Survival and tolerance to sorafenib in Child-Pugh B patients with hepatocellular carcinoma: a prospective study

Abstract

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.

AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma

“…The aforementioned prospective clinical trials were restricted to patients with a good performance status (ECOG 0–1), Child-Turcotte-Pugh A liver disease, and otherwise adequate organ function. There are limited clinical trials to guide systemic treatment for patients with Child-Turcotte-Pugh B liver disease 332–334 . Real-world data suggest well-selected patients with Child-Turcotte-Pugh B liver disease, particularly those with Child-Turcotte-Pugh B7 liver disease from cancer-related hyperbilirubinemia and hypoalbuminemia, can sometimes tolerate systemic therapies traditionally reserved for patients with Child-Turcotte-Pugh A liver disease.…”

“…There are limited clinical trials to guide systemic treatment for patients with Child-Turcotte-Pugh B liver disease. [332][333][334] Realworld data suggest well-selected patients with Child-Turcotte-Pugh B liver disease, particularly those with Child-Turcotte-Pugh B7 liver disease from cancerrelated hyperbilirubinemia and hypoalbuminemia, can sometimes tolerate systemic therapies traditionally reserved for patients with Child-Turcotte-Pugh A liver disease. For the larger group of patients with Child-Turcotte-Pugh B liver disease, careful patient selection is necessary to identify patients likely to benefit from systemic therapy.…”

Current status of first-line therapy, anti-angiogenic therapy and its combinations of other agents for unresectable hepatocellular carcinoma

“…In fact, GIDEON also shows that the overall safety profile and dosing strategy of sorafenib are similar across the different Child-Pugh subgroups[ 21 ]. In another prospective study by Leal et al [ 22 ], in a separate prospective score, specifically focusing on the use of sorafenib in Child-Pugh B patients, a median OS of 6.5 mo was reported, which was longer than historical controls for this population. In this study, sorafenib also proved to be tolerable, with a relatively low rate of TRAE discontinuations (27.7%)[ 22 ].…”

“…In another prospective study by Leal et al [ 22 ], in a separate prospective score, specifically focusing on the use of sorafenib in Child-Pugh B patients, a median OS of 6.5 mo was reported, which was longer than historical controls for this population. In this study, sorafenib also proved to be tolerable, with a relatively low rate of TRAE discontinuations (27.7%)[ 22 ]. As such, these results highlight that selected Child-Pugh B patients may also derive benefit from treatment with sorafenib, with a manageable toxicity profile.…”

Hepatocarcinoma: experiencia de la vida real en un centro especializado de Bogotá, Colombia

“…En este estudio, 35 pacientes recibieron sorafenib como tratamiento principal y 14 pacientes como segunda o tercera opción, con un promedio de uso para los 49 pacientes de 6,8 meses. En la literatura se mencionan supervivencias promedio entre 4,6 y 12 meses (33)(34)(35) . De los 14 pacientes con terapias combinadas, 8 habían recibido previamente ablación (5 recibieron luego TACE) y 6 recibieron TACE previamente.…”