Entry Detail
| General information | |
| Database: | DB00926 |
| Objective: | Sorafenib has shown survival benefits in patients with advanced hepatocellular carcinoma (hepatocellular carcinoma) and ChildPugh (CP) class A liver function. There are few prospective data on sorafenib in patients with hepatocellular carcinoma and CP class B. |
| Authors: | Pressiani T, et al |
| Title: | Sorafenib in patients with ChildPugh class A and B advanced hepatocellular carcinoma: a prospective feasibility analysis. |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23041587 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a prospective feasibility analysis |
| Key Patients Feature: | patients with ChildPugh class A and B advanced hepatocellular carcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were enrolled in a dualphase trial to determine survival and safety data according to liver function (class A or B) in patients receiving oral sorafenib 800 mg daily |
| Primary End Point: | PFS, TTP, OS |
| Secondary End Point: | NA |
| Patients Number: | 300 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | 4.1 months (0.03-16.0) |
| Median PFS A vs. C: | 3.9 months (0.1-35.3) |
| Median OS A vs. C: | 9.1 months (0.4-49.1) |
| Adverse Event(agent arm): | Most frequent AEs of any grade in the overall population were fatigue (55%), diarrhoea (54%), weight loss (51%), handfoot skin reaction (HFSR; 37%) and stomatitis (36%), most of which were grades 1 and 2 (according to Common Terminology Criteria for Adverse Events, v 3.0), but with fatigue, diarrhoea and HFSR occurring as grade 3 and 4 events in 15%, 14% and 10% of patients, respectively. |
| Conclusions: | Although patients with hepatocellular carcinoma and CP class B liver function have poorer outcomes than those with CP class A function, data suggest that patients with CP class B liver function can tolerate treatment and may still benefit from sorafenib. |