Study results published by the Journal of Clinical Oncology show that adding erlotinib (Tarceva) to gemcitabine(Drug information on gemcitabine) (Gemzar) chemotherapy significantly improves survival by 22% in patients with advanced pancreatic cancer. This survival increase is impressive, as pancreatic cancer is a particularly fatal form of of the disease. Despite significant advances in the treatment of many other tumors, treatment options for pancreatic patients are extremely limited and until now, no therapies have demonstrated an improvement in survival for the past decade.

"This study is important because it shows the benefit of a new approach to treat this deadly disease," said Dr. Malcolm Moore, study chair and chief of medical oncology and hematology at Princess Margaret Hospital, University of Toronto. "This is the first study in 10 years to demonstrate an improvement in survival in pancreatic cancer, and as a physician I'm delighted to have additional treatment options for my patients."

Key Results

Data from this study, conducted by the National Cancer Institute of Canada (NCIC), formed the basis of the recent European approval of erlotinib for the treatment of patients with metastatic pancreatic cancer (in combination with chemotherapy) announced in January this year. The results showed a statistically significant increase in overall survival in patients with advanced pancreatic cancer who received erlotinib plus gemcitabine, compared to patients receiving gemcitabine alone, with an overall 22% improvement in survival (P = .038). A higher percentage of patients were alive at 12 months in the group treated with erlotinib plus gemcitabine, compared to those treated with chemotherapy alone (23% vs 17%; P = .023). Progression-free survival was also significantly improved for patients treated with erlotinib (P = .004). Objective response rates were not significantly different between the arms, although 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.

The multicenter, randomized, double-blind, placebo-controlled phase III international study was conducted by the NCIC's Clinical Trials Group at Queen's University in cooperation with Australasian Gastro-Intestinal Trials Group and investigators in 15 other countries and cosponsored by OSI Pharmaceuticals. The study evaluated erlotinib at 100 mg/d or 150 mg/d in patients with locally advanced or metastatic pancreatic cancer. A total of 569 patients were randomized into the study, with 285 patients receiving erlotinib plus gemcitabine and 284 patients receiving placebo plus gemcitabine.

FDA Approvals

The results of the NCIC study were initially announced in January 2005 at the American Society of Clinical Oncology's Gastrointestinal Cancer Symposium. Erlotinib has been approved by the US Food and Drug Administration since November 2005 for treatment of locally advanced, unresectable, or metastatic pancreatic cancer in combination with gemcitabine chemotherapy. Erlotinib has also been approved in the US since November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Early-stage trials of erlotinib are currently being conducted in several other solid tumors as well.