| General information |
| Database: | DB00941 |
| Objective: | Growth factor overexpression, including epidermal growth factor receptor (EGFR) expression, is common in hepatocellular cancers. Erlotinib is a receptor tyrosine kinase inhibitor with specificity for EGFR. The primary objective of this study was to determine the proportion of hepatocellular carcinoma (hepatocellular carcinoma) patients treated with erlotinib who were alive and progression free (PFS) at 16 weeks of continuous treatment. |
| Authors: | Thomas MB, et al |
| Title: | Phase 2 study of erlotinib in patients with unresectable hepatocellular carcinoma. |
| Journal: | cancer |
| Year: | 2007 |
| PMID: | 17623837 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II study |
| Key Patients Feature: | Patients with unresectable hepatocellular carcinoma, no prior systemic therapy, performance status (PS) of 0, 1, or 2, and ChildsPugh (CP) cirrhosis A or B |
| Biomarker: | EGFR expression |
| Biomark Analysis: | No correlation between EGFR expression and outcome was found |
| Control Group Info: | single arm |
| Treatment Info: | pts received oral erlotinib 150 mg daily for 28day cycles. |
| Primary End Point: | the proportion of hepatocellular carcinoma (hepatocellular carcinoma) patients treated with erlotinib who were alive and progression free (PFS) at 16 weeks of continuous treatment. |
| Secondary End Point: | NA |
| Patients Number: | 40 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 43% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 43 weeks (10.75 months) |
| Adverse Event(agent arm): | he most common drugrelated adverse events (all grades, Table 3) were diarrhea, folliculitis, fatigue, pruritus, dry skin, xerostomia, and epistaxis. Grade 3 toxicities included diarrhea (7.5%), fatigue, (7.5%), and serum glutamic oxaloacetic transaminase (SGOT) elevation (7.5%). There were no grade 4 adverse events. Erlotinib administration was held in 1 patient for 14 days for superficial skin infection due to drugrelated folliculitis. |
| Conclusions: | Results of this study indicated that singleagent erlotinib is well tolerated and has modest diseasecontrol benefit in hepatocellular carcinoma, manifested as modestly prolonged PFS and OS when compared with historical controls |