Table 2.

Potential use of nivolumab and pembrolizumab as first-line therapy in HCC patients according tothe ITA.LI.CA database.

ITA.LI.CA Database	Number of HCCs = 11,483 (including recurrences)
(A) First-step removal	1. HCC diagnosis before 01/01/2008 = 3144
	2. HCC recurrence = 4453
	Number of patients = 3886 (01/01/2008-31/12/2016)
(B) Second step removal	Missing data = 1403
	Examined population = 2483 (100.0%)
(C) Third step removal	Nivolumab	Pembrolizumab
	Child-Pugh > B7 = 601 ECOG PST > 1 = 343 ECOG PST = 1, BCLC C, resected or RFA/PEI, MC-IN = 86 BCLC 0-A resected = 99 BCLC 0-A RFA/PEI = 238 BCLC B resected = 55 Transplantation = 55 TACE with CR/PR/SD = 577 PBC = 18 Autoimmune hepatitis = 5 Active HBV + HCV = 12 Active HBV + HDV = 12 Autoimmune diseases = 34 Active alcohol abuse = 323 Brain metastases = 2 Story of encephalopathy = 155 Severe ascites = 380 Malignancies previous 3 years = 27 HIV = 22 Leucocytes < 2000/mcL = 63 PLT < 60,000/mcL = 299 Hb < 9 g/dL = 107 GFR < 40 mL/min = 147 Total bilirubin > 3.0 mg/dL = 214 AST/ALT > 5× = 123 Albumin < 2.8 g/dL = 226 INR > 2.3 = 34	Child-Pugh > B7 = 601 ECOG PST > 1 = 343 ECOG PST = 1, BCLC C, resected or RFA/PEI, MC-IN = 86 BCLC 0-A resected = 99 BCLC 0-A RFA/PEI = 238 BCLC B resected = 55 Transplantation = 55 TACE with CR/PR/SD = 577 PBC = 18 Autoimmune hepatitis = 5 Active HBV = 95 Double infection HBV/HCV = 36 Autoimmune diseases = 34 Active alcohol abuse = 323 Brain metastases = 2 Story of encephalopathy = 155 Clinically apparent ascites = 1009 Malignancies previous 5 years = 43 HIV = 22 Leucocytes < 1200/mcL = 23 PLT < 60,000/mcL = 299 Hb < 8 g/dL = 33 sCr > 1.5 mg/dL = 121 GFR < 60 mL/min if sCr < 1.5 mg/dL = 502 Total bilirubin > 2.0 mg/dL = 440 AST/ALT > 5× = 123 Albumin < 3.0 mg/dL = 414 INR > 1.5× = 60 Variceal bleeding < 6 months = 103 Main branch PVT/IVC thrombosis = 187
	Final population = 525/2483 (21.1%)	Final population = 268/2483 (10.8%)

Abbreviations: ITA.LI.CA, Italian Liver Cancer; HCC, hepatocellular cancer; ECOG, Eastern Cooperative Oncology Group; PST, performance status; BCLC, Barcelona Clinic Liver Cancer; RFA, radio-frequency ablation; PEI, percutaneous ethanol injection; MC, Milan Criteria; TACE, trans-arterial chemoembolisation; CR, complete response; PR, partial response; SD, stable disease; PBC, primitive biliary cholangitis; HBV, hepatitis B virus; HCV, hepatitis C virus; HDV, hepatitis D virus; HIV, human immunodeficiency virus; PLT, platelets; Hb, hemoglobin; GFR, glomerular filtration rate; sCr, serum creatinine; AST, aspartate transaminases; ALT, alanine transaminases; INR, international normalised ratio; PVT, portal vein thrombosis; IVC, inferior vena cava.