| General information |
| Database: | DB00673 |
| Objective: | Patients with advanced pancreatic cancer have a poor prognosis and there have been no improvements in survival since the introduction of gemcitabine in 1996. Pancreatic tumors often overexpress human epidermal growth factor receptor type 1 (HER1/EGFR) and this is associated with a worse prognosis. They studied the effects of adding the HER1/EGFRtargeted agent erlotinib to gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer. |
| Authors: | Moore MJ, et al |
| Title: | Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. |
| Journal: | J Clin Oncol. |
| Year: | 2007 |
| PMID: | 17452677 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Erlotinib plus gemcitabine |
| Study Type: | a doubleblind, placebocontrolled, international, phase III trial |
| Key Patients Feature: | Patients had histologic or cytologic evidence of locally advanced or metastatic adenocarcinoma of the pancreas with measurable or assessable disease;ECOG performance status 0, 1, or 2; and adequate hematologic, renal, andhepatic function. Prior radiotherapy for local disease was allowed provideddisease progression had been documented, and treatment completed at least 4weeks before random assignment. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Erlotinib plus gemcitabine VS gemcitabine alone |
| Treatment Info: | patients were randomly assigned 1:1 to receive standard gemcitabine plus erlotinib (100 or 150 mg/d orally) or gemcitabine plus placebo in a doubleblind, internationalphase III trial. |
| Primary End Point: | overall survival |
| Secondary End Point: | NA |
| Patients Number: | 569 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The complete plus partial responserate was 8.6% with erlotinib and gemcitabine and 8.0% with placeboand gemcitabine, and the median duration of response was 163 days inboth arms. The incidence of stable disease was 48.9% with erlotiniband gemcitabine and 41.2% with placebo and gemcitabine. The overalldisease control rate (complete response plus partial response plus stable disease) was 57.5% on erlotinib and gemcitabine and 49.2% onplacebo and gemcitabine (P.07) |
| Disease Control Rate: | 57.5% on erlotinib and gemcitabine and 49.2% on placebo and gemcitabine (P .07). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.75 months v 3.55 months |
| Median OS A vs. C: | 6.24 months versus 5.91 months for the erlotinib and gemcitabine versus placebo and gemcitabine groups |
| Adverse Event(agent arm): | There was a higher incidence of some adverse events with erlotinib plus gemcitabine, but most were grade 1 or 2. |
| Conclusions: | To their knowledge, this randomizedphase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine. The recommended dose of erlotinib with gemcitabine for this indication is 100 mgd. |