Entry Detail
| General information | |
| Database: | DB00878 |
| Objective: | Sorafenib, a multikinase inhibitor with antiangiogenic activity, was recently approved for the treatment of advanced hepatocellular carcinoma (hepatocellular carcinoma). Metronomic chemotherapy using tegafur/uracil (4:1 molar ratio), an oral fluoropyrimidine, has been shown to enhance the antitumor effect of antiangiogenic agents in preclinical models. Thisphase II study evaluated the efficacy and safety of combining metronomic tegafur/uracil with sorafenib in patients with advanced hepatocellular carcinoma. |
| Authors: | Hsu CH, et al |
| Title: | Phase II study of combining sorafenib with metronomic tegafur/uracil for advanced hepatocellular carcinoma. |
| Journal: | J Hepatol. |
| Year: | 2010 |
| PMID: | 20416968 |
| 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: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | sorafenib with metronomic tegafur/uracil |
| Study Type: | Phase II study |
| Key Patients Feature: | Patients with histologically or cytologicallyproven hepatocellular carcinoma and ChildPugh class A liver function |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with sorafenib (400mg twice daily) and tegafur/uracil (125 mg/m(2) based on tegafur twice daily) continuously as firstline therapy for metastatic or locally advanced disease that could not be treated by locoregional therapies. |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | NA |
| Patients Number: | 53 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 8% |
| Disease Control Rate: | 57% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.7 months (95% C.I., 1.95.5) |
| Median OS A vs. C: | 7.4 months (95% C.I., 3.411.4) |
| Adverse Event(agent arm): | HFSR, fatigue, diarrhea, and anorexia were the most common AEs, and were reported in 53%, 51%, 49%, and 49% of the patients, respectively. T |
| Conclusions: | Metronomic chemotherapy with tegafururacil can be safely combined with sorafenib and shows preliminary activity to improve the efficacy of sorafenib in advanced hepatocellular carcinoma patients. |