| General information |
| Database: | DB00117 |
| Objective: | to determine the proportion of patients with advanced hepatocellular carcinoma who were progression free at 6 months treated with erlotinib |
| Authors: | Philip PA, et al |
| Title: | Phase II study of Erlotinib (OSI774) in patients with advanced hepatocellular cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2005 |
| PMID: | 16170173 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma not amenable to surgical or regional therapies |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II study |
| Key Patients Feature: | Patients with either unresectable or metastatic hepatocellular carcinoma were studied. Only one prior systemic or locoregional therapy was allowed. |
| Biomarker: | EGFR/HER1 expression |
| Biomark Analysis: | EGFR/HER1 expression was detected in 88% of the patients. |
| Control Group Info: | single arm |
| Treatment Info: | Erlotinib was given continuously at a dose of 150 mg per day orally. |
| Primary End Point: | ORR, DCR, PFS, OS, toxcity |
| Secondary End Point: | NA |
| Patients Number: | 38 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Three patients had partial radiologic responses of duration of 2, 10, and 11 months, respectively. |
| Disease Control Rate: | Disease control was seen in 59% of the patients. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Ttheylve (32%; CI 95%, 18 to 49) of the 38 patients with hepatocellular carcinoma were progression free at 6 months. |
| Median OS A vs. C: | Median overall survival time was 13 months. |
| Adverse Event(agent arm): | Ten patients (26%) had toxicityrelated dose reductions of erlotinib. Grade 3/4 skin toxicity or diarrhea was encountered in five and three patients, respectively. |
| Conclusions: | Results of this trial suggest a benefit for EGFRHER1 blockade with erlotinib in patients with hepatocellular carcinoma manifested by disease control. Additional studies with erlotinib as a single agent or in combination with other agents are warranted. |