| General information |
| Database: | DB00113 |
| Objective: | The bevacizumab/erlotinib combination was reported with high clinical activity for advanced hepatocellular carcinoma (hepatocellular carcinoma) by a phase II study conducted in the USA. This multicenter study across several Asian countries was to evaluate the safety and efficacy of the combination in this population. |
| Authors: | Hsu CH, et al |
| Title: | Bevacizumab with erlotinib as firstline therapy in Asian patients with advanced hepatocellular carcinoma: a multicenterphase II study. |
| Journal: | Oncology. |
| Year: | 2013 |
| PMID: | 23838576 |
| Trial Design |
| Clinical Trial Id: | NCT00605722 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma not amenable to surgical or regional therapies |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | Bevacizumab+ erlotinib |
| Study Type: | an openlabel, singlearm, multicenterphase II study |
| Key Patients Feature: | Patients with histologyproven hepatocellular carcinoma, advanced disease and ChildPugh class A liver function |
| Biomarker: | The expression of EGFR, phosphoAKT and vascular endothelial growth factor, the microvessel density and the EGFR gene copy number in hepatocellular carcinoma tissues |
| Biomark Analysis: | None of the evaluated biomarkers correlated with disease control or PFS. |
| Control Group Info: | single arm:bevacizumab 5 mg/kg intravenously every 2 weeks and erlotinib 150 mg/day orally as firstline therapy |
| Treatment Info: | pts received bevacizumab 5 mg/kg intravenously every 2 weeks and erlotinib 150 mg/day orally as firstline therapy. |
| Primary End Point: | progression free survival at 16 weeks (PFS16W). |
| Secondary End Point: | NA |
| Patients Number: | 51 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The PFS16W was 35.3% (95% CI 22.449.9), the median PFS was 2.9 months (95% CI, 1.34.4) |
| Median OS A vs. C: | the median overall survival was 10.7 months (95% CI, 6.215.2). |
| Adverse Event(agent arm): | Grade 3/4 toxicities were uncommon, including rash, acne (10% each), diarrhea (6%) and gastrointestinal bleeding (4%). |
| Conclusions: | Bevacizumab plus erlotinib showed good tolerability and modest activity in this Asian cohort. Further studies are warranted to identify the predictive biomarkers of this combination. |