Entry Detail
| General information | |
| Database: | DB00877 |
| Objective: | the phase III Sorafenib AsiaPacific (AP) trialconducted in China, Taiwan and South Korea confirmed that sorafenib improves overall survival (OS) and is safe for patients with advanced hepatocellular carcinoma (hepatocellular carcinoma). they performed a series of exploratory subset analyses to determine whether baseline status affected response to sorafenib. |
| Authors: | Cheng AL, et al |
| Title: | Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: subset analyses of the phase III Sorafenib AsiaPacific trial. |
| Journal: | Eur J Cancer. |
| Year: | 2012 |
| PMID: | 22240282 |
| 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: | subset analyses of the phase III Sorafenib AsiaPacific trial |
| Key Patients Feature: | patients with wellpreserved liver function (>95% ChildPugh A) with advanced hepatocellular carcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sorafenib versus placebo |
| Treatment Info: | pts were randomised 2:1 to sorafenib 400mg bid or matching placebo. |
| Primary End Point: | Subgroup assessments included OS, time to progression (TTP), disease control rate and safety. |
| Secondary End Point: | NA |
| Patients Number: | 226 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 30.5% versus 11.5% in patients with MVI and/or EHS who received sorafenib (n = 118) than in those who received placebo |
| Median Time to Progression: | Median TTP (2.7 versus 1.3 months) in patients with MVI and/or EHS who received sorafenib (n = 118) than in those who received placebo |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | Median OS (5.6 versus 4.1 months) were greater in patients with MVI and/or EHS who received sorafenib (n = 118) than in those who received placebo |
| Adverse Event(agent arm): | The most common grade 3/4 drugrelated AEs in sorafenibtreated patients were handfoot skin reaction, diarrhoea and fatigue, with fatigue being the most frequent AE in patients receiving placebo. |
| Conclusions: | The efficacy and safety profiles of sorafenib in the subpopulations described were comparable with those in the overall study population. These exploratory analyses suggest that sorafenib is effective for patients from the AP region with advanced hepatocellular carcinoma, irrespective of baseline status. |