC and building of a model including gender,age,afp, AFP-L3 and DCP (GALAD model) developed in a discovery set and validated in internal and external training sets Cutoff Sens. Spec. Overall BCLC 0-A BCLC B-D Johnson PJ, Cancer Epidemiol Biomarkers Prev pts with either (CLD (44) or HCC (54, 85% BCLC 0-A) enrolled Diagnostic performance of AFP, AP-L3,DCP (alone or combined) and of the GALAD model evaluated Caviglia GP, Hepatol Res 2016

35 Papatheodoridis GV, J Hepatol 2015

36 SVR reduces HCC risk in patients with advanced fibrosis Morgan RL, Ann Intern Med 2013 SVR: estimated pooled incidence of 1.05% per person-year No SVR: estimated pooled incidence of 3.3% per person-year

37 Cirrhosis is the strongest risk factor for HCC after the achievement of SVR El Serag HB, Hepatology 2016 Annual incidence 1.39% Annual incidence 0.16%

38 Cirhosis, age > yrs, male sex, alcohol>50 g/day, diabetes, steatosis > 33%, PLT<150,000/ml, AFP >10-20 ng/ml, increased GGT identified as risk factors for HCC in SVR patients D Ambrosio R, Colombo M, Liver Int 2016

39 CONCLUSIONS Based on available data, surveillance for HCC is effective in high risk populations The access to surveillance programs for HCC is still insufficient in Italy Ultrasound performed by experienced operators is the most appropriate tool to perform surveillance A 6-month interval between ultrasound evaluations remains a reasonable choice As a serological test for surveillance AFP has a suboptimal performance and other biomarkers are needed in this setting HBV cirrhotics treated with NUCs and HCV cirrhotics with SVR must continue to undergo surveillance for HCC

40 Thank you for the attention

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