| General information |
| Database: | DB00940 |
| Objective: | a phase II study was performed to evaluate the efficacy and tolerability of bevacizumab and erlotinib in advanced hepatocellular carcinoma (hepatocellular carcinoma) patients, and to investigate clinical and molecular predictors of outcome |
| Authors: | Kaseb AO, et al |
| Title: | Efficacy of bevacizumab plus erlotinib for advanced hepatocellular carcinoma and predictors of outcome: final results of a phase II trial. |
| Journal: | Oncology. |
| Year: | 2012 |
| PMID: | 22327795 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab erlotinib
|
| Target: | NA
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | bevacizumab + erlotinib |
| Study Type: | final results of a phase II trial |
| Key Patients Feature: | advanced hepatocellular carcinoma (hepatocellular carcinoma) patients |
| Biomarker: | Clinical characteristics and plasma biomarkers expression levels were analyzed |
| Biomark Analysis: | High plasma angiopoietin2, epidermal growth factor receptor, and endothelin1, and lack of acneiform rash were associated with poor outcome. |
| Control Group Info: | single arm |
| Treatment Info: | patients with advanced hepatocellular carcinoma received 10 mg/kg i.v. of bevacizumab every 14 days and 150 mg p.o. of erlotinib daily |
| Primary End Point: | progression free survival (PFS) at 16 weeks |
| Secondary End Point: | NA |
| Patients Number: | 59 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 24% |
| Disease Control Rate: | 80% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7.2 months (95% CI 5.68.3) |
| Median OS A vs. C: | 13.7 months (95% CI 9.619.7) |
| Adverse Event(agent arm): | NA |
| Conclusions: | The combination of bevacizumab with erlotinib achieved encouraging results in patients with advanced hepatocellular carcinoma. Current correlatives may help to guide future hepatocellular carcinoma studies |