| General information |
| Database: | DB00119 |
| Objective: | the EGFR pathway is overactive in hepatocellular carcinoma and BTC, single agent antiEGFR therapies confer modest activity.They conducted a phase I study of erlotinib and docetaxel in solid tumors, and noted good tolerability and sustained complete (5 years +) and partial responses in patients with hepatocellular carcinoma and BTC. This trial evaluated the efficacy of erlotinib with docetaxel in refractory hepatobiliary cancers. |
| Authors: | Chiorean EG, et al |
| Title: | Phase II trial of erlotinib and docetaxel in advanced and refractory hepatocellular and biliary cancers: Hoosier Oncology Group GI06101. |
| Journal: | Oncologist. |
| Year: | 2012 |
| PMID: | 22210086 |
| Trial Design |
| Clinical Trial Id: | Hoosier Oncology Group GI06101 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | erlotinib and docetaxel |
| Study Type: | a phase II Study |
| Key Patients Feature: | Patients with advanced BTC and hepatocellular carcinoma, allowed to have two prior systemic therapies |
| Biomarker: | KRAS gene mutations and Ecadherin expression |
| Biomark Analysis: | hepatocellular carcinoma patients with negative/low Ecadherin expression had higher median PFS (6.7 vs. 2.1 months) and OS (14.5 vs. 4 months). |
| Control Group Info: | single arm |
| Treatment Info: | Docetaxel 30 mg/m2 i.v. was administered on days 1, 8, 15, and erlotinib 150 mg was dosed orally on days 27, 914, 1628 of each 28day cycle. |
| Primary End Point: | 16 weeks progression free survival (PFS) |
| Secondary End Point: | response, stable disease, and overall survival. |
| Patients Number: | 25 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The 16week PFS was 64% for BTC (95% CI 29.784.5), and 38% for hepatocellular carcinoma (95% CI 14.162.8). BTC patients with grade more than and equal to 2 rash had higher median PFS (6.2 vs 2.2 months) and OS (14.2 vs. 4.2 months). hepatocellular carcinoma patients with negative/low Ecadherin expression had higher median PFS (6.7 vs. 2.1 months) and OS (14.5 vs. 4 months). |
| Median OS A vs. C: | Median overall survival was 5.7 and 6.7 months for BTC and hepatocellular carcinoma patients, respectively. |
| Adverse Event(agent arm): | No objective responses were seen. Seven BTC (64%) and 6 hepatocellular carcinoma patients (46%) had stable disease as best response, with a median duration of 16.1 weeks (95% CI 3.756.3) for BTC, and 17.6 weeks (95% CI 8.149.8) for hepatocellular carcinoma. |
| Conclusions: | the combination of erlotinib with docetaxel provided a 16week PFS of more than and equal to 30% but showed no appreciable differences in overall survival from historical data with singleagent erlotinib. While EGFR represents an important target in this group of malignancies, it is clear that hepatobiliary cancers are heterogeneous, thus a meaningful improvement in survival most likely will require careful treatment selection based on patient tumor's molecular and genetic profiling. |