About this Medicine article

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 by Malcolm J. Moore; David Goldstein; John Hamm; Arie Figer; Joel R. Hecht; Steven Gallinger; Heather J. Au; Pawel Murawa; David Walde; Robert A. Wolff; Daniel Campos; Robert Lim; Keyue Ding; Gary Clark; Theodora Voskoglou-Nomikos; Mieke Ptasynski; Wendy Parulekar is a Medicine article available to read on EtoBox.

## Purpose 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. We studied the effects of adding the HER1/EGFR-targeted agent erlotinib to gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer. ## Patients and Methods Patients were randomly assigned 1:1 to receive standard gemcitabine plus erlotinib (100 or 150 mg/d orally) or gemcitabine plus placebo in a double-blind, international phase III trial. The primary end point was overall survival. ## Results A total of 569 patients were randomly assigned. Overall survival based on an intent-to-treat analysis was significantly prolonged on the erlotinib/gemcitabine arm with a hazard ratio (HR) of 0.82 (95% CI, 0.69 to 0.99; P = .038, adjusted for stratification factors; median 6.24 months v 5.91 months). One-year survival was also greater with erlotinib plus gemcitabine (23% v 17%; P = .023). Progression-free survival was significantly longer with erlotinib

Author

Malcolm J. Moore; David Goldstein; John Hamm; Arie Figer; Joel R. Hecht; Steven Gallinger; Heather J. Au; Pawel Murawa; David Walde; Robert A. Wolff; Daniel Campos; Robert Lim; Keyue Ding; Gary Clark; Theodora Voskoglou-Nomikos; Mieke Ptasynski; Wendy Parulekar

Publisher

American Society of Clinical Oncology (ASCO)

Published

2007

Language

EN

Field

Medicine (Health Sciences)