PMID- 29948358 OWN - NLM STAT- MEDLINE DCOM- 20190603 LR - 20190603 IS - 1573-0646 (Electronic) IS - 0167-6997 (Linking) VI - 36 IP - 5 DP - 2018 Oct TI - Survival and tolerance to sorafenib in Child-Pugh B patients with hepatocellular carcinoma: a prospective study. PG - 911-918 LID - 10.1007/s10637-018-0621-x [doi] AB - Sorafenib has been widely used to treat unresectable hepatocellular carcinoma (HCC) but most studies have been done in Child-Pugh A (CP-A) patients with well-preserved liver function. We evaluated the overall survival (OS) and tolerance to sorafenib in a large cohort of Child-Pugh B (CP-B) HCC patients as compared to CP-A HCC patients. We prospectively studied 130 patients with advanced HCC who started sorafenib between January 2011 and December 2015. Patients were classified as CP-A (n = 65) or CP-B (n = 65). The average OS for all 130 patients was 10 months. CP-A patients had a median survival rate significantly longer than CP-B patients: 12 months vs. 6 months. The OS found in our group of CP-B patients was 6.5 months, which is higher than that found in most studies done so far. When stratified, our CP-B patients had better OS than ever reported. The dose of the drug was interrupted due to adverse events (AEs) in 38 (29%) of the patients, of whom 20 (30%) were CP-A patients and 18 (28%) were CP-B patients. This real-life cohort of CP-B HCC patients treated with sorafenib had a higher survival than that described in the literature, with a satisfactory safety profile. Despite the high prevalence of severe AEs in CP-B patients, there were fewer treatment interruptions in this group, indicating that Child-Pugh B patients can tolerate treatment and may benefit from sorafenib. FAU - Leal, Cassia Regina Guedes AU - Leal CRG AUID- ORCID: 0000-0002-9653-8088 AD - Hospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saude, Rio de Janeiro, RJ, 20221-903, Brazil. cassia.r.g.leal@gmail.com. AD - Universidade Federal Fluminense, Niteroi, Brazil. cassia.r.g.leal@gmail.com. FAU - Magalhaes, Cristiane AU - Magalhaes C AD - Instituto Nacional do Cancer (INCA), Rio de Janeiro, Brazil. FAU - Barbosa, Daniel AU - Barbosa D AD - Hospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saude, Rio de Janeiro, RJ, 20221-903, Brazil. FAU - Aquino, Diogo AU - Aquino D AD - Hospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saude, Rio de Janeiro, RJ, 20221-903, Brazil. FAU - Carvalho, Bernardo AU - Carvalho B AD - Hospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saude, Rio de Janeiro, RJ, 20221-903, Brazil. FAU - Balbi, Elizabeth AU - Balbi E AD - Hospital Quinta D'Or, Rio de Janeiro, Brazil. FAU - Pacheco, Lucio AU - Pacheco L AD - Hospital Quinta D'Or, Rio de Janeiro, Brazil. FAU - Perez, Renata AU - Perez R AD - Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil. AD - Instituto D'Or de Pesquisa e Ensino, Rio de Janeiro, Brazil. FAU - de Tarso Pinto, Paulo AU - de Tarso Pinto P AD - Hospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saude, Rio de Janeiro, RJ, 20221-903, Brazil. FAU - Setubal, Sergio AU - Setubal S AD - Universidade Federal Fluminense, Niteroi, Brazil. LA - eng PT - Clinical Trial, Phase II PT - Journal Article DEP - 20180613 PL - United States TA - Invest New Drugs JT - Investigational new drugs JID - 8309330 RN - 0 (Antineoplastic Agents) RN - 0 (Protein Kinase Inhibitors) RN - 0 (alpha-Fetoproteins) RN - 9ZOQ3TZI87 (Sorafenib) SB - IM MH - Aged MH - Antineoplastic Agents/*therapeutic use MH - Carcinoma, Hepatocellular/blood/classification/*drug therapy MH - Female MH - Humans MH - Liver Neoplasms/blood/classification/*drug therapy MH - Male MH - Middle Aged MH - Protein Kinase Inhibitors/*therapeutic use MH - Sorafenib/*therapeutic use MH - Survival Analysis MH - alpha-Fetoproteins/analysis OTO - NOTNLM OT - Child-Pugh A OT - Child-Pugh B OT - Hepatocellular carcinoma OT - Sorafenib EDAT- 2018/06/28 06:00 MHDA- 2019/06/04 06:00 CRDT- 2018/06/28 06:00 PHST- 2018/03/18 00:00 [received] PHST- 2018/06/07 00:00 [accepted] PHST- 2018/06/28 06:00 [pubmed] PHST- 2019/06/04 06:00 [medline] PHST- 2018/06/28 06:00 [entrez] AID - 10.1007/s10637-018-0621-x [pii] AID - 10.1007/s10637-018-0621-x [doi] PST - ppublish SO - Invest New Drugs. 2018 Oct;36(5):911-918. doi: 10.1007/s10637-018-0621-x. Epub 2018 Jun 13.