| General information |
| Database: | DB00943 |
| Objective: | Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are rational targets for therapy in hepatocellular cancer (hepatocellular carcinoma). |
| Authors: | Philip PA, et al |
| Title: | Phase 2 study of bevacizumab plus erlotinib in patients with advanced hepatocellular cancer. |
| Journal: | cancer |
| Year: | 2012 |
| PMID: | 21953248 |
| Trial Design |
| Clinical Trial Id: | NCT00365391 |
| Agent: | bevacizumab erlotinib
|
| Target: | NA
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | bevacizumab + erlotinib |
| Study Type: | IIstagephase II trial |
| Key Patients Feature: | Eligibility included an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 and Child's Pugh score of A or B, and 1 prior systemic therapy. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received erlotinib 150 mg daily and bevacizumab 10 mg/kg on days 1 and 15 every 28 days. |
| Primary End Point: | Objective tumor response |
| Secondary End Point: | NA |
| Patients Number: | 27 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 3.80% |
| Disease Control Rate: | 51.80% |
| Median Time to Progression: | 3.0 months (95% confidence interval [CI], 1.87.1). |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 9.5 months (95% CI, 7.117.1). |
| Adverse Event(agent arm): | The maximum grade of treatmentrelated adverse events was 3 and experienced by 15 (58%) of patients. The most common toxicities included (grade 1/2/3): rash (6/8/6 patients), hypertension (3/4/1 patients), fatigue (6/4/2 patients), and diarrhea (13/2/4 patients). A 79yearold white female died of acute respiratory failure due to pneumonia that was considered unrelated to the study drugs, occurring day 81 during the treatment cycle, after having received full bevacizumab and 75% of planned erlotinib. |
| Conclusions: | In this trial, erlotinib combined with bevacizumab had minimal activity in patients with advanced hepatocellular carcinoma based on objective response and progression free survival. The role of targeting EGFR and VEGF in hepatocellular carcinoma needs further evaluation in molecularly selected patients. |