Management of HepatoCellular Carcinoma

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1 9th Symposium GIC St Louis Management of HepatoCellular Carcinoma Overview Pierre A. Clavien, MD, PhD Department of Surgery University Hospital Zurich Zurich, Switzerland

2 Hepatocellular carcinoma (HCC) Most frequent liver malignancy incidence worldwide 1-5% yearly incidence in cirrhotics Challenge: - Poor liver reserve - Vascular invasion Surgical resection in only 20-30% Breitenstein S, Clavien et al. BJS 2009

3 Epidemiology (HCC) Incidence rates for HCC in the USA El-Serag et al. Gastroenterology 2007

4 Therapeutics options in HCC Chemoembolization Transplantation? Radiofrequency / PEI Surgical resection Cryosurgery Drugs, Immuno therapy

5 Therapeutics options in HCC Resection Ablation (RFA and PEI) Liver Transplantation Bridging therapies Adjuvant therapy

6 Liver resection for HCC Better selection of patients Resection of Child-Pugh A Absence of ascites Bilirubin < 1 mg/dl Prothrombin time > 70% (< 1.7) Refined criteria: ICG test < 10% Absence of active hepatitis (< 3N ) Absence of portal hypertension Assessment of liver regeneration

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8 Probability of survival (%) Probability of survival (%) Liver resection for HCC Portal hypertension % % 51% % 50% No Portal HT Portal HT + Bili < 1mg/dl Months Portal HT + Bili > 1mg/dl % Llovet JM et al, Sem Liver Disease 2005 Llovet JM et al, Hepatology 1999

9 Survival (%) Liver resection for HCC Anatomic Resection Disease-free survival Anatomical resection Limited resection P< Time after resection (months) Regimbeau JM, Belghiti J. Surgery 2002

10 Risk of postoperative liver failure Clavien PA et al. N Engl J Med, 2008

11 Liver resection for HCC Cirrhotic liver Child-Turcotte-Pugh A Child-Turcotte-Pugh B or C Portal hypertension No Yes Potential liver remnant >50% volume Yes No Retention of ICG at 15 minutes <14% <14 20% >20% Portal-vein embolisation Potential liver remnant >50% volume Resection Yes No No resection Clavien PA et al. N Engl J Med, 2008

12 Recurrence rate (%) Liver resection for HCC n 249 Recurrence 79% at 5 years Years No. at risk Imamura H, et al. J Hepatol 2003

13 Therapeutics options in HCC Resection Ablation (RFA and PEI) Liver Transplantation Bridging therapies Adjuvant therapy

14 RFA vs Percutaneous Ethanol Injection Meta-Analysis, 5 RCTs, n=701 patients Author Year PEI RF Lencioni /50 51/52 Lin /52 46/52 Shiina /114 93/118 Lin /62 52/62 Brunello /69 48/70 PEI Better RFA Pooled fixed effect (0.173/0.060) 244/ /354 Pooled random effect (0.186/0.049) Overall survival Orlando A, Cottone M et al. Am J Gastroenterol. 2009

15 RFA vs Percutaneous Ethanol Injection Meta-Analysis, 5 RCTs, n=701 patients Better RFA PEI Local recurrence Orlando A, Cottone M et al. Am J Gastroenterol. 2009

16 Resection vs. RFA for Small HCC 180 patients, Solitary, HCC 5 cm, No extrahepatic mets, no gross vascular invasion Child-Pugh class A were randomized to: Percutaneous local RFA Resection However: small sample size, inadequate power of study 21% of patients in RFA group withdrew their consent Major complications Hospital mortality Survival 1-year 2-year 3-year 4-year Ablation group n=90 Resection group n=90 P value 4.2% 55.6% <0.05 0% 1.1% NS 95.8% 82.1% 71.4% 67.9% 93.3% 82.3% 73.4% 64.0% NS

17 Resection vs. RFA for Small HCC Within Milan Criteria Hepatectomy (n 123) RFA (n 155) No difference Disease free survival Ueno S, et al. J Hepatobil Panc Surg 2009

18 Recurrence (%) Ablation for HCC Recurrence after RFA new lesions 81% (late) Local recurrence 10% (early) Months Lencioni R, et al. Radiology 2005

19 Therapeutics options in HCC Resection Ablation (RFA and PEI) Liver Transplantation Bridging therapies Adjuvant therapy

20 Liver Transplantation for HCC Transplantation: Rational Multifocal diseases Best oncologic resection Treats cirrhosis Restores normal hepatic function

21 History of OLT for HCC Authors years Mortality 3yr Survival Ringe % 20% Iwatsuki % 52% O Grady % 32% Bismuth % 49% Milan Criteria: Single < 5 cm / Two-three < 3 cm / No vascular invasion Mazzaferro % 83% Figueras % Llovet % 74% Bismuth % 68% Herrero % Hemming % 63% Beaujon % 73% Ravaioli %

22 Time on the Waiting List Transplantation decision Resection or Ablation Transplantation Tumor growth Vascular invasion Tumor Progression Risk of Drop-out (2-4% / months) Loss of benefit of Transplantation

23 Median Waiting Time Time on the Waiting List Evolution of Median Waiting Time for OLTx (UNOS) 800 MELD Year

24 Resection OLT? Salvage OLT?

25 98 Liver resection for HCC (met transplant criteria) Tumor recurrence: 75/98 (77%) Transplantability of Rec.: 17/75 (23%) 20 (20%) Secondary OLT 17 (17%) Recurrence & 3 (3%) Hepatic decompensation Compared with 195 Primary OLT for same HCC characteristics Adam R et al. Ann Surg,2003

26 Disease-free survival Survival after LTx for HCC 1.0 Log rank: p= % 58% % 29% Primary LT (n=195) LT after resection (n=17) Years OLT after liver resection is associated with an increased risk of recurrence and poorer outcome than primary OLT Adam R et al. Ann Surg,2003

27 Resection in 135 patients eligible for LT (Milan criteria) LT for Recurrent disease after resection (Salvage LT) 79% remained eligible at the time of recurrence HBV Poon RT et al. Ann Surg 2002

28 HCV 47 Resection of HCC in HCV patients eligible for LT Follow-up 37 months Recurrence present 23 (49%) Salvage LT Possible 9/23 (39%) Bridge better than Salvage? Salvage LT Not Possible 14/23 (61%) Multiple nodules 64% Large size 21% Portal thrombosis 14% Extrahepatic tumor 21% Chirica M, Belghiti J. Hepatology 2004 (abstract)

29 TACE as a bridge to OLT

30 TACE as a bridge to OLT No improving of long-term survival No increase of post-operative complications Insufficient evidence about TACE benefits Impact of hyperselective TACE? Lesurtel, Clavien, Am. J. Transplant. 2006

31 Therapeutics options in HCC Resection Ablation (RFA and PEI) Liver Transplantation Bridging therapies Adjuvant therapy

32 Prevention of HCC Recurrence No standard of care

33 Prevention of HCC Recurrence Adjuvant Interferon α Reference (Yr) Intervention IFN Control Outcome Ikeda 2000 Res, PEI Early recurrence Kubo 2001, 2002 Resection Late recurrence, survival Shiratori 2003 PEI nd&3rd recurrence Lin 2004 PEI Late recurrence, survival Sun 2006 Resection Early recurrence, survival Mazaffero 2006 Resection Late recurrence with HCV Lo 2007 Resection Early recurrence, survival Effects: Survival >>> recurrence Breitenstein S, Clavien PA et al. BJS 2009 Clavien PA. Ann Surg 2007

34 Sorafenib as adjuvant Treatment in the prevention Of Recurrence of hepatocellular carcinoma International (Europe, Americas, Asia Pacific, Japan), double-blind, placebo-controlled phase III adjuvant trial Prior treatment Resection RFA PEI Randomisation 1:1 Nexavar Primary endpoint Recurrence-free survival Eligibility criteria Child Pugh score 5 7 Intermediate or high risk of Stratification Prior curative treatment Geographical region n=1, mg b.i.d. Placebo Secondary endpoints Time to recurrence Overall survival Biomarkers Other recurrence b.i.d. = twice daily NCT

35 Conclusions In non-cirrhotic patients, surgical resection and perhaps ablation are the standard of care OLT is still the best oncologic treatment of HCC in cirrhotic patients Resection/Ablation and Transplantation should be associated rather than opposed Recurrence after resection and ablation remains the major issue Need for an effective adjuvant treatment after resection or ablation

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