Changing epidemiology of HCC in Italy
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1 Changing epidemiology of HCC in Italy G. Svegliati-Baroni Clinica di Gastroenterologia SOS Epatopatie Croniche-Trapianto di Fegato Università Politecnica delle Marche, Ancona
2 Worldwide estimated new PLC cases and mortality (2012) Incidence 782,000 new PLCs worldwide 5th most common cancer in men (554,000 cases, 7.5% of total) and 9th in women (228,000 cases, 3.4%) Mortality 2nd most common cause of death from cancer worldwide, responsible for nearly 746,000 deaths HCC is the main cause of mortality in compensated cirrhosis Globocan, IARC 2012
3 Liver cancer 2016 Hepatocellular carcinoma (HCC) accounts for >90% of primary liver cancers. Liver cancer is the fifth most common cancer among men, the ninth most common cancer among women; Liver cancer is the second most common cause of cancer death for men and women combined; Ratio of mortality to incidence: 0.95 Ferlay et al., Int J Cancer 2015
4 Annual Report to the Nation on the Status of Cancer overall cancer incidence rates decreased 0.7%/year; death rates declined by 1.5%/year overall; deaths from liver cancer increased at the highest rate of all cancer sites for both sexes; CDC recommends a 1-time HCV test for persons born during 1945 through ACS, CDC, NCI, NAACCR Ryerson et al., Cancer 2016
5 Incidence rates of primary liver cancer according to geographical distribution in Europe EASL-EORTC CPG, J Hepatol 2012
6 Worldwide estimated new PLC cases and deaths Male Female Demographic risk factors: - male gender - geographic area Globocan, 2012 IARC
7 Rete AIRTUM COVERAGE: NORTH-WEST 41% NORTH-EAST 69% CENTRE 26% SOUTH/ISLAN DS 32% Copertura: 50% territorio nazionale
8 Primary Liver Cancer Italian epidemiological data From 1996 to 2014 incidence and mortality have shown a trend to slow progressive reduction Incidence:Mortality = 1.3 Males. Estimation of trends of cancer incidence ( ) and mortality ( ). Standardized rates to the European population. I-APC: : 0,9* ( 1,5; 0,4) M-APC: : 1,3 ( 2,1; 0,5) Incidence:Mortality = 1.0 Females. Estimation of trends of cancer incidence ( ) and mortality ( ). Standardized rates to the European population. I-APC: : 1.5 ( 0,7; 4,8) : -4,4* (-8,2; -0,5) M-APC: : 1,* ( 2,7; 0,8) APC = Annual Percent Change; I = Incidence; M = Mortality AIOM-CCM-AIRTUM, 2014
9 MORTALITY RATES FOR LIVER DISEASE POTENTIALLY CURED WITH LIVER TRANSPLANTATION AISF Libro Bianco dell Epatologia Italiana - Istituto Superiore di Sanità
10 Temporal trends of complications in patients with initially compensated cirhosis Child-Pugh class A patients (n = 312), median follow-up: 93 months - HCC is the most frequent complication - HCC is most frequently the first complication HCC Benvegnù et al. Gut 2004
11 The long-term outcome of HCV compensated cirrhosis: a 17-yr follow-up of 214 Pts Cumulative probability of events 100 Pts still at risk Annual Incidence rate HCC 3.9% Ascites 2.9% Jaundice 2.0% GI bleeding 0.7% EPS 0.1% HCC Ascites Jaundice GI bleeding EPS Years Sangiovanni A et al Hepatology 2006
12 Geographical distribution of risk factors >80% HCC associated with HBV or HCV
13 Annual risk of HCC in treated HBV patients Weighted mean annual incidence of HCC Entecavir Untreated Non-cirrhosis 0.7% 2.9% Cirrhosis 3.8% 5.0% Papatheodoridis GV et al., J Hepatol 2015; 62:
14 Irrespective of SVR achievement, all patients should continue surveillance because the risk of occurrence of HCC was not entirely avoided. Bruno S et al., Hepatology 2007; Cardoso AC et al., J Hepatol 2010; Morgan et al., Hepatology 2010; van der Meer AJ, JAMA 2012
15 Effects of Viral Eradication in Patients With Hepatitis C Virus and Cirrhosis Differ With Stage of Portal Hypertension 444 patients, 218 stage stage 2, mena follow-up 7.5 yrs HCC development Stage 1 (without EV) Stage 2 (with EV) 7 SVR patients, mean time 6.5 years, 87% BCLC-A 92 non-svr patients, mean time 4.7 years, 68% BCLC-A 2.9% year 0.7% year 3.6% year 0.9% year Di Marco et al., Gastroenterology 2016
16 Death or OLTx Effects of Viral Eradication in Patients With Hepatitis C Virus and Cirrhosis Differ With Stage of Portal Hypertension 444 patients, 218 stage stage 2, mena follow-up 7.5 yrs Di Marco et al., Gastroenterology 2016
17 Effects of Viral Eradication in Patients With Hepatitis C Virus and Cirrhosis Differ With Stage of Portal Hypertension 444 patients, 218 stage stage 2, mena follow-up 7.5 yrs Di Marco et al., Gastroenterology 2016
18 Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population (Bruno et al., J Hep 2016)
19 Risk factors of HCC >80% associated with HBV o HCV ( viral cancer) Pisani et al., Cancer Epidemiol Biomarkers Prev 1997 Western society HCC is becoming an addiction-environmental cancer: Drugs Alcohol Food Tobacco smoking Environmental contaminants
20 adulti HCC
21
22 ITAlian.LIver.CAncer network 2015 (since 1998): 6597 pts. GE MI Treviglio PR PI PD 1,2 BO 1,2,3,4 FI Roma 1,2 BZ Seriate Negrar Faenza VT NA 1,2 PA 1,2 AN 1. Benvegnù L. (PD) 2. Borzio F. (MI) 3. Cammà C. (PA) 4. Caturelli E. (VT) 5. Ciccarese F. (Treviglio) 6. Colecchia A (BO) 7. Di Marco M. (Seriate) 8. Farinati F. (PD) 9. Giannini E. (GE) 10. Masotto A. (Negrar) 11. Nardone G (NA) 12. Felder M. (BZ) 13. Foschi G.F. (Faenza) 14. Gasbarrini A. (Roma) 15. Missale G. (PR) 16. Morisco F. (NA) 17. Piscaglia F. (BO) 18. Rapaccini G.L. (Roma) 19. Sacco R. (PI) 20. Svegliati-Baroni G. (AN) 21. Trevisani F. (BO) 22. Virdone R. (PA) 23. Zoli M. (BO) Database ITA.LI.CA 2015
23 The changing scenario of hepatocellular carcinoma in the new century in Italy Patients (%) Mean age (±SD) years Total n n n n ± ± ± 10.6 <0.001 P HCC Cirrhosis Ageing Age (years) Bucci L et al., in revision Database ITA.LI.CA 2015
24 Percentage Etiology of HCC in Italy: observed and expected temporal trends 11 centers, 3027 patients, recruitment period Subject to PATH Program Disclaimer Santi V. et al., for ITA.LI.CA, J Hepatol 2012;56:
25 The changing scenario of hepatocellular carcinoma in the new century in Italy p < Viral Non viral Bucci L et al., in revision Database ITA.LI.CA 2015
26 Percentage Etiology of HCC: observed regional differences in Italy HCV prevalence ( ) 80 p<0.001 p< p= North Center South Bucci L et al., in revision Database ITA.LI.CA 2015
27 Percentage Etiology of HCC: observed regional differences in Italy HBV HCV Multietiology No viruses North Centre South Bucci L et al., in revision Database ITA.LI.CA 2015
28 Percentage The changing scenario of hepatocellular carcinoma in the new century in Italy HBV HCV Multietiology No viruses Bucci L et al., in revision Database ITA.LI.CA 2015
29 Percentage The changing scenario of hepatocellular carcinoma in the new century in Italy HBV HCV Multietiology No viruses Bucci L et al., in revision Database ITA.LI.CA 2015
30 Percentage Virus-free HCC in ITA.LI.CA: temporal trends in the new century Alcohol 10 NAFLD Multietiology Others Bucci L et al., in revision Database ITA.LI.CA 2015
31 Emerging protective factors for HCC: mediterranean diet Case-control study: 518 HCC vs 772 controls Report = lowest adherence to MD 9= highest adherence to MD Model adjusted for: center, age, sex, education, body mass index, smoking, diabetes, non-alcohol energy intake, and HBsAg and/or anti-hcv positivity. Turati F et al., J Hepatol 2015;60:606-11
32 Percentage (%) The changing scenario of hepatocellular carcinoma in the new century in Italy Total n n n n Cirrhosis 94.3% 94.6% 90.4% <0.001 P 100 Prevalence of cirrhosis by aetiology Viral p < Non viral Proportion of HCC patients with a non cirrhotic liver Bucci L et al., in revision Database ITA.LI.CA 2015
33
34 145 NAFLD-HCC vs 611 HCV-HCC from January 2010 to December 2012 Cirrhosis was detected in 78 of 145 NAFLD patients (53.8%)
35
36 Risk of HCC development in cirrhosis Social alcohol intake compared with no alcohol intake Ascha et al., Hepatology 2010
37 Percentage The changing scenario of hepatocellular carcinoma in the new century in Italy Percentage Type of diagnosis p = p <0.001 p <0.001 B 100 p <0.001 p = Surveillance interval 40 p = p = Surveillance Incidental Symptoms 40 p <0.001 Modality of HCC diagnosis 20 p = >13 Interval (months) Bucci L et al., in revision Database ITA.LI.CA 2015
38 % patients Surveillance for HCC by aetiology in ITA.LI.CA Percentage of cases diagnosed during regular surveillance 68% 37% 39% HCV n Alcohol n. 864 NASH/ Crypt. n. 271 Bucci L et al., in revision Database ITA.LI.CA 2015
39 Hepatocellular Carcinoma in Patients With Cryptogenic Cirrhosis Database ITA.LI.CA , 2042 HCC Giannini et al., CGH 2009
40 Hepatocellular Carcinoma in Patients With Cryptogenic Cirrhosis Database ITA.LI.CA , 2042 HCC HCV CC Giannini et al., CGH 2009
41
42
43 HCC Tumor Characterists: NAFLD vs HCV HCC on NAFLD n=145 HCC on HCV n=611 Crude mean overall survival NAFLD = 27.2 months HCV = 34.4 months (P = 0.015). Survival rates at 1 year and 3 years NAFLD = 76.4% and 48.7% HCV = 84.2% and 61.1% Piscaglia et al., Hepatology 2016
44 HCC Tumor Characterists: NAFLD vs HCV HCC on NAFLD n=145 HCC on HCV n=611 Mean overall survival lead time adjusted NAFLD = 25.5 months HCV = 33.7 months (P = 0.015). Survival rates at 1 year and 3 years NAFLD = 76.4% and 48.7% HCV = 84.2% and 61.1% Piscaglia et al., Hepatology 2016
45 HCC in NAFLD vs HCV after propensity score matching Mean overall survival NAFLD = 30.2 months HCV = 36.9 months (P = 0.33). Survival rates at 1 year and 3 years NAFLD = 87.4% and 72.6% HCV = 91.9% and 63.3% Mean overall survival of HCC on NAFLD NAFLD with cirrhosis = 28.5 m NAFLD without cirrhosis = 34.9 m (P = ns). No significant impact of cirrhosis Piscaglia et al., Hepatology 2016
46 HCC in NAFLD vs HCV: only Milan-in submitted to curative therapies Mean overall survival NAFLD = 38.6 months HCV = 41.0 months (P = ns). NAFLD HCC patients die more of non liver related causes than HCV HCC patients Piscaglia et al., Hepatology 2016
47 These results highlight the need to focus future research on identifying those patients with NAFLD who require surveillance in order to establish earlier diagnosis and offer them treatment, which in our series appeared to be as effective as that provided for patients with HCV at an early stage.
48 EASL CPG 2016 Screening for HCC-NAFLD
49 The changing scenario of hepatocellular carcinoma in the new century in Italy BCLC Total n P <0.001 Stage % 5.4% 7.9% ( ) Stage A % 37.2% 38.3% ( ) Stage B % 15.6% 14.9% ( ) Stage C % 30.8% 30.5% ( ) Stage D % 11.0% 8.4% Tumor size 4562 < cm % 30.1% 29.1% ( ) cm % 51.4% 48.1% ( ) > 5 cm % 18.5% 22.8% ( ) Database ITA.LI.CA 2015
50 Primary Liver Cancer Italian epidemiological data (AIRTUM 2015) 21% nel 2009
51 The changing scenario of hepatocellular carcinoma in the new century in Italy Survival probability (%) Survival probability (%) Overall survival at 5-yrs: 39.2% All patients (n. 5118) Viral patients (n. 3622) Non-viral patients (n. 1444) G1: median OS (95% CI) 30.7 ( ) G2: median OS (95% CI) 32.2 ( ) G3: median OS (95% CI) 40.4 ( ) G1: median OS (95% CI) 31.5 ( ) G2: median OS (95% CI) 33.2 ( ) G3: median OS (95% CI) 40.4 ( ) G1: median OS (95% CI) 24.8 ( ) G2: median OS (95% CI) 27.5 ( ) G3: median OS (95% CI) 35.3 ( ) p<0.001 p=0.001 p= BCLC 0+A (n.1884) G1: median OS (95% CI) 45.8 ( ) G2: median OS (95% CI) 57.5 ( ) G3: median OS (95% CI) nd BCLC B (n. 704) BCLC C (n. 1223) G1: median OS (95% CI) 20.8 ( ) G2: median OS (95% CI) 27.2 ( ) G3: median OS (95% CI) 30.6 ( ) G1: median OS (95% CI) 14.2 ( ) G2: median OS (95% CI) 17.5 ( ) G3: median OS (95% CI) 15.9 ( ) p<0.001 p=0.004 p= Bucci L et al., in revision Months Database ITA.LI.CA 2015
52 Epidemiology of HCC in ITALY: take home messages The incidence and mortality of HCC is decreasing, particularly in men. The etiologic scenario is changing, with a reduction in HCV-related tumors and a progressive rise of non-viral tumor, particularly of metabolic HCCs. The proportion of HCCs detected during a correct surveillance is moderately increasing, being this trend curbed by the spreading out of non-viral tumors. In clinical series, almost 50% of HCC are diagnosed at early stages, with an increase of very early tumors. Nevertheless, large tumors (>5 cm) are increasing. The treatment distribution and outcome are changed in all HCC stages, likely reflecting a more appropriate selection of candidates and technical refinements for each approach. Overall survival is improving both in viral and non-viral patients. However, in population-based registries the 5-year survival rate remains dismal.
53 Mr. ITA.LI.CA
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