Entry Detail
| General information | |
| Database: | DB00880 |
| Objective: | Hepatocellular carcinoma (hepatocellular carcinoma) tumour spread is partly dependent on neoangiogenesis. In this openlabel, multicentre, phase II trial done in Europe and Asia, sunitinib, a multitargeted tyrosinekinase inhibitor with antiangiogenic properties, was assessed in patients with advanced unresectable hepatocellular carcinoma |
| Authors: | Faivre S, et al |
| Title: | Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an openlabel, multicentre, phase II study. |
| Journal: | Lancet Oncol. |
| Year: | 2009 |
| PMID: | 19586800 |
| Trial Design | |
| Clinical Trial Id: | NCT00247676 |
| 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, multicentre, phase II study |
| Key Patients Feature: | Patients aged over 18 years with histologically proven hepatocellular carcinoma not amenable to curative surgery and a life expectancy of at least 3 months were eligible |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | eligible patients were enrolled and treated with repeated cycles of oral sunitinib (50 mg/day for 4 weeks, follotheyd by 2 weeks off treatment). |
| Primary End Point: | objective response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, with an expected response rate of 15% |
| Secondary End Point: | NA |
| Patients Number: | 37 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 2.7% (95% CI 0.114.2) |
| Disease Control Rate: | 37.8% (95% CI 22.5-55.2) |
| Median Time to Progression: | 5.3 months (2.7-7.9) |
| Median PFS A vs. C: | 3.7 months (95% CI 1.8-6.5) |
| Median OS A vs. C: | 8.0 months (4.4-13.1) |
| Adverse Event(agent arm): | most frequently reported were asthenia (16 patients; 43.2%), anorexia (14; 37.8%), diarrhoea (13; 35.1%), epistaxis (11; 29.7%), nausea (37; 29.7%), and hand-foot syndrome (11; 29.7%). The most common grade 3 or 4 events included thrombocytopenia (14; 37.8%), neutropenia (nine; 24.3%), leucopenia (five; 13.5%), anaemia (four; 10.8%), asthenia (five; 13.5%), and hand-foot syndrome (four; 10.8%). |
| Conclusions: | Sunitinib showed pronounced toxicities at a dose of 50 mgday in patients with unresectable hepatocellular carcinoma. The response rate was low, and the study did not meet the primary endpoint based on RECIST criteria. |