Entry Detail
| General information | |
| Database: | DB00102 |
| Objective: | Openlabel, phase 3 trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer |
| Authors: | Cheng AL, et al |
| Title: | Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomizedphase III trial. |
| Journal: | J Clin Oncol. |
| Year: | 2013 |
| PMID: | 24081937 |
| Trial Design | |
| Clinical Trial Id: | NCT00699374. |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an Openlabel, phase III trial |
| Key Patients Feature: | Patients at least 18 years old had histologically confirmed, locally advanced or metastatic hepatocellular carcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sorafenib 400 mg twice daily |
| Treatment Info: | Patients were stratified and randomly assigned to receive sunitinib 37.5 mg once per day or sorafenib 400 mg twice per day. |
| Primary End Point: | overall survival (OS). |
| Secondary End Point: | progression free survival (PFS), time to progression (TTP), and safety. |
| Patients Number: | 1074 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.6 v 3.0; HR, 1.13; onesided P = .8785; twosided P = .2286; TTP: 4.1 v 3.8 months; HR, 1.13; onesided P = .8312; twosided P = .3082 |
| Median OS A vs. C: | 7.9 vs 10.2 ([HR], 1.30; onesided P = .9990; twosided P = .0014); |
| Adverse Event(agent arm): | Sunitinib was associated with more frequent and severe adverse events (AEs) than sorafenib. Common grade 3/4 AEs were thrombocytopenia (29.7%) and neutropenia (25.7%) for sunitinib; handfoot syndrome (21.2%) for sorafenib. Discontinuations owing to AEs were similar (sunitinib, 13.3%; sorafenib, 12.7%). |
| Conclusions: | OS with sunitinib was not superior or equivalent but was significantly inferior to sorafenib. OS was comparable in Asian and hepatitis Binfected patients. OS was superior in hepatitis Cinfected patients who received sorafenib. Sunitinibtreated patients reported more frequent and severe toxicity. |