BACKGROUND: Few data are available on the safety and efficacy of sorafenib in patients with multifocal hepatocellular carcinoma (HCC) and advanced liver cirrhosis. METHODS: Between May 2006 and December 2007, we treated 59 patients (Child-Pugh class A/B/C, 26/23/10) with unresectable HCC withsorafenib (daily target dose, 400 mg twice daily). Data were collected retrospectively. Survival curves were calculated via the Kaplan-Meier method. RESULTS: One patient (Child-Pugh class B) had a partial response, 14 patients (Child-Pugh class A/B/C, 5/7/2) had stable disease, and 32 patients (Child-Pugh class A/B/C, 15/11/6) had progressive disease; 12 patients were not evaluable because they had no follow-up radiologic evaluation. In the intention-to-treat group, the median time to progression and overall survival (OS) time were 2.8 months (range, 1.4-6.5 months) and 6.5 months (range, 0.4-17.4 months), respectively. Well-preserved liver function and lower Barcelona Clinic Liver Cancer stage were associated with a longer OS time on univariate analysis. There were four severe gastrointestinal bleedings (grade 4-5; Child-Pugh class B/C, 2/2). Most drug-related side effects were low grade and manageable irrespective of liver function. CONCLUSIONS:Sorafenib is effective and safe in patients with multifocal HCC and Child-Pugh class A cirrhosis. Survival in Child-Pugh class B patients is significantly less than in Child-Pugh class A patients, warranting a prospective randomized trial with a placebo group. Child-Pugh class C patients have a limited life expectancy despite sorafenib treatment because of their severe underlying disease and derive little benefit from sorafenib treatment.
RCT Entities:
BACKGROUND: Few data are available on the safety and efficacy of sorafenib in patients with multifocal hepatocellular carcinoma (HCC) and advanced liver cirrhosis. METHODS: Between May 2006 and December 2007, we treated 59 patients (Child-Pugh class A/B/C, 26/23/10) with unresectable HCC with sorafenib (daily target dose, 400 mg twice daily). Data were collected retrospectively. Survival curves were calculated via the Kaplan-Meier method. RESULTS: One patient (Child-Pugh class B) had a partial response, 14 patients (Child-Pugh class A/B/C, 5/7/2) had stable disease, and 32 patients (Child-Pugh class A/B/C, 15/11/6) had progressive disease; 12 patients were not evaluable because they had no follow-up radiologic evaluation. In the intention-to-treat group, the median time to progression and overall survival (OS) time were 2.8 months (range, 1.4-6.5 months) and 6.5 months (range, 0.4-17.4 months), respectively. Well-preserved liver function and lower Barcelona Clinic Liver Cancer stage were associated with a longer OS time on univariate analysis. There were four severe gastrointestinal bleedings (grade 4-5; Child-Pugh class B/C, 2/2). Most drug-related side effects were low grade and manageable irrespective of liver function. CONCLUSIONS:Sorafenib is effective and safe in patients with multifocal HCC and Child-Pugh class A cirrhosis. Survival in Child-Pugh class B patients is significantly less than in Child-Pugh class A patients, warranting a prospective randomized trial with a placebo group. Child-Pugh class C patients have a limited life expectancy despite sorafenib treatment because of their severe underlying disease and derive little benefit from sorafenib treatment.
Authors: Javier Tejeda-Maldonado; Ignacio García-Juárez; Jonathan Aguirre-Valadez; Adrián González-Aguirre; Mario Vilatobá-Chapa; Alejandra Armengol-Alonso; Francisco Escobar-Penagos; Aldo Torre; Juan Francisco Sánchez-Ávila; Diego Luis Carrillo-Pérez Journal: World J Hepatol Date: 2015-03-27
Authors: Andrea L Inghilesi; Donatella Gallori; Lorenzo Antonuzzo; Paolo Forte; Daniela Tomcikova; Umberto Arena; Stefano Colagrande; Silvia Pradella; Bernardo Fani; Elena Gianni; Luca Boni; Giacomo Laffi; Francesco Di Costanzo; Fabio Marra Journal: World J Gastroenterol Date: 2014-01-21 Impact factor: 5.742