Patients with advanced pancreatic cancer have a poor prognosis.
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.
Dr Malcolm Moore and colleagues from the USA, Canada, Israel, Poland, Argentina, Singapore and Australia studied the effects of adding the HER1/EGFR-targeted agent erlotinib to gemcitabine.
The patients had unresectable, locally advanced, or metastatic pancreatic cancer.
|Progression-free survival was longer with erlotinib plus gemcitabine |
|Journal of Clinical Oncology |
Patients were randomly assigned 1:1 to receive standard gemcitabine plus erlotinib or gemcitabine plus placebo.
The research team conducted a double-blind, international phase III trial.
The primary end point was overall survival.
A total of 569 patients were randomly assigned.
Overall survival based on an intent-to-treat analysis was prolonged on the erlotinib/gemcitabine arm with a hazard ratio of 0.8.
The team found that 1-year survival was also greater with erlotinib plus gemcitabine.
Progression-free survival was significantly longer with erlotinib plus gemcitabine with an estimated HR of 0.77.
Objective response rates were not significantly different between the study arms.
However, the team found that more patients on erlotinib had disease stabilization.
There was a higher incidence of some adverse events with erlotinib plus gemcitabine, but most were grade 1 or 2.
Dr Moore's team concluded, "To our knowledge, this randomized phase 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 mg/d".