Prospective validation of the CLIP score: a new prognostic system for patient with cirrhosis and hepatocellular carcinoma

Izzo, Francesco; 1 Oreste Cuomo,; 2 Gaetano Capuano,; 3 Giuseppe Ruggiero,; 4 Roberto Mazzanti,; 5 Fabio Farinati,; 7 Participating Investigators: Bruno Daniele, 6 Silvana E. l. b. a.; 1 Sandro Pignata,; 1 Francesco Cremona,; 1 Francesco Izzo,; 1 Valerio Parisi,; 1 Francesco Fiore,; 1 Paolo Vallone,; 1 Francesco Perrone1,; 29,; Cuomo, Oreste; 2 Massimo Di Palma,; 2 Emilio Manno,; 2 Giuseppe Militerno2,; Budillon, Gabriele; 3 Gaetano Capuano,; 3 Lucia Cimino,; 3 Domenico Pomponi3,; Luigi Elio Adinolfi,; 4 Enrico Ragone,; 4 Giuseppe Ruggiero,; 4 Riccardo Utili4,; Arena, Umberto; 5 Giuseppe Di Fiore,; 5 Paolo Gentilini,; 5 Roberto Mazzanti5,; Farinati, Fabio; 6 Michela Rinaldi6,; Elba, Silvana; 7 Angelo Coviello,; 7 Onofrio Giuseppe Manghisi7,; Crispino, Bernardino; 8 Raffaele Laviscio,; 8 Guido Piai8,; Caporaso, Nicola; 9 Ilario De Sio9,; Belli, Giulio; 10 Antonio Iannelli,; 10 Mario Luigi Santangelo10,; Giovanni Battista Gaeta,; 11 Tiziana Ascione,; 11 Giuseppe Giusti11,; D’Angelo, Valentina; 12 Giampiero Francica,; 12 Giampiero Marone12,; Pasquale, Giuseppe; 13 Felice Piccinino,; 13 Maria Stanzione13,; Angelo Raffaele Bianco,; 14 Sabino De Placido,; 14 Giovannella Palmieri14,; D’Agostino, Luciano; 15 Daniele Mattera,; Puzziello, Alessandro; Aiello, Antonino; 16 Oscar Ferrau`,; 16 Maria Antonietta Freni16,; Aloisio, Vincenza; 17 Antonio Giorgio,; 17 Anna Perrotta17,; Calandra, Maria; 18 Luigi Castellano,; 18 Camillo Del Vecchio Blanco18,; Castiglione, Fabiana; 19 Gabriele Mazzacca,; 19 Antonio Rispo19,; Colurcio, Raffaele; 20 Bruno Galanti,; 20 Michele Russo20,; Palmentieri, Bruno; Persico, Marcello; Felder, Martina; 22 Laura Zancanella22,; Belli, Mario; 23 Giuseppe Colantuoni,; 23 Guido De Sena23,; Guardascione, Francesco; 24 Gino Petrelli24,; Lamorgese, Bruno; 25 Luigi Manzione25,; Pedicini26, Tonino; D’Aprile27, Modesto; Ciro G. a. l. l. o., 28; 29 Participating Institutions 1Istituto Nazionale Tumori,; Napoli,; Cardarelli, 2Ospedale A.; Napoli,; 3gastroenterologia, Ii; Universita` Federico II,; Napoli,; 4Terapia Medica II Seconda Universita` di Napoli,; 5Medicina Interna Universita` di Firenze,; 6Malattie dell’apparato digerente Universita` di Padova,; 7IRCCS De Bellis,; Grotte, Castellana; 8Ospedale di Marcianise,; Magrassi, 9Dipartimento di Internistica Clinica F.; Sun,; dei Trapianti, 10Chirurgia Generale e.; Fed,; 11Istituto di Malattie Infettive, I; Sun,; Ascalesi, 12ospedale; Napoli,; Subtropicali SUN, 13Malattie Tropicali e.; 14Oncologia Medica FED,; Chirurgia Generale FED, 15Dipartimento Patologia Digestiva e.; 16gastroenterologia,; Universita` di Messina,; Cotugno, 17ospedale; Napoli,; Sun, 18gastroenterologia; 19gastroenterologia, I; Fed,; Aids, 20servizio; Sun,; 21VII Medicina Generale ed Epatologia,; Sun,; Civile, 22ospedale; Bolzano,; Civile, 23ospedale; Avellino,; 24Ospedale di Giugliano,; Napoli,; Carlo, 25Ospedale S.; Potenza,; Fatebenefratelli, 26ospedale; Benevento,; Maria Goretti, 27Ospedale S.; Latina,; 28Metodologia Epidemiologica Clinica,; Sun,; 29Centro Elaborazione Dati Clinici del Mezzogiorno,; CNR PF ACRO,

doi:10.1053/he.2000.5628

Prognosis of patients with cirrhosis and hepatocellular carcinoma (HCC) depends on both residual liver function and tumor extension. The CLIP score includes Child-Pugh stage, tumor morphology and extension, serum alfa-fetoprotein (AFP) levels, and portal vein thrombosis. We externally validated the CLIP score and compared its discriminatory ability and predictive power with that of the Okuda staging system in 196 patients with cirrhosis and HCC prospectively enrolled in a randomized trial. No significant associations were found between the CLIP score and the age, sex, and pattern of viral infection. There was a strong correlation between the CLIP score and the Okuda stage, As of June 1999, 150 patients (76.5%) had died. Median survival time was 11 months, overall, and it was 36, 22, 9, 7, and 3 months for CLIP categories 0, 1, 2, 3, and 4 to 6, respectively. In multivariate analysis, the CLIP score had additional explanatory power above that of the Okuda stage. This was true for both patients treated with locoregional therapy or not. A quantitative estimation of 2-year survival predictive power showed that the CLIP score explained 37% of survival variability, compared with 21% explained by Okuda stage. In conclusion, the CLIP score, compared with the Okuda staging system, gives more accurate prognostic information, is statistically more efficient, and has a greater survival predictive power. It could be useful in treatment planning by improving baseline prognostic evaluation of patients with RCC, and could be used in prospective therapeutic trials as a stratification variable, reducing the variability of results owing to patient selection.